HIV Infections
Conditions
Keywords
HIV, Antiretroviral therapy, Maintenance, Long acting, LATTE
Brief summary
This study (POLAR), is designed to assess the antiviral activity and safety of CAB LA plus RPV LA, administered Q2M, in approximately 100 adult HIV-1 infected, antiretroviral therapy (ART) experienced participants. Participants will rollover from the NCT01641809 (LATTE) study, who have completed minimum duration of Week 312 and with demonstrated HIV-1 ribonucleic acid (RNA) suppression (less than \[\<\]50 copies (c) per milliliter \[mL\]), while receiving a two-drug regimen consisting of once-daily oral CAB at 30 milligram (mg) plus RPV at 25 mg. The participants will be offered the option to switch to the LA, intramuscular injections of CAB LA plus RPV LA, Q2M or the oral fixed dose combination (FDC) of dolutegravir (DTG) plus RPV, for the continued maintenance of HIV-1 RNA suppression, known as the Maintenance Phase (From Day 1 to Commercial Approval). Duration of study will vary from country to country, until regimen receives regulatory approval and becomes commercially available. The study plans to enroll approximately 100 participants. Any participant who receives at least one dose of CAB LA and/or RPV LA and discontinues the CAB LA plus RPV LA regimen for any reason will enter a 52-week Long-Term Follow-Up (LTFU) phase. Those participants must remain on suppressive highly active antiretroviral therapy (HAART) for at least 52 weeks after the last dose of CAB LA and or RPV LA.
Interventions
DRUGCAB LA
Administered CAB LA (600 mg) Q2M, as intramuscular injection.
DRUGRPV LA
Administered RPV LA (900 mg), Q2M, as intramuscular injection.
DRUGRPV
Oral dose of RPV 25 mg, administered once daily from Day 1 up to Month 12
DRUGDTG
Oral dose of DTG 50 mg administered once daily from Day 1 up to Month 12.
Sponsors
Janssen, LP
ViiV Healthcare
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This is an open-label study, thus no masking.
Intervention model description
This is an Intervention Model, with parallel assignment, where the primary purpose of the study is, treatment, with 2 arms and no masking.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Aged 18 years or older (or \>=19 where required by local regulatory agencies), at the time of signing the informed consent. * A female participant is eligible to participate if she is not pregnant (as confirmed by a negative urine human chorionic gonadotrophin \[hCG\] test at Day 1), not lactating, and at least with one of following conditions: (a) Non-reproductive potential defined as: (i) Pre-menopausal females with one of the conditions as documented tubal ligation; Documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, Hysterectomy, Documented Bilateral Oophorectomy. (ii) Postmenopausal defined as 12 months of spontaneous amenorrhea \[in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) and estradiol levels consistent with menopause (refer to laboratory reference ranges for confirmatory levels)\]. 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. (b) 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, 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 the methods of contraception. * Capable of giving signed informed consent. * Must have been on oral CAB 30 mg plus RPV 25 mg regimen through at minimum Week 300 of the LATTE study as per LATTE protocol dosing requirements and until Day 1 of the POLAR study. Any disruptions in dosing during LATTE must be discussed with the Medical Monitor for a final determination of eligibility. * Plasma HIV-1 RNA \<50 c/mL at Week 300. If participant has plasma HIV-1 RNA \>= 50 c/mL at Week 300 in LATTE, a single repeat to determine eligibility may be allowed ONLY after consultation with the medical monitor.
Exclusion criteria
* During the last 6 months of participation in LATTE, consecutive (2 or more sequential) plasma HIV-1 RNA measurements \>=50 c/mL. * During the last 6 months of participation in LATTE, any HIV-1 RNA measurement \>=200 c/mL. * Any evidence of a current Center for Disease Control and Prevention (CDC) Stage 3 disease \[CDC, 2014\], except cutaneous Kaposi's sarcoma not requiring systemic therapy. * Participants with moderate to severe hepatic impairment determined by Child-Pugh classification. * Any pre-existing physical or mental condition (including substance use 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. * Participants who, in the investigator's judgment, pose a significant suicide risk. Participant's recent history of suicidal behavior and/or suicidal ideation should be considered when evaluating for suicide risk. * Participants 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 for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (anti-HBc), Hepatitis B surface antibody (anti-HBs) and HBV 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. * 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 within 12 months must be excluded. (HCV treatment on study may be permitted, following consultation with the medical monitor). * Participants with HCV co-infection will be allowed entry into this study if: Liver enzymes meet entry criteria; HCV Disease has undergone appropriate work-up, and is not advanced. * 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 inconclusive, the fibrosis- 4 (Fib-4) score will be used to verify eligibility where Fib-4 score \>3.25 is exclusionary; Fib-4 scores 1.45 - 3.25 requires Medical Monitor consultation where the Fibrosis 4 Score Formula: age multiplied by aspartate amino transferase (AST) divided by platelets multiplied by square of alanine aminotransferase (ALT). * Unstable liver disease (as defined by any of the following: presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, or persistent jaundice or cirrhosis), 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. * 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. * Ongoing malignancy other than cutaneous Kaposi's sarcoma, basal cell carcinoma, or resected, non-invasive cutaneous squamous cell carcinoma, or cervical intraepithelial neoplasia; other localized malignancies require agreement between the investigator and the Study medical monitor for inclusion of the participant prior to randomization. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the study drugs 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 (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 with the exception of the use of low dose acetylsalicylic acid (less than or equal to \[\<=\]325 mg) or hereditary coagulation and platelet disorders such as hemophilia or Von Willebrand Disease. * Corrected QT interval (QTc (Bazett)) \>450 millisecond (msec) or QTc (Bazett) \>480 msec for participants with bundle branch block. * Any verified Grade 4 laboratory abnormality over the last 6 months in LATTE. A single repeat test is allowed to verify a result. * Any acute laboratory abnormality over the last 6 months in LATTE, which, in the opinion of the investigator, would preclude the participant's participation in the study of an investigational compound. * ALT\>=5 times upper limit of normal (ULN) or ALT \>= 3 times ULN and bilirubin \>= 1.5 times ULN (with \>35 percent \[%\] direct bilirubin) over the last 6 months in LATTE. * Exposure to an experimental drug (with the exception of those in the LATTE study including CAB and RPV) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to Day 1 of this study. * Treatment with any of the following agents within 28 days of Day 1: radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy with the exception of isoniazid (isonicotinylhydrazid \[INH\]); anti-coagulation agents. * Immunomodulators that alter immune responses such as chronic systemic corticosteroids, interleukins, or interferons. * Use of medications which are associated with Torsade de Pointes must be discussed with the Medical Monitor to determine eligibility. * Participants receiving any prohibited medication and who are unwilling or unable to switch to an alternate medication.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase] | At Month 12 [Maintenance Phase] | Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase] | At Month 12 [Maintenance Phase] | Percentage of participants with HIV-1 RNA \<50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. |
| Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase | Up to End of Maintenance Phase (up to Month 52 for CAB LA+RPV LA Q2M group, up to Month 12 for DTG+RPV group) | Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL. |
| Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | At Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 [Maintenance Phase] | Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase] | Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Standard Deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000. |
| Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase] | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000. |
| Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000. |
| Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000. |
| Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase] | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. |
| Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. |
| Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm | Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | An adverse event 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. A SAE is defined as 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 judgement. |
| Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm | Up to Month 12 [Maintenance Phase] | An adverse event 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. A SAE is defined as 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 judgement. |
| Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE). |
| Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Up to Month 12 [Maintenance Phase] | Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE). |
| Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Up to End of Maintenance Phase (up to Month 52) | Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). |
| Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Up to Month 12 [Maintenance Phase] | Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). |
| Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Up to End of Maintenance Phase (up to Month 52) | The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). |
| Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Up to Month 12 [Maintenance Phase] | The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). |
| Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Up to End of Maintenance Phase (up to Month 52) | An adverse event 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. Number of participants with adverse events leading to permanent withdrawal has been presented. |
| Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Up to Month 12 [Maintenance Phase] | An adverse event 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. Number of participants with adverse events leading to permanent withdrawal has been presented. |
| Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00. |
| Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.00(0) is defined as SD resulted below the detectable limit of the assay and approximate to 0.00(0). |
| Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, direct high density lipoprotein cholesterol, LDL cholesterol calculation, direct low density lipoprotein cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | At Baseline (Day 1) | Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides. |
| Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Absolute Values of Urine Potential of Hydrogen (pH) | At Baseline (Day 1) | 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 in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase] | At Month 6 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000. |
| Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase) | Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] | At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
| Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | At Baseline (Day 1) | Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. |
| Absolute Values of Urine Creatinine | At Baseline (Day 1) | Urine samples were collected for the analysis of urine creatinine. |
| Absolute Values of Urine Phosphate | At Baseline (Day 1) | Urine samples were collected for the analysis of urine phosphate. |
| Change From Baseline in Individual Item Score of HIVTSQs | At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 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. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00. |
| Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) | At Month 12 (compared with Baseline [Day 1]) [Maintenance Phase] | 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 represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score was not computed and remained missing. |
| Absolute Values of Urine Specific Gravity | At Baseline (Day 1) | Urine 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. |
| Number of Participants With Treatment Emergent Genotypic Resistance | Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria. |
| Number of Participants With Treatment Emergent Phenotypic Resistance | Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase) | Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. |
| Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted Impact Score (WIS) was calculated for the 26 domain items by multiplying impact score(IS) (-3\[maximum {max.} negative impact\] to +1\[max. positive impact\] by the corresponding importance score (3 \[very important\] to 0\[not all important\]). Average Weighted Impact (AWI) score was calculated by summing individual weighted IS and dividing by the number of domain items. The ranges of WIS and average IS were from -9(max. negative) to +3(max. positive);higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value). SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00. |
| Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase] | HIVTSQs 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 as compared to the past few weeks; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma Trough Concentration (Ctrough) for CAB LA | Pre-dose (Day 1) and Month 12 [Maintenance Phase] | Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted. |
| Ctrough for RPV LA | Pre-dose (Day 1) and Month 12 [Maintenance Phase] | Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted. |
Countries
Canada, United States
Participant flow
Recruitment details
This was a multicenter, open-label, rollover study evaluating the efficacy, safety and tolerability of long acting (LA) cabotegravir (CAB) plus LA rilpivirine (RPV) administered every 2 months (Q2M) in human immunodeficiency virus-1 (HIV-1) adult participants who were virologically suppressed and participated in study LAI116482 (NCT01641809).
