HIV Infections
Conditions
Keywords
Antiretroviral agent, Maintenance, rilpivirine, dolutegravir, TMC278, Triumeq, non-nucleoside reverse transcriptase inhibitor, once monthly, every 4 weeks, once daily, GSK1265744, CAB, Tivicay, Long-Acting Intramuscular rilpivirine, lamivudine, integrase inhibitor, Long-Acting Intramuscular Cabotegravir, ART naïve, cabotegravir, abacavir
Brief summary
The First Long-Acting Injectable Regimen (FLAIR) study is being conducted to establish if human immunodeficiency virus type-1 (HIV-1) infected adult participants whose virus is virologically suppressed on an integrase inhibitor single tablet regimen (INI STR) will remain suppressed after switching to a two-drug intramuscular (IM) long-acting (LA) regimen of cabotegravir (CAB) and rilpivirine (RPV). In this study, the INI STR will be limited to abacavir/dolutegravir/lamivudine (ABC/DTG/3TC). FLAIR is a Phase 3, multi-phase, randomized, open label, active-controlled, multicenter, parallel-group, non-inferiority study in HIV-1, anti-retroviral therapy (ART)-naïve adult participants. This study is designed to demonstrate the non-inferior antiviral activity of switching to a two drug CAB LA 400 mg + RPV LA 600 mg regimen every 4 weeks (Q4W: monthly) compared to remaining on ABC/DTG/3TC over 48 weeks (4 weeks oral CAB + RPV, 44 weeks LA therapy). Participants who are HLA-B\*5701 positive at Screening may enroll into the study and receive DTG plus a non-abacavir containing dual nucleoside reverse transcriptase inhibitor (NRTI) regimen. Eligible participants will enroll into the Induction Phase of the study and receive ABC/DTG/3TC for 20 weeks (Week \[-20\] to Day 1). Participants who have an HIV 1 ribose nucleic acid (RNA) \<50 copies per milliliter (c/mL) at Week (-4) will be randomized (1:1) into the Maintenance Phase at Day 1 to either continue ABC/DTG/3TC or to discontinue ABC/DTG/3TC and begin oral therapy with CAB 30 mg + RPV 25 mg once daily for approximately 4 Weeks, followed by monthly CAB LA + RPV LA injections from visit Week 4b until study completion or withdrawal. Participants who successfully complete Week 100 (without meeting study defined withdrawal criteria and who remain virologically suppressed through Week 96: HIV-1 RNA \<50 c/mL) will be given the option to switch to the LA arm in the Extension Phase (using an optional oral lead-in with CAB + RPV) or be withdrawn from the study. Participants will continue to receive injections every 4 weeks during the Extension Phase until CAB LA and RPV LA are either locally approved and commercially available, the participant no longer derives clinical benefit, the participant meets a protocol-defined reason for discontinuation, or until development of either CAB LA or RPV LA is terminated.
Interventions
It is a white oval shaped film coated 30 mg tablets for oral administration. CAB Tablet is composed of cabotegravir sodium, lactose monohydrate, microcrystalline cellulose, hypromellose, sodium starch glycolate, magnesium stearate, and white film-coat.
It is a 25 mg tablet with off-white, round, biconvex, film-coated and debossed on one side with "TMC" and the other side with "25". Each tablet contains RPV hydrochloride, and the inactive ingredients croscarmellose sodium, lactose monohydrate, magnesium stearate, polysorbate 20, povidone K30 and silicified microcrystalline cellulose.
It is a sterile white to slightly pink suspension containing 200 mg/mL of CAB as free acid for administration by intramuscular (IM) injection. Each vial is for single-dose use containing a withdrawable volume of 2.0 mL, and does not require dilution prior to administration. CAB LA is composed of cabotegravir free acid, polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection.
It is a sterile white suspension containing 300 mg/mL of RPV as the free base. The route of administration is by intramuscular (IM) injection. Each vial contains a nominal fill of 2.0 mL, and does not require dilution prior to administration. RPV LA requires refrigeration and must be protected from light. RPV LA is composed of RPV free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection.
DRUGABC/DTG/3TC STR - Tablet
It is a purple, biconvex, oval, tablet debossed with "572 Tri" on one side, film-coated tablet contains abacavir sulphate equivalent to 600 mg of abacavir, dolutegravir sodium equivalent to 50 mg dolutegravir, and 300 mg of lamivudine. The inactive ABC/DTG/3TC tablet ingredients include D-mannitol, magnesium stearate, microcrystalline cellulose, povidone, and sodium starch glycolate.
DRUGDTG Tablet
It is a yellow, round, biconvex, 50 mg film-coated tablet debossed with "SV 572" on one side and "50" on the other side. Each tablet of DTG also contains the following inactive ingredients: D-mannitol, microcrystalline cellulose, povidone K29/32, sodium starch glycolate, and sodium stearyl fumarate.
Sponsors
ViiV Healthcare
Janssen Pharmaceuticals
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- HIV-1 infected, ART-naive men or women aged 18 years or greater at the time of signing the informed consent. - HIV-1 infection as documented by Screening plasma HIV-1 RNA \>=1000 c/mL; - Antiretroviral-naive (\<=10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection). Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary. - Female Participants: A female participant is eligible to participate if she is not pregnant at Screening and first day of Induction Phase (as confirmed by a negative serum human chorionic gonadotrophin \[hCG\] test), not lactating, and at least one of the following conditions applies: Non-reproductive potential defined as: Pre-menopausal females with one of the following: Documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion; Hysterectomy; Documented Bilateral Oophorectomy; Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment. Reproductive potential and agrees to follow one of the options listed in the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) from 30 days prior to the first dose of study medication, throughout the study, and for at least 30 days after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of CAB LA and RPV LA. The investigator is responsible for ensuring that participants understand how to properly use these methods of contraception. All participants in the study should be counseled on safer sexual practices including the use and benefit/risk of effective barrier methods (e.g., male condom) and on the risk of HIV transmission to an uninfected partner. - Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the consent form and in this protocol. - In France, a participant will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
- Women who are pregnant, breastfeeding, or plan to become pregnant or breastfeed during the study. - Any evidence at Screening of an active Centers for Disease and Prevention Control (CDC) Stage 3 disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy or historic or current cluster of differentiation4+ (CD4+) cell count \<200 cells/ cubic millimeter (mm\^3) are not exclusionary. - Participants with known moderate to severe hepatic impairment. - Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the participant's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the participant. - Participants determined by the Investigator to have a high risk of seizures, including participants with an unstable or poorly controlled seizure disorder. A participant with a prior history of seizure may be considered for enrolment if the Investigator believes the risk of seizure recurrence is low. All cases of prior seizure history should be discussed with the Medical Monitor prior to enrolment. - Participant who, in the investigator's judgment, poses a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. - The participant has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. - Evidence of Hepatitis B virus (HBV) infection based on the results of testing at Screening for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti HBc), Hepatitis B surface antibody (anti-HBs) and HBV dioxyribose nucleic acid (DNA) as follows: Participants positive for HBsAg are excluded; Participants negative for anti-HBs but positive for anti-HBc (negative HBsAg status) and positive for HBV DNA are excluded. Note: Participants positive for anti-HBc (negative HBsAg status) and positive for anti-HBs (past and/or current evidence) are immune to HBV and are not excluded. - Asymptomatic individuals with chronic hepatitis C virus (HCV) infection will not be excluded, however Investigators must carefully assess if therapy specific for HCV infection is required; participants who are anticipated to require HCV treatment prior to Week 48 of the Maintenance Phase must be excluded. HCV treatment on study may be permitted post Week 48, following consultation with the Medical Monitor. Participants with HCV co-infection will be allowed entry into Phase 3 studies if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, HCV is not advanced, and will not require treatment prior to the Week 48 visit. Additional information (where available) on participants with HCV co-infection at screening should include results from any liver biopsy, fibroscan, ultrasound, or other fibrosis evaluation, history of cirrhosis or other decompensated liver disease, prior treatment, and timing/plan for HCV treatment. In the event that recent biopsy or imaging data is not available or is inconclusive, the Fib-4 score will be used to verify eligibility. A Fib-4 score \> 3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation. Fibrosis 4 Score Formula: (Age x AST)/(Platelets x \[square root of ALT\]). - Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice), known biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones or otherwise stable chronic liver disease per investigator assessment). - History of liver cirrhosis with or without hepatitis viral co-infection. - Ongoing or clinically relevant pancreatitis. - All participants will be screened for syphilis (rapid plasma reagin \[RPR\]). Participants with untreated syphilis infection, defined as a positive RPR without clear documentation of treatment, are excluded. Participants with a positive RPR test who have not been treated may be rescreened at least 30 days after completion of antibiotic treatment for syphilis. - Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical, anal or penile intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the study Medical Monitor for inclusion of the participant prior to enrollment. - Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the participant unable to receive study medication. - History or presence of allergy or intolerance to the study drugs or their components or drugs of their class. In addition, if heparin is used during pharmacokinetic sampling (PK) sampling, participants with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. - Current or anticipated need for chronic anti-coagulation. - Alanine aminotransferase (ALT) \>=3 times upper limit normal (ULN). - Clinically significant cardiovascular disease, as defined by history/evidence of congestive heart failure, symptomatic arrhythmia, angina/ischemia, coronary artery bypass grafting (CABG) surgery or percutaneous transluminal coronary angioplasty (PTCA) or any clinically significant cardiac disease. - Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of investigational product (IP). - Treatment with any of the following agents within 28 days of Screening: radiation therapy; cytotoxic chemotherapeutic agents; tuberculosis (TB) therapy, with the exception of treatment of latent TB with isoniazid; Immunomodulators that alter immune responses (such as chronic systemic corticosteroids, interleukins, or interferons). Note: Participants using short-term (e.g. =\<21 day) systemic corticosteroid treatment, topical, inhaled or intranasal corticosteroids are eligible for enrollment. - Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. - Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP. - Use of medications which are associated with Torsades de Pointes - Any evidence of primary resistance to non-nuclease reverse transcriptase inhibitors (NNRTIs) (except for K103N which is allowed), or any known resistance to INIs from historical resistance test results. Note: re-tests of Screening genotypes are allowed only at the discretion of the study virologist. - Participants who are HLA-B\*5701 positive and are unable to use an nuclease reverse transcriptase inhibitors (NRTI) backbone that does not contain abacavir (participants who are HLA-B\*5701 positive may be enrolled if they use a NRTI backbone that does not contain abacavir; HLA-B\*5701 positive participants may be excluded from the study if local provision of an alternate NRTI backbone is not possible). - Any verified Grade 4 laboratory abnormality. A single repeat test is allowed during the Screening Phase to verify a result. - Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the participant's participation in the study of an investigational compound. - Participant has estimated creatinine clearance \<50 mL/min/1.73m\^2 via the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation. - Participants who are currently participating in or anticipate to be selected for any other interventional study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48 | Week 48 | Percentage of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48 | Week 48 | Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA \<50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders. |
| Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48 | Week 48 | Percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC |
| Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase | Week 48 | The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL. |
| Absolute Values for Plasma HIV-1 RNA at Week 48 | Week 48 | Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. |
| Change From Baseline Values for Plasma HIV-1 RNA at Week 48 | Baseline (Day 1) and at Week 48 | Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline. |
| Absolute Values for CD4+ Lymphocyte Count at Week 48 | Week 48 | Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC |
| Change From Baseline Values for CD4+ Lymphocyte Count at Week 48 | Baseline (Day 1) and Week 48 | Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value. |
| Number of Participants With Disease Progression | Day 1 up to an average of 59 weeks | Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria). |
| Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Day 1 up to an average of 59 Weeks | An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in \>=5% of participants within any arm is reported |
| Number of Participants With Severity of Adverse Events | Up to Week 48 | Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm. |
| Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points. |
| Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. |
| Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. |
| Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. |
| Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints. |
| Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI). |
| Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Baseline (Day 1) and at Week 48 | Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. |
| Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented. |
| Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). |
| Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Erythrocytes | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Hematocrit | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline for Hematology Parameters: Hemoglobin | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Baseline (Day 1) and at Week 48 | Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value. |
| Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48 | Baseline (Day 1) and at Week 48 | Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density. |
| Change From Baseline Values in Urine pH Over Time Including Week 48 | Baseline (Day 1) and at Weeks 4, 24 and 48 | Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48 | Up to Week 48 | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented. |
| Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Baseline (Day 1) and at Week 48 | Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100. |
| Number of Participants With Phenotypic Resistance Through Week 48 | Week 48 | Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC\>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and \> clinical lower cutoff),sensitive(FC\<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria |
| Number of Participants With Genotypic Resistance Through Week 48 | Week 48 | Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented. |
| Area Under the Curve (AUC) for CAB LA | Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48 | AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data. |
| AUC for RPV LA | Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48 | AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA |
| Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected at indicated time points for PK analysis of CAB LA. |
| Ctrough for RPV LA Evaluable | Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48 | Blood samples were collected at indicated time points for PK analysis of RPV LA. |
| Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41 | Week 41- 1 Week post dose | Blood samples will be collected at indicated time points for PK analysis of CAB LA. |
| Cmax in Plasma for RPV LA Evaluable at Week 41 | Week 41- 1 Week post dose | Blood samples will be collected at indicated time points for PK analysis of RPV LA. |
| Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Weeks 5 and at Weeks 41 and 48 | PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis |
| Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Weeks 5, 41 and 48 | PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis. |
| Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm | Weeks 4b, 5, 40 and 41 | The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF. |
| Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | Baseline (Day 1) and at Weeks 24 and 48 | The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:\[100 divided by (20 minus 4)\]\*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
| Change From Baseline in HIV Medication, MEDWO Using HATQoL | Baseline and at Weeks 24 and 48 | The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
| Change From Baseline in DISWO Using HATQoL | Baseline and at Weeks 24 and 48 | The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
| Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | Baseline and at Weeks 24 and 48 | The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
| Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Baseline and at Weeks 4b, 24 and 44 | HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented. |
| Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48 | Week 48 | HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
| Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Baseline and at Weeks 4b, 24 and 44 | HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. |
| Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Baseline and at Weeks 8, 24 and 48 | ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100\*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. |
Countries
Japan, Russia, South Africa, Spain, United Kingdom, United States
Contacts
STUDY_DIRECTORGSK Clinical Trials
ViiV Healthcare
Participant flow
Recruitment details
This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection
Pre-assignment details
A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis
Participants by arm
| Arm | Count |
|---|---|
| CAB LA + RPV LA (Q4W) Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period. | 283 |
| ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA | 283 |
| Total | 566 |
Baseline characteristics
| Characteristic | Total | ABC/ DTG/ 3TC | CAB LA + RPV LA (Q4W) |
|---|---|---|---|
| Age, Continuous | 35.9 Years STANDARD_DEVIATION 9.99 | 36.0 Years STANDARD_DEVIATION 9.82 | 35.9 Years STANDARD_DEVIATION 10.17 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 9 Participants | 6 Participants | 3 Participants |
| Race/Ethnicity, Customized Asian-Central/South Asian Heritage | 3 Participants | 1 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian-East Asian Heritage | 3 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Japanese Heritage | 20 Participants | 12 Participants | 8 Participants |
| Race/Ethnicity, Customized Asian-South East Asian Heritage | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 103 Participants | 56 Participants | 47 Participants |
| Race/Ethnicity, Customized Missing | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized Multiple | 7 Participants | 3 Participants | 4 Participants |
| Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized White-Arabic/North African Heritage | 8 Participants | 3 Participants | 5 Participants |
| Race/Ethnicity, Customized White-White /Caucasian/European Heritage | 409 Participants | 198 Participants | 211 Participants |
| Sex: Female, Male Female | 127 Participants | 64 Participants | 63 Participants |
| Sex: Female, Male Male | 439 Participants | 219 Participants | 220 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 283 | 0 / 283 |
| other Total, other adverse events | 252 / 283 | 138 / 283 |
| serious Total, serious adverse events | 18 / 283 | 12 / 283 |
Outcome results
Primary
Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48
Percentage of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event).
Time frame: Week 48
Population: Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the Maintenance Phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48 | 2.1 Percentage of Participants |
| ABC/ DTG/ 3TC | Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48 | 2.5 Percentage of Participants |
95% CI: [-2.8, 2.1]
Secondary
Absolute Values for CD4+ Lymphocyte Count at Week 48
Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC
Time frame: Week 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for CD4+ Lymphocyte Count at Week 48 | 703.2 Cells per cubic millimeter | Standard Deviation 285.75 |
| ABC/ DTG/ 3TC | Absolute Values for CD4+ Lymphocyte Count at Week 48 | 731.2 Cells per cubic millimeter | Standard Deviation 272.49 |
Secondary
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 8, n=212, 278 | 43.5 Grams per liter | Standard Deviation 2.85 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 28, n=253, 268 | 44.4 Grams per liter | Standard Deviation 3.09 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 16, n=255, 269 | 44.1 Grams per liter | Standard Deviation 2.99 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 32, n=255, 268 | 44.6 Grams per liter | Standard Deviation 3.17 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 4, n=280, 277 | 43.7 Grams per liter | Standard Deviation 3.03 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 36, n=254, 261 | 44.1 Grams per liter | Standard Deviation 3.05 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 20, n=260, 272 | 44.1 Grams per liter | Standard Deviation 3.11 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 40, n=250, 266 | 44.8 Grams per liter | Standard Deviation 3.02 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 12, n=270, 276 | 43.7 Grams per liter | Standard Deviation 3.06 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 44, n=258, 263 | 44.7 Grams per liter | Standard Deviation 2.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 24, n=261, 268 | 44.3 Grams per liter | Standard Deviation 3.08 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 48, n=247, 262 | 44.6 Grams per liter | Standard Deviation 2.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Baseline (Day 1), n=283, 283 | 43.8 Grams per liter | Standard Deviation 3.04 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 48, n=247, 262 | 44.6 Grams per liter | Standard Deviation 2.86 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Baseline (Day 1), n=283, 283 | 44.1 Grams per liter | Standard Deviation 2.8 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 4, n=280, 277 | 43.8 Grams per liter | Standard Deviation 2.7 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 8, n=212, 278 | 43.9 Grams per liter | Standard Deviation 2.76 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 12, n=270, 276 | 44.1 Grams per liter | Standard Deviation 2.87 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 16, n=255, 269 | 44.0 Grams per liter | Standard Deviation 2.78 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 20, n=260, 272 | 43.9 Grams per liter | Standard Deviation 2.72 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 24, n=261, 268 | 44.2 Grams per liter | Standard Deviation 2.6 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 28, n=253, 268 | 44.5 Grams per liter | Standard Deviation 2.66 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 32, n=255, 268 | 44.4 Grams per liter | Standard Deviation 2.76 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 36, n=254, 261 | 44.3 Grams per liter | Standard Deviation 2.63 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 40, n=250, 266 | 44.5 Grams per liter | Standard Deviation 2.76 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 44, n=258, 263 | 44.4 Grams per liter | Standard Deviation 2.71 |
Secondary
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance.
Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 40, n=250, 266 | 104.3 mL/min/1.73/m^2 | Standard Deviation 16.47 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 20, n=261, 271 | 105.5 mL/min/1.73/m^2 | Standard Deviation 15.19 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 8, n=211, 278 | 104.9 mL/min/1.73/m^2 | Standard Deviation 15.64 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 24, n=261, 268 | 105.1 mL/min/1.73/m^2 | Standard Deviation 16.05 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 28, n=253, 268 | 105.3 mL/min/1.73/m^2 | Standard Deviation 16.18 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 32, n=254, 268 | 105.1 mL/min/1.73/m^2 | Standard Deviation 16.1 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 12, n=270, 276 | 104.8 mL/min/1.73/m^2 | Standard Deviation 16.08 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 36, n=254, 262 | 104.7 mL/min/1.73/m^2 | Standard Deviation 15.88 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 4, n=278, 277 | 101.2 mL/min/1.73/m^2 | Standard Deviation 16.56 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 44, n=258, 263 | 104.4 mL/min/1.73/m^2 | Standard Deviation 16.73 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 16, n=254, 269 | 104.2 mL/min/1.73/m^2 | Standard Deviation 15.03 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 48, n=247, 261 | 103.6 mL/min/1.73/m^2 | Standard Deviation 16.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Baseline (Day 1), n=283, 283 | 94.3 mL/min/1.73/m^2 | Standard Deviation 17.61 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 48, n=247, 261 | 96.9 mL/min/1.73/m^2 | Standard Deviation 18.21 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Baseline (Day 1), n=283, 283 | 97.9 mL/min/1.73/m^2 | Standard Deviation 17.7 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 28, n=253, 268 | 98.8 mL/min/1.73/m^2 | Standard Deviation 17.4 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 40, n=250, 266 | 98.3 mL/min/1.73/m^2 | Standard Deviation 17.25 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 4, n=278, 277 | 96.5 mL/min/1.73/m^2 | Standard Deviation 17.14 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 8, n=211, 278 | 98.1 mL/min/1.73/m^2 | Standard Deviation 17.46 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 12, n=270, 276 | 98.6 mL/min/1.73/m^2 | Standard Deviation 17.77 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 16, n=254, 269 | 97.6 mL/min/1.73/m^2 | Standard Deviation 16.84 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 20, n=261, 271 | 98.0 mL/min/1.73/m^2 | Standard Deviation 17.67 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 24, n=261, 268 | 97.9 mL/min/1.73/m^2 | Standard Deviation 17.33 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 32, n=254, 268 | 98.8 mL/min/1.73/m^2 | Standard Deviation 17.39 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 36, n=254, 262 | 98.0 mL/min/1.73/m^2 | Standard Deviation 16.6 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. | Week 44, n=258, 263 | 98.9 mL/min/1.73/m^2 | Standard Deviation 16.67 |
Secondary
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 16, n=254, 269 | 30.8 Units per liter | Standard Deviation 22.39 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 20, n=260, 270 | 31.3 Units per liter | Standard Deviation 23.46 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 28, n=253, 268 | 30.3 Units per liter | Standard Deviation 18.71 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 4, n=278, 276 | 31.7 Units per liter | Standard Deviation 27.17 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 32, n=254, 268 | 33.5 Units per liter | Standard Deviation 35.38 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 24, n=260, 268 | 31.3 Units per liter | Standard Deviation 22.6 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 8, n=211, 278 | 31.5 Units per liter | Standard Deviation 21.15 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 40, n=250, 266 | 32.6 Units per liter | Standard Deviation 27.07 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 36, n=254, 261 | 31.5 Units per liter | Standard Deviation 20.49 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 44, n=258, 263 | 36.3 Units per liter | Standard Deviation 45.04 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 12, n=270, 276 | 31.4 Units per liter | Standard Deviation 23.94 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 48, n=247, 261 | 30.1 Units per liter | Standard Deviation 20.31 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Baseline (Day 1), n=283, 283 | 31.0 Units per liter | Standard Deviation 21.04 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 48, n=247, 261 | 32.6 Units per liter | Standard Deviation 28.96 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 20, n=260, 270 | 31.9 Units per liter | Standard Deviation 19.13 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Baseline (Day 1), n=283, 283 | 30.9 Units per liter | Standard Deviation 28.89 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 4, n=278, 276 | 32.6 Units per liter | Standard Deviation 24.73 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 8, n=211, 278 | 31.3 Units per liter | Standard Deviation 19.96 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 12, n=270, 276 | 33.6 Units per liter | Standard Deviation 23.37 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 24, n=260, 268 | 32.2 Units per liter | Standard Deviation 21.08 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 28, n=253, 268 | 33.0 Units per liter | Standard Deviation 22.56 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 32, n=254, 268 | 33.2 Units per liter | Standard Deviation 32.95 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 36, n=254, 261 | 31.2 Units per liter | Standard Deviation 20.03 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 40, n=250, 266 | 32.1 Units per liter | Standard Deviation 22.19 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 44, n=258, 263 | 33.0 Units per liter | Standard Deviation 24.09 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 16, n=254, 269 | 32.1 Units per liter | Standard Deviation 18.99 |
Secondary
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 4, n=281, 277 | 66.2 International units per liter | Standard Deviation 19.56 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Baseline (Day 1), n=283, 283 | 197.8 International units per liter | Standard Deviation 291.21 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 8, n=212, 278 | 66.8 International units per liter | Standard Deviation 18.82 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 8, n=212, 278 | 20.8 International units per liter | Standard Deviation 17.43 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 12, n=270, 276 | 66.8 International units per liter | Standard Deviation 19.8 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 40, n=250, 266 | 23.1 International units per liter | Standard Deviation 12.22 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 16, n=255, 269 | 66.7 International units per liter | Standard Deviation 19.96 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 12, n=270, 276 | 21.4 International units per liter | Standard Deviation 16.94 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 20, n=260, 272 | 67.6 International units per liter | Standard Deviation 19.11 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 4, n=280, 277 | 230.2 International units per liter | Standard Deviation 447.94 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 24, n=261, 268 | 67.1 International units per liter | Standard Deviation 19.68 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 16, n=255, 269 | 21.6 International units per liter | Standard Deviation 17.61 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 28, n=253, 268 | 67.4 International units per liter | Standard Deviation 20.05 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 28, n=253, 268 | 24.8 International units per liter | Standard Deviation 16.5 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 32, n=256, 268 | 68.0 International units per liter | Standard Deviation 22.17 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 20, n=260, 272 | 25.8 International units per liter | Standard Deviation 72.51 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 36, n=255, 261 | 69.5 International units per liter | Standard Deviation 26.86 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 8, n=212, 278 | 258.0 International units per liter | Standard Deviation 928.82 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 40, n=250, 266 | 67.4 International units per liter | Standard Deviation 18.94 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 24, n=261, 268 | 23.9 International units per liter | Standard Deviation 31.14 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 44, n=258, 263 | 67.7 International units per liter | Standard Deviation 18.59 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 44, n=258, 263 | 24.4 International units per liter | Standard Deviation 15.66 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 48, n=247, 262 | 66.4 International units per liter | Standard Deviation 17.95 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 28, n=253, 268 | 22.5 International units per liter | Standard Deviation 19.78 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Baseline (Day 1), n=283, 283 | 28.8 International units per liter | Standard Deviation 90.66 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 12, n=270, 276 | 201.8 International units per liter | Standard Deviation 348.13 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 4, n=281, 277 | 25.1 International units per liter | Standard Deviation 32.67 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 32, n=256, 268 | 38.5 International units per liter | Standard Deviation 293.55 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 8, n=212, 278 | 23.6 International units per liter | Standard Deviation 20.85 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 36, n=255, 261 | 23.0 International units per liter | Standard Deviation 12.44 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 12, n=270, 276 | 22.8 International units per liter | Standard Deviation 10.38 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 36, n=255, 261 | 20.3 International units per liter | Standard Deviation 13.92 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 16, n=255, 269 | 23.0 International units per liter | Standard Deviation 10.71 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 16, n=255, 269 | 179.7 International units per liter | Standard Deviation 248.71 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 20, n=260, 272 | 25.3 International units per liter | Standard Deviation 32.64 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 40, n=250, 266 | 20.9 International units per liter | Standard Deviation 17.32 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 20, n=260, 272 | 215.7 International units per liter | Standard Deviation 539.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST Week 48, n=247, 262 | 22.3 International units per liter | Standard Deviation 10.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 24, n=261, 268 | 248.6 International units per liter | Standard Deviation 628.44 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 44, n=258, 263 | 22.2 International units per liter | Standard Deviation 27.14 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 28, n=253, 268 | 252.7 International units per liter | Standard Deviation 673.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Baseline (Day 1), n=283, 283 | 28.7 International units per liter | Standard Deviation 125.27 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 32, n=256, 268 | 175.8 International units per liter | Standard Deviation 223.16 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 48, n=247, 262 | 20.1 International units per liter | Standard Deviation 21.78 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 36, n=254, 261 | 219.0 International units per liter | Standard Deviation 507.3 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 32, n=256, 268 | 37.1 International units per liter | Standard Deviation 233.23 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 40, n=250, 266 | 220.5 International units per liter | Standard Deviation 507.68 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Baseline (Day 1), n=283, 283 | 66.5 International units per liter | Standard Deviation 22.06 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 44, n=258, 263 | 254.0 International units per liter | Standard Deviation 477.19 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 4, n=281, 277 | 25.1 International units per liter | Standard Deviation 64.74 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 48, n=247, 262 | 185.5 International units per liter | Standard Deviation 227.54 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 24, n=261, 268 | 25.9 International units per liter | Standard Deviation 25.16 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 48, n=247, 262 | 323.6 International units per liter | Standard Deviation 2637.27 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 24, n=261, 268 | 21.2 International units per liter | Standard Deviation 9.73 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 28, n=253, 268 | 21.7 International units per liter | Standard Deviation 10.61 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 32, n=256, 268 | 20.7 International units per liter | Standard Deviation 6.42 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 36, n=255, 261 | 22.4 International units per liter | Standard Deviation 17.37 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 40, n=250, 266 | 21.0 International units per liter | Standard Deviation 6.51 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 44, n=258, 263 | 21.9 International units per liter | Standard Deviation 13.25 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST Week 48, n=247, 262 | 23.5 International units per liter | Standard Deviation 42.49 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Baseline (Day 1), n=283, 283 | 199.8 International units per liter | Standard Deviation 482.84 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 4, n=280, 277 | 173.0 International units per liter | Standard Deviation 220.54 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 8, n=212, 278 | 152.9 International units per liter | Standard Deviation 146.05 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 12, n=270, 276 | 182.6 International units per liter | Standard Deviation 387.61 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 16, n=255, 269 | 234.0 International units per liter | Standard Deviation 576.62 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Baseline (Day 1), n=283, 283 | 19.5 International units per liter | Standard Deviation 14.76 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 4, n=281, 277 | 17.9 International units per liter | Standard Deviation 11.1 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 8, n=212, 278 | 18.4 International units per liter | Standard Deviation 11.34 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 12, n=270, 276 | 19.2 International units per liter | Standard Deviation 11.29 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 16, n=255, 269 | 20.3 International units per liter | Standard Deviation 13.34 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 20, n=260, 272 | 19.6 International units per liter | Standard Deviation 15.78 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 24, n=261, 268 | 19.1 International units per liter | Standard Deviation 11.91 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 28, n=253, 268 | 19.6 International units per liter | Standard Deviation 10.73 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 32, n=256, 268 | 19.0 International units per liter | Standard Deviation 11.56 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 36, n=255, 261 | 21.2 International units per liter | Standard Deviation 31.68 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 40, n=250, 266 | 19.5 International units per liter | Standard Deviation 12.35 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 44, n=258, 263 | 19.8 International units per liter | Standard Deviation 17.43 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALT, Week 48, n=247, 262 | 19.7 International units per liter | Standard Deviation 16.58 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Baseline (Day 1), n=283, 283 | 67.1 International units per liter | Standard Deviation 22.98 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 4, n=281, 277 | 65.5 International units per liter | Standard Deviation 17.07 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 8, n=212, 278 | 66.3 International units per liter | Standard Deviation 17.49 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 12, n=270, 276 | 66.1 International units per liter | Standard Deviation 17.23 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 16, n=255, 269 | 66.1 International units per liter | Standard Deviation 17.89 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 20, n=260, 272 | 65.6 International units per liter | Standard Deviation 16.71 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 24, n=261, 268 | 66.1 International units per liter | Standard Deviation 17.96 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 28, n=253, 268 | 67.5 International units per liter | Standard Deviation 18.07 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 32, n=256, 268 | 66.6 International units per liter | Standard Deviation 17.65 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 36, n=255, 261 | 68.3 International units per liter | Standard Deviation 20.19 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 40, n=250, 266 | 67.7 International units per liter | Standard Deviation 18.3 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 44, n=258, 263 | 68.2 International units per liter | Standard Deviation 18.62 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | ALP, Week 48, n=247, 262 | 67.7 International units per liter | Standard Deviation 18.15 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Baseline (Day 1), n=283, 283 | 22.5 International units per liter | Standard Deviation 14.8 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 4, n=281, 277 | 20.9 International units per liter | Standard Deviation 8.47 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 8, n=212, 278 | 20.5 International units per liter | Standard Deviation 6.26 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 12, n=270, 276 | 21.0 International units per liter | Standard Deviation 8.14 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 16, n=255, 269 | 22.8 International units per liter | Standard Deviation 14.03 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | AST, Week 20, n=260, 272 | 22.7 International units per liter | Standard Deviation 23.48 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 20, n=260, 272 | 258.9 International units per liter | Standard Deviation 1109.04 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 24, n=261, 268 | 183.1 International units per liter | Standard Deviation 368.02 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 28, n=253, 268 | 194.5 International units per liter | Standard Deviation 506.24 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 32, n=256, 268 | 160.0 International units per liter | Standard Deviation 176.09 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 36, n=254, 261 | 215.2 International units per liter | Standard Deviation 460.38 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 40, n=250, 266 | 149.5 International units per liter | Standard Deviation 115.14 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) | CK, Week 44, n=258, 263 | 181.9 International units per liter | Standard Deviation 428.28 |
Secondary
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 28, n=253, 268 | 10.4 Micromoles per liter | Standard Deviation 5.67 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 44, n=258, 263 | 2.4 Micromoles per liter | Standard Deviation 1.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 16, n=254, 268 | 2.4 Micromoles per liter | Standard Deviation 1.46 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 20, n=260, 272 | 2.4 Micromoles per liter | Standard Deviation 1.54 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 24, n=260, 266 | 2.3 Micromoles per liter | Standard Deviation 1.2 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 28, n=253, 268 | 2.5 Micromoles per liter | Standard Deviation 1.29 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Baseline (Day 1), n=283, 283 | 9.3 Micromoles per liter | Standard Deviation 5.12 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 4, n=281, 277 | 10.7 Micromoles per liter | Standard Deviation 6.37 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 8, n=212, 278 | 10.1 Micromoles per liter | Standard Deviation 4.62 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 12, n=270, 276 | 10.5 Micromoles per liter | Standard Deviation 5.45 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 16, n=255, 269 | 10.6 Micromoles per liter | Standard Deviation 5.49 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 20, n=260, 272 | 10.3 Micromoles per liter | Standard Deviation 5.29 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 24, n=261, 268 | 10.0 Micromoles per liter | Standard Deviation 5.09 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 32, n=256, 268 | 2.5 Micromoles per liter | Standard Deviation 3.48 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 36, n=255, 260 | 2.4 Micromoles per liter | Standard Deviation 2.24 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 40, n=249, 266 | 2.3 Micromoles per liter | Standard Deviation 1.29 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 48, n=247, 262 | 2.3 Micromoles per liter | Standard Deviation 1.26 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Baseline (Day 1), n=283, 283 | 89.00 Micromoles per liter | Standard Deviation 16.061 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 4, n=280, 277 | 82.99 Micromoles per liter | Standard Deviation 15.599 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 8, n=212, 278 | 79.50 Micromoles per liter | Standard Deviation 14.103 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 12, n=270, 276 | 79.25 Micromoles per liter | Standard Deviation 14.433 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 16, n=255, 269 | 79.58 Micromoles per liter | Standard Deviation 14.509 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 20, n=261, 272 | 78.50 Micromoles per liter | Standard Deviation 13.966 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 24, n=262, 268 | 79.10 Micromoles per liter | Standard Deviation 15.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 28, n=253, 268 | 78.79 Micromoles per liter | Standard Deviation 14.741 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 32, n=255, 268 | 78.89 Micromoles per liter | Standard Deviation 14.558 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 36, n=254, 262 | 79.58 Micromoles per liter | Standard Deviation 14.973 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 40, n=250, 266 | 79.50 Micromoles per liter | Standard Deviation 15.615 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 44, n=258, 263 | 80.04 Micromoles per liter | Standard Deviation 15.401 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 48, n=247, 262 | 79.95 Micromoles per liter | Standard Deviation 15.613 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 32, n=256, 268 | 10.5 Micromoles per liter | Standard Deviation 7.86 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 36, n=255, 260 | 9.9 Micromoles per liter | Standard Deviation 6.35 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 40, n=250, 266 | 10.2 Micromoles per liter | Standard Deviation 5.26 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 44, n=258, 263 | 10.3 Micromoles per liter | Standard Deviation 5.15 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 48, n=247, 262 | 10.3 Micromoles per liter | Standard Deviation 5.23 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Baseline (Day 1), n=283, 283 | 2.3 Micromoles per liter | Standard Deviation 1.32 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 4, n=277, 277 | 2.4 Micromoles per liter | Standard Deviation 1.47 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 8, n=212, 278 | 2.4 Micromoles per liter | Standard Deviation 1.17 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 12, n=269, 273 | 2.5 Micromoles per liter | Standard Deviation 1.26 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 48, n=247, 262 | 8.9 Micromoles per liter | Standard Deviation 3.71 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 40, n=249, 266 | 2.1 Micromoles per liter | Standard Deviation 0.98 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 12, n=270, 276 | 84.63 Micromoles per liter | Standard Deviation 15.155 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 44, n=258, 263 | 2.1 Micromoles per liter | Standard Deviation 0.95 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 36, n=254, 262 | 84.75 Micromoles per liter | Standard Deviation 14.352 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 28, n=253, 268 | 8.6 Micromoles per liter | Standard Deviation 3.9 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 16, n=254, 268 | 2.1 Micromoles per liter | Standard Deviation 0.95 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 16, n=255, 269 | 85.18 Micromoles per liter | Standard Deviation 14.997 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 20, n=260, 272 | 2.1 Micromoles per liter | Standard Deviation 0.9 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 32, n=256, 268 | 8.7 Micromoles per liter | Standard Deviation 3.95 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 24, n=260, 266 | 2.1 Micromoles per liter | Standard Deviation 0.96 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 20, n=261, 272 | 85.02 Micromoles per liter | Standard Deviation 15.488 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 12, n=269, 273 | 2.1 Micromoles per liter | Standard Deviation 0.91 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Baseline (Day 1), n=283, 283 | 9.4 Micromoles per liter | Standard Deviation 4.68 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 24, n=262, 268 | 85.05 Micromoles per liter | Standard Deviation 14.69 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 4, n=281, 277 | 8.9 Micromoles per liter | Standard Deviation 4.4 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 36, n=255, 260 | 8.5 Micromoles per liter | Standard Deviation 3.42 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 8, n=212, 278 | 8.8 Micromoles per liter | Standard Deviation 3.85 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 28, n=253, 268 | 84.38 Micromoles per liter | Standard Deviation 15.023 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 12, n=270, 276 | 8.6 Micromoles per liter | Standard Deviation 3.53 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Baseline (Day 1), n=283, 283 | 2.2 Micromoles per liter | Standard Deviation 1.09 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 16, n=255, 269 | 8.7 Micromoles per liter | Standard Deviation 3.74 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 32, n=255, 268 | 84.50 Micromoles per liter | Standard Deviation 15.047 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 20, n=260, 272 | 8.5 Micromoles per liter | Standard Deviation 3.4 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 40, n=250, 266 | 8.5 Micromoles per liter | Standard Deviation 3.52 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 28, n=253, 268 | 2.1 Micromoles per liter | Standard Deviation 0.94 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 8, n=212, 278 | 2.1 Micromoles per liter | Standard Deviation 0.93 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 32, n=256, 268 | 2.1 Micromoles per liter | Standard Deviation 0.94 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 40, n=250, 266 | 84.70 Micromoles per liter | Standard Deviation 14.808 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 36, n=255, 260 | 2.0 Micromoles per liter | Standard Deviation 0.89 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 44, n=258, 263 | 8.8 Micromoles per liter | Standard Deviation 3.78 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 44, n=258, 263 | 83.90 Micromoles per liter | Standard Deviation 14.604 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 48, n=247, 262 | 2.2 Micromoles per liter | Standard Deviation 1 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 4, n=277, 277 | 2.1 Micromoles per liter | Standard Deviation 1.08 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Baseline (Day 1), n=283, 283 | 85.80 Micromoles per liter | Standard Deviation 15.66 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 48, n=247, 262 | 90.88 Micromoles per liter | Standard Deviation 87.655 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 4, n=280, 277 | 86.43 Micromoles per liter | Standard Deviation 14.655 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 24, n=261, 268 | 8.9 Micromoles per liter | Standard Deviation 3.86 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 8, n=212, 278 | 85.50 Micromoles per liter | Standard Deviation 15.925 |
Secondary
Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48
Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 8, n=212, 278 | 1.096 Millimoles per liter | Standard Deviation 0.1742 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 44, n=257, 263 | 22.9 Millimoles per liter | Standard Deviation 2.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 28, n=253, 268 | 4.20 Millimoles per liter | Standard Deviation 0.298 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 48, n=247, 262 | 22.5 Millimoles per liter | Standard Deviation 2.18 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 16, n=255, 269 | 139.4 Millimoles per liter | Standard Deviation 1.76 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Baseline (Day 1), n=283, 283 | 104.6 Millimoles per liter | Standard Deviation 2.32 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 40, n=250, 266 | 4.19 Millimoles per liter | Standard Deviation 0.301 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 4, n=280, 277 | 104.6 Millimoles per liter | Standard Deviation 2.22 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 8, n=212, 278 | 104.7 Millimoles per liter | Standard Deviation 1.96 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Baseline (Day 1), n=283, 283 | 22.4 Millimoles per liter | Standard Deviation 2.24 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 12, n=270, 276 | 104.6 Millimoles per liter | Standard Deviation 2.16 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Baseline (Day 1), n=283, 283 | 4.12 Millimoles per liter | Standard Deviation 0.301 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 16, n=255, 269 | 104.4 Millimoles per liter | Standard Deviation 2.31 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 44, n=258, 263 | 4.21 Millimoles per liter | Standard Deviation 0.302 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 36, n=254, 261 | 139.3 Millimoles per liter | Standard Deviation 1.87 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 24, n=261, 268 | 104.4 Millimoles per liter | Standard Deviation 2.33 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 28, n=253, 268 | 104.5 Millimoles per liter | Standard Deviation 2.2 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 48, n=247, 262 | 4.13 Millimoles per liter | Standard Deviation 0.288 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 32, n=255, 268 | 104.4 Millimoles per liter | Standard Deviation 2.46 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 20, n=260, 272 | 104.3 Millimoles per liter | Standard Deviation 2.28 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 36, n=254, 261 | 104.4 Millimoles per liter | Standard Deviation 2.42 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Baseline (Day 1), n=283, 283 | 139.2 Millimoles per liter | Standard Deviation 1.89 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 40, n=250, 266 | 104.8 Millimoles per liter | Standard Deviation 2.55 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 4, n=280, 276 | 23.0 Millimoles per liter | Standard Deviation 2.29 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 44, n=258, 263 | 104.7 Millimoles per liter | Standard Deviation 2.19 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 40, n=250, 266 | 139.3 Millimoles per liter | Standard Deviation 2.04 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 48, n=247, 262 | 104.7 Millimoles per liter | Standard Deviation 2.21 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 8, n=212, 278 | 22.8 Millimoles per liter | Standard Deviation 2.07 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Baseline (Day 1), n=283, 283 | 5.21 Millimoles per liter | Standard Deviation 1.632 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 4, n=280, 277 | 4.27 Millimoles per liter | Standard Deviation 0.308 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 4, n=236, 230 | 5.27 Millimoles per liter | Standard Deviation 1.322 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 12, n=270, 276 | 22.6 Millimoles per liter | Standard Deviation 2.5 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 8, n=172, 227 | 5.31 Millimoles per liter | Standard Deviation 1.347 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 4, n=280, 277 | 139.5 Millimoles per liter | Standard Deviation 1.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 12, n=229, 216 | 5.26 Millimoles per liter | Standard Deviation 0.911 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 8, n=212, 278 | 5.32 Millimoles per liter | Standard Deviation 1.485 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 16, n=204, 213 | 5.36 Millimoles per liter | Standard Deviation 1.804 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 8, n=212, 278 | 139.4 Millimoles per liter | Standard Deviation 1.78 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 20, n=209, 218 | 5.32 Millimoles per liter | Standard Deviation 0.735 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 32, n=255, 268 | 4.21 Millimoles per liter | Standard Deviation 0.295 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 24, n=221, 214 | 5.35 Millimoles per liter | Standard Deviation 1.219 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 20, n=260, 272 | 139.4 Millimoles per liter | Standard Deviation 1.75 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 28, n=207, 211 | 5.35 Millimoles per liter | Standard Deviation 1.633 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 48, n=247, 262 | 5.37 Millimoles per liter | Standard Deviation 1.402 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 32, n=201, 213 | 5.44 Millimoles per liter | Standard Deviation 1.355 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 24, n=261, 268 | 139.3 Millimoles per liter | Standard Deviation 1.82 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 36, n=199, 204 | 5.35 Millimoles per liter | Standard Deviation 0.797 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 12, n=270, 276 | 1.097 Millimoles per liter | Standard Deviation 0.1802 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 40, n=203, 202 | 5.44 Millimoles per liter | Standard Deviation 1.319 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 28, n=253, 268 | 139.4 Millimoles per liter | Standard Deviation 1.8 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 44, n=208, 202 | 5.34 Millimoles per liter | Standard Deviation 0.991 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 36, n=254, 261 | 4.21 Millimoles per liter | Standard Deviation 0.314 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 48, n=248, 251 | 5.22 Millimoles per liter | Standard Deviation 0.895 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 4, n=279, 277 | 1.137 Millimoles per liter | Standard Deviation 0.1774 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 32, n=255, 268 | 139.4 Millimoles per liter | Standard Deviation 1.83 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 16, n=255, 269 | 1.104 Millimoles per liter | Standard Deviation 0.1806 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 8, n=212, 278 | 4.22 Millimoles per liter | Standard Deviation 0.302 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 20, n=260, 272 | 1.078 Millimoles per liter | Standard Deviation 0.1843 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Baseline (Day 1), n=283, 283 | 1.103 Millimoles per liter | Standard Deviation 0.1747 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 24, n=261, 268 | 1.106 Millimoles per liter | Standard Deviation 0.1797 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 16, n=255, 269 | 22.9 Millimoles per liter | Standard Deviation 2.4 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 28, n=253, 268 | 1.094 Millimoles per liter | Standard Deviation 0.1814 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 32, n=255, 268 | 1.105 Millimoles per liter | Standard Deviation 0.1769 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 12, n=270, 276 | 4.21 Millimoles per liter | Standard Deviation 0.305 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 36, n=254, 261 | 1.102 Millimoles per liter | Standard Deviation 0.1862 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 20, n=260, 272 | 22.8 Millimoles per liter | Standard Deviation 2.3 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 40, n=250, 266 | 1.093 Millimoles per liter | Standard Deviation 0.1699 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 44, n=258, 263 | 1.096 Millimoles per liter | Standard Deviation 0.1851 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 24, n=261, 268 | 23.0 Millimoles per liter | Standard Deviation 2.71 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Baseline (Day 1), n=283, 283 | 5.30 Millimoles per liter | Standard Deviation 1.468 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 44, n=258, 263 | 139.5 Millimoles per liter | Standard Deviation 1.95 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 4, n=280, 277 | 5.33 Millimoles per liter | Standard Deviation 1.424 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 16, n=255, 269 | 4.21 Millimoles per liter | Standard Deviation 0.283 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 12, n=270, 276 | 5.28 Millimoles per liter | Standard Deviation 1.424 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 48, n=247, 262 | 139.4 Millimoles per liter | Standard Deviation 1.68 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 16, n=255, 269 | 5.26 Millimoles per liter | Standard Deviation 1.385 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 48, n=247, 262 | 1.096 Millimoles per liter | Standard Deviation 0.1888 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 20, n=260, 272 | 5.18 Millimoles per liter | Standard Deviation 1.349 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 28, n=253, 268 | 23.0 Millimoles per liter | Standard Deviation 2.31 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 24, n=261, 268 | 5.38 Millimoles per liter | Standard Deviation 1.489 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 20, n=260, 272 | 4.21 Millimoles per liter | Standard Deviation 0.32 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 28, n=253, 268 | 5.32 Millimoles per liter | Standard Deviation 1.422 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 32, n=255, 268 | 23.0 Millimoles per liter | Standard Deviation 2.31 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 32, n=255, 268 | 5.43 Millimoles per liter | Standard Deviation 1.44 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 12, n=270, 276 | 139.5 Millimoles per liter | Standard Deviation 1.8 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 36, n=254, 261 | 5.31 Millimoles per liter | Standard Deviation 1.396 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 36, n=253, 261 | 23.1 Millimoles per liter | Standard Deviation 2.37 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 40, n=250, 266 | 5.40 Millimoles per liter | Standard Deviation 1.523 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 24, n=261, 268 | 4.24 Millimoles per liter | Standard Deviation 0.322 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 44, n=258, 263 | 5.38 Millimoles per liter | Standard Deviation 1.543 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 40, n=249, 265 | 22.8 Millimoles per liter | Standard Deviation 2.34 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 44, n=258, 263 | 5.24 Millimoles per liter | Standard Deviation 1.512 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 4, n=280, 277 | 104.7 Millimoles per liter | Standard Deviation 2.13 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 24, n=261, 268 | 104.5 Millimoles per liter | Standard Deviation 2.42 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 48, n=248, 251 | 5.22 Millimoles per liter | Standard Deviation 0.69 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Baseline (Day 1), n=283, 283 | 1.097 Millimoles per liter | Standard Deviation 0.1765 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 4, n=279, 277 | 1.112 Millimoles per liter | Standard Deviation 0.185 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 8, n=212, 278 | 1.114 Millimoles per liter | Standard Deviation 0.1858 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 28, n=253, 268 | 1.119 Millimoles per liter | Standard Deviation 0.1893 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 48, n=247, 262 | 1.120 Millimoles per liter | Standard Deviation 0.2341 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Baseline (Day 1), n=283, 283 | 4.14 Millimoles per liter | Standard Deviation 0.288 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 32, n=255, 268 | 4.21 Millimoles per liter | Standard Deviation 0.315 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 36, n=254, 261 | 4.22 Millimoles per liter | Standard Deviation 0.314 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 40, n=250, 266 | 4.20 Millimoles per liter | Standard Deviation 0.305 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Baseline (Day 1), n=283, 283 | 139.2 Millimoles per liter | Standard Deviation 1.76 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 12, n=270, 276 | 139.3 Millimoles per liter | Standard Deviation 1.84 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 16, n=255, 269 | 139.4 Millimoles per liter | Standard Deviation 1.94 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 36, n=254, 261 | 139.5 Millimoles per liter | Standard Deviation 1.7 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 40, n=250, 266 | 139.5 Millimoles per liter | Standard Deviation 1.84 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 8, n=212, 278 | 5.12 Millimoles per liter | Standard Deviation 1.48 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 48, n=247, 262 | 5.27 Millimoles per liter | Standard Deviation 2.305 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 4, n=280, 277 | 4.20 Millimoles per liter | Standard Deviation 0.327 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 8, n=212, 278 | 4.22 Millimoles per liter | Standard Deviation 0.343 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 12, n=270, 276 | 4.19 Millimoles per liter | Standard Deviation 0.282 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 16, n=255, 269 | 4.18 Millimoles per liter | Standard Deviation 0.303 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 20, n=260, 272 | 4.19 Millimoles per liter | Standard Deviation 0.313 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 24, n=261, 268 | 4.21 Millimoles per liter | Standard Deviation 0.312 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 28, n=253, 268 | 4.23 Millimoles per liter | Standard Deviation 0.294 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Baseline (Day 1), n=283, 283 | 22.4 Millimoles per liter | Standard Deviation 2.1 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 44, n=258, 263 | 4.21 Millimoles per liter | Standard Deviation 0.324 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Potassium, Week 48, n=247, 262 | 4.17 Millimoles per liter | Standard Deviation 0.449 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 4, n=280, 276 | 22.6 Millimoles per liter | Standard Deviation 2.28 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 8, n=212, 278 | 22.3 Millimoles per liter | Standard Deviation 2.27 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 4, n=280, 277 | 139.4 Millimoles per liter | Standard Deviation 1.83 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 8, n=212, 278 | 139.3 Millimoles per liter | Standard Deviation 1.86 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 20, n=260, 272 | 139.5 Millimoles per liter | Standard Deviation 1.77 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 24, n=261, 268 | 139.4 Millimoles per liter | Standard Deviation 1.95 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 28, n=253, 268 | 139.5 Millimoles per liter | Standard Deviation 1.83 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 32, n=255, 268 | 139.4 Millimoles per liter | Standard Deviation 1.72 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 12, n=270, 276 | 22.2 Millimoles per liter | Standard Deviation 2.34 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 16, n=255, 269 | 22.3 Millimoles per liter | Standard Deviation 2.5 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 20, n=260, 272 | 22.4 Millimoles per liter | Standard Deviation 2.32 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 44, n=258, 263 | 139.6 Millimoles per liter | Standard Deviation 1.79 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Sodium, Week 48, n=247, 262 | 139.5 Millimoles per liter | Standard Deviation 1.75 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 28, n=253, 268 | 22.8 Millimoles per liter | Standard Deviation 2.47 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 32, n=255, 268 | 22.7 Millimoles per liter | Standard Deviation 2.35 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 36, n=253, 261 | 22.5 Millimoles per liter | Standard Deviation 2.26 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 40, n=249, 265 | 22.6 Millimoles per liter | Standard Deviation 2.39 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 44, n=257, 263 | 22.4 Millimoles per liter | Standard Deviation 2.12 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 48, n=247, 262 | 22.3 Millimoles per liter | Standard Deviation 2.04 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Baseline (Day 1), n=283, 283 | 104.3 Millimoles per liter | Standard Deviation 2.32 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 8, n=212, 278 | 104.6 Millimoles per liter | Standard Deviation 2.32 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 12, n=270, 276 | 104.7 Millimoles per liter | Standard Deviation 2.35 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 16, n=255, 269 | 104.7 Millimoles per liter | Standard Deviation 2.24 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 20, n=260, 272 | 104.7 Millimoles per liter | Standard Deviation 2.06 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 28, n=253, 268 | 104.5 Millimoles per liter | Standard Deviation 2.28 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 32, n=255, 268 | 104.5 Millimoles per liter | Standard Deviation 2.33 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 36, n=254, 261 | 104.7 Millimoles per liter | Standard Deviation 2.2 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 40, n=250, 266 | 104.7 Millimoles per liter | Standard Deviation 2.25 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 44, n=258, 263 | 105.0 Millimoles per liter | Standard Deviation 2.22 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Chloride, Week 48, n=247, 262 | 104.7 Millimoles per liter | Standard Deviation 2.28 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Baseline (Day 1), n=283, 283 | 5.17 Millimoles per liter | Standard Deviation 0.932 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 4, n=236, 230 | 5.23 Millimoles per liter | Standard Deviation 0.734 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 8, n=172, 227 | 5.19 Millimoles per liter | Standard Deviation 0.644 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 12, n=229, 216 | 5.27 Millimoles per liter | Standard Deviation 0.616 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 16, n=204, 213 | 5.28 Millimoles per liter | Standard Deviation 0.801 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 20, n=209, 218 | 5.26 Millimoles per liter | Standard Deviation 0.634 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 24, n=221, 214 | 5.21 Millimoles per liter | Standard Deviation 0.634 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 28, n=207, 211 | 5.23 Millimoles per liter | Standard Deviation 0.614 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 32, n=201, 213 | 5.27 Millimoles per liter | Standard Deviation 0.6 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 36, n=199, 204 | 5.31 Millimoles per liter | Standard Deviation 0.96 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 40, n=203, 202 | 5.35 Millimoles per liter | Standard Deviation 0.753 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Glucose, Week 44, n=208, 202 | 5.35 Millimoles per liter | Standard Deviation 0.709 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 12, n=270, 276 | 1.106 Millimoles per liter | Standard Deviation 0.1876 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 16, n=255, 269 | 1.119 Millimoles per liter | Standard Deviation 0.1823 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 20, n=260, 272 | 1.114 Millimoles per liter | Standard Deviation 0.1812 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 24, n=261, 268 | 1.109 Millimoles per liter | Standard Deviation 0.1791 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 32, n=255, 268 | 1.104 Millimoles per liter | Standard Deviation 0.1945 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 36, n=254, 261 | 1.122 Millimoles per liter | Standard Deviation 0.1872 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 40, n=250, 266 | 1.114 Millimoles per liter | Standard Deviation 0.1837 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Phosphate, Week 44, n=258, 263 | 1.120 Millimoles per liter | Standard Deviation 0.1903 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Baseline (Day 1), n=283, 283 | 5.17 Millimoles per liter | Standard Deviation 1.458 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 4, n=280, 277 | 5.14 Millimoles per liter | Standard Deviation 1.508 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 12, n=270, 276 | 5.20 Millimoles per liter | Standard Deviation 1.574 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 16, n=255, 269 | 5.20 Millimoles per liter | Standard Deviation 1.561 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 20, n=260, 272 | 5.22 Millimoles per liter | Standard Deviation 1.483 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 24, n=261, 268 | 5.11 Millimoles per liter | Standard Deviation 1.449 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 28, n=253, 268 | 5.21 Millimoles per liter | Standard Deviation 1.406 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 32, n=255, 268 | 5.17 Millimoles per liter | Standard Deviation 1.491 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 36, n=254, 261 | 5.23 Millimoles per liter | Standard Deviation 1.556 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | Urea, Week 40, n=250, 266 | 5.26 Millimoles per liter | Standard Deviation 1.566 |
| ABC/ DTG/ 3TC | Absolute Values for Clinical Chemistry Parameters: Total Carbon-dioxide (CO2), Chloride, Glucose, Phosphate, Potassium, Sodium and Urea Over Time Including Week 48 | CO2, Week 24, n=261, 268 | 22.8 Millimoles per liter | Standard Deviation 2.19 |
Secondary
Absolute Values for Fasting Lipid Panel Overtime Including Week 48
Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.
Time frame: Baseline (Day 1) and at Week 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Total Cholesterol, Baseline (Day 1), n=268, 275 | 4.44 Millimoles per liter | Standard Deviation 0.928 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | LDL cholesterol, Week 48, n=238, 237 | 2.697 Millimoles per liter | Standard Deviation 0.9158 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Total Cholesterol, Week 48, n=240, 239 | 4.65 Millimoles per liter | Standard Deviation 1.021 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | HDL cholesterol, Baseline (Day 1), n=268, 275 | 1.249 Millimoles per liter | Standard Deviation 0.3761 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | HDL cholesterol, Week 48, n=240, 239 | 1.359 Millimoles per liter | Standard Deviation 0.4096 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | LDL cholesterol, Baseline (Day 1), n=267, 275 | 2.557 Millimoles per liter | Standard Deviation 0.7991 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Triglycerides, Baseline (Day 1), n=268, 275 | 1.387 Millimoles per liter | Standard Deviation 0.9142 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Triglycerides, Week 48, n=240, 239 | 1.323 Millimoles per liter | Standard Deviation 0.9333 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Triglycerides, Week 48, n=240, 239 | 1.341 Millimoles per liter | Standard Deviation 0.9059 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Total Cholesterol, Baseline (Day 1), n=268, 275 | 4.42 Millimoles per liter | Standard Deviation 0.986 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | LDL cholesterol, Baseline (Day 1), n=267, 275 | 2.529 Millimoles per liter | Standard Deviation 0.787 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | HDL cholesterol, Week 48, n=240, 239 | 1.376 Millimoles per liter | Standard Deviation 0.4335 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Triglycerides, Baseline (Day 1), n=268, 275 | 1.294 Millimoles per liter | Standard Deviation 0.7392 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | Total Cholesterol, Week 48, n=240, 239 | 4.46 Millimoles per liter | Standard Deviation 0.944 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | LDL cholesterol, Week 48, n=238, 237 | 2.472 Millimoles per liter | Standard Deviation 0.7693 |
| ABC/ DTG/ 3TC | Absolute Values for Fasting Lipid Panel Overtime Including Week 48 | HDL cholesterol, Baseline (Day 1), n=268, 275 | 1.302 Millimoles per liter | Standard Deviation 0.3851 |
Secondary
Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 36, n=250, 259 | 0.209 10^9 cells per Liter | Standard Deviation 0.2043 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 12, n=267, 272 | 2.032 10^9 cells per Liter | Standard Deviation 0.6095 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 44, n=249, 260 | 0.040 10^9 cells per Liter | Standard Deviation 0.0246 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 16, n=247, 259 | 2.028 10^9 cells per Liter | Standard Deviation 0.6931 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 40, n=244, 245 | 0.203 10^9 cells per Liter | Standard Deviation 0.1837 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 20, n=247, 259 | 2.028 10^9 cells per Liter | Standard Deviation 0.6284 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 4, n=277, 270 | 0.024 10^9 cells per Liter | Standard Deviation 0.0136 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 24, n=256, 260 | 2.014 10^9 cells per Liter | Standard Deviation 0.6456 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 44, n=249, 260 | 0.198 10^9 cells per Liter | Standard Deviation 0.1867 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 28, n=239, 258 | 2.051 10^9 cells per Liter | Standard Deviation 0.6592 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 48, n=239, 258 | 0.038 10^9 cells per Liter | Standard Deviation 0.0214 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 32, n=246, 263 | 2.037 10^9 cells per Liter | Standard Deviation 0.6543 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 48, n=239, 258 | 0.182 10^9 cells per Liter | Standard Deviation 0.1508 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 36, n=250, 259 | 2.023 10^9 cells per Liter | Standard Deviation 0.6878 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 16, n=251, 263 | 225.5 10^9 cells per Liter | Standard Deviation 55.49 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 24, n=256, 260 | 0.037 10^9 cells per Liter | Standard Deviation 0.0245 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 20, n=255, 264 | 233.8 10^9 cells per Liter | Standard Deviation 60.98 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Baseline (Day 1), n=283, 283 | 5.82 10^9 cells per Liter | Standard Deviation 1.792 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 24, n=256, 261 | 233.9 10^9 cells per Liter | Standard Deviation 58.12 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Baseline (Day 1), n=283, 283 | 0.142 10^9 cells per Liter | Standard Deviation 0.1238 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 28, n=245, 258 | 233.7 10^9 cells per Liter | Standard Deviation 61.56 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 4, n=279, 272 | 6.41 10^9 cells per Liter | Standard Deviation 1.989 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 32, n=249, 262 | 235.0 10^9 cells per Liter | Standard Deviation 62.74 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 12, n=267, 272 | 0.025 10^9 cells per Liter | Standard Deviation 0.0166 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 8, n=211, 275 | 6.04 10^9 cells per Liter | Standard Deviation 1.806 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 36, n=248, 259 | 237.3 10^9 cells per Liter | Standard Deviation 58.56 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 4, n=277, 270 | 0.164 10^9 cells per Liter | Standard Deviation 0.147 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 40, n=244, 245 | 2.021 10^9 cells per Liter | Standard Deviation 0.6646 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 12, n=270, 275 | 5.88 10^9 cells per Liter | Standard Deviation 1.59 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 40, n=244, 254 | 233.9 10^9 cells per Liter | Standard Deviation 56.93 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 44, n=249, 260 | 1.997 10^9 cells per Liter | Standard Deviation 0.6748 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 28, n=239, 258 | 0.039 10^9 cells per Liter | Standard Deviation 0.0249 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 44, n=254, 261 | 236.7 10^9 cells per Liter | Standard Deviation 58.18 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 16, n=252, 265 | 6.08 10^9 cells per Liter | Standard Deviation 2.045 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 48, n=239, 258 | 1.926 10^9 cells per Liter | Standard Deviation 0.6126 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 8, n=210, 272 | 0.169 10^9 cells per Liter | Standard Deviation 0.1401 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 20, n=254, 265 | 6.08 10^9 cells per Liter | Standard Deviation 1.788 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 48, n=240, 255 | 232.8 10^9 cells per Liter | Standard Deviation 57.07 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Baseline (Day 1), n=283, 283 | 0.382 10^9 cells per Liter | Standard Deviation 0.1666 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Baseline (Day 1), n=283, 283 | 0.022 10^9 cells per Liter | Standard Deviation 0.0124 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 4, n=277, 270 | 0.422 10^9 cells per Liter | Standard Deviation 0.1778 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 24, n=258, 264 | 6.11 10^9 cells per Liter | Standard Deviation 1.841 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 8, n=210, 272 | 0.415 10^9 cells per Liter | Standard Deviation 0.1824 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 12, n=267, 272 | 0.165 10^9 cells per Liter | Standard Deviation 0.1375 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 12, n=267, 272 | 0.395 10^9 cells per Liter | Standard Deviation 0.1662 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 28, n=244, 263 | 6.17 10^9 cells per Liter | Standard Deviation 1.929 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 32, n=246, 263 | 0.044 10^9 cells per Liter | Standard Deviation 0.0254 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 16, n=247, 259 | 0.438 10^9 cells per Liter | Standard Deviation 0.1859 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 32, n=253, 266 | 6.07 10^9 cells per Liter | Standard Deviation 1.925 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 20, n=247, 259 | 0.455 10^9 cells per Liter | Standard Deviation 0.1927 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 16, n=247, 259 | 0.177 10^9 cells per Liter | Standard Deviation 0.1538 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 24, n=256, 260 | 0.438 10^9 cells per Liter | Standard Deviation 0.1859 