Pre-assignment details
This study was conducted in 2 phases (Maintenance Phase and Long-term Follow-up \[LTFU\] Phase). Maintenance Phase was defined from Baseline (Day 1) up to Month 52. LTFU Phase was defined as approximately 12 months for participants who discontinued from the CAB LA+RPV LA treatment before Month 52 and complied with protocol-defined criteria for withdrawal. Participants in both the phases were mutually inclusive.
Participants by arm
| Arm | Count |
|---|---|
| CAB LA + RPV LA Q2M Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 milligrams (mg) plus RPV 25 mg and who successfully completed Week 300 received their first dose CAB LA (600 mg) plus RPV LA (900 mg) injections within 2 hours of the final oral dose of LATTE given on the same day. The second loading injections were administered 1 month after initial loading dose, with subsequent injections (CAB LA 600 mg + RPV LA 900 mg) occurring Q2M thereafter. Participants continued to receive the treatment until the study intervention was locally approved and commercially available. Participants who received at least one dose of CAB LA and/or RPV LA and discontinued the CAB LA + RPV LA regimen for any reason entered a 52-week long-term follow-up (LTFU) Phase. | 90 |
| DTG + RPV Eligible participants from LAI116482 (NCT01641809 \[LATTE\]) study who were administered oral CAB 30 mg plus RPV 25 mg and who successfully completed Week 300 received their first dose of the Dolutegravir (DTG) 50 mg plus RPV 25 mg, once daily as oral regimen on Day 1 until Month 12 in the current study. These participants were not eligible for the LTFU phase. | 7 |
| Total | 97 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Maintenance Phase | Adverse Event | 1 | 0 | 0 |
| Maintenance Phase | DECISION BY SUBJECT OR PROXY | 7 | 0 | 0 |
| Maintenance Phase | Lack of Efficacy | 1 | 0 | 0 |
| Maintenance Phase | Lost to Follow-up | 1 | 0 | 0 |
| Maintenance Phase | STUDY SITE TERMINATED BY SPONSOR | 3 | 0 | 0 |
| Maintenance Phase | SUBJECT REACHED PROTOCOL-DEFINED STOPPING CRITERIA | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | DTG + RPV | Total | CAB LA + RPV LA Q2M |
|---|---|---|---|
| Age, Continuous Overall Study | 49.1 Years STANDARD_DEVIATION 11.42 | 41.7 Years STANDARD_DEVIATION 9.8 | 41.2 Years STANDARD_DEVIATION 9.49 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Asian-Japanese/East Asian/South East Asian Heritage | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Black or African American | 3 Participants | 24 Participants | 21 Participants |
| Race/Ethnicity, Customized Multiple | 0 Participants | 4 Participants | 4 Participants |
| Race/Ethnicity, Customized White | 4 Participants | 67 Participants | 63 Participants |
| Sex: Female, Male Female | 0 Participants | 2 Participants | 2 Participants |
| Sex: Female, Male Male | 7 Participants | 95 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 90 | 0 / 7 | 0 / 6 |
| other Total, other adverse events | 86 / 90 | 3 / 7 | 0 / 6 |
| serious Total, serious adverse events | 10 / 90 | 0 / 7 | 0 / 6 |
Outcome results
Primary
Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and DTG + RPV regimen in HIV-1 infected antiretroviral therapy (ART) experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time frame: At Month 12 [Maintenance Phase]
Population: Intent-to-treat-Exposed (ITT-E) population comprised of all participants who received at least one dose of investigational product (IP) during on or after Day 1 visit. Participants were analyzed according to the selected treatment regardless of what treatment was actually received.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase] | 0 Percentage of participants |
| DTG + RPV | Percentage of Participants With HIV-ribonucleic Acid (RNA) >=50 Copies Per Milliliter (c/mL) as Per Food and Drug Administration (FDA) Snapshot Algorithm at Month 12 [Maintenance Phase] | 0 Percentage of participants |
Secondary
Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | 780.3 Cells per cubic millimeter | Standard Deviation 145.22 |
| CAB LA + RPV LA Q2M | Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | 728.9 Cells per cubic millimeter | Standard Deviation 147.06 |
| CAB LA + RPV LA Q2M | Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Baseline (Day 1) | 804.3 Cells per cubic millimeter | Standard Deviation 167.73 |
| CAB LA + RPV LA Q2M | Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | 777.0 Cells per cubic millimeter | Standard Deviation 251.37 |
| CAB LA + RPV LA Q2M | Absolute Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | 790.4 Cells per cubic millimeter | Standard Deviation 141.8 |
Secondary
Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | 912.8 Cells per cubic millimeter | Standard Deviation 262.4 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | 910.3 Cells per cubic millimeter | Standard Deviation 286.21 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 905.9 Cells per cubic millimeter | Standard Deviation 274.22 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | 867.3 Cells per cubic millimeter | Standard Deviation 266.36 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | 931.1 Cells per cubic millimeter | Standard Deviation 220.94 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 905.7 Cells per cubic millimeter | Standard Deviation 292.61 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | 1011.0 Cells per cubic millimeter | Standard Deviation 292.74 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | 818.5 Cells per cubic millimeter | Standard Deviation 291.82 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | 755.0 Cells per cubic millimeter | Standard Deviation 182.43 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | 716.3 Cells per cubic millimeter | Standard Deviation 143.21 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Baseline (Day 1) | 873.0 Cells per cubic millimeter | Standard Deviation 233.37 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | 868.1 Cells per cubic millimeter | Standard Deviation 261.49 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 879.8 Cells per cubic millimeter | Standard Deviation 280.88 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | 1046.8 Cells per cubic millimeter | Standard Deviation 435.74 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | 857 Cells per cubic millimeter | Standard Deviation 277.46 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | 859.2 Cells per cubic millimeter | Standard Deviation 283.23 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | 917.5 Cells per cubic millimeter | Standard Deviation 295.27 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | 853.7 Cells per cubic millimeter | Standard Deviation 280.49 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | 967.3 Cells per cubic millimeter | Standard Deviation 300.72 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | 865.4 Cells per cubic millimeter | Standard Deviation 225.93 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 925.7 Cells per cubic millimeter | Standard Deviation 271.7 |
| CAB LA + RPV LA Q2M | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | 1220.8 Cells per cubic millimeter | Standard Deviation 536.73 |
| DTG + RPV | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 717.8 Cells per cubic millimeter | Standard Deviation 188.88 |
| DTG + RPV | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | 954.8 Cells per cubic millimeter | Standard Deviation 259.47 |
| DTG + RPV | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | 837.2 Cells per cubic millimeter | Standard Deviation 224.49 |
| DTG + RPV | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | 766.5 Cells per cubic millimeter | Standard Deviation 184.84 |
| DTG + RPV | Absolute Values for Cluster of Differentiation 4 Plus (CD4+) for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | 775.0 Cells per cubic millimeter | Standard Deviation 293.45 |
Secondary
Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA have been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Standard Deviation (SD)=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: From Baseline (Day 1) up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 1.591 Log 10 copies per milliliter | Standard Deviation 0.0104 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | 1.590 Log 10 copies per milliliter | Standard Deviation 0.0025 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Baseline (Day 1) | 1.591 Log 10 copies per milliliter | Standard Deviation 0.0085 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 1.594 Log 10 copies per milliliter | Standard Deviation 0.0305 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | 1.590 Log 10 copies per milliliter | Standard Deviation 0.0042 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 10 | 1.594 Log 10 copies per milliliter | Standard Deviation 0.0384 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 14 | 1.593 Log 10 copies per milliliter | Standard Deviation 0.0216 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | 1.598 Log 10 copies per milliliter | Standard Deviation 0.0555 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 18 | 1.592 Log 10 copies per milliliter | Standard Deviation 0.0217 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | 1.592 Log 10 copies per milliliter | Standard Deviation 0.0153 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | 1.602 Log 10 copies per milliliter | Standard Deviation 0.0882 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 1.611 Log 10 copies per milliliter | Standard Deviation 0.1246 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | 1.594 Log 10 copies per milliliter | Standard Deviation 0.0334 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| DTG + RPV | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| DTG + RPV | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | 1.616 Log 10 copies per milliliter | Standard Deviation 0.0581 |
| DTG + RPV | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| DTG + RPV | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | 2.027 Log 10 copies per milliliter | Standard Deviation 1.0696 |
| DTG + RPV | Absolute Values for HIV-1 RNA of CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | 1.852 Log 10 copies per milliliter | Standard Deviation 0.4338 |
Secondary
Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | Baseline (Day 1) | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Absolute Values for HIV-1 RNA of DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | 1.590 Log 10 copies per milliliter | Standard Deviation 0 |
Secondary
Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, HDL cholesterol direct, LDL cholesterol calculation, LDL cholesterol direct and triglycerides.
Time frame: At Baseline (Day 1)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | Cholesterol | 4.88 Millimoles per liter | Standard Deviation 1.352 |
| CAB LA + RPV LA Q2M | Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | Direct HDL cholesterol | 1.59 Millimoles per liter | Standard Deviation 0.258 |
| CAB LA + RPV LA Q2M | Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | Direct LDL cholesterol | 4.45 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | Triglycerides | 1.52 Millimoles per liter | Standard Deviation 1.493 |
| CAB LA + RPV LA Q2M | Absolute Values of Clinical Chemistry Parameters: Cholesterol, Direct HDL Cholesterol, LDL Calculation, Direct LDL Cholesterol and Triglycerides for DTG + RPV Arm at Baseline | LDL cholesterol calculation | 2.29 Millimoles per liter | Standard Deviation 0.52 |
Secondary
Absolute Values of Urine Creatinine
Urine samples were collected for the analysis of urine creatinine.
Time frame: At Baseline (Day 1)
Population: Safety Population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values of Urine Creatinine | 14875.6 Micromoles per liter | Standard Deviation 9267.95 |
| DTG + RPV | Absolute Values of Urine Creatinine | 12112.9 Micromoles per liter | Standard Deviation 7186.16 |
Secondary
Absolute Values of Urine Phosphate
Urine samples were collected for the analysis of urine phosphate.
Time frame: At Baseline (Day 1)
Population: Safety Population
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values of Urine Phosphate | 18.2 Millimoles per liter | Standard Deviation 15.306 |
| DTG + RPV | Absolute Values of Urine Phosphate | 14.7 Millimoles per liter | Standard Deviation 6.917 |
Secondary
Absolute Values of Urine Potential of Hydrogen (pH)
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: At Baseline (Day 1)
Population: Safety Population. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values of Urine Potential of Hydrogen (pH) | 6.1 pH | Standard Deviation 0.739 |
| DTG + RPV | Absolute Values of Urine Potential of Hydrogen (pH) | 6.5 pH | Standard Deviation 0.345 |
Secondary
Absolute Values of Urine Specific Gravity
Urine 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.
Time frame: At Baseline (Day 1)
Population: Safety Population. Only those participants with data available at specified time points has been presented.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Absolute Values of Urine Specific Gravity | 1.0 Ratio | Standard Deviation 0.007 |
| DTG + RPV | Absolute Values of Urine Specific Gravity | 1.0 Ratio | Standard Deviation 0.007 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase
Blood samples were collected for the analysis of clinical chemical parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 34 | -0.8 Grams per liter | Standard Deviation 2.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 4 | -0.9 Grams per liter | Standard Deviation 2.46 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 8 | -0.8 Grams per liter | Standard Deviation 2.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 12 | -0.9 Grams per liter | Standard Deviation 2.67 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 14 | 2.0 Grams per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 16 | -0.7 Grams per liter | Standard Deviation 2.81 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 20 | -0.3 Grams per liter | Standard Deviation 2.47 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 24 | -0.8 Grams per liter | Standard Deviation 2.98 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 26 | 0.8 Grams per liter | Standard Deviation 2.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 28 | -1.1 Grams per liter | Standard Deviation 2.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 30 | -0.3 Grams per liter | Standard Deviation 1.51 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 32 | -1.2 Grams per liter | Standard Deviation 2.69 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 36 | -1.1 Grams per liter | Standard Deviation 2.8 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 38 | -1.0 Grams per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 40 | -0.9 Grams per liter | Standard Deviation 3 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 42 | -3.0 Grams per liter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 44 | -0.9 Grams per liter | Standard Deviation 2.5 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 46 | -3.3 Grams per liter | Standard Deviation 3.5 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 48 | -1.4 Grams per liter | Standard Deviation 2.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 50 | -2.5 Grams per liter | Standard Deviation 2.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 52 | -1.0 Grams per liter | Standard Deviation 2 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | Month 2 | -0.8 Grams per liter | Standard Deviation 2.31 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | LTFU Month 3 | -1.5 Grams per liter | Standard Deviation 1.29 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | LTFU Month 6 | -3.0 Grams per liter | Standard Deviation 3.22 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | LTFU Month 9 | -2.8 Grams per liter | Standard Deviation 3.06 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | LTFU Month 12 | -3.2 Grams per liter | Standard Deviation 2.05 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Albumin for CAB LA + RPV LA Q2M Arm up to LTFU Phase | LTFU Month 1 | -3.4 Grams per liter | Standard Deviation 2.88 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: albumin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -1.6 Grams per liter | Standard Deviation 3.87 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -1.4 Grams per liter | Standard Deviation 2.3 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -1.3 Grams per liter | Standard Deviation 2.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Albumin for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -2.6 Grams per liter | Standard Deviation 2.37 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | 0.00 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.178 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -0.08 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.183 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -0.10 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.157 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -0.20 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.241 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -0.03 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.161 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | 0.00 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.084 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -0.04 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.168 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -0.13 Milliliter per second per 1.73 meter^2 | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 0.01 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.142 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -0.10 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.132 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -0.03 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.184 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -0.14 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.129 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -0.04 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.165 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | 0.03 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.117 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | 0.00 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.214 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 0.02 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.168 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | 0.01 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.143 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | 0.00 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.165 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -0.02 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.167 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 0.02 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.094 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | 0.03 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.128 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -0.02 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.154 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | -0.23 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.177 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -0.14 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.164 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -0.18 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.118 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -0.16 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.243 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted for BSA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -0.19 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.18 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -0.12 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.071 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -0.27 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.204 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted BSA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -0.12 Milliliter per second per 1.73 meter^2 | Standard Deviation 0.145 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | 1.9 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.7 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | 0.8 Milliliter per minute per 1.73 meter^2 | Standard Deviation 8.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | 0.4 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -1.7 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.06 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -2.1 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.71 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -0.5 Milliliter per minute per 1.73 meter^2 | Standard Deviation 5.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -2.7 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -8.0 Milliliter per minute per 1.73 meter^2 | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -6.0 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.94 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -1.9 Milliliter per minute per 1.73 meter^2 | Standard Deviation 11.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -8.5 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.78 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | 2.0 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -0.5 Milliliter per minute per 1.73 meter^2 | Standard Deviation 12.85 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -5.0 Milliliter per minute per 1.73 meter^2 | Standard Deviation 11.01 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 1.8 Milliliter per minute per 1.73 meter^2 | Standard Deviation 5.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -6.5 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.44 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -12.3 Milliliter per minute per 1.73 meter^2 | Standard Deviation 14.47 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 0.8 Milliliter per minute per 1.73 meter^2 | Standard Deviation 8.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -2.8 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.92 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 1.7 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | 1.4 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -0.2 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.69 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -1.2 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.26 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | -14.3 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.63 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -10.0 Milliliter per minute per 1.73 meter^2 | Standard Deviation 14.62 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -8.8 Milliliter per minute per 1.73 meter^2 | Standard Deviation 9.87 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -11.0 Milliliter per minute per 1.73 meter^2 | Standard Deviation 7.11 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: GFR from creatinine adjusted using CKD-EPI. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -11.7 Milliliter per minute per 1.73 meter^2 | Standard Deviation 10.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -7.4 Milliliter per minute per 1.73 meter^2 | Standard Deviation 4.28 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -16.6 Milliliter per minute per 1.73 meter^2 | Standard Deviation 12.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: GFR From Creatinine Adjusted Using CKD-EPI for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -7.3 Milliliter per minute per 1.73 meter^2 | Standard Deviation 8.71 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -0.1 Units per liter | Standard Deviation 29.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 3.7 Units per liter | Standard Deviation 47.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | 24.5 Units per liter | Standard Deviation 64.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -1.3 Units per liter | Standard Deviation 29.43 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -2.9 Units per liter | Standard Deviation 36.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -6.4 Units per liter | Standard Deviation 31.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -4.0 Units per liter | Standard Deviation 32.29 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -2.0 Units per liter | Standard Deviation 34.89 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 11.0 Units per liter | Standard Deviation 4.55 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -1.9 Units per liter | Standard Deviation 26.19 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -1.0 Units per liter | Standard Deviation 14.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | 5.5 Units per liter | Standard Deviation 56.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -12.8 Units per liter | Standard Deviation 45.17 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | 4.9 Units per liter | Standard Deviation 51.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | 20.0 Units per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 0.7 Units per liter | Standard Deviation 41.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -12.7 Units per liter | Standard Deviation 27.39 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 5.6 Units per liter | Standard Deviation 40.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -33.3 Units per liter | Standard Deviation 118.26 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | 3.7 Units per liter | Standard Deviation 31.55 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -3.0 Units per liter | Standard Deviation 28.28 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | 3.2 Units per liter | Standard Deviation 12.24 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | 27.4 Units per liter | Standard Deviation 48.97 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 1.5 Units per liter | Standard Deviation 10.6 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | 10.8 Units per liter | Standard Deviation 30.53 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | 3.7 Units per liter | Standard Deviation 9.4 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Lipase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | 5.2 Units per liter | Standard Deviation 6.38 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: lipase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | 2.6 Units per liter | Standard Deviation 6.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | 4.4 Units per liter | Standard Deviation 4.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | 1.3 Units per liter | Standard Deviation 6.85 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Lipase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | 26.0 Units per liter | Standard Deviation 49.76 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 30 | 3.3 International units per liter | Standard Deviation 29.38 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 4 | -1.0 International units per liter | Standard Deviation 26.15 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 8 | 0.0 International units per liter | Standard Deviation 29.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 12 | 4.0 International units per liter | Standard Deviation 44.62 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 14 | -7.5 International units per liter | Standard Deviation 61.52 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 16 | -2.5 International units per liter | Standard Deviation 24.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 20 | -3.4 International units per liter | Standard Deviation 18.61 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 24 | -3.0 International units per liter | Standard Deviation 17.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 26 | -21.7 International units per liter | Standard Deviation 49.26 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 38 | 2.5 International units per liter | Standard Deviation 4.95 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 48 | -2.6 International units per liter | Standard Deviation 11.38 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 50 | -4.5 International units per liter | Standard Deviation 7.78 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 52 | -3.5 International units per liter | Standard Deviation 13.62 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 52 | -67.7 International units per liter | Standard Deviation 84.29 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 28 | 1.0 International units per liter | Standard Deviation 31.18 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 30 | 11.2 International units per liter | Standard Deviation 49.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 32 | -0.9 International units per liter | Standard Deviation 18.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 34 | -7.0 International units per liter | Standard Deviation 30.17 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 36 | 0.2 International units per liter | Standard Deviation 18.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 40 | -1.7 International units per liter | Standard Deviation 19.97 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 42 | -1.5 International units per liter | Standard Deviation 6.36 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 44 | -0.5 International units per liter | Standard Deviation 14.51 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 46 | 0.5 International units per liter | Standard Deviation 3.79 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 26 | -2.2 International units per liter | Standard Deviation 23.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 28 | 1.0 International units per liter | Standard Deviation 12.89 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 30 | 2.3 International units per liter | Standard Deviation 19.06 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 32 | 2.4 International units per liter | Standard Deviation 11.79 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 34 | 0.4 International units per liter | Standard Deviation 10.26 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 20 | -7.5 International units per liter | Standard Deviation 49.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 24 | -7.2 International units per liter | Standard Deviation 50.49 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 26 | -11.5 International units per liter | Standard Deviation 15.