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 36, n=252, 259 | 6.11 10^9 cells per Liter | Standard Deviation 1.992 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 28, n=239, 258 | 0.471 10^9 cells per Liter | Standard Deviation 0.1916 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 16, n=247, 259 | 0.030 10^9 cells per Liter | Standard Deviation 0.0212 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 32, n=246, 263 | 0.462 10^9 cells per Liter | Standard Deviation 0.1898 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 40, n=246, 253 | 5.96 10^9 cells per Liter | Standard Deviation 1.773 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 36, n=250, 259 | 0.458 10^9 cells per Liter | Standard Deviation 0.2116 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 20, n=247, 259 | 0.185 10^9 cells per Liter | Standard Deviation 0.1617 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 40, n=244, 245 | 0.438 10^9 cells per Liter | Standard Deviation 0.174 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 44, n=256, 262 | 6.03 10^9 cells per Liter | Standard Deviation 2 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 44, n=249, 260 | 0.440 10^9 cells per Liter | Standard Deviation 0.1907 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 36, n=250, 259 | 0.042 10^9 cells per Liter | Standard Deviation 0.0237 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 48, n=239, 258 | 0.402 10^9 cells per Liter | Standard Deviation 0.1911 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 48, n=243, 260 | 5.85 10^9 cells per Liter | Standard Deviation 1.884 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Baseline (Day 1), n=283, 283 | 3.246 10^9 cells per Liter | Standard Deviation 1.3715 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 4, n=278, 269 | 233.1 10^9 cells per Liter | Standard Deviation 56.85 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 4, n=277, 270 | 3.573 10^9 cells per Liter | Standard Deviation 1.5681 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 24, n=256, 260 | 0.193 10^9 cells per Liter | Standard Deviation 0.1591 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 8, n=210, 272 | 3.334 10^9 cells per Liter | Standard Deviation 1.3166 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 8, n=207, 273 | 226.9 10^9 cells per Liter | Standard Deviation 53.23 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 12, n=267, 272 | 3.271 10^9 cells per Liter | Standard Deviation 1.2151 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 8, n=210, 272 | 0.023 10^9 cells per Liter | Standard Deviation 0.0135 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 12, n=269, 271 | 226.6 10^9 cells per Liter | Standard Deviation 55.07 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 20, n=247, 259 | 3.406 10^9 cells per Liter | Standard Deviation 1.4209 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 28, n=239, 258 | 0.206 10^9 cells per Liter | Standard Deviation 0.1634 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 24, n=256, 260 | 3.428 10^9 cells per Liter | Standard Deviation 1.4938 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 40, n=244, 245 | 0.041 10^9 cells per Liter | Standard Deviation 0.0248 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 28, n=239, 258 | 3.439 10^9 cells per Liter | Standard Deviation 1.5379 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Baseline (Day 1), n=283, 283 | 2.022 10^9 cells per Liter | Standard Deviation 0.6893 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 32, n=246, 263 | 3.367 10^9 cells per Liter | Standard Deviation 1.567 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 36, n=250, 259 | 3.388 10^9 cells per Liter | Standard Deviation 1.5215 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 32, n=246, 263 | 0.206 10^9 cells per Liter | Standard Deviation 0.1779 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 40, n=244, 245 | 3.274 10^9 cells per Liter | Standard Deviation 1.3654 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 4, n=277, 270 | 2.227 10^9 cells per Liter | Standard Deviation 0.7321 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 44, n=249, 260 | 3.398 10^9 cells per Liter | Standard Deviation 1.5679 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 20, n=247, 259 | 0.035 10^9 cells per Liter | Standard Deviation 0.0254 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 48, n=239, 258 | 3.309 10^9 cells per Liter | Standard Deviation 1.4923 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 8, n=210, 272 | 2.102 10^9 cells per Liter | Standard Deviation 0.698 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Baseline (Day 1), n=283, 282 | 226.7 10^9 cells per Liter | Standard Deviation 55.39 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 16, n=247, 259 | 3.410 10^9 cells per Liter | Standard Deviation 1.7208 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Baseline (Day 1), n=283, 282 | 230.6 10^9 cells per Liter | Standard Deviation 58.33 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 32, n=246, 263 | 3.392 10^9 cells per Liter | Standard Deviation 1.4892 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Baseline (Day 1), n=283, 283 | 0.022 10^9 cells per Liter | Standard Deviation 0.0138 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 4, n=277, 270 | 0.024 10^9 cells per Liter | Standard Deviation 0.0142 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 8, n=210, 272 | 0.023 10^9 cells per Liter | Standard Deviation 0.0122 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 12, n=267, 272 | 0.023 10^9 cells per Liter | Standard Deviation 0.0144 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 16, n=247, 259 | 0.028 10^9 cells per Liter | Standard Deviation 0.0209 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 20, n=247, 259 | 0.032 10^9 cells per Liter | Standard Deviation 0.0256 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 24, n=256, 260 | 0.036 10^9 cells per Liter | Standard Deviation 0.0256 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 28, n=239, 258 | 0.038 10^9 cells per Liter | Standard Deviation 0.0247 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 32, n=246, 263 | 0.038 10^9 cells per Liter | Standard Deviation 0.0246 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 36, n=250, 259 | 0.040 10^9 cells per Liter | Standard Deviation 0.025 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 40, n=244, 245 | 0.041 10^9 cells per Liter | Standard Deviation 0.0252 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 44, n=249, 260 | 0.040 10^9 cells per Liter | Standard Deviation 0.0257 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 48, n=239, 258 | 0.038 10^9 cells per Liter | Standard Deviation 0.0246 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Baseline (Day 1), n=283, 283 | 0.141 10^9 cells per Liter | Standard Deviation 0.1449 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 4, n=277, 270 | 0.154 10^9 cells per Liter | Standard Deviation 0.1535 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 8, n=210, 272 | 0.150 10^9 cells per Liter | Standard Deviation 0.1393 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 12, n=267, 272 | 0.157 10^9 cells per Liter | Standard Deviation 0.1481 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 16, n=247, 259 | 0.162 10^9 cells per Liter | Standard Deviation 0.1434 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 20, n=247, 259 | 0.166 10^9 cells per Liter | Standard Deviation 0.1675 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 24, n=256, 260 | 0.172 10^9 cells per Liter | Standard Deviation 0.1518 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 28, n=239, 258 | 0.179 10^9 cells per Liter | Standard Deviation 0.1659 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 32, n=246, 263 | 0.169 10^9 cells per Liter | Standard Deviation 0.1466 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 36, n=250, 259 | 0.172 10^9 cells per Liter | Standard Deviation 0.154 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 40, n=244, 245 | 0.174 10^9 cells per Liter | Standard Deviation 0.1495 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 44, n=249, 260 | 0.180 10^9 cells per Liter | Standard Deviation 0.1723 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 48, n=239, 258 | 0.172 10^9 cells per Liter | Standard Deviation 0.1533 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Baseline (Day 1), n=283, 283 | 5.68 10^9 cells per Liter | Standard Deviation 1.684 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 4, n=279, 272 | 6.11 10^9 cells per Liter | Standard Deviation 1.77 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 8, n=211, 275 | 6.00 10^9 cells per Liter | Standard Deviation 1.714 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 12, n=270, 275 | 6.08 10^9 cells per Liter | Standard Deviation 1.836 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 16, n=252, 265 | 6.11 10^9 cells per Liter | Standard Deviation 1.887 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 20, n=254, 265 | 6.15 10^9 cells per Liter | Standard Deviation 1.926 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 24, n=258, 264 | 6.16 10^9 cells per Liter | Standard Deviation 2.046 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 28, n=244, 263 | 6.17 10^9 cells per Liter | Standard Deviation 1.939 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 32, n=253, 266 | 6.12 10^9 cells per Liter | Standard Deviation 1.918 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 36, n=252, 259 | 6.23 10^9 cells per Liter | Standard Deviation 2.104 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 40, n=246, 253 | 6.12 10^9 cells per Liter | Standard Deviation 2.076 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 44, n=256, 262 | 6.19 10^9 cells per Liter | Standard Deviation 1.97 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 4, n=278, 269 | 233.4 10^9 cells per Liter | Standard Deviation 56.56 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 8, n=207, 273 | 232.0 10^9 cells per Liter | Standard Deviation 56.31 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 12, n=269, 271 | 235.5 10^9 cells per Liter | Standard Deviation 57.26 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 48, n=243, 260 | 5.99 10^9 cells per Liter | Standard Deviation 1.986 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Baseline (Day 1), n=283, 283 | 1.957 10^9 cells per Liter | Standard Deviation 0.6408 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 4, n=277, 270 | 2.197 10^9 cells per Liter | Standard Deviation 0.7198 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 8, n=210, 272 | 2.110 10^9 cells per Liter | Standard Deviation 0.7015 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 12, n=267, 272 | 2.117 10^9 cells per Liter | Standard Deviation 0.7162 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 16, n=247, 259 | 2.130 10^9 cells per Liter | Standard Deviation 0.7245 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 20, n=247, 259 | 2.121 10^9 cells per Liter | Standard Deviation 0.6995 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 24, n=256, 260 | 2.111 10^9 cells per Liter | Standard Deviation 0.7092 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 28, n=239, 258 | 2.106 10^9 cells per Liter | Standard Deviation 0.6679 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 32, n=246, 263 | 2.112 10^9 cells per Liter | Standard Deviation 0.695 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 16, n=251, 263 | 239.9 10^9 cells per Liter | Standard Deviation 70.4 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 20, n=255, 264 | 243.4 10^9 cells per Liter | Standard Deviation 62.06 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 24, n=256, 261 | 244.2 10^9 cells per Liter | Standard Deviation 59.95 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 28, n=245, 258 | 247.2 10^9 cells per Liter | Standard Deviation 63.18 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 32, n=249, 262 | 245.3 10^9 cells per Liter | Standard Deviation 60.25 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 36, n=250, 259 | 2.098 10^9 cells per Liter | Standard Deviation 0.6921 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 36, n=248, 259 | 248.1 10^9 cells per Liter | Standard Deviation 59.57 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 40, n=244, 245 | 2.030 10^9 cells per Liter | Standard Deviation 0.6357 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 40, n=244, 254 | 247.4 10^9 cells per Liter | Standard Deviation 63.85 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 44, n=249, 260 | 2.068 10^9 cells per Liter | Standard Deviation 0.6754 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 48, n=239, 258 | 2.003 10^9 cells per Liter | Standard Deviation 0.7651 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 44, n=254, 261 | 249.5 10^9 cells per Liter | Standard Deviation 71.56 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Baseline (Day 1), n=283, 283 | 0.366 10^9 cells per Liter | Standard Deviation 0.1705 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 4, n=277, 270 | 0.398 10^9 cells per Liter | Standard Deviation 0.1778 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 8, n=210, 272 | 0.380 10^9 cells per Liter | Standard Deviation 0.1771 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 12, n=267, 272 | 0.383 10^9 cells per Liter | Standard Deviation 0.157 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 48, n=240, 255 | 246.0 10^9 cells per Liter | Standard Deviation 70.35 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 16, n=247, 259 | 0.409 10^9 cells per Liter | Standard Deviation 0.181 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 20, n=247, 259 | 0.423 10^9 cells per Liter | Standard Deviation 0.1904 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 24, n=256, 260 | 0.438 10^9 cells per Liter | Standard Deviation 0.1897 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 28, n=239, 258 | 0.447 10^9 cells per Liter | Standard Deviation 0.2003 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 32, n=246, 263 | 0.459 10^9 cells per Liter | Standard Deviation 0.2107 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 36, n=250, 259 | 0.456 10^9 cells per Liter | Standard Deviation 0.2021 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 40, n=244, 245 | 0.442 10^9 cells per Liter | Standard Deviation 0.2038 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 44, n=249, 260 | 0.428 10^9 cells per Liter | Standard Deviation 0.1965 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 48, n=239, 258 | 0.396 10^9 cells per Liter | Standard Deviation 0.1857 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Baseline (Day 1), n=283, 283 | 3.205 10^9 cells per Liter | Standard Deviation 1.2803 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 4, n=277, 270 | 3.342 10^9 cells per Liter | Standard Deviation 1.3344 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 8, n=210, 272 | 3.316 10^9 cells per Liter | Standard Deviation 1.3588 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 12, n=267, 272 | 3.379 10^9 cells per Liter | Standard Deviation 1.4884 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 16, n=247, 259 | 3.432 10^9 cells per Liter | Standard Deviation 1.5052 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 20, n=247, 259 | 3.433 10^9 cells per Liter | Standard Deviation 1.562 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 24, n=256, 260 | 3.424 10^9 cells per Liter | Standard Deviation 1.6766 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 28, n=239, 258 | 3.423 10^9 cells per Liter | Standard Deviation 1.5514 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 36, n=250, 259 | 3.468 10^9 cells per Liter | Standard Deviation 1.6269 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 40, n=244, 245 | 3.477 10^9 cells per Liter | Standard Deviation 1.7021 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 44, n=249, 260 | 3.503 10^9 cells per Liter | Standard Deviation 1.5486 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Basophils, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 48, n=239, 258 | 3.419 10^9 cells per Liter | Standard Deviation 1.5186 |
Secondary
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume
Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 8, n=211, 275 | 92.3 Femtoliters | Standard Deviation 4.86 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 28, n=246, 265 | 89.3 Femtoliters | Standard Deviation 4.64 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 16, n=254, 265 | 89.9 Femtoliters | Standard Deviation 4.43 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 32, n=254, 267 | 89.6 Femtoliters | Standard Deviation 4.69 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 4, n=279, 273 | 94.1 Femtoliters | Standard Deviation 4.77 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 36, n=252, 261 | 89.5 Femtoliters | Standard Deviation 4.65 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 20, n=255, 267 | 89.3 Femtoliters | Standard Deviation 4.46 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 40, n=246, 255 | 90.3 Femtoliters | Standard Deviation 4.62 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 12, n=270, 275 | 91.0 Femtoliters | Standard Deviation 4.64 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 44, n=256, 262 | 90.7 Femtoliters | Standard Deviation 5.05 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 24, n=259, 264 | 89.4 Femtoliters | Standard Deviation 4.33 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 48, n=243, 260 | 91.2 Femtoliters | Standard Deviation 5.21 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Baseline (Day 1), n=283, 283 | 94.8 Femtoliters | Standard Deviation 4.94 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 48, n=243, 260 | 95.4 Femtoliters | Standard Deviation 6.6 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Baseline (Day 1), n=283, 283 | 94.3 Femtoliters | Standard Deviation 5.69 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 4, n=279, 273 | 94.6 Femtoliters | Standard Deviation 5.85 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 8, n=211, 275 | 94.6 Femtoliters | Standard Deviation 5.78 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 12, n=270, 275 | 94.0 Femtoliters | Standard Deviation 5.81 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 16, n=254, 265 | 94.1 Femtoliters | Standard Deviation 5.78 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 20, n=255, 267 | 93.9 Femtoliters | Standard Deviation 5.64 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 24, n=259, 264 | 93.8 Femtoliters | Standard Deviation 5.69 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 28, n=246, 265 | 93.5 Femtoliters | Standard Deviation 5.78 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 32, n=254, 267 | 93.6 Femtoliters | Standard Deviation 5.9 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 36, n=252, 261 | 94.1 Femtoliters | Standard Deviation 5.65 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 40, n=246, 255 | 94.4 Femtoliters | Standard Deviation 6.09 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume | Week 44, n=256, 262 | 94.6 Femtoliters | Standard Deviation 6.32 |
Secondary
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes
Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 8, n=211, 275 | 4.76 10^12 cells per Liter | Standard Deviation 0.435 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 28, n=246, 265 | 4.87 10^12 cells per Liter | Standard Deviation 0.416 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 16, n=254, 265 | 4.87 10^12 cells per Liter | Standard Deviation 0.43 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 32, n=254, 267 | 4.83 10^12 cells per Liter | Standard Deviation 0.435 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 4, n=279, 273 | 4.67 10^12 cells per Liter | Standard Deviation 0.423 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 36, n=252, 261 | 4.82 10^12 cells per Liter | Standard Deviation 0.403 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 20, n=255, 267 | 4.89 10^12 cells per Liter | Standard Deviation 0.418 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 40, n=246, 255 | 4.81 10^12 cells per Liter | Standard Deviation 0.407 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 12, n=270, 275 | 4.82 10^12 cells per Liter | Standard Deviation 0.435 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 44, n=256, 262 | 4.79 10^12 cells per Liter | Standard Deviation 0.425 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 24, n=259, 264 | 4.87 10^12 cells per Liter | Standard Deviation 0.418 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 48, n=243, 260 | 4.74 10^12 cells per Liter | Standard Deviation 0.443 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Baseline (Day 1), n=283, 283 | 4.59 10^12 cells per Liter | Standard Deviation 0.434 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 48, n=243, 260 | 4.59 10^12 cells per Liter | Standard Deviation 0.437 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Baseline (Day 1), n=283, 283 | 4.65 10^12 cells per Liter | Standard Deviation 0.412 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 4, n=279, 273 | 4.62 10^12 cells per Liter | Standard Deviation 0.406 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 8, n=211, 275 | 4.67 10^12 cells per Liter | Standard Deviation 0.41 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 12, n=270, 275 | 4.66 10^12 cells per Liter | Standard Deviation 0.419 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 16, n=254, 265 | 4.66 10^12 cells per Liter | Standard Deviation 0.407 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 20, n=255, 267 | 4.64 10^12 cells per Liter | Standard Deviation 0.41 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 24, n=259, 264 | 4.67 10^12 cells per Liter | Standard Deviation 0.425 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 28, n=246, 265 | 4.69 10^12 cells per Liter | Standard Deviation 0.395 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 32, n=254, 267 | 4.66 10^12 cells per Liter | Standard Deviation 0.418 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 36, n=252, 261 | 4.64 10^12 cells per Liter | Standard Deviation 0.395 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 40, n=246, 255 | 4.63 10^12 cells per Liter | Standard Deviation 0.409 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes | Week 44, n=256, 262 | 4.59 10^12 cells per Liter | Standard Deviation 0.403 |
Secondary
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit
Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 8, n=211, 275 | 0.4382 Proportion of red blood cells in blood | Standard Deviation 0.04056 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 28, n=246, 265 | 0.4342 Proportion of red blood cells in blood | Standard Deviation 0.03519 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 16, n=254, 265 | 0.4366 Proportion of red blood cells in blood | Standard Deviation 0.03769 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 32, n=254, 267 | 0.4318 Proportion of red blood cells in blood | Standard Deviation 0.03623 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 4, n=279, 273 | 0.4387 Proportion of red blood cells in blood | Standard Deviation 0.03809 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 36, n=252, 261 | 0.4301 Proportion of red blood cells in blood | Standard Deviation 0.03392 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 20, n=255, 267 | 0.4363 Proportion of red blood cells in blood | Standard Deviation 0.03574 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 40, n=246, 255 | 0.4328 Proportion of red blood cells in blood | Standard Deviation 0.03433 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 12, n=270, 275 | 0.4377 Proportion of red blood cells in blood | Standard Deviation 0.0402 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 44, n=256, 262 | 0.4332 Proportion of red blood cells in blood | Standard Deviation 0.0357 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 24, n=259, 264 | 0.4351 Proportion of red blood cells in blood | Standard Deviation 0.0358 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 48, n=243, 260 | 0.4310 Proportion of red blood cells in blood | Standard Deviation 0.03875 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Baseline (Day 1), n=283, 283 | 0.4341 Proportion of red blood cells in blood | Standard Deviation 0.03889 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 48, n=243, 260 | 0.4361 Proportion of red blood cells in blood | Standard Deviation 0.04156 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Baseline (Day 1), n=283, 283 | 0.4370 Proportion of red blood cells in blood | Standard Deviation 0.03887 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 4, n=279, 273 | 0.4363 Proportion of red blood cells in blood | Standard Deviation 0.03832 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 8, n=211, 275 | 0.4403 Proportion of red blood cells in blood | Standard Deviation 0.03978 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 12, n=270, 275 | 0.4373 Proportion of red blood cells in blood | Standard Deviation 0.04144 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 16, n=254, 265 | 0.4371 Proportion of red blood cells in blood | Standard Deviation 0.0389 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 20, n=255, 267 | 0.4349 Proportion of red blood cells in blood | Standard Deviation 0.03839 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 24, n=259, 264 | 0.4366 Proportion of red blood cells in blood | Standard Deviation 0.03901 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 28, n=246, 265 | 0.4374 Proportion of red blood cells in blood | Standard Deviation 0.03867 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 32, n=254, 267 | 0.4347 Proportion of red blood cells in blood | Standard Deviation 0.04025 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 36, n=252, 261 | 0.4349 Proportion of red blood cells in blood | Standard Deviation 0.03774 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 40, n=246, 255 | 0.4358 Proportion of red blood cells in blood | Standard Deviation 0.03845 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit | Week 44, n=256, 262 | 0.4328 Proportion of red blood cells in blood | Standard Deviation 0.03847 |
Secondary
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin
Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 44, n=256, 262 | 145.1 Grams per liter | Standard Deviation 12.79 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 48, n=243, 260 | 143.8 Grams per liter | Standard Deviation 13.56 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Baseline (Day 1), n=283, 283 | 142.5 Grams per liter | Standard Deviation 13.59 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 4, n=279, 273 | 144.3 Grams per liter | Standard Deviation 13.34 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 8, n=211, 275 | 143.9 Grams per liter | Standard Deviation 13.84 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 12, n=270, 275 | 144.5 Grams per liter | Standard Deviation 13.89 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 16, n=254, 265 | 145.3 Grams per liter | Standard Deviation 13.52 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 20, n=255, 267 | 145.4 Grams per liter | Standard Deviation 12.69 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 24, n=259, 264 | 145.0 Grams per liter | Standard Deviation 13.14 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 28, n=246, 265 | 145.3 Grams per liter | Standard Deviation 12.8 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 32, n=254, 267 | 145.1 Grams per liter | Standard Deviation 13.37 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 36, n=252, 261 | 144.6 Grams per liter | Standard Deviation 12.27 |
| CAB LA + RPV LA (Q4W) | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 40, n=246, 255 | 145.9 Grams per liter | Standard Deviation 12.32 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 32, n=254, 267 | 146.2 Grams per liter | Standard Deviation 14.8 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 44, n=256, 262 | 145.0 Grams per liter | Standard Deviation 14.13 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 20, n=255, 267 | 144.8 Grams per liter | Standard Deviation 13.87 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 40, n=246, 255 | 146.2 Grams per liter | Standard Deviation 13.85 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Baseline (Day 1), n=283, 283 | 143.1 Grams per liter | Standard Deviation 13.51 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 24, n=259, 264 | 145.3 Grams per liter | Standard Deviation 14.07 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 4, n=279, 273 | 143.4 Grams per liter | Standard Deviation 13.47 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 36, n=252, 261 | 146.2 Grams per liter | Standard Deviation 13.85 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 8, n=211, 275 | 144.7 Grams per liter | Standard Deviation 13.59 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 28, n=246, 265 | 146.5 Grams per liter | Standard Deviation 14.17 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 12, n=270, 275 | 144.7 Grams per liter | Standard Deviation 14.66 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 48, n=243, 260 | 145.4 Grams per liter | Standard Deviation 14.56 |
| ABC/ DTG/ 3TC | Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin | Week 16, n=254, 265 | 144.6 Grams per liter | Standard Deviation 13.88 |
Secondary
Absolute Values for Plasma HIV-1 RNA at Week 48
Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.
Time frame: Week 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Absolute Values for Plasma HIV-1 RNA at Week 48 | 1.513 log10 copies/mL | Standard Deviation 0.0954 |
| ABC/ DTG/ 3TC | Absolute Values for Plasma HIV-1 RNA at Week 48 | 1.518 log10 copies/mL | Standard Deviation 0.1152 |
Secondary
Area Under the Curve (AUC) for CAB LA
AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.
Time frame: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Area Under the Curve (AUC) for CAB LA | 2517.40 Hours*micrograms per milliliter |
Secondary
AUC for RPV LA
AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA
Time frame: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48
Population: PK Population.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | AUC for RPV LA | 63989.13 Hours*nanograms per milliliter |
Secondary
Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm
The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.
Time frame: Weeks 4b, 5, 40 and 41
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm | Week 5 | 1.8 Scores on a scale | Standard Deviation 2.78 |
| CAB LA + RPV LA (Q4W) | Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm | Week 40 | 0.8 Scores on a scale | Standard Deviation 2.72 |
| CAB LA + RPV LA (Q4W) | Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm | Week 41 | 0.4 Scores on a scale | Standard Deviation 2.69 |
Secondary
Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets
Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 8, n=210, 272 | 0.002 10^9 cells per Liter | Standard Deviation 0.0161 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 12, n=267, 272 | 0.016 10^9 cells per Liter | Standard Deviation 0.1234 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 8, n=207, 273 | -0.9 10^9 cells per Liter | Standard Deviation 29.09 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 16, n=247, 259 | 0.059 10^9 cells per Liter | Standard Deviation 0.1548 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 40, n=246, 253 | 0.16 10^9 cells per Liter | Standard Deviation 1.497 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 20, n=247, 259 | 0.070 10^9 cells per Liter | Standard Deviation 0.1583 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 16, n=247, 259 | 0.020 10^9 cells per Liter | Standard Deviation 0.4971 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 24, n=256, 260 | 0.059 10^9 cells per Liter | Standard Deviation 0.1442 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 16, n=252, 265 | 0.32 10^9 cells per Liter | Standard Deviation 1.641 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 28, n=239, 258 | 0.086 10^9 cells per Liter | Standard Deviation 0.1584 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 40, n=244, 245 | 0.062 10^9 cells per Liter | Standard Deviation 0.1623 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 32, n=246, 263 | 0.081 10^9 cells per Liter | Standard Deviation 0.153 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 24, n=258, 264 | 0.34 10^9 cells per Liter | Standard Deviation 1.581 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 40, n=244, 245 | 0.056 10^9 cells per Liter | Standard Deviation 0.1378 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 28, n=244, 263 | 0.34 10^9 cells per Liter | Standard Deviation 1.713 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 48, n=239, 258 | 0.024 10^9 cells per Liter | Standard Deviation 0.1395 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 40, n=244, 245 | 0.006 10^9 cells per Liter | Standard Deviation 0.5303 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 4, n=277, 270 | 0.313 10^9 cells per Liter | Standard Deviation 1.3508 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 32, n=253, 266 | 0.28 10^9 cells per Liter | Standard Deviation 1.726 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 8, n=210, 272 | 0.084 10^9 cells per Liter | Standard Deviation 1.131 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 36, n=252, 259 | 0.34 10^9 cells per Liter | Standard Deviation 1.549 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 12, n=267, 272 | 0.032 10^9 cells per Liter | Standard Deviation 1.3016 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 20, n=247, 259 | 0.132 10^9 cells per Liter | Standard Deviation 1.4116 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 24, n=256, 260 | 0.015 10^9 cells per Liter | Standard Deviation 0.0247 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 44, n=249, 260 | 0.057 10^9 cells per Liter | Standard Deviation 0.1598 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 28, n=239, 258 | 0.193 10^9 cells per Liter | Standard Deviation 1.5833 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 32, n=246, 263 | 0.144 10^9 cells per Liter | Standard Deviation 1.5739 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 44, n=256, 262 | 0.22 10^9 cells per Liter | Standard Deviation 1.732 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 36, n=250, 259 | 0.170 10^9 cells per Liter | Standard Deviation 1.3865 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 36, n=250, 259 | 0.084 10^9 cells per Liter | Standard Deviation 0.1685 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 48, n=243, 260 | 0.09 10^9 cells per Liter | Standard Deviation 1.455 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 44, n=249, 260 | 0.156 10^9 cells per Liter | Standard Deviation 1.5382 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 20, n=247, 259 | 0.044 10^9 cells per Liter | Standard Deviation 0.1478 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 48, n=239, 258 | 0.110 10^9 cells per Liter | Standard Deviation 1.3697 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 4, n=278, 269 | 5.7 10^9 cells per Liter | Standard Deviation 29.1 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 4, n=277, 270 | 0.198 10^9 cells per Liter | Standard Deviation 0.5156 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 12, n=269, 271 | 0.8 10^9 cells per Liter | Standard Deviation 32.49 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 44, n=249, 260 | 0.062 10^9 cells per Liter | Standard Deviation 0.1522 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 16, n=251, 263 | 1.6 10^9 cells per Liter | Standard Deviation 33.34 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 20, n=255, 264 | 7.6 10^9 cells per Liter | Standard Deviation 38.18 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 8, n=210, 272 | 0.054 10^9 cells per Liter | Standard Deviation 0.4812 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 24, n=256, 261 | 6.5 10^9 cells per Liter | Standard Deviation 36.11 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 48, n=239, 258 | 0.039 10^9 cells per Liter | Standard Deviation 0.1416 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 28, n=245, 258 | 8.6 10^9 cells per Liter | Standard Deviation 38.23 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 12, n=267, 272 | 0.012 10^9 cells per Liter | Standard Deviation 0.4632 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 32, n=249, 262 | 7.9 10^9 cells per Liter | Standard Deviation 40.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 36, n=248, 259 | 12.1 10^9 cells per Liter | Standard Deviation 38.48 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 4, n=277, 270 | 0.024 10^9 cells per Liter | Standard Deviation 0.1099 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 40, n=244, 254 | 8.2 10^9 cells per Liter | Standard Deviation 36.08 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 16, n=247, 259 | 0.215 10^9 cells per Liter | Standard Deviation 1.5752 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 44, n=254, 261 | 9.4 10^9 cells per Liter | Standard Deviation 38.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 20, n=247, 259 | 0.030 10^9 cells per Liter | Standard Deviation 0.4889 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 48, n=240, 255 | 7.7 10^9 cells per Liter | Standard Deviation 39.61 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 24, n=256, 260 | 0.014 10^9 cells per Liter | Standard Deviation 0.5195 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 36, n=250, 259 | 0.021 10^9 cells per Liter | Standard Deviation 0.0235 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 4, n=277, 270 | 0.002 10^9 cells per Liter | Standard Deviation 0.0155 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 20, n=254, 265 | 0.27 10^9 cells per Liter | Standard Deviation 1.505 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 12, n=267, 272 | 0.003 10^9 cells per Liter | Standard Deviation 0.0181 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 28, n=239, 258 | 0.021 10^9 cells per Liter | Standard Deviation 0.5389 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 16, n=247, 259 | 0.008 10^9 cells per Liter | Standard Deviation 0.0215 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 20, n=247, 259 | 0.013 10^9 cells per Liter | Standard Deviation 0.025 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 24, n=256, 260 | 0.218 10^9 cells per Liter | Standard Deviation 1.489 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 28, n=239, 258 | 0.017 10^9 cells per Liter | Standard Deviation 0.0265 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 32, n=246, 263 | 0.022 10^9 cells per Liter | Standard Deviation 0.0266 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 32, n=246, 263 | 0.021 10^9 cells per Liter | Standard Deviation 0.5195 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 24, n=256, 260 | 0.051 10^9 cells per Liter | Standard Deviation 0.1307 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 44, n=249, 260 | 0.018 10^9 cells per Liter | Standard Deviation 0.0246 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 48, n=239, 258 | 0.016 10^9 cells per Liter | Standard Deviation 0.0218 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 36, n=250, 259 | 0.028 10^9 cells per Liter | Standard Deviation 0.5261 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 40, n=244, 245 | 0.055 10^9 cells per Liter | Standard Deviation 1.4372 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 12, n=267, 272 | 0.023 10^9 cells per Liter | Standard Deviation 0.1305 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 16, n=247, 259 | 0.037 10^9 cells per Liter | Standard Deviation 0.1425 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 44, n=249, 260 | -0.021 10^9 cells per Liter | Standard Deviation 0.6176 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 28, n=239, 258 | 0.061 10^9 cells per Liter | Standard Deviation 0.1367 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 32, n=246, 263 | 0.061 10^9 cells per Liter | Standard Deviation 0.1556 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 40, n=244, 245 | 0.020 10^9 cells per Liter | Standard Deviation 0.0252 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 36, n=250, 259 | 0.070 10^9 cells per Liter | Standard Deviation 0.1797 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 48, n=239, 258 | -0.074 10^9 cells per Liter | Standard Deviation 0.5191 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 4, n=277, 270 | 0.038 10^9 cells per Liter | Standard Deviation 0.1269 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 4, n=279, 272 | 0.57 10^9 cells per Liter | Standard Deviation 1.404 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 8, n=211, 275 | 0.18 10^9 cells per Liter | Standard Deviation 1.278 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 8, n=210, 272 | 0.023 10^9 cells per Liter | Standard Deviation 0.1101 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 12, n=270, 275 | 0.07 10^9 cells per Liter | Standard Deviation 1.402 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 8, n=210, 272 | 0.022 10^9 cells per Liter | Standard Deviation 0.1464 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 8, n=210, 272 | 0.013 10^9 cells per Liter | Standard Deviation 0.16 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 8, n=210, 272 | 0.001 10^9 cells per Liter | Standard Deviation 0.0153 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 16, n=247, 259 | 0.006 10^9 cells per Liter | Standard Deviation 0.0227 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 24, n=256, 260 | 0.014 10^9 cells per Liter | Standard Deviation 0.0269 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 28, n=239, 258 | 0.016 10^9 cells per Liter | Standard Deviation 0.0251 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 36, n=250, 259 | 0.018 10^9 cells per Liter | Standard Deviation 0.0249 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 44, n=249, 260 | 0.018 10^9 cells per Liter | Standard Deviation 0.0265 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 4, n=277, 270 | 0.013 10^9 cells per Liter | Standard Deviation 0.122 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 12, n=267, 272 | 0.018 10^9 cells per Liter | Standard Deviation 0.1082 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 20, n=247, 259 | 0.027 10^9 cells per Liter | Standard Deviation 0.1288 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 24, n=256, 260 | 0.030 10^9 cells per Liter | Standard Deviation 0.1124 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 28, n=239, 258 | 0.037 10^9 cells per Liter | Standard Deviation 0.1393 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 40, n=244, 245 | 0.035 10^9 cells per Liter | Standard Deviation 0.1155 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 44, n=249, 260 | 0.038 10^9 cells per Liter | Standard Deviation 0.141 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 4, n=279, 272 | 0.42 10^9 cells per Liter | Standard Deviation 1.383 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 20, n=254, 265 | 0.44 10^9 cells per Liter | Standard Deviation 1.48 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 24, n=258, 264 | 0.45 10^9 cells per Liter | Standard Deviation 1.725 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 32, n=253, 266 | 0.42 10^9 cells per Liter | Standard Deviation 1.748 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 20, n=247, 259 | 0.146 10^9 cells per Liter | Standard Deviation 0.5292 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 40, n=244, 245 | 0.054 10^9 cells per Liter | Standard Deviation 0.5106 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 48, n=239, 258 | 0.039 10^9 cells per Liter | Standard Deviation 0.5936 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 36, n=250, 259 | 0.086 10^9 cells per Liter | Standard Deviation 0.1772 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 44, n=249, 260 | 0.057 10^9 cells per Liter | Standard Deviation 0.1558 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 12, n=267, 272 | 0.185 10^9 cells per Liter | Standard Deviation 1.3016 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 16, n=247, 259 | 0.211 10^9 cells per Liter | Standard Deviation 1.4233 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 28, n=239, 258 | 0.221 10^9 cells per Liter | Standard Deviation 1.3274 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 48, n=239, 258 | 0.201 10^9 cells per Liter | Standard Deviation 1.3169 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 4, n=278, 269 | 4.3 10^9 cells per Liter | Standard Deviation 31.11 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 16, n=251, 263 | 9.3 10^9 cells per Liter | Standard Deviation 51.53 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 32, n=249, 262 | 14.6 10^9 cells per Liter | Standard Deviation 34.28 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 16, n=252, 265 | 0.41 10^9 cells per Liter | Standard Deviation 1.621 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 28, n=244, 263 | 0.48 10^9 cells per Liter | Standard Deviation 1.551 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 36, n=252, 259 | 0.52 10^9 cells per Liter | Standard Deviation 1.789 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 40, n=246, 253 | 0.42 10^9 cells per Liter | Standard Deviation 1.614 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 44, n=256, 262 | 0.49 10^9 cells per Liter | Standard Deviation 1.626 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 48, n=243, 260 | 0.29 10^9 cells per Liter | Standard Deviation 1.52 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 4, n=277, 270 | 0.231 10^9 cells per Liter | Standard Deviation 0.5066 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 8, n=210, 272 | 0.155 10^9 cells per Liter | Standard Deviation 0.5088 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 12, n=267, 272 | 0.164 10^9 cells per Liter | Standard Deviation 0.556 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 16, n=247, 259 | 0.158 10^9 cells per Liter | Standard Deviation 0.5246 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 24, n=256, 260 | 0.148 10^9 cells per Liter | Standard Deviation 0.5716 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 28, n=239, 258 | 0.145 10^9 cells per Liter | Standard Deviation 0.5469 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 32, n=246, 263 | 0.129 10^9 cells per Liter | Standard Deviation 0.5812 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 36, n=250, 259 | 0.132 10^9 cells per Liter | Standard Deviation 0.5258 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Lymphocytes, Week 44, n=249, 260 | 0.098 10^9 cells per Liter | Standard Deviation 0.5139 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 4, n=277, 270 | 0.031 10^9 cells per Liter | Standard Deviation 0.1528 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 12, n=267, 272 | 0.018 10^9 cells per Liter | Standard Deviation 0.1613 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 16, n=247, 259 | 0.035 10^9 cells per Liter | Standard Deviation 0.1618 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 20, n=247, 259 | 0.053 10^9 cells per Liter | Standard Deviation 0.179 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 24, n=256, 260 | 0.070 10^9 cells per Liter | Standard Deviation 0.1599 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 28, n=239, 258 | 0.077 10^9 cells per Liter | Standard Deviation 0.1806 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 32, n=246, 263 | 0.088 10^9 cells per Liter | Standard Deviation 0.1841 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 40, n=244, 245 | 0.076 10^9 cells per Liter | Standard Deviation 0.1651 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Monocytes, Week 48, n=239, 258 | 0.031 10^9 cells per Liter | Standard Deviation 0.1389 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 4, n=277, 270 | 0.130 10^9 cells per Liter | Standard Deviation 1.1869 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 8, n=210, 272 | 0.125 10^9 cells per Liter | Standard Deviation 1.2775 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 20, n=247, 259 | 0.217 10^9 cells per Liter | Standard Deviation 1.313 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 24, n=256, 260 | 0.217 10^9 cells per Liter | Standard Deviation 1.4694 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 32, n=246, 263 | 0.175 10^9 cells per Liter | Standard Deviation 1.5009 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 36, n=250, 259 | 0.243 10^9 cells per Liter | Standard Deviation 1.4938 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 40, n=244, 245 | 0.259 10^9 cells per Liter | Standard Deviation 1.4739 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Neutrophils, Week 44, n=249, 260 | 0.273 10^9 cells per Liter | Standard Deviation 1.4445 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 8, n=207, 273 | 2.2 10^9 cells per Liter | Standard Deviation 35.14 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 12, n=269, 271 | 6.2 10^9 cells per Liter | Standard Deviation 36.23 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 20, n=255, 264 | 13.4 10^9 cells per Liter | Standard Deviation 39.24 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 24, n=256, 261 | 14.4 10^9 cells per Liter | Standard Deviation 35.15 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 28, n=245, 258 | 18.4 10^9 cells per Liter | Standard Deviation 38.56 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 36, n=248, 259 | 18.6 10^9 cells per Liter | Standard Deviation 35.81 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 40, n=244, 254 | 17.7 10^9 cells per Liter | Standard Deviation 43.3 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 44, n=254, 261 | 19.3 10^9 cells per Liter | Standard Deviation 47.64 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Platelets, Week 48, n=240, 255 | 16.4 10^9 cells per Liter | Standard Deviation 47.45 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 4, n=277, 270 | 0.002 10^9 cells per Liter | Standard Deviation 0.0155 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 12, n=267, 272 | 0.001 10^9 cells per Liter | Standard Deviation 0.0157 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 20, n=247, 259 | 0.010 10^9 cells per Liter | Standard Deviation 0.0271 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 32, n=246, 263 | 0.017 10^9 cells per Liter | Standard Deviation 0.0227 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 40, n=244, 245 | 0.019 10^9 cells per Liter | Standard Deviation 0.0243 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Basophils, Week 48, n=239, 258 | 0.016 10^9 cells per Liter | Standard Deviation 0.0243 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 8, n=210, 272 | 0.009 10^9 cells per Liter | Standard Deviation 0.1075 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 16, n=247, 259 | 0.022 10^9 cells per Liter | Standard Deviation 0.1262 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 32, n=246, 263 | 0.029 10^9 cells per Liter | Standard Deviation 0.1158 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 36, n=250, 259 | 0.030 10^9 cells per Liter | Standard Deviation 0.1303 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Eosinophils, Week 48, n=239, 258 | 0.030 10^9 cells per Liter | Standard Deviation 0.1183 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 8, n=211, 275 | 0.32 10^9 cells per Liter | Standard Deviation 1.374 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Basophil, Eosinophils, Leukocytes, Lymphocytes, Neutrophils, Monocytes, and Platelets | Leukocytes, Week 12, n=270, 275 | 0.40 10^9 cells per Liter | Standard Deviation 1.465 |
Secondary
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume
Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 20, n=255, 267 | -5.6 Femtoliters | Standard Deviation 2.72 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 24, n=259, 264 | -5.6 Femtoliters | Standard Deviation 2.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 28, n=246, 265 | -5.6 Femtoliters | Standard Deviation 2.97 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 32, n=254, 267 | -5.3 Femtoliters | Standard Deviation 3.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 36, n=252, 261 | -5.3 Femtoliters | Standard Deviation 3 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 40, n=246, 255 | -4.8 Femtoliters | Standard Deviation 3.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 44, n=256, 262 | -4.2 Femtoliters | Standard Deviation 3.12 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 48, n=243, 260 | -3.7 Femtoliters | Standard Deviation 3.12 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 4, n=279, 273 | -0.7 Femtoliters | Standard Deviation 1.66 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 8, n=211, 275 | -2.5 Femtoliters | Standard Deviation 2.33 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 12, n=270, 275 | -3.8 Femtoliters | Standard Deviation 2.49 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 16, n=254, 265 | -5.1 Femtoliters | Standard Deviation 2.63 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 12, n=270, 275 | -0.3 Femtoliters | Standard Deviation 2.48 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 20, n=255, 267 | -0.5 Femtoliters | Standard Deviation 2.55 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 44, n=256, 262 | 0.2 Femtoliters | Standard Deviation 2.81 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 24, n=259, 264 | -0.5 Femtoliters | Standard Deviation 2.58 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 8, n=211, 275 | 0.2 Femtoliters | Standard Deviation 2.06 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 28, n=246, 265 | -0.9 Femtoliters | Standard Deviation 2.52 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 48, n=243, 260 | 1.0 Femtoliters | Standard Deviation 2.93 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 32, n=254, 267 | -0.9 Femtoliters | Standard Deviation 2.55 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 16, n=254, 265 | -0.2 Femtoliters | Standard Deviation 2.65 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 36, n=252, 261 | -0.6 Femtoliters | Standard Deviation 2.45 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 4, n=279, 273 | 0.2 Femtoliters | Standard Deviation 1.56 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume | Week 40, n=246, 255 | -0.1 Femtoliters | Standard Deviation 2.64 |
Secondary
Change From Baseline for Hematology Parameters: Erythrocytes
Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 4, n=279, 273 | 0.08 10^12 cells per Liter | Standard Deviation 0.226 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 8, n=211, 275 | 0.18 10^12 cells per Liter | Standard Deviation 0.249 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 12, n=270, 275 | 0.23 10^12 cells per Liter | Standard Deviation 0.269 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 16, n=254, 265 | 0.30 10^12 cells per Liter | Standard Deviation 0.263 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 20, n=255, 267 | 0.31 10^12 cells per Liter | Standard Deviation 0.272 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 24, n=259, 264 | 0.31 10^12 cells per Liter | Standard Deviation 0.254 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 28, n=246, 265 | 0.29 10^12 cells per Liter | Standard Deviation 0.248 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 32, n=254, 267 | 0.25 10^12 cells per Liter | Standard Deviation 0.283 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 36, n=252, 261 | 0.23 10^12 cells per Liter | Standard Deviation 0.263 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 40, n=246, 255 | 0.23 10^12 cells per Liter | Standard Deviation 0.246 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 44, n=256, 262 | 0.21 10^12 cells per Liter | Standard Deviation 0.234 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Erythrocytes | Week 48, n=243, 260 | 0.16 10^12 cells per Liter | Standard Deviation 0.264 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 44, n=256, 262 | -0.06 10^12 cells per Liter | Standard Deviation 0.243 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 4, n=279, 273 | -0.03 10^12 cells per Liter | Standard Deviation 0.228 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 28, n=246, 265 | 0.04 10^12 cells per Liter | Standard Deviation 0.259 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 8, n=211, 275 | 0.02 10^12 cells per Liter | Standard Deviation 0.239 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 40, n=246, 255 | -0.01 10^12 cells per Liter | Standard Deviation 0.239 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 12, n=270, 275 | 0.01 10^12 cells per Liter | Standard Deviation 0.273 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 32, n=254, 267 | 0.01 10^12 cells per Liter | Standard Deviation 0.259 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 16, n=254, 265 | 0.01 10^12 cells per Liter | Standard Deviation 0.255 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 48, n=243, 260 | -0.06 10^12 cells per Liter | Standard Deviation 0.257 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 20, n=255, 267 | -0.01 10^12 cells per Liter | Standard Deviation 0.242 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 36, n=252, 261 | -0.01 10^12 cells per Liter | Standard Deviation 0.25 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Erythrocytes | Week 24, n=259, 264 | 0.02 10^12 cells per Liter | Standard Deviation 0.242 |
Secondary
Change From Baseline for Hematology Parameters: Hematocrit
Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 4, n=279, 273 | 0.0046 Proportion of red blood cells in blood | Standard Deviation 0.02082 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 28, n=246, 265 | -0.0003 Proportion of red blood cells in blood | Standard Deviation 0.02262 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 12, n=270, 275 | 0.0040 Proportion of red blood cells in blood | Standard Deviation 0.02383 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 32, n=254, 267 | -0.0017 Proportion of red blood cells in blood | Standard Deviation 0.02607 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 16, n=254, 265 | 0.0035 Proportion of red blood cells in blood | Standard Deviation 0.02338 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 36, n=252, 261 | -0.0041 Proportion of red blood cells in blood | Standard Deviation 0.02515 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 40, n=246, 255 | -0.0014 Proportion of red blood cells in blood | Standard Deviation 0.02461 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 20, n=255, 267 | 0.0024 Proportion of red blood cells in blood | Standard Deviation 0.02335 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 44, n=256, 262 | -0.0011 Proportion of red blood cells in blood | Standard Deviation 0.0223 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 8, n=211, 275 | 0.0053 Proportion of red blood cells in blood | Standard Deviation 0.02344 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 48, n=243, 260 | -0.0027 Proportion of red blood cells in blood | Standard Deviation 0.02571 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hematocrit | Week 24, n=259, 264 | 0.0021 Proportion of red blood cells in blood | Standard Deviation 0.02299 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 48, n=243, 260 | -0.0019 Proportion of red blood cells in blood | Standard Deviation 0.02572 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 36, n=252, 261 | -0.0032 Proportion of red blood cells in blood | Standard Deviation 0.02407 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 4, n=279, 273 | -0.0013 Proportion of red blood cells in blood | Standard Deviation 0.02213 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 8, n=211, 275 | 0.0026 Proportion of red blood cells in blood | Standard Deviation 0.02314 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 16, n=254, 265 | -0.0003 Proportion of red blood cells in blood | Standard Deviation 0.02489 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 20, n=255, 267 | -0.0033 Proportion of red blood cells in blood | Standard Deviation 0.02323 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 24, n=259, 264 | -0.0012 Proportion of red blood cells in blood | Standard Deviation 0.02337 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 28, n=246, 265 | -0.0001 Proportion of red blood cells in blood | Standard Deviation 0.0246 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 32, n=254, 267 | -0.0032 Proportion of red blood cells in blood | Standard Deviation 0.02503 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 40, n=246, 255 | -0.0017 Proportion of red blood cells in blood | Standard Deviation 0.02388 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 44, n=256, 262 | -0.0045 Proportion of red blood cells in blood | Standard Deviation 0.02328 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hematocrit | Week 12, n=270, 275 | -0.0000 Proportion of red blood cells in blood | Standard Deviation 0.02618 |