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 28 | -7.3 International units per liter | Standard Deviation 57.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, Month 2 | -1.1 International units per liter | Standard Deviation 16.99 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 2 | 0.2 International units per liter | Standard Deviation 8.29 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 4 | 0.2 International units per liter | Standard Deviation 14.2 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 8 | 2.0 International units per liter | Standard Deviation 11.58 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 12 | 2.1 International units per liter | Standard Deviation 12.39 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 14 | -15.5 International units per liter | Standard Deviation 33.23 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 16 | 1.7 International units per liter | Standard Deviation 10.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 20 | 5.5 International units per liter | Standard Deviation 11.5 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 24 | 2.3 International units per liter | Standard Deviation 12.64 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 36 | 3.3 International units per liter | Standard Deviation 9.81 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 38 | -10.0 International units per liter | Standard Deviation 14.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 40 | 5.7 International units per liter | Standard Deviation 14.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 42 | 7.0 International units per liter | Standard Deviation 2.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 44 | 5.3 International units per liter | Standard Deviation 16.34 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 46 | 1.8 International units per liter | Standard Deviation 7.89 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 48 | 3.3 International units per liter | Standard Deviation 12.21 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 50 | 10.5 International units per liter | Standard Deviation 2.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, Month 52 | -2.5 International units per liter | Standard Deviation 7.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 2 | -5.6 International units per liter | Standard Deviation 47.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 4 | -5.0 International units per liter | Standard Deviation 50.5 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 8 | -5.3 International units per liter | Standard Deviation 49.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 12 | -2.7 International units per liter | Standard Deviation 54.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 14 | 0.0 International units per liter | Standard Deviation 16.97 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 16 | -5.1 International units per liter | Standard Deviation 51.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 32 | -6.7 International units per liter | Standard Deviation 51.96 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 34 | -6.4 International units per liter | Standard Deviation 16.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 36 | -5.0 International units per liter | Standard Deviation 54.45 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 38 | -2.0 International units per liter | Standard Deviation 7.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 40 | -8.4 International units per liter | Standard Deviation 52.46 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 42 | -0.5 International units per liter | Standard Deviation 3.54 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 44 | -2.0 International units per liter | Standard Deviation 9.01 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 46 | -4.3 International units per liter | Standard Deviation 3.59 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 48 | -3.0 International units per liter | Standard Deviation 8.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 50 | -4.5 International units per liter | Standard Deviation 3.54 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, Month 52 | -6.0 International units per liter | Standard Deviation 7.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 2 | -255.2 International units per liter | Standard Deviation 2327.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 4 | -204.0 International units per liter | Standard Deviation 2483.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 8 | -237.0 International units per liter | Standard Deviation 2362.99 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 12 | -252.0 International units per liter | Standard Deviation 2429.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 14 | 120.0 International units per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 16 | -245.1 International units per liter | Standard Deviation 2421.43 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 20 | -292.8 International units per liter | Standard Deviation 2390.38 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 24 | -290.0 International units per liter | Standard Deviation 2435.94 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 26 | -44.0 International units per liter | Standard Deviation 115.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 28 | -393.7 International units per liter | Standard Deviation 2738.54 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 30 | -33.2 International units per liter | Standard Deviation 238.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 32 | -276.7 International units per liter | Standard Deviation 2518.73 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 34 | -17.0 International units per liter | Standard Deviation 173.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 36 | -318.6 International units per liter | Standard Deviation 2488.91 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 38 | -21.0 International units per liter | Standard Deviation 32.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 40 | -341.7 International units per liter | Standard Deviation 2552.6 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 42 | 30.5 International units per liter | Standard Deviation 31.82 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 44 | -15.9 International units per liter | Standard Deviation 463.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 46 | 6.0 International units per liter | Standard Deviation 50.28 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 48 | 1.0 International units per liter | Standard Deviation 140.26 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, Month 50 | -136.5 International units per liter | Standard Deviation 178.9 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, LTFU Month 1 | -5.0 International units per liter | Standard Deviation 7.07 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, LTFU Month 3 | 2.8 International units per liter | Standard Deviation 29.93 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, LTFU Month 6 | -7.7 International units per liter | Standard Deviation 48.87 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, LTFU Month 9 | -6.0 International units per liter | Standard Deviation 15.17 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALT, LTFU Month 12 | 0.2 International units per liter | Standard Deviation 54.36 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, LTFU Month 9 | 1.5 International units per liter | Standard Deviation 6.86 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, LTFU Month 12 | 14.6 International units per liter | Standard Deviation 41.38 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, LTFU Month 1 | -3.6 International units per liter | Standard Deviation 19.24 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, LTFU Month 3 | -10.3 International units per liter | Standard Deviation 23.91 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, LTFU Month 6 | -5.0 International units per liter | Standard Deviation 24.71 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, LTFU Month 12 | 0.0 International units per liter | Standard Deviation 26.31 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, LTFU Month 6 | 50.8 International units per liter | Standard Deviation 157.89 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, LTFU Month 9 | -8.8 International units per liter | Standard Deviation 88.04 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, LTFU Month 12 | 844.2 International units per liter | Standard Deviation 1731.52 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | ALP, LTFU Month 9 | -5.7 International units per liter | Standard Deviation 18.28 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, LTFU Month 1 | -18.0 International units per liter | Standard Deviation 21.76 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatine kinase, LTFU Month 3 | 81.3 International units per liter | Standard Deviation 245.69 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, LTFU Month 1 | 3.6 International units per liter | Standard Deviation 18.68 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, LTFU Month 3 | 8.5 International units per liter | Standard Deviation 4.51 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | AST, LTFU Month 6 | 1.5 International units per liter | Standard Deviation 12.82 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemical parameters including ALT, ALP, AST and creatinine kinase. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline was defined as post-dose visit value minus Baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Month 3 | -0.7 International units per liter | Standard Deviation 22.37 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Month 6 | -4.3 International units per liter | Standard Deviation 19.99 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Month 9 | 1.7 International units per liter | Standard Deviation 8.16 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Month 12 | -0.3 International units per liter | Standard Deviation 32.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALP, Month 3 | 1.4 International units per liter | Standard Deviation 10.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALP, Month 6 | 1.6 International units per liter | Standard Deviation 8.04 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALP, Month 9 | -1.1 International units per liter | Standard Deviation 11.74 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALP, Month 12 | 10.0 International units per liter | Standard Deviation 33.16 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Month 3 | -0.6 International units per liter | Standard Deviation 10.61 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Month 9 | -1.4 International units per liter | Standard Deviation 6.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Month 12 | -0.6 International units per liter | Standard Deviation 14.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Month 3 | -66.6 International units per liter | Standard Deviation 287.66 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Month 6 | -107.9 International units per liter | Standard Deviation 112.18 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Month 9 | -90.6 International units per liter | Standard Deviation 163.4 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Month 12 | -134.0 International units per liter | Standard Deviation 149.59 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and Creatinine Kinase for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Month 6 | -3.3 International units per liter | Standard Deviation 7.3 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 42 | 4.73 Micromoles per liter | Standard Deviation 7.524 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 4 | -1.0 Micromoles per liter | Standard Deviation 5.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 8 | -1.0 Micromoles per liter | Standard Deviation 4.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 12 | -0.5 Micromoles per liter | Standard Deviation 4.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 14 | 2.0 Micromoles per liter | Standard Deviation 8.49 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 16 | -1.0 Micromoles per liter | Standard Deviation 4.99 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 20 | -1.4 Micromoles per liter | Standard Deviation 3.76 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 24 | -0.8 Micromoles per liter | Standard Deviation 5.16 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 26 | 0.0 Micromoles per liter | Standard Deviation 4.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 28 | -0.9 Micromoles per liter | Standard Deviation 3.36 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 30 | 2.0 Micromoles per liter | Standard Deviation 3.58 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 32 | -1.0 Micromoles per liter | Standard Deviation 5.4 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 34 | 0.0 Micromoles per liter | Standard Deviation 7.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 36 | -0.4 Micromoles per liter | Standard Deviation 4.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 42 | -1.0 Micromoles per liter | Standard Deviation 4.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 44 | -0.9 Micromoles per liter | Standard Deviation 4.36 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 46 | -3.5 Micromoles per liter | Standard Deviation 2.52 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 48 | -1.7 Micromoles per liter | Standard Deviation 3.92 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 50 | 1.0 Micromoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 52 | -1.3 Micromoles per liter | Standard Deviation 4.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 38 | 0.27 Micromoles per liter | Standard Deviation 4.007 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 40 | -2.71 Micromoles per liter | Standard Deviation 8.065 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 2 | -1.0 Micromoles per liter | Standard Deviation 4.33 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 44 | 0.11 Micromoles per liter | Standard Deviation 11.223 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 38 | -2.0 Micromoles per liter | Standard Deviation 2.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, Month 40 | -1.6 Micromoles per liter | Standard Deviation 4.87 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 46 | 8.63 Micromoles per liter | Standard Deviation 13.822 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 48 | 0.01 Micromoles per liter | Standard Deviation 9.828 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 50 | -3.50 Micromoles per liter | Standard Deviation 4.95 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 52 | -2.50 Micromoles per liter | Standard Deviation 16.393 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 2 | -1.84 Micromoles per liter | Standard Deviation 7.121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 4 | -1.70 Micromoles per liter | Standard Deviation 9.393 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 8 | -0.98 Micromoles per liter | Standard Deviation 7.977 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 10 | -1.14 Micromoles per liter | Standard Deviation 9.204 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 14 | -1.80 Micromoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 16 | 1.15 Micromoles per liter | Standard Deviation 9.508 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 20 | -0.50 Micromoles per liter | Standard Deviation 9.569 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 24 | 3.57 Micromoles per liter | Standard Deviation 10.039 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 26 | 1.03 Micromoles per liter | Standard Deviation 9.423 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 28 | 4.64 Micromoles per liter | Standard Deviation 10.159 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 30 | 9.87 Micromoles per liter | Standard Deviation 8.19 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 32 | 1.07 Micromoles per liter | Standard Deviation 9.648 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 34 | 1.06 Micromoles per liter | Standard Deviation 8.331 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, Month 36 | 0.76 Micromoles per liter | Standard Deviation 9.661 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, LTFU Month 1 | -3.2 Micromoles per liter | Standard Deviation 5.76 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, LTFU Month 3 | 1.5 Micromoles per liter | Standard Deviation 7.72 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, LTFU Month 6 | 1.3 Micromoles per liter | Standard Deviation 9.27 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, LTFU Month 9 | 1.0 Micromoles per liter | Standard Deviation 9.1 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Bilirubin, LTFU Month 12 | -0.8 Micromoles per liter | Standard Deviation 6.1 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, LTFU Month 1 | 3.00 Micromoles per liter | Standard Deviation 12.761 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, LTFU Month 3 | 13.48 Micromoles per liter | Standard Deviation 9.469 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, LTFU Month 6 | 8.42 Micromoles per liter | Standard Deviation 12.726 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, LTFU Month 9 | 6.65 Micromoles per liter | Standard Deviation 7.731 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Creatinine, LTFU Month 12 | 9.74 Micromoles per liter | Standard Deviation 7.416 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameters: bilirubin and creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Month 3 | -1.7 Micromoles per liter | Standard Deviation 4.23 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Month 6 | -1.4 Micromoles per liter | Standard Deviation 3.21 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Month 9 | -0.9 Micromoles per liter | Standard Deviation 2.54 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Month 12 | -1.4 Micromoles per liter | Standard Deviation 3.78 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Month 3 | 11.89 Micromoles per liter | Standard Deviation 8.89 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Month 6 | 8.36 Micromoles per liter | Standard Deviation 4.419 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Month 9 | 16.56 Micromoles per liter | Standard Deviation 10.131 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Bilirubin, Creatinine for DTG+ RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Month 12 | 7.47 Micromoles per liter | Standard Deviation 7.328 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.00(0) is defined as SD resulted below the detectable limit of the assay and approximate to 0.00(0).