Secondary
Change From Baseline for Hematology Parameters: Hemoglobin
Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 24, n=259, 264 | 2.7 Grams per liter | Standard Deviation 7.32 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 28, n=246, 265 | 2.7 Grams per liter | Standard Deviation 6.8 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 12, n=270, 275 | 2.1 Grams per liter | Standard Deviation 7.47 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 32, n=254, 267 | 2.7 Grams per liter | Standard Deviation 8.08 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 40, n=246, 255 | 3.2 Grams per liter | Standard Deviation 7.91 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 36, n=252, 261 | 2.0 Grams per liter | Standard Deviation 7.93 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 16, n=254, 265 | 2.9 Grams per liter | Standard Deviation 6.98 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 8, n=211, 275 | 1.9 Grams per liter | Standard Deviation 7.29 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 44, n=256, 262 | 2.5 Grams per liter | Standard Deviation 7.66 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 20, n=255, 267 | 2.9 Grams per liter | Standard Deviation 7.43 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 48, n=243, 260 | 1.4 Grams per liter | Standard Deviation 7.98 |
| CAB LA + RPV LA (Q4W) | Change From Baseline for Hematology Parameters: Hemoglobin | Week 4, n=279, 273 | 1.8 Grams per liter | Standard Deviation 6.59 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 48, n=243, 260 | 2.1 Grams per liter | Standard Deviation 8.33 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 4, n=279, 273 | 0.1 Grams per liter | Standard Deviation 6.47 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 8, n=211, 275 | 1.3 Grams per liter | Standard Deviation 7.26 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 12, n=270, 275 | 1.5 Grams per liter | Standard Deviation 8.28 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 16, n=254, 265 | 1.4 Grams per liter | Standard Deviation 7.88 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 20, n=255, 267 | 1.4 Grams per liter | Standard Deviation 7.18 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 28, n=246, 265 | 3.3 Grams per liter | Standard Deviation 7.75 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 32, n=254, 267 | 2.9 Grams per liter | Standard Deviation 7.73 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 36, n=252, 261 | 2.8 Grams per liter | Standard Deviation 7.73 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 40, n=246, 255 | 3.1 Grams per liter | Standard Deviation 7.85 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 44, n=256, 262 | 1.8 Grams per liter | Standard Deviation 7.62 |
| ABC/ DTG/ 3TC | Change From Baseline for Hematology Parameters: Hemoglobin | Week 24, n=259, 264 | 2.0 Grams per liter | Standard Deviation 7.11 |
Secondary
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 20, n=260, 272 | 2.3 International units per liter | Standard Deviation 32.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 48, n=247, 262 | 1.1 International units per liter | Standard Deviation 12.75 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 24, n=261, 268 | 2.8 International units per liter | Standard Deviation 24.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 16, n=255, 269 | -0.1 International units per liter | Standard Deviation 11.31 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 4, n=281, 277 | 3.7 International units per liter | Standard Deviation 49.9 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 8, n=212, 278 | 1.0 International units per liter | Standard Deviation 14.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 32, n=256, 268 | 1.9 International units per liter | Standard Deviation 15.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 12, n=270, 276 | 1.0 International units per liter | Standard Deviation 15.8 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 36, n=255, 261 | 3.3 International units per liter | Standard Deviation 20.31 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 16, n=255, 269 | 1.2 International units per liter | Standard Deviation 16.61 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 40, n=250, 266 | 0.2 International units per liter | Standard Deviation 13.31 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 20, n=260, 272 | 5.3 International units per liter | Standard Deviation 72.8 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 20, n=260, 272 | 1.5 International units per liter | Standard Deviation 10.2 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 24, n=261, 268 | 3.3 International units per liter | Standard Deviation 30 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 4, n=280, 277 | 31.1 International units per liter | Standard Deviation 456.63 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 12, n=270, 276 | 1.2 International units per liter | Standard Deviation 420.32 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 32, n=256, 268 | 18.1 International units per liter | Standard Deviation 293.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 44, n=258, 263 | 1.4 International units per liter | Standard Deviation 11 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 36, n=255, 261 | -0.1 International units per liter | Standard Deviation 14.1 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 16, n=255, 269 | -18.0 International units per liter | Standard Deviation 316.74 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 28, n=253, 268 | 49.9 International units per liter | Standard Deviation 669.37 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 44, n=258, 263 | 1.7 International units per liter | Standard Deviation 27.55 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 28, n=253, 268 | 1.9 International units per liter | Standard Deviation 18.82 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 4, n=281, 277 | 1.5 International units per liter | Standard Deviation 24.47 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 28, n=253, 268 | 1.7 International units per liter | Standard Deviation 15.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 32, n=256, 268 | 14.0 International units per liter | Standard Deviation 233.48 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 36, n=255, 261 | -0.1 International units per liter | Standard Deviation 12.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 24, n=261, 268 | 1.2 International units per liter | Standard Deviation 9.57 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 48, n=247, 262 | -0.2 International units per liter | Standard Deviation 22.91 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 44, n=258, 263 | 1.3 International units per liter | Standard Deviation 16.49 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 8, n=212, 278 | 0.7 International units per liter | Standard Deviation 19.9 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST Week 48, n=247, 262 | -0.8 International units per liter | Standard Deviation 11.88 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 4, n=281, 277 | 0.3 International units per liter | Standard Deviation 11.04 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 8, n=212, 278 | 53.5 International units per liter | Standard Deviation 907.83 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 16, n=255, 269 | 0.8 International units per liter | Standard Deviation 10.34 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 8, n=212, 278 | 0.6 International units per liter | Standard Deviation 10.41 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 20, n=260, 272 | 19.2 International units per liter | Standard Deviation 536.7 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 12, n=270, 276 | -0.3 International units per liter | Standard Deviation 10.74 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 24, n=261, 268 | 47.3 International units per liter | Standard Deviation 635.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 12, n=270, 276 | 1.4 International units per liter | Standard Deviation 12.71 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 28, n=253, 268 | 1.4 International units per liter | Standard Deviation 10.57 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 32, n=256, 268 | -24.5 International units per liter | Standard Deviation 298.7 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 40, n=250, 266 | 0.6 International units per liter | Standard Deviation 17.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 36, n=254, 261 | 14.7 International units per liter | Standard Deviation 515.62 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 40, n=250, 266 | 24.8 International units per liter | Standard Deviation 544.72 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 44, n=258, 263 | 54.8 International units per liter | Standard Deviation 526.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 48, n=247, 262 | -17.8 International units per liter | Standard Deviation 309.33 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 40, n=250, 266 | 1.8 International units per liter | Standard Deviation 9.84 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 48, n=247, 262 | 121.1 International units per liter | Standard Deviation 2682.33 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 44, n=258, 263 | 0.8 International units per liter | Standard Deviation 16.75 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 16, n=255, 269 | -0.3 International units per liter | Standard Deviation 17.99 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 20, n=260, 272 | -1.1 International units per liter | Standard Deviation 17.35 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 24, n=261, 268 | -0.7 International units per liter | Standard Deviation 17.03 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 28, n=253, 268 | 0.6 International units per liter | Standard Deviation 17.28 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 36, n=255, 261 | 1.3 International units per liter | Standard Deviation 20.9 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 44, n=258, 263 | 1.2 International units per liter | Standard Deviation 17.62 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 4, n=281, 277 | -1.6 International units per liter | Standard Deviation 14.58 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 8, n=212, 278 | -2.0 International units per liter | Standard Deviation 14.13 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 12, n=270, 276 | -1.5 International units per liter | Standard Deviation 15.34 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 16, n=255, 269 | 1.0 International units per liter | Standard Deviation 16.68 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 28, n=253, 268 | -0.9 International units per liter | Standard Deviation 16.99 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 32, n=256, 268 | -1.9 International units per liter | Standard Deviation 14.68 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST Week 48, n=247, 262 | 0.8 International units per liter | Standard Deviation 44.7 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 12, n=270, 276 | -17.2 International units per liter | Standard Deviation 605.92 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 36, n=254, 261 | 12.2 International units per liter | Standard Deviation 674.76 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 40, n=250, 266 | -51.7 International units per liter | Standard Deviation 497.7 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 44, n=258, 263 | -20.1 International units per liter | Standard Deviation 652.24 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 48, n=247, 262 | 0.1 International units per liter | Standard Deviation 18.81 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 4, n=281, 277 | -1.3 International units per liter | Standard Deviation 15.74 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 8, n=212, 278 | -0.5 International units per liter | Standard Deviation 17 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 12, n=270, 276 | -0.7 International units per liter | Standard Deviation 17.4 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 32, n=256, 268 | -0.3 International units per liter | Standard Deviation 18.11 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 40, n=250, 266 | 0.7 International units per liter | Standard Deviation 18.5 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALP, Week 48, n=247, 262 | 0.7 International units per liter | Standard Deviation 17.54 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 8, n=212, 278 | -0.9 International units per liter | Standard Deviation 11.86 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 12, n=270, 276 | -0.1 International units per liter | Standard Deviation 13.27 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 16, n=255, 269 | 1.5 International units per liter | Standard Deviation 13.99 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 20, n=260, 272 | 0.2 International units per liter | Standard Deviation 17.04 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 24, n=261, 268 | -0.4 International units per liter | Standard Deviation 12.75 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 28, n=253, 268 | 0.2 International units per liter | Standard Deviation 12.72 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 32, n=256, 268 | -0.4 International units per liter | Standard Deviation 13.08 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 36, n=255, 261 | 1.7 International units per liter | Standard Deviation 32.63 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 40, n=250, 266 | 0.0 International units per liter | Standard Deviation 14.84 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 20, n=260, 272 | 0.2 International units per liter | Standard Deviation 26.46 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 24, n=261, 268 | -1.5 International units per liter | Standard Deviation 16 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 36, n=255, 261 | -0.2 International units per liter | Standard Deviation 22.03 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 40, n=250, 266 | -1.5 International units per liter | Standard Deviation 15.24 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | AST, Week 44, n=258, 263 | -0.5 International units per liter | Standard Deviation 18.31 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 4, n=280, 277 | -27.0 International units per liter | Standard Deviation 523.89 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 8, n=212, 278 | -46.6 International units per liter | Standard Deviation 499.91 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 16, n=255, 269 | 40.2 International units per liter | Standard Deviation 746.32 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 20, n=260, 272 | 57.3 International units per liter | Standard Deviation 1208.73 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 24, n=261, 268 | -19.6 International units per liter | Standard Deviation 605.13 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 28, n=253, 268 | -8.5 International units per liter | Standard Deviation 705.35 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | CK, Week 32, n=256, 268 | -42.5 International units per liter | Standard Deviation 509.77 |
| ABC/ DTG/ 3TC | Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK | ALT, Week 4, n=281, 277 | -1.4 International units per liter | Standard Deviation 11.14 |
Secondary
Change From Baseline in DISWO Using HATQoL
The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Baseline and at Weeks 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in DISWO Using HATQoL | Week 48, n=253, 258 | -3.6 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in DISWO Using HATQoL | Week 24, n=252, 253 | -0.8 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in DISWO Using HATQoL | Week 24, n=252, 253 | 0.5 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in DISWO Using HATQoL | Week 48, n=253, 258 | 1.1 Scores on a scale |
p-value: 0.55295% CI: [-5.7, 3]ANCOVA
p-value: 0.03395% CI: [-8.9, -0.4]ANCOVA
Secondary
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12)
The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Baseline and at Weeks 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | MCS, Week 24, n=251, 253 | -0.045 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | MCS, Week 48, n=252, 258 | -0.013 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | PCS, Week 24, n=251, 253 | -0.019 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | PCS, Week 48, n=252, 258 | -0.294 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | PCS, Week 48, n=252, 258 | -0.126 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | MCS, Week 24, n=251, 253 | -1.066 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | PCS, Week 24, n=251, 253 | -0.201 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) | MCS, Week 48, n=252, 258 | -1.116 Scores on a scale |
p-value: 0.12295% CI: [-0.275, 2.318]ANCOVA
p-value: 0.10995% CI: [-0.248, 2.453]ANCOVA
p-value: 0.64595% CI: [-0.594, 0.958]ANCOVA
p-value: 0.68995% CI: [-0.994, 0.657]ANCOVA
Secondary
Change From Baseline in HIV Medication, MEDWO Using HATQoL
The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Baseline and at Weeks 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in HIV Medication, MEDWO Using HATQoL | Week 24, n=252, 253 | 3.2 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in HIV Medication, MEDWO Using HATQoL | Week 48, n=253, 258 | 1.4 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in HIV Medication, MEDWO Using HATQoL | Week 24, n=252, 253 | 1.4 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in HIV Medication, MEDWO Using HATQoL | Week 48, n=253, 258 | 1.3 Scores on a scale |
p-value: 0.11695% CI: [-0.4, 3.9]ANCOVA
p-value: 0.94495% CI: [-2.3, 2.5]ANCOVA
Secondary
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44
HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline and at Weeks 4b, 24 and 44
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 12; Week 44, n=257, 258 | -0.5 Scores on a scale | Standard Deviation 1.2 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 4; Week 4b, n=257, 0 | 0.1 Scores on a scale | Standard Deviation 1.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 4; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 1.08 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 6; Week 24, n=257, 255 | 0.3 Scores on a scale | Standard Deviation 1.47 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 6; Week 44, n=257, 258 | 0.3 Scores on a scale | Standard Deviation 1.7 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 9; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 0.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 2; Week 4b, n=257, 0 | 0.0 Scores on a scale | Standard Deviation 0.61 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 2; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 0.62 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 3; Week 4b, n=257, 0 | 0.2 Scores on a scale | Standard Deviation 1.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 3; Week 24, n=257, 255 | -0.1 Scores on a scale | Standard Deviation 1.21 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 3; Week 44, n=257, 258 | -0.0 Scores on a scale | Standard Deviation 1.35 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 4; Week 24, n=257, 255 | 0.1 Scores on a scale | Standard Deviation 1.03 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 5; Week 4b, n=257, 0 | 0.1 Scores on a scale | Standard Deviation 0.98 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 5; Week 24, n=257, 255 | 0.4 Scores on a scale | Standard Deviation 1.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 5; Week 44, n=257, 258 | 0.3 Scores on a scale | Standard Deviation 1.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 6; Week 4b, n=257, 0 | 0.1 Scores on a scale | Standard Deviation 1.4 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 7; Week 4b, n=257, 0 | 0.0 Scores on a scale | Standard Deviation 0.83 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 7; Week 24, n=257, 255 | 0.0 Scores on a scale | Standard Deviation 0.79 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 7; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 0.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 8; Week 4b, n=257, 0 | -0.0 Scores on a scale | Standard Deviation 1.06 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 8; Week 24, n=257, 255 | 0.2 Scores on a scale | Standard Deviation 1.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 8; Week 44, n=257, 258 | 0.2 Scores on a scale | Standard Deviation 1.27 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 9; Week 4b, n=257, 0 | -0.1 Scores on a scale | Standard Deviation 0.85 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 9; Week 24, n=257, 255 | 0.0 Scores on a scale | Standard Deviation 0.78 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 10; Week 4b, n=257, 0 | -0.1 Scores on a scale | Standard Deviation 1.16 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 10; Week 24, n=257, 256 | 0.4 Scores on a scale | Standard Deviation 1.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 11; Week 4b, n=257, 0 | -0.0 Scores on a scale | Standard Deviation 1.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 11; Week 24, n=257, 255 | 0.2 Scores on a scale | Standard Deviation 1.18 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 12; Week 24, n=257, 255 | -0.4 Scores on a scale | Standard Deviation 1.26 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 2; Week 44, n=257, 258 | -0.1 Scores on a scale | Standard Deviation 0.61 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 10; Week 44, n=257, 259 | 0.4 Scores on a scale | Standard Deviation 1.33 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 11; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 1.18 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 12; Week 4b, n=257, 0 | -0.0 Scores on a scale | Standard Deviation 0.99 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 1; Week 4b, n=257, 0 | -0.0 Scores on a scale | Standard Deviation 0.91 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 1; Week 24, n=257, 255 | 0.1 Scores on a scale | Standard Deviation 0.96 |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 1; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 1.02 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 10; Week 24, n=257, 256 | -0.1 Scores on a scale | Standard Deviation 1.35 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 9; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 1.01 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 11; Week 24, n=257, 255 | -0.1 Scores on a scale | Standard Deviation 0.99 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 5; Week 24, n=257, 255 | -0.1 Scores on a scale | Standard Deviation 1.05 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 8; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 1.11 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 12; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 1.29 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 5; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 1.06 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 11; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 0.97 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 1; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 0.95 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 6; Week 24, n=257, 255 | -0.1 Scores on a scale | Standard Deviation 1.63 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 1; Week 44, n=257, 258 | 0.0 Scores on a scale | Standard Deviation 0.93 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 6; Week 44, n=257, 258 | 0.2 Scores on a scale | Standard Deviation 1.48 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 8; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 1.16 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 2; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 0.87 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 2; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 0.62 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 12; Week 24, n=257, 255 | 0.1 Scores on a scale | Standard Deviation 1.19 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 7; Week 24, n=257, 255 | 0.0 Scores on a scale | Standard Deviation 1.02 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 3; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 1.16 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 10; Week 44, n=257, 259 | -0.0 Scores on a scale | Standard Deviation 1.2 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 3; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 1.22 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 7; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 0.95 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 4; Week 24, n=257, 255 | -0.0 Scores on a scale | Standard Deviation 1.14 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 4; Week 44, n=257, 258 | 0.1 Scores on a scale | Standard Deviation 1.1 |
| ABC/ DTG/ 3TC | Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 | Item 9; Week 24, n=257, 255 | -0.1 Scores on a scale | Standard Deviation 1.11 |
Secondary
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire
The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:\[100 divided by (20 minus 4)\]\*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Baseline (Day 1) and at Weeks 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | Week 24, n=252, 253 | 0.4 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | Week 48, n=253, 258 | 0.9 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | Week 24, n=252, 253 | -0.8 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire | Week 48, n=253, 258 | 0.0 Scores on a scale |
p-value: 0.30795% CI: [-1.1, 3.6]ANCOVA
p-value: 0.47295% CI: [-1.5, 3.2]ANCOVA
Secondary
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44
HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented.
Time frame: Baseline and at Weeks 4b, 24 and 44
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Week 4b, n=257, 0 | 0.2 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Week 24, n=257, 253 | 1.6 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Week 44, n=257, 256 | 1.3 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Week 24, n=257, 253 | -0.5 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 | Week 44, n=257, 256 | 0.5 Scores on a scale |
p-value: <0.00195% CI: [1, 3.4]ANCOVA
p-value: 0.21795% CI: [-0.4, 1.9]ANCOVA
Secondary
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire
ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100\*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Baseline and at Weeks 8, 24 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 8, n=253, 256 | 3.3 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 24, 255, 261 | 3.7 Scores on a scale |
| CAB LA + RPV LA (Q4W) | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 48, n=255, 262 | 3.0 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 8, n=253, 256 | 1.2 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 24, 255, 261 | 1.1 Scores on a scale |
| ABC/ DTG/ 3TC | Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using General Acceptance Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire | Week 48, n=255, 262 | 0.8 Scores on a scale |
p-value: 0.23295% CI: [-1.4, 5.7]ANCOVA
p-value: 0.15495% CI: [-1, 6.4]ANCOVA
p-value: 0.23695% CI: [-1.4, 5.8]ANCOVA
Secondary
Change From Baseline Values for CD4+ Lymphocyte Count at Week 48
Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value.
Time frame: Baseline (Day 1) and Week 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for CD4+ Lymphocyte Count at Week 48 | 40.2 Cells per cubic millimeter | Standard Deviation 195.17 |
| ABC/ DTG/ 3TC | Change From Baseline Values for CD4+ Lymphocyte Count at Week 48 | 79.9 Cells per cubic millimeter | Standard Deviation 194.55 |
Secondary
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin
Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 28, n=253, 268 | 0.5 Grams per liter | Standard Deviation 2.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 20, n=260, 272 | 0.2 Grams per liter | Standard Deviation 2.51 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 24, n=261, 268 | 0.5 Grams per liter | Standard Deviation 2.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 32, n=255, 268 | 0.7 Grams per liter | Standard Deviation 2.47 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 36, n=254, 261 | 0.3 Grams per liter | Standard Deviation 2.44 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 48, n=247, 262 | 0.7 Grams per liter | Standard Deviation 2.4 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 40, n=250, 266 | 0.9 Grams per liter | Standard Deviation 2.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 44, n=258, 263 | 0.9 Grams per liter | Standard Deviation 2.44 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 4, n=280, 277 | -0.1 Grams per liter | Standard Deviation 2.15 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 8, n=212, 278 | -0.1 Grams per liter | Standard Deviation 2.32 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 16, n=255, 269 | 0.2 Grams per liter | Standard Deviation 2.23 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 12, n=270, 276 | -0.1 Grams per liter | Standard Deviation 2.38 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 16, n=255, 269 | -0.1 Grams per liter | Standard Deviation 2.48 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 12, n=270, 276 | 0.0 Grams per liter | Standard Deviation 2.58 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 40, n=250, 266 | 0.5 Grams per liter | Standard Deviation 2.46 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 8, n=212, 278 | -0.3 Grams per liter | Standard Deviation 2.25 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 24, n=261, 268 | 0.2 Grams per liter | Standard Deviation 2.37 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 28, n=253, 268 | 0.4 Grams per liter | Standard Deviation 2.32 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 48, n=247, 262 | 0.5 Grams per liter | Standard Deviation 2.63 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 32, n=255, 268 | 0.4 Grams per liter | Standard Deviation 2.6 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 20, n=260, 272 | -0.2 Grams per liter | Standard Deviation 2.47 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 36, n=254, 261 | 0.3 Grams per liter | Standard Deviation 2.52 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 44, n=258, 263 | 0.4 Grams per liter | Standard Deviation 2.49 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin | Week 4, n=280, 277 | -0.3 Grams per liter | Standard Deviation 2.14 |
Secondary
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance
Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 4, n=278, 277 | 6.9 mL/min/1.73/m^2 | Standard Deviation 10.16 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 8, n=211, 278 | 10.0 mL/min/1.73/m^2 | Standard Deviation 11.83 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 12, n=270, 276 | 10.7 mL/min/1.73/m^2 | Standard Deviation 11.49 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 16, n=254, 269 | 10.4 mL/min/1.73/m^2 | Standard Deviation 11.28 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 20, n=261, 271 | 10.9 mL/min/1.73/m^2 | Standard Deviation 11.45 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 24, n=261, 268 | 10.5 mL/min/1.73/m^2 | Standard Deviation 11.38 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 28, n=253, 268 | 10.9 mL/min/1.73/m^2 | Standard Deviation 11.9 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 32, n=254, 268 | 10.6 mL/min/1.73/m^2 | Standard Deviation 11.45 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 36, n=254, 262 | 10.3 mL/min/1.73/m^2 | Standard Deviation 11.94 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 40, n=250, 266 | 10.2 mL/min/1.73/m^2 | Standard Deviation 12.57 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 44, n=258, 263 | 9.8 mL/min/1.73/m^2 | Standard Deviation 11.61 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 48, n=247, 261 | 9.5 mL/min/1.73/m^2 | Standard Deviation 11.35 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 24, n=261, 268 | 0.2 mL/min/1.73/m^2 | Standard Deviation 9.63 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 48, n=247, 261 | -0.7 mL/min/1.73/m^2 | Standard Deviation 10.86 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 4, n=278, 277 | -1.2 mL/min/1.73/m^2 | Standard Deviation 8.72 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 36, n=254, 262 | 0.2 mL/min/1.73/m^2 | Standard Deviation 10.08 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 8, n=211, 278 | 0.2 mL/min/1.73/m^2 | Standard Deviation 9.13 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 28, n=253, 268 | 1.0 mL/min/1.73/m^2 | Standard Deviation 9.9 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 12, n=270, 276 | 0.9 mL/min/1.73/m^2 | Standard Deviation 9.83 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 44, n=258, 263 | 1.4 mL/min/1.73/m^2 | Standard Deviation 9.88 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 16, n=254, 269 | -0.3 mL/min/1.73/m^2 | Standard Deviation 10.23 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 32, n=254, 268 | 1.1 mL/min/1.73/m^2 | Standard Deviation 10.05 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 20, n=261, 271 | 0.3 mL/min/1.73/m^2 | Standard Deviation 9.9 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance | Week 40, n=250, 266 | 0.7 mL/min/1.73/m^2 | Standard Deviation 9.19 |
Secondary
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase
Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 8, n=211, 278 | 0.8 Units per liter | Standard Deviation 19.07 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 4, n=278, 276 | 1.6 Units per liter | Standard Deviation 23.51 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 12, n=270, 276 | 1.3 Units per liter | Standard Deviation 18.55 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 16, n=254, 269 | 0.8 Units per liter | Standard Deviation 20.27 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 20, n=260, 270 | 1.6 Units per liter | Standard Deviation 16.26 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 24, n=260, 268 | 0.9 Units per liter | Standard Deviation 18.74 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 28, n=253, 268 | -0.4 Units per liter | Standard Deviation 16.73 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 32, n=254, 268 | 2.9 Units per liter | Standard Deviation 29.88 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 36, n=254, 261 | 1.0 Units per liter | Standard Deviation 17.45 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 40, n=250, 266 | 2.3 Units per liter | Standard Deviation 22.71 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 44, n=258, 263 | 5.7 Units per liter | Standard Deviation 41.87 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 48, n=247, 261 | 0.7 Units per liter | Standard Deviation 16.14 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 44, n=258, 263 | 1.6 Units per liter | Standard Deviation 29.05 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 28, n=253, 268 | 1.8 Units per liter | Standard Deviation 29.09 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 4, n=278, 276 | 1.8 Units per liter | Standard Deviation 30.92 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 8, n=211, 278 | 0.4 Units per liter | Standard Deviation 27.41 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 40, n=250, 266 | 0.6 Units per liter | Standard Deviation 27.95 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 12, n=270, 276 | 2.5 Units per liter | Standard Deviation 29.44 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 32, n=254, 268 | 2.0 Units per liter | Standard Deviation 34.42 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 16, n=254, 269 | 1.2 Units per liter | Standard Deviation 27.24 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 48, n=247, 261 | 1.1 Units per liter | Standard Deviation 32.35 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 20, n=260, 270 | 0.8 Units per liter | Standard Deviation 27.96 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 36, n=254, 261 | -0.1 Units per liter | Standard Deviation 28.89 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase | Week 24, n=260, 268 | 0.9 Units per liter | Standard Deviation 27.58 |
Secondary
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48
Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 12, n=270, 276 | 0.0 Millimoles per liter | Standard Deviation 2.1 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 24, n=261, 268 | 0.09 Millimoles per liter | Standard Deviation 1.459 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 16, n=255, 269 | -0.2 Millimoles per liter | Standard Deviation 2.32 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 28, n=253, 268 | 0.02 Millimoles per liter | Standard Deviation 1.412 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 20, n=260, 272 | -0.3 Millimoles per liter | Standard Deviation 2.49 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 36, n=254, 261 | 0.05 Millimoles per liter | Standard Deviation 1.451 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 24, n=261, 268 | -0.2 Millimoles per liter | Standard Deviation 2.4 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 36, n=253, 261 | 0.7 Millimoles per liter | Standard Deviation 2.54 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 32, n=255, 268 | -0.2 Millimoles per liter | Standard Deviation 2.37 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 36, n=254, 261 | -0.1 Millimoles per liter | Standard Deviation 2.46 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 44, n=258, 263 | 0.3 Millimoles per liter | Standard Deviation 2.3 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 44, n=258, 263 | 0.1 Millimoles per liter | Standard Deviation 2.4 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 4, n=280, 277 | 0.15 Millimoles per liter | Standard Deviation 0.334 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 48, n=247, 262 | 0.2 Millimoles per liter | Standard Deviation 2.11 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 8, n=212, 278 | 0.04 Millimoles per liter | Standard Deviation 1.315 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 32, n=255, 268 | 0.16 Millimoles per liter | Standard Deviation 1.364 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 48, n=247, 262 | 0.0 Millimoles per liter | Standard Deviation 2.23 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 20, n=260, 272 | 0.09 Millimoles per liter | Standard Deviation 0.374 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 8, n=212, 278 | 0.2 Millimoles per liter | Standard Deviation 2.51 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 12, n=270, 276 | -0.010 Millimoles per liter | Standard Deviation 0.1825 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 40, n=250, 266 | 0.07 Millimoles per liter | Standard Deviation 0.347 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 16, n=255, 269 | 0.000 Millimoles per liter | Standard Deviation 0.1789 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 40, n=250, 266 | 0.07 Millimoles per liter | Standard Deviation 1.466 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 12, n=270, 276 | 0.2 Millimoles per liter | Standard Deviation 2.56 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 44, n=258, 263 | 0.12 Millimoles per liter | Standard Deviation 1.361 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 40, n=250, 266 | 0.1 Millimoles per liter | Standard Deviation 2.35 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 48, n=247, 262 | 0.09 Millimoles per liter | Standard Deviation 1.362 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 16, n=255, 269 | 0.4 Millimoles per liter | Standard Deviation 2.55 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 16, n=255, 269 | 0.2 Millimoles per liter | Standard Deviation 2.1 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 24, n=261, 268 | -0.001 Millimoles per liter | Standard Deviation 0.1907 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 20, n=260, 272 | 0.3 Millimoles per liter | Standard Deviation 2.52 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 28, n=253, 268 | -0.007 Millimoles per liter | Standard Deviation 0.1894 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 28, n=253, 268 | -0.2 Millimoles per liter | Standard Deviation 2.21 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 24, n=261, 268 | 0.6 Millimoles per liter | Standard Deviation 2.84 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 36, n=254, 261 | -0.006 Millimoles per liter | Standard Deviation 0.1798 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 32, n=255, 268 | 0.3 Millimoles per liter | Standard Deviation 2.13 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 40, n=250, 266 | -0.011 Millimoles per liter | Standard Deviation 0.1851 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 44, n=258, 263 | -0.004 Millimoles per liter | Standard Deviation 0.1824 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 4, n=279, 277 | 0.032 Millimoles per liter | Standard Deviation 0.1865 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 48, n=247, 262 | -0.007 Millimoles per liter | Standard Deviation 0.1784 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 28, n=253, 268 | 0.5 Millimoles per liter | Standard Deviation 2.51 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 8, n=212, 278 | 0.10 Millimoles per liter | Standard Deviation 0.348 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 16, n=255, 269 | 0.02 Millimoles per liter | Standard Deviation 1.394 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 12, n=270, 276 | 0.09 Millimoles per liter | Standard Deviation 0.352 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 36, n=254, 261 | 0.2 Millimoles per liter | Standard Deviation 2.16 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 16, n=255, 269 | 0.10 Millimoles per liter | Standard Deviation 0.321 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 8, n=212, 278 | -0.016 Millimoles per liter | Standard Deviation 0.1834 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 32, n=255, 268 | 0.5 Millimoles per liter | Standard Deviation 2.72 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 24, n=261, 268 | 0.12 Millimoles per liter | Standard Deviation 0.353 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 40, n=250, 266 | 0.1 Millimoles per liter | Standard Deviation 2.08 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 28, n=253, 268 | 0.08 Millimoles per liter | Standard Deviation 0.341 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 40, n=249, 265 | 0.4 Millimoles per liter | Standard Deviation 2.53 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 32, n=255, 268 | 0.09 Millimoles per liter | Standard Deviation 0.334 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 4, n=280, 276 | 0.6 Millimoles per liter | Standard Deviation 2.67 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 36, n=254, 261 | 0.10 Millimoles per liter | Standard Deviation 0.353 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 4, n=280, 277 | 0.04 Millimoles per liter | Standard Deviation 1.292 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 44, n=258, 263 | 0.08 Millimoles per liter | Standard Deviation 0.353 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 44, n=257, 263 | 0.4 Millimoles per liter | Standard Deviation 2.71 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 48, n=247, 262 | 0.01 Millimoles per liter | Standard Deviation 0.343 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 20, n=260, 272 | -0.029 Millimoles per liter | Standard Deviation 0.1932 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 4, n=280, 277 | 0.3 Millimoles per liter | Standard Deviation 2.25 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 48, n=247, 262 | 0.0 Millimoles per liter | Standard Deviation 2.7 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 8, n=212, 278 | 0.1 Millimoles per liter | Standard Deviation 1.98 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 12, n=270, 276 | -0.01 Millimoles per liter | Standard Deviation 1.287 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 12, n=270, 276 | 0.3 Millimoles per liter | Standard Deviation 1.84 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 4, n=280, 277 | 0.0 Millimoles per liter | Standard Deviation 2.13 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 20, n=260, 272 | -0.07 Millimoles per liter | Standard Deviation 1.359 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 20, n=260, 272 | 0.2 Millimoles per liter | Standard Deviation 2.08 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 8, n=212, 278 | 0.0 Millimoles per liter | Standard Deviation 2.05 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 24, n=261, 268 | 0.2 Millimoles per liter | Standard Deviation 2.02 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 32, n=255, 268 | -0.004 Millimoles per liter | Standard Deviation 0.1806 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 28, n=253, 268 | 0.2 Millimoles per liter | Standard Deviation 1.88 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 32, n=255, 268 | 0.06 Millimoles per liter | Standard Deviation 0.345 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 20, n=260, 272 | 0.1 Millimoles per liter | Standard Deviation 2.38 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 4, n=279, 277 | 0.014 Millimoles per liter | Standard Deviation 0.1771 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 28, n=253, 268 | 0.1 Millimoles per liter | Standard Deviation 2.18 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 32, n=255, 268 | 0.3 Millimoles per liter | Standard Deviation 2.34 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 48, n=247, 262 | 0.3 Millimoles per liter | Standard Deviation 2.09 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 16, n=255, 269 | 0.017 Millimoles per liter | Standard Deviation 0.1892 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 40, n=250, 266 | 0.015 Millimoles per liter | Standard Deviation 0.1753 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 48, n=247, 262 | 0.020 Millimoles per liter | Standard Deviation 0.2333 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 40, n=250, 266 | 0.06 Millimoles per liter | Standard Deviation 0.345 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 28, n=253, 268 | 0.4 Millimoles per liter | Standard Deviation 1.82 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 32, n=255, 268 | 0.3 Millimoles per liter | Standard Deviation 2.02 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 36, n=254, 261 | 0.4 Millimoles per liter | Standard Deviation 1.94 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 48, n=247, 262 | 0.3 Millimoles per liter | Standard Deviation 1.72 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 4, n=280, 277 | -0.05 Millimoles per liter | Standard Deviation 1.24 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 20, n=260, 272 | 0.04 Millimoles per liter | Standard Deviation 1.19 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 36, n=254, 261 | 0.04 Millimoles per liter | Standard Deviation 1.265 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 40, n=250, 266 | 0.4 Millimoles per liter | Standard Deviation 2.13 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 44, n=258, 263 | 0.4 Millimoles per liter | Standard Deviation 2.01 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 4, n=280, 276 | 0.2 Millimoles per liter | Standard Deviation 2.32 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 8, n=212, 278 | -0.1 Millimoles per liter | Standard Deviation 2.24 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 12, n=270, 276 | -0.1 Millimoles per liter | Standard Deviation 2.26 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 16, n=255, 269 | -0.1 Millimoles per liter | Standard Deviation 2.72 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 8, n=212, 278 | -0.05 Millimoles per liter | Standard Deviation 1.278 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 24, n=261, 268 | 0.4 Millimoles per liter | Standard Deviation 2.56 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 12, n=270, 276 | 0.04 Millimoles per liter | Standard Deviation 1.34 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 16, n=255, 269 | 0.01 Millimoles per liter | Standard Deviation 1.171 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 28, n=253, 268 | 0.4 Millimoles per liter | Standard Deviation 2.39 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 32, n=255, 268 | 0.3 Millimoles per liter | Standard Deviation 2.37 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 36, n=253, 261 | 0.2 Millimoles per liter | Standard Deviation 2.35 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 40, n=249, 265 | 0.2 Millimoles per liter | Standard Deviation 2.61 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 44, n=257, 263 | 0.1 Millimoles per liter | Standard Deviation 2.37 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | CO2, Week 48, n=247, 262 | 0.0 Millimoles per liter | Standard Deviation 2.27 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 4, n=280, 277 | 0.5 Millimoles per liter | Standard Deviation 2.17 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 8, n=212, 278 | 0.3 Millimoles per liter | Standard Deviation 2.14 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 12, n=270, 276 | 0.4 Millimoles per liter | Standard Deviation 2.16 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 16, n=255, 269 | 0.3 Millimoles per liter | Standard Deviation 2.39 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 20, n=260, 272 | 0.4 Millimoles per liter | Standard Deviation 2.15 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 24, n=261, 268 | 0.2 Millimoles per liter | Standard Deviation 2.47 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 36, n=254, 261 | 0.4 Millimoles per liter | Standard Deviation 2.37 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 40, n=250, 266 | 0.4 Millimoles per liter | Standard Deviation 2.2 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 24, n=261, 268 | -0.08 Millimoles per liter | Standard Deviation 1.154 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Chloride, Week 44, n=258, 263 | 0.7 Millimoles per liter | Standard Deviation 2.23 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 28, n=253, 268 | 0.02 Millimoles per liter | Standard Deviation 1.23 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 32, n=255, 268 | -0.03 Millimoles per liter | Standard Deviation 1.33 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 8, n=212, 278 | 0.017 Millimoles per liter | Standard Deviation 0.1855 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 12, n=270, 276 | 0.009 Millimoles per liter | Standard Deviation 0.1772 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 40, n=250, 266 | 0.05 Millimoles per liter | Standard Deviation 1.312 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 44, n=258, 263 | 0.03 Millimoles per liter | Standard Deviation 1.29 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Urea, Week 48, n=247, 262 | 0.06 Millimoles per liter | Standard Deviation 2.189 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 20, n=260, 272 | 0.016 Millimoles per liter | Standard Deviation 0.1764 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 24, n=261, 268 | 0.011 Millimoles per liter | Standard Deviation 0.1852 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 28, n=253, 268 | 0.019 Millimoles per liter | Standard Deviation 0.1882 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 32, n=255, 268 | 0.005 Millimoles per liter | Standard Deviation 0.2092 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 36, n=254, 261 | 0.021 Millimoles per liter | Standard Deviation 0.1965 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Phosphate, Week 44, n=258, 263 | 0.020 Millimoles per liter | Standard Deviation 0.1801 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 4, n=280, 277 | 0.06 Millimoles per liter | Standard Deviation 0.368 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 8, n=212, 278 | 0.08 Millimoles per liter | Standard Deviation 0.346 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 12, n=270, 276 | 0.05 Millimoles per liter | Standard Deviation 0.305 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 16, n=255, 269 | 0.04 Millimoles per liter | Standard Deviation 0.314 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 20, n=260, 272 | 0.04 Millimoles per liter | Standard Deviation 0.364 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 24, n=261, 268 | 0.07 Millimoles per liter | Standard Deviation 0.309 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 28, n=253, 268 | 0.08 Millimoles per liter | Standard Deviation 0.35 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 36, n=254, 261 | 0.08 Millimoles per liter | Standard Deviation 0.347 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 44, n=258, 263 | 0.06 Millimoles per liter | Standard Deviation 0.338 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Potassium, Week 48, n=247, 262 | 0.03 Millimoles per liter | Standard Deviation 0.496 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 4, n=280, 277 | 0.2 Millimoles per liter | Standard Deviation 1.95 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 8, n=212, 278 | 0.1 Millimoles per liter | Standard Deviation 1.92 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 12, n=270, 276 | 0.1 Millimoles per liter | Standard Deviation 1.89 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 16, n=255, 269 | 0.3 Millimoles per liter | Standard Deviation 2.21 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 20, n=260, 272 | 0.4 Millimoles per liter | Standard Deviation 1.79 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 | Sodium, Week 24, n=261, 268 | 0.2 Millimoles per liter | Standard Deviation 2.12 |
Secondary
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine
Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 8, n=212, 278 | -9.25 Micromoles per liter | Standard Deviation 9.936 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 32, n=256, 268 | 1.3 Micromoles per liter | Standard Deviation 6.44 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 48, n=247, 262 | 1.1 Micromoles per liter | Standard Deviation 4.18 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 8, n=212, 278 | 0.9 Micromoles per liter | Standard Deviation 4.04 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 12, n=270, 276 | 1.2 Micromoles per liter | Standard Deviation 4.15 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 16, n=255, 269 | 1.2 Micromoles per liter | Standard Deviation 4.3 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 20, n=260, 272 | 1.1 Micromoles per liter | Standard Deviation 4.14 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 24, n=261, 268 | 0.8 Micromoles per liter | Standard Deviation 4.12 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 28, n=253, 268 | 1.2 Micromoles per liter | Standard Deviation 4.41 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 36, n=255, 260 | 0.6 Micromoles per liter | Standard Deviation 5.36 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 40, n=250, 266 | 0.9 Micromoles per liter | Standard Deviation 4.31 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 44, n=258, 263 | 1.2 Micromoles per liter | Standard Deviation 4.34 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 4, n=277, 277 | 0.2 Micromoles per liter | Standard Deviation 1.4 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 8, n=212, 278 | 0.2 Micromoles per liter | Standard Deviation 1.3 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 12, n=269, 273 | 0.2 Micromoles per liter | Standard Deviation 1.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 16, n=254, 268 | 0.2 Micromoles per liter | Standard Deviation 1.44 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 20, n=260, 272 | 0.2 Micromoles per liter | Standard Deviation 1.57 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 24, n=260, 266 | 0.1 Micromoles per liter | Standard Deviation 1.46 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 28, n=253, 268 | 0.2 Micromoles per liter | Standard Deviation 1.26 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 32, n=256, 268 | 0.3 Micromoles per liter | Standard Deviation 3.39 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 36, n=255, 260 | 0.1 Micromoles per liter | Standard Deviation 2.18 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 40, n=249, 266 | 0.1 Micromoles per liter | Standard Deviation 1.42 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 44, n=258, 263 | 0.2 Micromoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 48, n=247, 262 | 0.0 Micromoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 4, n=280, 277 | -6.07 Micromoles per liter | Standard Deviation 9.696 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 4, n=281, 277 | 1.4 Micromoles per liter | Standard Deviation 4.74 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 12, n=270, 276 | -9.89 Micromoles per liter | Standard Deviation 9.703 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 16, n=255, 269 | -9.75 Micromoles per liter | Standard Deviation 9.572 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 20, n=261, 272 | -10.10 Micromoles per liter | Standard Deviation 9.839 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 24, n=262, 268 | -9.73 Micromoles per liter | Standard Deviation 9.499 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 28, n=253, 268 | -10.34 Micromoles per liter | Standard Deviation 9.731 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 32, n=255, 268 | -9.77 Micromoles per liter | Standard Deviation 9.166 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 36, n=254, 262 | -9.57 Micromoles per liter | Standard Deviation 9.712 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 40, n=250, 266 | -9.60 Micromoles per liter | Standard Deviation 10.656 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 44, n=258, 263 | -9.02 Micromoles per liter | Standard Deviation 9.562 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 48, n=247, 262 | -8.97 Micromoles per liter | Standard Deviation 9.742 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 16, n=254, 268 | -0.1 Micromoles per liter | Standard Deviation 1.14 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 16, n=255, 269 | -0.3 Micromoles per liter | Standard Deviation 3.61 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 20, n=260, 272 | -0.7 Micromoles per liter | Standard Deviation 4.02 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 28, n=253, 268 | -0.7 Micromoles per liter | Standard Deviation 3.75 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 4, n=280, 277 | 0.61 Micromoles per liter | Standard Deviation 7.635 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 32, n=256, 268 | -0.6 Micromoles per liter | Standard Deviation 4.05 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 40, n=250, 266 | -1.10 Micromoles per liter | Standard Deviation 7.875 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 20, n=260, 272 | -0.1 Micromoles per liter | Standard Deviation 1.14 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 36, n=255, 260 | -0.1 Micromoles per liter | Standard Deviation 1.16 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 24, n=262, 268 | -0.75 Micromoles per liter | Standard Deviation 8.327 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 32, n=255, 268 | -1.26 Micromoles per liter | Standard Deviation 9.243 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 44, n=258, 263 | -1.91 Micromoles per liter | Standard Deviation 8.306 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 4, n=281, 277 | -0.3 Micromoles per liter | Standard Deviation 3.77 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 24, n=260, 266 | -0.1 Micromoles per liter | Standard Deviation 1.1 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 8, n=212, 278 | -0.5 Micromoles per liter | Standard Deviation 4.17 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 8, n=212, 278 | -0.24 Micromoles per liter | Standard Deviation 8.838 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 12, n=270, 276 | -0.7 Micromoles per liter | Standard Deviation 4.51 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 28, n=253, 268 | -0.1 Micromoles per liter | Standard Deviation 1.22 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 36, n=254, 262 | -0.74 Micromoles per liter | Standard Deviation 8.565 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 32, n=256, 268 | -0.1 Micromoles per liter | Standard Deviation 1.08 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 24, n=261, 268 | -0.4 Micromoles per liter | Standard Deviation 3.85 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 12, n=270, 276 | -1.20 Micromoles per liter | Standard Deviation 8.71 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 28, n=253, 268 | -1.33 Micromoles per liter | Standard Deviation 8.892 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 36, n=255, 260 | -0.7 Micromoles per liter | Standard Deviation 4.28 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 40, n=249, 266 | -0.1 Micromoles per liter | Standard Deviation 1.26 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 40, n=250, 266 | -0.8 Micromoles per liter | Standard Deviation 4.32 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 4, n=277, 277 | -0.1 Micromoles per liter | Standard Deviation 1.33 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 16, n=255, 269 | -0.33 Micromoles per liter | Standard Deviation 8.964 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 44, n=258, 263 | -0.4 Micromoles per liter | Standard Deviation 4.28 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Bilirubin, Week 48, n=247, 262 | -0.3 Micromoles per liter | Standard Deviation 4.17 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 44, n=258, 263 | -0.1 Micromoles per liter | Standard Deviation 1.19 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 48, n=247, 262 | 5.00 Micromoles per liter | Standard Deviation 85.535 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 8, n=212, 278 | -0.1 Micromoles per liter | Standard Deviation 1.19 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 48, n=247, 262 | 0.0 Micromoles per liter | Standard Deviation 1.19 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Direct bilirubin, Week 12, n=269, 273 | 0.0 Micromoles per liter | Standard Deviation 1.22 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine | Creatinine, Week 20, n=261, 272 | -0.68 Micromoles per liter | Standard Deviation 8.7 |
Secondary
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48
Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value.
Time frame: Baseline (Day 1) and at Week 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Glucose, Week 48, n=248, 251 | 0.02 Millimoles per liter | Standard Deviation 1.22 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Total Cholesterol, Week 48, n=240, 239 | 0.09 Millimoles per liter | Standard Deviation 0.658 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Triglycerides, Week 48, n=240, 239 | -0.085 Millimoles per liter | Standard Deviation 0.7167 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | HDL cholesterol, Week 48, n=240, 239 | 0.109 Millimoles per liter | Standard Deviation 0.2587 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | LDL cholesterol, Week 48, n=238, 237 | 0.122 Millimoles per liter | Standard Deviation 0.5807 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | LDL cholesterol, Week 48, n=238, 237 | -0.045 Millimoles per liter | Standard Deviation 0.5384 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Glucose, Week 48, n=248, 251 | 0.04 Millimoles per liter | Standard Deviation 0.923 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | HDL cholesterol, Week 48, n=240, 239 | 0.076 Millimoles per liter | Standard Deviation 0.2478 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Triglycerides, Week 48, n=240, 239 | 0.073 Millimoles per liter | Standard Deviation 0.8361 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 | Total Cholesterol, Week 48, n=240, 239 | 0.05 Millimoles per liter | Standard Deviation 0.607 |
Secondary
Change From Baseline Values for Plasma HIV-1 RNA at Week 48
Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline.