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 44 | 0.34 Millimoles per liter | Standard Deviation 1.475 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 4 | -0.1 Millimoles per liter | Standard Deviation 2 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 8 | -0.2 Millimoles per liter | Standard Deviation 2.22 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 12 | -0.7 Millimoles per liter | Standard Deviation 2.18 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 14 | 2.0 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 16 | 0.3 Millimoles per liter | Standard Deviation 2.25 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 20 | -0.2 Millimoles per liter | Standard Deviation 2.17 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 24 | -0.6 Millimoles per liter | Standard Deviation 2.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 26 | 1.7 Millimoles per liter | Standard Deviation 3.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 28 | 0.3 Millimoles per liter | Standard Deviation 2.61 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 30 | 1.7 Millimoles per liter | Standard Deviation 2.73 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 32 | 0.4 Millimoles per liter | Standard Deviation 2.43 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 34 | 0.4 Millimoles per liter | Standard Deviation 3.13 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 36 | 0.5 Millimoles per liter | Standard Deviation 2.46 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 38 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 40 | 1.1 Millimoles per liter | Standard Deviation 2.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 42 | 0.5 Millimoles per liter | Standard Deviation 0.71 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 44 | 0.7 Millimoles per liter | Standard Deviation 2.61 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 46 | 0.0 Millimoles per liter | Standard Deviation 3.74 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 48 | 0.4 Millimoles per liter | Standard Deviation 2.25 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 2 | 1.0 Millimoles per liter | Standard Deviation 2.06 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 4 | 1.1 Millimoles per liter | Standard Deviation 2.2 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 8 | 1.2 Millimoles per liter | Standard Deviation 2.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 12 | 1.0 Millimoles per liter | Standard Deviation 2.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 14 | -5.0 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 16 | 0.3 Millimoles per liter | Standard Deviation 2.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 20 | 0.5 Millimoles per liter | Standard Deviation 2.52 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 24 | 0.3 Millimoles per liter | Standard Deviation 2.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 26 | -2.5 Millimoles per liter | Standard Deviation 1.97 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 28 | -0.3 Millimoles per liter | Standard Deviation 2.42 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 4 | 0.42 Millimoles per liter | Standard Deviation 0.684 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 8 | 0.47 Millimoles per liter | Standard Deviation 0.842 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 12 | 0.32 Millimoles per liter | Standard Deviation 0.662 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 14 | -1.60 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 16 | 0.36 Millimoles per liter | Standard Deviation 0.754 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 20 | 0.33 Millimoles per liter | Standard Deviation 0.838 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 24 | 0.19 Millimoles per liter | Standard Deviation 0.654 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 26 | -0.17 Millimoles per liter | Standard Deviation 1.457 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 28 | 0.30 Millimoles per liter | Standard Deviation 0.694 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 34 | 0.95 Millimoles per liter | Standard Deviation 2.475 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 36 | 0.26 Millimoles per liter | Standard Deviation 0.77 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 40 | 0.25 Millimoles per liter | Standard Deviation 0.929 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 42 | 0.20 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 44 | 0.54 Millimoles per liter | Standard Deviation 1.044 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 44 | -0.04 Millimoles per liter | Standard Deviation 0.406 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 48 | -0.01 Millimoles per liter | Standard Deviation 0.374 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 50 | 0.00 Millimoles per liter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 52 | 0.17 Millimoles per liter | Standard Deviation 0.589 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 8 | 0.6 Millimoles per liter | Standard Deviation 1.96 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 12 | 0.2 Millimoles per liter | Standard Deviation 1.88 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 20 | 0.4 Millimoles per liter | Standard Deviation 1.96 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 24 | 0.5 Millimoles per liter | Standard Deviation 1.84 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 26 | 0.2 Millimoles per liter | Standard Deviation 2.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 28 | 0.3 Millimoles per liter | Standard Deviation 2.12 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 30 | -0.8 Millimoles per liter | Standard Deviation 2.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 32 | 0.4 Millimoles per liter | Standard Deviation 2.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 34 | -0.6 Millimoles per liter | Standard Deviation 4.72 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 36 | -0.1 Millimoles per liter | Standard Deviation 2.26 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 38 | 1.0 Millimoles per liter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 40 | -0.1 Millimoles per liter | Standard Deviation 2.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 42 | -1.0 Millimoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 44 | 0.2 Millimoles per liter | Standard Deviation 2.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 46 | 0.0 Millimoles per liter | Standard Deviation 2.94 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 48 | 0.1 Millimoles per liter | Standard Deviation 1.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 50 | 1.0 Millimoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 52 | 2.5 Millimoles per liter | Standard Deviation 3.15 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 2 | 0.13 Millimoles per liter | Standard Deviation 1.253 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 4 | -0.06 Millimoles per liter | Standard Deviation 1.346 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 8 | 0.28 Millimoles per liter | Standard Deviation 1.131 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 12 | -0.11 Millimoles per liter | Standard Deviation 1.318 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 14 | -0.50 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 16 | 0.13 Millimoles per liter | Standard Deviation 1.444 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 20 | 0.17 Millimoles per liter | Standard Deviation 1.332 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 24 | 0.15 Millimoles per liter | Standard Deviation 1.474 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 26 | -0.92 Millimoles per liter | Standard Deviation 0.736 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 28 | -0.01 Millimoles per liter | Standard Deviation 1.628 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 30 | 0.17 Millimoles per liter | Standard Deviation 1.941 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 32 | 0.14 Millimoles per liter | Standard Deviation 1.419 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 2 | -0.4 Millimoles per liter | Standard Deviation 1.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 2 | -0.00 Millimoles per liter | Standard Deviation 0.176 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 4 | -0.00 Millimoles per liter | Standard Deviation 0.191 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 42 | 0.10 Millimoles per liter | Standard Deviation 0.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 44 | 0.00 Millimoles per liter | Standard Deviation 0.201 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 46 | 0.02 Millimoles per liter | Standard Deviation 0.125 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 52 | -0.22 Millimoles per liter | Standard Deviation 0.216 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 16 | 0.00 Millimoles per liter | Standard Deviation 0.339 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 20 | 0.01 Millimoles per liter | Standard Deviation 0.374 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 28 | -0.09 Millimoles per liter | Standard Deviation 0.388 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 30 | 0.08 Millimoles per liter | Standard Deviation 0.293 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 46 | -0.20 Millimoles per liter | Standard Deviation 0.455 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 2 | 0.2 Millimoles per liter | Standard Deviation 1.84 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 4 | 0.6 Millimoles per liter | Standard Deviation 2.1 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 14 | -3.0 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, Month 16 | 0.5 Millimoles per liter | Standard Deviation 2.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 34 | 0.50 Millimoles per liter | Standard Deviation 2 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 36 | 0.22 Millimoles per liter | Standard Deviation 1.393 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 38 | 1.00 Millimoles per liter | Standard Deviation 0.707 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 40 | 0.27 Millimoles per liter | Standard Deviation 1.39 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 42 | 0.25 Millimoles per liter | Standard Deviation 1.061 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 46 | 0.63 Millimoles per liter | Standard Deviation 2.056 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 48 | 0.26 Millimoles per liter | Standard Deviation 1.266 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 50 | 0.50 Millimoles per liter | Standard Deviation 1.414 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, Month 52 | -0.83 Millimoles per liter | Standard Deviation 1.211 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 50 | 1.0 Millimoles per liter | Standard Deviation 2.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, Month 52 | 1.3 Millimoles per liter | Standard Deviation 4.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 30 | -1.7 Millimoles per liter | Standard Deviation 2.42 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 32 | -0.4 Millimoles per liter | Standard Deviation 2.31 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 34 | -1.8 Millimoles per liter | Standard Deviation 2.28 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 36 | -0.5 Millimoles per liter | Standard Deviation 2.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 38 | 1.0 Millimoles per liter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 40 | -0.1 Millimoles per liter | Standard Deviation 2.4 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 42 | -2.0 Millimoles per liter | Standard Deviation 4.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 44 | 0.1 Millimoles per liter | Standard Deviation 2.18 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 46 | 0.5 Millimoles per liter | Standard Deviation 2.65 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 48 | -0.3 Millimoles per liter | Standard Deviation 2.31 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 50 | 0.0 Millimoles per liter | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, Month 52 | -0.2 Millimoles per liter | Standard Deviation 2.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 2 | 0.32 Millimoles per liter | Standard Deviation 0.568 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 30 | -0.36 Millimoles per liter | Standard Deviation 0.709 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 32 | 0.34 Millimoles per liter | Standard Deviation 0.792 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 38 | 0.20 Millimoles per liter | Standard Deviation 0.566 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 46 | 0.40 Millimoles per liter | Standard Deviation 0.265 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 48 | 0.12 Millimoles per liter | Standard Deviation 0.593 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 50 | 0.40 Millimoles per liter | Standard Deviation 0.283 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, Month 52 | 2.10 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 8 | -0.02 Millimoles per liter | Standard Deviation 0.206 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 12 | -0.02 Millimoles per liter | Standard Deviation 0.199 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 14 | 0.25 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 16 | -0.02 Millimoles per liter | Standard Deviation 0.199 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 20 | -0.00 Millimoles per liter | Standard Deviation 0.227 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 24 | -0.01 Millimoles per liter | Standard Deviation 0.198 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 26 | -0.14 Millimoles per liter | Standard Deviation 0.206 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 28 | -0.05 Millimoles per liter | Standard Deviation 0.216 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 30 | 0.05 Millimoles per liter | Standard Deviation 0.268 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 32 | -0.02 Millimoles per liter | Standard Deviation 0.186 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 34 | -0.02 Millimoles per liter | Standard Deviation 0.27 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 36 | -0.01 Millimoles per liter | Standard Deviation 0.192 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 38 | -0.30 Millimoles per liter | Standard Deviation 0.212 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 40 | 0.00 Millimoles per liter | Standard Deviation 0.214 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 48 | 0.01 Millimoles per liter | Standard Deviation 0.192 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, Month 50 | -0.20 Millimoles per liter | Standard Deviation 0.141 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 2 | 0.06 Millimoles per liter | Standard Deviation 0.392 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 4 | -0.02 Millimoles per liter | Standard Deviation 0.45 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 8 | 0.05 Millimoles per liter | Standard Deviation 0.408 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 12 | 0.06 Millimoles per liter | Standard Deviation 0.375 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 14 | 0.00 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 24 | -0.04 Millimoles per liter | Standard Deviation 0.384 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 26 | 0.10 Millimoles per liter | Standard Deviation 0.228 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 32 | 0.00 Millimoles per liter | Standard Deviation 0.432 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 34 | 0.18 Millimoles per liter | Standard Deviation 0.37 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 36 | -0.06 Millimoles per liter | Standard Deviation 0.411 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 38 | 0.35 Millimoles per liter | Standard Deviation 0.354 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 40 | -0.06 Millimoles per liter | Standard Deviation 0.42 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, Month 42 | -0.10 Millimoles per liter | Standard Deviation 0.424 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, LTFU Month 1 | -0.37 Millimoles per liter | Standard Deviation 0.058 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, LTFU Month 3 | -0.45 Millimoles per liter | Standard Deviation 0.354 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, LTFU Month 6 | -0.40 Millimoles per liter | Standard Deviation 0.627 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, LTFU Month 12 | -0.12 Millimoles per liter | Standard Deviation 0.084 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, LTFU Month 9 | -0.17 Millimoles per liter | Standard Deviation 1.291 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, LTFU Month 12 | -0.30 Millimoles per liter | Standard Deviation 0.671 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, LTFU Month 9 | 0.8 Millimoles per liter | Standard Deviation 2.14 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, LTFU Month 12 | -0.2 Millimoles per liter | Standard Deviation 2.28 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, LTFU Month 1 | 1.0 Millimoles per liter | Standard Deviation 3.39 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, LTFU Month 3 | 1.5 Millimoles per liter | Standard Deviation 2.52 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, LTFU Month 1 | -0.03 Millimoles per liter | Standard Deviation 0.222 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, LTFU Month 6 | -0.02 Millimoles per liter | Standard Deviation 0.175 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, LTFU Month 9 | -0.05 Millimoles per liter | Standard Deviation 0.165 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, LTFU Month 12 | 0.11 Millimoles per liter | Standard Deviation 0.143 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, LTFU Month 6 | 0.7 Millimoles per liter | Standard Deviation 2.58 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, LTFU Month 9 | 1.0 Millimoles per liter | Standard Deviation 2.97 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Carbon dioxide, LTFU Month 12 | 0.2 Millimoles per liter | Standard Deviation 2.28 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, LTFU Month 3 | 0.10 Millimoles per liter | Standard Deviation 0.606 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, LTFU Month 6 | 0.13 Millimoles per liter | Standard Deviation 0.501 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Phosphate, LTFU Month 3 | 0.11 Millimoles per liter | Standard Deviation 0.225 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, LTFU Month 9 | 0.17 Millimoles per liter | Standard Deviation 0.873 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, LTFU Month 12 | 0.10 Millimoles per liter | Standard Deviation 0.212 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, LTFU Month 6 | 0.2 Millimoles per liter | Standard Deviation 0.75 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, LTFU Month 9 | 0.2 Millimoles per liter | Standard Deviation 0.75 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, LTFU Month 12 | -0.4 Millimoles per liter | Standard Deviation 0.89 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Glucose, LTFU Month 9 | 0.02 Millimoles per liter | Standard Deviation 0.259 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, LTFU Month 1 | 1.0 Millimoles per liter | Standard Deviation 1.22 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Sodium, LTFU Month 3 | -0.5 Millimoles per liter | Standard Deviation 1.91 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Potassium, LTFU Month 1 | 0.04 Millimoles per liter | Standard Deviation 0.313 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, LTFU Month 1 | 0.6 Millimoles per liter | Standard Deviation 3.91 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, LTFU Month 3 | -1.8 Millimoles per liter | Standard Deviation 3.3 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Chloride, LTFU Month 6 | 0.2 Millimoles per liter | Standard Deviation 2.32 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, LTFU Month 1 | -0.80 Millimoles per liter | Standard Deviation 0.758 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, LTFU Month 3 | 0.25 Millimoles per liter | Standard Deviation 0.866 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Urea, LTFU Month 6 | -1.08 Millimoles per liter | Standard Deviation 0.861 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameters: carbon dioxide, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Carbon dioxide, Month 3 | -1.0 Millimoles per liter | Standard Deviation 1.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Carbon dioxide, Month 6 | -1.7 Millimoles per liter | Standard Deviation 1.5 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Carbon dioxide, Month 9 | -1.9 Millimoles per liter | Standard Deviation 2.85 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Carbon dioxide, Month 12 | -1.9 Millimoles per liter | Standard Deviation 2.48 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Chloride, Month 3 | 1.0 Millimoles per liter | Standard Deviation 1.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Chloride, Month 6 | 1.7 Millimoles per liter | Standard Deviation 2.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Chloride, Month 9 | 1.0 Millimoles per liter | Standard Deviation 0.82 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Potassium, Month 3 | -0.26 Millimoles per liter | Standard Deviation 0.378 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Potassium, Month 6 | -0.03 Millimoles per liter | Standard Deviation 0.25 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Potassium, Month 9 | 0.01 Millimoles per liter | Standard Deviation 0.135 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Potassium, Month 12 | -0.06 Millimoles per liter | Standard Deviation 0.257 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Month 3 | 0.1 Millimoles per liter | Standard Deviation 1.68 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Urea, Month 3 | 1.43 Millimoles per liter | Standard Deviation 0.732 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Urea, Month 6 | 1.14 Millimoles per liter | Standard Deviation 1.144 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Urea, Month 9 | 1.86 Millimoles per liter | Standard Deviation 1.994 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Urea, Month 12 | 0.71 Millimoles per liter | Standard Deviation 0.756 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Chloride, Month 12 | 1.0 Millimoles per liter | Standard Deviation 2.08 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Month 3 | 0.08 Millimoles per liter | Standard Deviation 0.259 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Month 6 | 0.16 Millimoles per liter | Standard Deviation 0.483 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Month 9 | 0.15 Millimoles per liter | Standard Deviation 0.7 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Month 12 | 0.07 Millimoles per liter | Standard Deviation 0.55 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Month 3 | 0.02 Millimoles per liter | Standard Deviation 0.131 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Month 6 | 0.08 Millimoles per liter | Standard Deviation 0.177 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Month 9 | 0.05 Millimoles per liter | Standard Deviation 0.178 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Month 12 | -0.05 Millimoles per liter | Standard Deviation 0.101 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Month 6 | -0.9 Millimoles per liter | Standard Deviation 0.9 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Month 9 | -1.0 Millimoles per liter | Standard Deviation 2.58 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Carbon Dioxide, Chloride, Glucose, Phosphate, Potassium, Sodium and Urea for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Month 12 | -1.1 Millimoles per liter | Standard Deviation 1.07 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameters: cholesterol, direct high density lipoprotein cholesterol, LDL cholesterol calculation, direct low density lipoprotein cholesterol and triglycerides. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 26 | -0.20 Millimoles per liter | Standard Deviation 0.888 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 24 | 0.13 Millimoles per liter | Standard Deviation 0.849 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 26 | 0.48 Millimoles per liter | Standard Deviation 0.569 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 28 | 0.00 Millimoles per liter | Standard Deviation 0.906 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 30 | 0.07 Millimoles per liter | Standard Deviation 1.378 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 32 | -0.87 Millimoles per liter | Standard Deviation 0.601 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 34 | 0.67 Millimoles per liter | Standard Deviation 1.378 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 40 | -0.85 Millimoles per liter | Standard Deviation 0.804 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 44 | 0.27 Millimoles per liter | Standard Deviation 0.106 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 46 | -0.10 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 48 | -0.15 Millimoles per liter | Standard Deviation 0.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 32 | -0.80 Millimoles per liter | Standard Deviation 0.989 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 34 | -0.43 Millimoles per liter | Standard Deviation 0.353 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 40 | -0.04 Millimoles per liter | Standard Deviation 1.724 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 44 | 1.61 Millimoles per liter | Standard Deviation 0.834 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 46 | 0.44 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 48 | 0.18 Millimoles per liter | Standard Deviation 0.056 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 12 | -0.05 Millimoles per liter | Standard Deviation 0.224 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 26 | -0.05 Millimoles per liter | Standard Deviation 0.154 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 24 | -0.02 Millimoles per liter | Standard Deviation 0.23 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 28 | -0.05 Millimoles per liter | Standard Deviation 0.241 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 30 | 0.25 Millimoles per liter | Standard Deviation 0.141 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 32 | -0.20 Millimoles per liter | Standard Deviation 0.353 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 34 | -0.07 Millimoles per liter | Standard Deviation 0.247 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 40 | 0.08 Millimoles per liter | Standard Deviation 0.368 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 44 | -0.27 Millimoles per liter | Standard Deviation 0.247 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 46 | -0.35 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, Month 48 | -0.20 Millimoles per liter | Standard Deviation 0.212 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 12 | 0.10 Millimoles per liter | Standard Deviation 0.718 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 24 | 0.14 Millimoles per liter | Standard Deviation 0.823 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 26 | 0.73 Millimoles per liter | Standard Deviation 0.613 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 28 | 0.06 Millimoles per liter | Standard Deviation 0.913 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 30 | 0.31 Millimoles per liter | Standard Deviation 2.128 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 32 | -0.30 Millimoles per liter | Standard Deviation 0.502 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 34 | 0.95 Millimoles per liter | Standard Deviation 1.286 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 40 | -0.91 Millimoles per liter | Standard Deviation 0.202 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 44 | -0.18 Millimoles per liter | Standard Deviation 0.53 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 46 | 0.05 