Time frame: Baseline (Day 1) and at Week 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values for Plasma HIV-1 RNA at Week 48 | -0.006 log10 copies/mL | Standard Deviation 0.1026 |
| ABC/ DTG/ 3TC | Change From Baseline Values for Plasma HIV-1 RNA at Week 48 | 0.001 log10 copies/mL | Standard Deviation 0.1435 |
Secondary
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48
Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 4, n=211, 215 | -0.16 Grams per mole | Standard Deviation 18.641 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 24,n=137, 184 | 0.30 Grams per mole | Standard Deviation 4.941 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 24, n=151, 204 | 2.23 Grams per mole | Standard Deviation 35.187 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 4,n=199, 194 | 0.36 Grams per mole | Standard Deviation 6.714 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 48, n=194, 197 | -1.86 Grams per mole | Standard Deviation 21.898 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 48,n=181, 184 | -0.53 Grams per mole | Standard Deviation 17.469 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 48, n=194, 197 | 0.26 Grams per mole | Standard Deviation 8.18 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 4,n=199, 194 | 0.23 Grams per mole | Standard Deviation 4.062 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 24,n=137, 184 | 1.06 Grams per mole | Standard Deviation 7.186 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 4, n=211, 215 | 0.19 Grams per mole | Standard Deviation 6.439 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine protein/creatinine, Week 24, n=151, 204 | 1.32 Grams per mole | Standard Deviation 12.171 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 | Urine albumin/creatinine ratio, Week 48,n=181, 184 | 0.19 Grams per mole | Standard Deviation 3.944 |
Secondary
Change From Baseline Values in Urine Creatinine Over Time Including Week 48
Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 48, n=260, 258 | -1359.2 Micromoles per liter | Standard Deviation 9059.43 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 4, n=277, 272 | -519.5 Micromoles per liter | Standard Deviation 9558.55 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 24, n=193, 258 | -597.4 Micromoles per liter | Standard Deviation 9405.95 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 24, n=193, 258 | -17.1 Micromoles per liter | Standard Deviation 9575.04 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 48, n=260, 258 | -505.4 Micromoles per liter | Standard Deviation 8873.05 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Creatinine Over Time Including Week 48 | Week 4, n=277, 272 | -429.0 Micromoles per liter | Standard Deviation 9540.31 |
Secondary
Change From Baseline Values in Urine Phosphate Over Time Including Week 48
Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 4, n=275, 273 | 1.842 Micromoles per liter | Standard Deviation 18.4414 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 24, n=192, 260 | 0.585 Micromoles per liter | Standard Deviation 19.2777 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 48, n=259, 258 | 0.043 Micromoles per liter | Standard Deviation 17.3741 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 4, n=275, 273 | -0.693 Micromoles per liter | Standard Deviation 18.483 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 24, n=192, 260 | -0.689 Micromoles per liter | Standard Deviation 16.95 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Phosphate Over Time Including Week 48 | Week 48, n=259, 258 | 0.304 Micromoles per liter | Standard Deviation 16.7073 |
Secondary
Change From Baseline Values in Urine pH Over Time Including Week 48
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 4, n=271, 266 | 0.12 pH | Standard Deviation 0.833 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 24, n=191, 252 | -0.01 pH | Standard Deviation 0.889 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 48, n=255, 252 | 0.01 pH | Standard Deviation 0.926 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 48, n=255, 252 | -0.10 pH | Standard Deviation 0.988 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 4, n=271, 266 | 0.01 pH | Standard Deviation 0.884 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine pH Over Time Including Week 48 | Week 24, n=191, 252 | -0.07 pH | Standard Deviation 0.91 |
Secondary
Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48
Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.
Time frame: Baseline (Day 1) and at Week 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48 | -0.33 Nanomoles per liter | Standard Deviation 0.938 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48 | -0.24 Nanomoles per liter | Standard Deviation 0.932 |
Secondary
Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48
Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 4, n=271, 266 | -0.0004 Ratio of urine density to water density | Standard Deviation 0.00837 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 24, n=191, 252 | -0.0001 Ratio of urine density to water density | Standard Deviation 0.00805 |
| CAB LA + RPV LA (Q4W) | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 48, n=255, 252 | -0.0009 Ratio of urine density to water density | Standard Deviation 0.00784 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 24, n=191, 252 | -0.0002 Ratio of urine density to water density | Standard Deviation 0.00825 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 4, n=271, 266 | -0.0005 Ratio of urine density to water density | Standard Deviation 0.00798 |
| ABC/ DTG/ 3TC | Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 | Week 48, n=255, 252 | -0.0007 Ratio of urine density to water density | Standard Deviation 0.00783 |
Secondary
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF)
PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis
Time frame: Weeks 5 and at Weeks 41 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Leg movement, Week 41 | -0.58 Scores on a scale | Standard Deviation 0.88 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Acceptance, Week 41 | -0.36 Scores on a scale | Standard Deviation 0.959 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Bother of ISRs, Week 41 | -0.14 Scores on a scale | Standard Deviation 0.551 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Bother of ISRs, Week 48 | -0.14 Scores on a scale | Standard Deviation 0.639 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Leg movement, Week 48 | -0.63 Scores on a scale | Standard Deviation 0.964 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Sleep, Week 41 | -0.57 Scores on a scale | Standard Deviation 0.925 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Sleep, Week 48 | -0.58 Scores on a scale | Standard Deviation 1.033 |
| CAB LA + RPV LA (Q4W) | Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) | Acceptance, Week 48 | -0.40 Scores on a scale | Standard Deviation 0.943 |
p-value: <0.001Wilcoxon (Mann-Whitney)
Secondary
Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48
HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.
Time frame: Week 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48 | 29.6 Scores on a scale | Standard Error 0.49 |
| ABC/ DTG/ 3TC | Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48 | 25.5 Scores on a scale | Standard Error 0.48 |
p-value: <0.00195% CI: [2.8, 5.5]ANOVA
Secondary
Cmax in Plasma for RPV LA Evaluable at Week 41
Blood samples will be collected at indicated time points for PK analysis of RPV LA.
Time frame: Week 41- 1 Week post dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Cmax in Plasma for RPV LA Evaluable at Week 41 | 106.3 Nanograms per milliliter |
Secondary
Ctrough for RPV LA Evaluable
Blood samples were collected at indicated time points for PK analysis of RPV LA.
Time frame: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 8, n=251 | 41.23 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 12, n=236 | 46.86 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 16, n=217 | 50.01 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 20, n=233 | 52.76 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 24, n=228 | 55.56 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 28, n=220 | 59.46 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 32, n=220 | 66.88 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 36, n=215 | 69.09 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 40, n=210 | 75.71 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 44, n=216 | 77.96 Nanograms per milliliter |
| CAB LA + RPV LA (Q4W) | Ctrough for RPV LA Evaluable | Pre-dose, Week 48, n=197 | 82.38 Nanograms per milliliter |
Secondary
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41
Blood samples will be collected at indicated time points for PK analysis of CAB LA.
Time frame: Week 41- 1 Week post dose
Population: PK Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41 | 4.0334 Micrograms per milliliter |
Secondary
Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.
Time frame: Up to Week 48
Population: Safety Population.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48 | 4 Participants |
Secondary
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48
The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 2+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 1+, n=276, 276 | 15 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), Trace, n=282, 282 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 3+, n=282, 282 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), Trace, n=276, 276 | 30 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 1+, n=276, 276 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 2+, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 1+, n=276, 276 | 12 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 2+, n=276, 276 | 9 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 3+, n=276, 276 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, Trace, n=276, 276 | 13 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 2+, n=276, 276 | 6 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 3+, n=276, 276 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, Trace, n=276, 276 | 25 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 1+, n=276, 276 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 2+, n=276, 276 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 3+, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, Trace, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 1+, n=278, 272 | 14 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 2+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, Trace, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 1+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, Trace, n=278, 272 | 20 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 3+, n=278, 272 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, Trace,n=278, 272 | 19 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 2+, n=278, 272 | 6 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 3+, n=278, 272 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 4, positive, n=278, 272 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 1+, n=278, 272 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 2+, n=278, 272 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 3+, n=195, 258 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, Trace, n=195, 258 | 13 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase,Week 24, Trace,n=195, 258 | 15 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 24, positive, n=195, 258 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, Trace, n=195, 258 | 9 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 1+, n=195, 258 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 2+, n=195, 258 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 3+, n=195, 258 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, Trace, n=195, 258 | 11 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 1+, n=195, 258 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 2+, n=195, 258 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 2+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 2+, n=261, 259 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 48, positive, n=261, 259 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, Trace, n=261, 259 | 14 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 1+, n=261, 259 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 2+, n=261, 259 | 6 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 3+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, Trace, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 1+, n=261, 259 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 2+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 3+, n=261, 259 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, Trace, n=261, 259 | 12 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 1+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 2+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 3+, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48,Trace,n=261, 259 | 12 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 1+, n=261, 259 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin,Baseline (Day 1),Trace, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 2+, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 3+, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 1+, n=282, 282 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 2+, n=282, 282 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 3+, n=276, 276 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase,Baseline,Trace,n=276, 276 | 22 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Baseline, positive, n=276, 276 | 6 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 1+, n=276, 276 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 3+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 2+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 3+, n=278, 272 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 1+, n=278, 272 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 1+, n=278, 272 | 9 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, Trace, n=278, 272 | 11 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 1+, n=278, 272 | 8 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 2+, n=278, 272 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 3+, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, Trace, n=278, 272 | 12 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, 3+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 3+, n=278, 272 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, Trace, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, 1+, n=195, 258 | 7 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | , Urine bilirubin, Week 24, 2+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, Trace, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 1+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 1+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 2+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 2+, n=195, 258 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 3+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 1+, n=195, 258 | 8 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 2+, n=195, 258 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 3+, n=195, 258 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 3+, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, Trace, n=261, 259 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 1+, n=261, 259 | 9 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 3+, n=261, 259 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, Trace, n=261, 259 | 9 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 1+, n=261, 259 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 2+, n=261, 259 | 8 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 3+, n=261, 259 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 3+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, Trace, n=278, 272 | 13 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 3+, n=261, 259 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 1+, n=276, 276 | 22 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 2+, n=276, 276 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Baseline (Day 1), 3+, n=276, 276 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 2+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), Trace, n=282, 282 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 2+, n=282, 282 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, Trace, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 3+, n=282, 282 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 2+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), Trace, n=276, 276 | 29 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 1+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 1+, n=276, 276 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 2+, n=278, 272 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 2+, n=276, 276 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 2+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 1+, n=276, 276 | 14 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, Trace, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 2+, n=276, 276 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 48, 3+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Baseline, 3+, n=276, 276 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Baseline, positive, n=276, 276 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 3+, n=278, 272 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, Trace, n=276, 276 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, Trace, n=261, 259 | 13 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 3+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 3+, n=276, 276 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 2+, n=261, 259 | 7 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, Trace, n=276, 276 | 20 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 1+, n=261, 259 | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 1+, n=276, 276 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase,Week 24, Trace,n=195, 258 | 28 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 2+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 3+, n=276, 276 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, 3+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, Trace, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 48, 3+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 1+, n=278, 272 | 28 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 1+, n=278, 272 | 11 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 2+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 4, 3+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48,Trace,n=261, 259 | 15 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, Trace, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 2+, n=278, 272 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 1+, n=278, 272 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 2+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 4, 3+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 2+, n=276, 276 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 1+, n=278, 272 | 5 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin,Baseline (Day 1),Trace, n=276, 276 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 2+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 1+, n=261, 259 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, 3+, n=278, 272 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, 3+, n=278, 272 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, Trace,n=278, 272 | 23 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 1+, n=278, 272 | 17 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 1+, n=195, 258 | 12 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, Trace, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Baseline (Day 1), 1+, n=282, 282 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 4, 1+, n=278, 272 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 4, Trace, n=278, 272 | 24 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 1+, n=261, 259 | 8 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Baseline, 2+, n=276, 276 | 7 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 24, 1+, n=195, 258 | 14 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | , Urine bilirubin, Week 24, 2+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 1+, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 2+, n=195, 258 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Baseline (Day 1), 3+, n=276, 276 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 3+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 24, 3+, n=195, 258 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase,Baseline,Trace,n=276, 276 | 21 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 24, positive, n=195, 258 | 5 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, Trace, n=195, 258 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, Trace, n=195, 258 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 2+, n=195, 258 | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 1+, n=195, 258 | 8 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine glucose, Week 24, 3+, n=195, 258 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 2+, n=195, 258 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, Trace, n=195, 258 | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 24, 3+, n=195, 258 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, Trace, n=261, 259 | 8 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, Trace, n=195, 258 | 21 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Baseline, 1+, n=276, 276 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 1+, n=195, 258 | 7 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 4, Trace, n=278, 272 | 21 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine ketones, Week 24, 1+, n=195, 258 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 1+, n=261, 259 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 24, 3+, n=195, 258 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 48, 3+, n=261, 259 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 2+, n=278, 272 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 48, positive, n=261, 259 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 2+, n=261, 259 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine occult blood, Week 48, 3+, n=261, 259 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine leukocyte esterase, Week 4, 3+, n=278, 272 | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine nitrite, Week 4, positive, n=278, 272 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, Trace, n=261, 259 | 23 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine protein, Week 48, 2+, n=261, 259 | 6 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 1+, n=261, 259 | 12 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 | Urine bilirubin, Week 48, 2+, n=261, 259 | 0 Participants |
Secondary
Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase
The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase | 3 Participants |
Secondary
Number of Participants With Disease Progression
Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).
Time frame: Day 1 up to an average of 59 weeks
Population: ITT-E Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Disease Progression | 9 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Disease Progression | 11 Participants |
Secondary
Number of Participants With Genotypic Resistance Through Week 48
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.
Time frame: Week 48
Population: CVF Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, resistance possible | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, resistance possible | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, sensitive | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, 3TC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, 3TC, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, 3TC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, EFV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, EFV, resistance possible | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, EFV, sensitive | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, resistant | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, resistance possible | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, resistance possible | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, sensitive | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, 3TC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, DTG, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, EVG, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, RAL, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, DLV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, EFV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | INI, EFV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, EFV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, ETR, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, RPV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, 3TC, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, 3TC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ABC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, FTC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, TDF, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ZDV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, d4T, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NRTI, ddI, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, ATV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, DRV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, FPV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, IDV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, LPV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, NFV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, RTV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, SQV/r, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | PI, TPV/r, resistance possible | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Genotypic Resistance Through Week 48 | NNRTI, NVP, sensitive | 3 Participants |
Secondary
Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48
Percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48 | 94 Percentage of Participants |
| ABC/ DTG/ 3TC | Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48 | 94 Percentage of Participants |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in \>=5% of participants within any arm is reported
Time frame: Day 1 up to an average of 59 Weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Any non-SAE | 252 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Any SAE | 18 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Any non-SAE | 138 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) | Any SAE | 12 Participants |
Secondary
Number of Participants With Phenotypic Resistance Through Week 48
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC\>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and \> clinical lower cutoff),sensitive(FC\<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria
Time frame: Week 48
Population: CVF Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, sensitive | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, resistant | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, resistant | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, resistant | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, resistant | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, sensitive | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, partially sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, resistant | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, sensitive | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, partially sensitive | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, resistant | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, sensitive | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, partially sensitive | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, DTG, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, LPV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, EFV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ZDV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, RPV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, NFV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, d4T, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, TDF, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, CAB, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, ETR, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, RTV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ddI, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, ABC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, ATV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, EVG, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, SQV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, DRV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, 3TC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, NVP, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, FPV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | INI, RAL, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, TPV, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, sensitive | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NRTI, FTC, resistant | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | NNRTI, DLV, partially sensitive | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Phenotypic Resistance Through Week 48 | PI, IDV, resistant | 0 Participants |
Secondary
Number of Participants With Severity of Adverse Events
Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.
Time frame: Up to Week 48
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Severity of Adverse Events | Grade 2 | 143 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Severity of Adverse Events | Grade 3 | 23 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Severity of Adverse Events | Grade 4 | 8 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Severity of Adverse Events | Grade 5 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Severity of Adverse Events | Grade 1 | 93 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Severity of Adverse Events | Grade 1 | 119 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Severity of Adverse Events | Grade 5 | 0 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Severity of Adverse Events | Grade 3 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Severity of Adverse Events | Grade 2 | 95 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Severity of Adverse Events | Grade 4 | 1 Participants |
Secondary
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48
Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0).
Time frame: Baseline (Day 1) and at Weeks 4, 24 and 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=7, n=195, 258 | 22 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=7, n=261, 259 | 24 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=5.5, n=276, 276 | 104 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=5.5, n=278, 272 | 83 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=7.5, n=195, 258 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=6.5, n=276, 276 | 29 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=7, n=278, 272 | 25 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=7, n=276, 276 | 27 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=8, n=276, 276 | 4 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=8, n=195, 258 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH>9.0, n=276, 276 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=8.5, n=276, 276 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=6, n=278, 272 | 68 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=8.5, n=195, 258 | 3 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=6.5, n=278, 272 | 48 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=7.5, n=278, 272 | 10 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=8, n=278, 272 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH>9.0, n=195, 258 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=8.5, n=278, 272 | 6 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=6, n=276, 276 | 66 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH>9.0, n=278, 272 | 0 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=5, n=261, 259 | 54 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=5.5, n=195, 258 | 55 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=5, n=195, 258 | 42 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=6, n=195, 258 | 47 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=6.5, n=195, 258 | 19 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=5.5, n=261, 259 | 81 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=5, n=278, 272 | 33 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=7.5, n=261, 259 | 14 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=6, n=261, 259 | 50 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=8, n=261, 259 | 5 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=7.5, n=276, 276 | 7 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=8.5, n=261, 259 | 2 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=6.5, n=261, 259 | 30 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH>9.0, n=261, 259 | 1 Participants |
| CAB LA + RPV LA (Q4W) | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=5, n=276, 276 | 36 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH>9.0, n=261, 259 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=5, n=276, 276 | 32 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=7, n=276, 276 | 27 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=7.5, n=276, 276 | 12 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=8, n=276, 276 | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH>9.0, n=276, 276 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=5, n=278, 272 | 41 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=7, n=278, 272 | 22 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=7.5, n=278, 272 | 12 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=5, n=195, 258 | 50 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=6, n=195, 258 | 51 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=7, n=195, 258 | 16 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=7.5, n=195, 258 | 13 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=8, n=195, 258 | 2 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=8.5, n=195, 258 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH>9.0, n=195, 258 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=5, n=261, 259 | 57 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=5.5, n=261, 259 | 77 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=6, n=261, 259 | 61 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=6.5, n=261, 259 | 27 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=5.5, n=276, 276 | 101 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=6, n=276, 276 | 62 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=6.5, n=276, 276 | 35 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Baseline (Day 1), pH=8.5, n=276, 276 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=5.5, n=278, 272 | 81 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=6, n=278, 272 | 71 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=6.5, n=278, 272 | 36 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=8, n=278, 272 | 5 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH=8.5, n=278, 272 | 1 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 4, pH>9.0, n=278, 272 | 3 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=5.5, n=195, 258 | 78 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 24, pH=6.5, n=195, 258 | 46 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=7, n=261, 259 | 18 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=7.5, n=261, 259 | 10 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=8, n=261, 259 | 4 Participants |
| ABC/ DTG/ 3TC | Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 | Week 48, pH=8.5, n=261, 259 | 3 Participants |
Secondary
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48
Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100.
Time frame: Baseline (Day 1) and at Week 48
Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Cholesterol, Week 48, Overall, n=240, 239 | 5.09 Millimoles per liter | Standard Deviation 15.695 |
| CAB LA + RPV LA (Q4W) | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | HDL cholesterol, Week 48, Overall, n=240, 239 | 15.448 Millimoles per liter | Standard Deviation 78.5208 |
| CAB LA + RPV LA (Q4W) | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | LDL cholesterol, Week 48, Overall, n=238, 237 | 7.048 Millimoles per liter | Standard Deviation 29.2139 |
| CAB LA + RPV LA (Q4W) | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Triglycerides, Week 48, Overall, n=240, 239 | 2.633 Millimoles per liter | Standard Deviation 44.1663 |
| ABC/ DTG/ 3TC | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Triglycerides, Week 48, Overall, n=240, 239 | 14.252 Millimoles per liter | Standard Deviation 62.2823 |
| ABC/ DTG/ 3TC | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | Cholesterol, Week 48, Overall, n=240, 239 | 2.32 Millimoles per liter | Standard Deviation 14.456 |
| ABC/ DTG/ 3TC | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | LDL cholesterol, Week 48, Overall, n=238, 237 | 0.462 Millimoles per liter | Standard Deviation 23.9648 |
| ABC/ DTG/ 3TC | Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 | HDL cholesterol, Week 48, Overall, n=240, 239 | 7.361 Millimoles per liter | Standard Deviation 20.3088 |
Secondary
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire
PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.
Time frame: Weeks 5, 41 and 48
Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 5, moderate, n=270 | 16 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 5, little acceptable, n=270 | 11 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 5, not at all acceptable, n=270 | 5 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 41, little acceptable, n=276 | 4 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 41, not at all acceptable, n=276 | 1 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 5, totally acceptable, n=270 | 47 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions,Week 5, very acceptable, n=270 | 29 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 5, little acceptable, n=270 | 6 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 5, not at all, n=270 | 3 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 5, totally acceptable, n=270 | 33 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 5, very acceptable, n=270 | 28 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 5, moderate acceptable, n=270 | 24 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, week 41, totally, n=276 | 57 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 41, very acceptable, n=276 | 29 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 41, moderate, n=276 | 11 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 41, little acceptable, n=276 | 3 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 41, not at all, n=276 | 1 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 41, totally acceptable, n=276 | 45 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 41, very acceptable, n=276 | 35 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 41, moderate acceptable, n=276 | 14 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, week 48, totally, n=278 | 55 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 48, very acceptable, n=278 | 31 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 48, moderate, n=278 | 11 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 48, little acceptable, n=278 | 2 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Local reactions, Week 48, not at all, n=278 | 1 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 48, totally acceptable, n=278 | 49 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 48, very acceptable, n=278 | 35 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 48, moderate acceptable, n=278 | 12 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 48 little acceptable, n=278 | 3 Percentage of participants |
| CAB LA + RPV LA (Q4W) | Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire | Pain, Week 48, not at all acceptable, n=278 | 1 Percentage of participants |
Secondary
Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48
Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA \<50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.
Time frame: Week 48
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA + RPV LA (Q4W) | Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48 | 94 Percentage of Participants |
| ABC/ DTG/ 3TC | Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48 | 93 Percentage of Participants |
95% CI: [-3.7, 4.5]
Secondary
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable
Blood samples were collected at indicated time points for PK analysis of CAB LA.
Time frame: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48
Population: PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 24, n=227 | 2.3827 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 28, n=220 | 2.4683 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 32, n=219 | 2.6729 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 8, n=250 | 1.5616 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 12, n=237 | 2.0141 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 16, n=215 | 2.0960 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 20, n=233 | 2.1739 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 36, n=215 | 2.8590 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 40, n=210 | 2.9378 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 44, n=217 | 3.0133 Microgram per milliliter |
| CAB LA + RPV LA (Q4W) | Plasma Trough Concentration (Ctrough) for CAB LA Evaluable | Pre-dose, Week 48, n=197 | 3.1325 Microgram per milliliter |
Other Pre-specified
Number of Participants With Different Demographic Parameters for Inter-subject Variability
Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.
Time frame: Up to Week 48
Population: PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.