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, Month 48 | -0.03 Millimoles per liter | Standard Deviation 0.311 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct LDL cholesterol, Month 12 | 0.21 Millimoles per liter | Standard Deviation 0.367 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct LDL cholesterol, Month 24 | -0.23 Millimoles per liter | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 12 | 0.28 Millimoles per liter | Standard Deviation 1.965 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 24 | 0.20 Millimoles per liter | Standard Deviation 1.071 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, Month 12 | 0.12 Millimoles per liter | Standard Deviation 0.76 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 28 | -0.02 Millimoles per liter | Standard Deviation 0.705 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, Month 30 | -1.06 Millimoles per liter | Standard Deviation 1.329 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, LTFU Month 1 | -0.87 Millimoles per liter | Standard Deviation 1.097 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Cholesterol, LTFU Month 12 | -0.68 Millimoles per liter | Standard Deviation 1.362 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, LTFU Month 1 | -0.29 Millimoles per liter | Standard Deviation 0.834 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Triglycerides, LTFU Month 12 | -0.64 Millimoles per liter | Standard Deviation 1.088 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, LTFU Month 1 | -0.55 Millimoles per liter | Standard Deviation 0.989 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, LTFU Month 1 | -0.18 Millimoles per liter | Standard Deviation 0.213 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Direct HDL cholesterol, LTFU Month 12 | -0.04 Millimoles per liter | Standard Deviation 0.29 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameters: Cholesterol, High Density Lipoprotein, Cholesterol Direct, Low Density Lipoprotein Cholesterol Calculation, and Cholesterol Direct, Triglycerides for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LDL cholesterol calculation, LTFU Month 12 | -0.34 Millimoles per liter | Standard Deviation 1.51 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | 0.20 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.698 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | 0.05 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.279 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 0.55 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.861 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | 0.11 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.153 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -1.01 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -0.48 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.191 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | 0.43 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.425 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -1.09 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.39 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 1.65 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.64 |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | 1.37 Total Cholesterol/HDL Cholesterol Ratio | — |
| CAB LA + RPV LA Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | 0.30 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.434 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -0.28 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.916 |
| DTG + RPV | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -0.51 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 1.078 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase]
Blood samples were collected for the analysis of clinical chemistry parameter: total cholesterol/ HDL cholesterol ratio. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Month 6 (compared with Baseline [Day 1]) [Maintenance Phase]
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 Q2M | Change From Baseline in Clinical Chemistry Parameter: Total Cholesterol/ HDL Cholesterol Ratio for DTG + RPV Arm at Month 6 [Maintenance Phase] | 0.55 Total Cholesterol/HDL Cholesterol Ratio | Standard Deviation 0.679 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -3.71 Femtoliters | Standard Deviation 3.217 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | 2.00 Femtoliters | Standard Deviation 4.243 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -6.75 Femtoliters | Standard Deviation 2.63 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -2.77 Femtoliters | Standard Deviation 3.355 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -3.67 Femtoliters | Standard Deviation 3.512 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -1.78 Femtoliters | Standard Deviation 2.592 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -1.50 Femtoliters | Standard Deviation 0.707 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -1.07 Femtoliters | Standard Deviation 1.731 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -2.84 Femtoliters | Standard Deviation 3.167 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | 0.50 Femtoliters | Standard Deviation 2.121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -2.30 Femtoliters | Standard Deviation 3.339 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -1.00 Femtoliters | Standard Deviation 2.828 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -4.00 Femtoliters | Standard Deviation 3.847 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | -2.04 Femtoliters | Standard Deviation 2.186 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -1.42 Femtoliters | Standard Deviation 2.527 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -1.28 Femtoliters | Standard Deviation 2.528 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -2.91 Femtoliters | Standard Deviation 2.379 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -1.93 Femtoliters | Standard Deviation 2.544 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -1.35 Femtoliters | Standard Deviation 2.985 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | -2.60 Femtoliters | Standard Deviation 0.894 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -3.18 Femtoliters | Standard Deviation 2.918 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -6.75 Femtoliters | Standard Deviation 2.5 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | -4.00 Femtoliters | Standard Deviation 3.742 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -0.83 Femtoliters | Standard Deviation 4.167 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -1.33 Femtoliters | Standard Deviation 4.457 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -1.60 Femtoliters | Standard Deviation 6.504 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -3.20 Femtoliters | Standard Deviation 3.962 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: erythrocytes mean corpuscular volume. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -1.00 Femtoliters | Standard Deviation 1 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -0.14 Femtoliters | Standard Deviation 1.952 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | 0.14 Femtoliters | Standard Deviation 1.574 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocyte Mean Corpuscular Volume for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | 0.29 Femtoliters | Standard Deviation 1.704 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -0.200 10^12 cells per liter | Standard Deviation 0.5177 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -0.064 10^12 cells per liter | Standard Deviation 0.2773 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | -0.021 10^12 cells per liter | Standard Deviation 0.3185 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -0.085 10^12 cells per liter | Standard Deviation 0.3164 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -0.063 10^12 cells per liter | Standard Deviation 0.3279 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -0.034 10^12 cells per liter | Standard Deviation 0.3014 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -0.020 10^12 cells per liter | Standard Deviation 0.2754 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | -0.450 10^12 cells per liter | Standard Deviation 0.0707 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -0.061 10^12 cells per liter | Standard Deviation 0.3181 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 0.020 10^12 cells per liter | Standard Deviation 0.1924 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -0.113 10^12 cells per liter | Standard Deviation 0.2949 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -0.075 10^12 cells per liter | Standard Deviation 0.05 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -0.087 10^12 cells per liter | Standard Deviation 0.3801 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -0.233 10^12 cells per liter | Standard Deviation 0.1155 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -0.090 10^12 cells per liter | Standard Deviation 0.3591 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -0.350 10^12 cells per liter | Standard Deviation 0.3536 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -0.056 10^12 cells per liter | Standard Deviation 0.3528 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | 0.025 10^12 cells per liter | Standard Deviation 0.4272 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -0.072 10^12 cells per liter | Standard Deviation 0.4086 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -0.100 10^12 cells per liter | Standard Deviation 0.1414 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -0.090 10^12 cells per liter | Standard Deviation 0.3196 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -0.300 10^12 cells per liter | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -0.160 10^12 cells per liter | Standard Deviation 0.4722 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 0.075 10^12 cells per liter | Standard Deviation 0.2217 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -0.250 10^12 cells per liter | Standard Deviation 0.2811 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -0.433 10^12 cells per liter | Standard Deviation 0.2944 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Erythrocytes for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -0.160 10^12 cells per liter | Standard Deviation 0.2408 |
Secondary
Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: erythrocytes. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -0.171 10^12 cells per liter | Standard Deviation 0.1113 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -0.171 10^12 cells per liter | Standard Deviation 0.1704 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -0.143 10^12 cells per liter | Standard Deviation 0.0976 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Erythrocytes for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -0.114 10^12 cells per liter | Standard Deviation 0.1464 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -0.033 Proportion of red blood cells in blood | Standard Deviation 0.01697 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -0.012 Proportion of red blood cells in blood | Standard Deviation 0.02668 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | -0.010 Proportion of red blood cells in blood | Standard Deviation 0.01723 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -0.026 Proportion of red blood cells in blood | Standard Deviation 0.02663 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -0.011 Proportion of red blood cells in blood | Standard Deviation 0.02731 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -0.040 Proportion of red blood cells in blood | Standard Deviation 0.00822 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -0.022 Proportion of red blood cells in blood | Standard Deviation 0.03499 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -0.037 Proportion of red blood cells in blood | Standard Deviation 0.01442 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -0.017 Proportion of red blood cells in blood | Standard Deviation 0.0334 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -0.034 Proportion of red blood cells in blood | Standard Deviation 0.02192 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -0.025 Proportion of red blood cells in blood | Standard Deviation 0.03938 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -0.021 Proportion of red blood cells in blood | Standard Deviation 0.03702 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -0.041 Proportion of red blood cells in blood | Standard Deviation 0.04229 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | -0.032 Proportion of red blood cells in blood | Standard Deviation 0.00707 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -0.011 Proportion of red blood cells in blood | Standard Deviation 0.02762 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | -0.012 Proportion of red blood cells in blood | Standard Deviation 0.02935 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -0.015 Proportion of red blood cells in blood | Standard Deviation 0.02809 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -0.011 Proportion of red blood cells in blood | Standard Deviation 0.0276 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -0.017 Proportion of red blood cells in blood | Standard Deviation 0.02824 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -0.023 Proportion of red blood cells in blood | Standard Deviation 0.03088 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -0.006 Proportion of red blood cells in blood | Standard Deviation 0.00353 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -0.019 Proportion of red blood cells in blood | Standard Deviation 0.03114 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -0.022 Proportion of red blood cells in blood | Standard Deviation 0.03928 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -0.028 Proportion of red blood cells in blood | Standard Deviation 0.01864 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | -0.012 Proportion of red blood cells in blood | Standard Deviation 0.02102 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -0.027 Proportion of red blood cells in blood | Standard Deviation 0.03065 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hematocrit for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -0.044 Proportion of red blood cells in blood | Standard Deviation 0.02265 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: hematocrit. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -0.013 Proportion of red blood cells in blood | Standard Deviation 0.01491 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -0.015 Proportion of red blood cells in blood | Standard Deviation 0.01516 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -0.013 Proportion of red blood cells in blood | Standard Deviation 0.01287 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hematocrit for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -0.013 Proportion of red blood cells in blood | Standard Deviation 0.01332 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | -2.30 Grams per liter | Standard Deviation 8.054 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 0.60 Grams per liter | Standard Deviation 6.804 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | -8.50 Grams per liter | Standard Deviation 6.364 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -3.50 Grams per liter | Standard Deviation 11.358 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -2.11 Grams per liter | Standard Deviation 8.801 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | -1.57 Grams per liter | Standard Deviation 9.433 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -3.29 Grams per liter | Standard Deviation 8.542 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -3.19 Grams per liter | Standard Deviation 8.814 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | -3.44 Grams per liter | Standard Deviation 8.293 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | -13.00 Grams per liter | Standard Deviation 1.414 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | -3.35 Grams per liter | Standard Deviation 8.671 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -4.06 Grams per liter | Standard Deviation 8.281 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -4.00 Grams per liter | Standard Deviation 4.243 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -4.13 Grams per liter | Standard Deviation 11.183 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -8.33 Grams per liter | Standard Deviation 3.215 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -4.86 Grams per liter | Standard Deviation 10.749 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -4.51 Grams per liter | Standard Deviation 9.701 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | -6.27 Grams per liter | Standard Deviation 11.766 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -6.50 Grams per liter | Standard Deviation 2.121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -7.41 Grams per liter | Standard Deviation 9.341 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -9.00 Grams per liter | Standard Deviation 9.899 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -6.67 Grams per liter | Standard Deviation 11.605 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -3.40 Grams per liter | Standard Deviation 7.956 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 1.50 Grams per liter | Standard Deviation 3.697 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -4.67 Grams per liter | Standard Deviation 9.993 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -10.00 Grams per liter | Standard Deviation 6 |
| DTG + RPV | Change From Baseline in Hematology Parameter: Hemoglobin for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | -1.20 Grams per liter | Standard Deviation 14.464 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameter: hemoglobin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -3.57 Grams per liter | Standard Deviation 6.554 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -4.86 Grams per liter | Standard Deviation 3.891 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -4.29 Grams per liter | Standard Deviation 2.928 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameter: Hemoglobin for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -4.57 Grams per liter | Standard Deviation 5.062 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 38 | 9.50 10^9 cells per liter | Standard Deviation 38.891 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 12 | -0.003 10^9 cells per liter | Standard Deviation 0.02501 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 16 | 0.003 10^9 cells per liter | Standard Deviation 0.02629 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 20 | 0.003 10^9 cells per liter | Standard Deviation 0.02751 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 22 | -0.020 10^9 cells per liter | Standard Deviation 0.04243 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 24 | 0.001 10^9 cells per liter | Standard Deviation 0.02306 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 26 | -0.004 10^9 cells per liter | Standard Deviation 0.01673 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 28 | 0.008 10^9 cells per liter | Standard Deviation 0.02919 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 30 | 0.007 10^9 cells per liter | Standard Deviation 0.03862 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 4 | 0.056 10^9 cells per liter | Standard Deviation 1.19574 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 40 | 12.52 10^9 cells per liter | Standard Deviation 33.756 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 42 | 18.50 10^9 cells per liter | Standard Deviation 9.434 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 44 | 21.07 10^9 cells per liter | Standard Deviation 40.846 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 46 | 28.50 10^9 cells per liter | Standard Deviation 14.849 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 48 | 16.70 10^9 cells per liter | Standard Deviation 38.627 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 50 | -2.50 10^9 cells per liter | Standard Deviation 7.778 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 52 | 22.50 10^9 cells per liter | Standard Deviation 54.357 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 8 | 0.120 10^9 cells per liter | Standard Deviation 1.18605 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 12 | -0.134 10^9 cells per liter | Standard Deviation 1.03311 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 16 | 0.129 10^9 cells per liter | Standard Deviation 1.23997 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 20 | -0.158 10^9 cells per liter | Standard Deviation 1.09672 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 22 | -0.890 10^9 cells per liter | Standard Deviation 1.14551 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 24 | 0.019 10^9 cells per liter | Standard Deviation 1.06166 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 26 | -0.788 10^9 cells per liter | Standard Deviation 0.92394 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 28 | 0.025 10^9 cells per liter | Standard Deviation 1.1087 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 30 | -0.065 10^9 cells per liter | Standard Deviation 0.70174 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 32 | 0.265 10^9 cells per liter | Standard Deviation 1.4571 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 34 | -0.310 10^9 cells per liter | Standard Deviation 0.32187 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 36 | 0.027 10^9 cells per liter | Standard Deviation 1.15025 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 38 | -0.005 10^9 cells per liter | Standard Deviation 1.70413 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 40 | -0.100 10^9 cells per liter | Standard Deviation 1.23231 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 42 | 0.000 10^9 cells per liter | Standard Deviation 1.35532 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 44 | -0.049 10^9 cells per liter | Standard Deviation 1.19998 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 46 | 1.015 10^9 cells per liter | Standard Deviation 1.30815 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 48 | 0.005 10^9 cells per liter | Standard Deviation 1.16199 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 50 | -1.665 10^9 cells per liter | Standard Deviation 1.26572 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 52 | 0.151 10^9 cells per liter | Standard Deviation 0.58952 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 2 | 3.77 10^9 cells per liter | Standard Deviation 23.389 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 4 | 5.40 10^9 cells per liter | Standard Deviation 30.889 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 8 | 3.74 10^9 cells per liter | Standard Deviation 24.695 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 12 | 1.14 10^9 cells per liter | Standard Deviation 32.005 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 16 | 8.37 10^9 cells per liter | Standard Deviation 34.613 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 20 | 4.19 10^9 cells per liter | Standard Deviation 33.235 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 22 | -10.50 10^9 cells per liter | Standard Deviation 24.749 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 24 | 5.36 10^9 cells per liter | Standard Deviation 29.747 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 26 | 31.00 10^9 cells per liter | Standard Deviation 34.728 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 28 | 7.05 10^9 cells per liter | Standard Deviation 36.502 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 30 | 10.00 10^9 cells per liter | Standard Deviation 41.873 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 32 | 16.29 10^9 cells per liter | Standard Deviation 43.183 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 34 | 24.67 10^9 cells per liter | Standard Deviation 28.024 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, Month 36 | 18.09 10^9 cells per liter | Standard Deviation 40.388 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 2 | -0.000 10^9 cells per liter | Standard Deviation 0.022 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 20 | 0.197 10^9 cells per liter | Standard Deviation 0.49264 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 22 | 0.815 10^9 cells per liter | Standard Deviation 0.82731 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 24 | 0.184 10^9 cells per liter | Standard Deviation 0.53796 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 26 | 0.064 10^9 cells per liter | Standard Deviation 0.30262 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 28 | 0.269 10^9 cells per liter | Standard Deviation 0.50159 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 30 | 0.657 10^9 cells per liter | Standard Deviation 0.34219 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 32 | 0.294 10^9 cells per liter | Standard Deviation 0.54583 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 34 | 0.260 10^9 cells per liter | Standard Deviation 0.58813 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 36 | 0.176 10^9 cells per liter | Standard Deviation 0.53181 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 38 | 0.185 10^9 cells per liter | Standard Deviation 0.71418 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 40 | 0.193 10^9 cells per liter | Standard Deviation 0.51843 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 42 | 0.990 10^9 cells per liter | Standard Deviation 0.23388 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 44 | 0.090 10^9 cells per liter | Standard Deviation 0.5594 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 46 | -0.375 10^9 cells per liter | Standard Deviation 0.86974 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 48 | 0.225 10^9 cells per liter | Standard Deviation 0.55785 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 50 | -0.765 10^9 cells per liter | Standard Deviation 0.54447 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 52 | 0.580 10^9 cells per liter | Standard Deviation 0.26967 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 2 | 0.022 10^9 cells per liter | Standard Deviation 0.11715 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 4 | 0.048 10^9 cells per liter | Standard Deviation 0.14689 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 8 | 0.026 10^9 cells per liter | Standard Deviation 0.16979 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 12 | -0.021 10^9 cells per liter | Standard Deviation 0.15241 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 16 | 0.060 10^9 cells per liter | Standard Deviation 0.14219 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 20 | 0.032 10^9 cells per liter | Standard Deviation 0.15386 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 22 | 0.060 10^9 cells per liter | Standard Deviation 0.11314 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 24 | 0.039 10^9 cells per liter | Standard Deviation 0.15115 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 26 | -0.012 10^9 cells per liter | Standard Deviation 0.08585 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 28 | 0.093 10^9 cells per liter | Standard Deviation 0.15913 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 30 | 0.105 10^9 cells per liter | Standard Deviation 0.11328 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 32 | 0.030 10^9 cells per liter | Standard Deviation 0.13926 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 34 | -0.060 10^9 cells per liter | Standard Deviation 0.06557 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 36 | 0.016 10^9 cells per liter | Standard Deviation 0.1685 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 38 | 0.195 10^9 cells per liter | Standard Deviation 0.12021 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 40 | 0.037 10^9 cells per liter | Standard Deviation 0.17293 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 42 | 0.230 10^9 cells per liter | Standard Deviation 0.11358 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 44 | 0.003 10^9 cells per liter | Standard Deviation 0.14568 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 4 | 0.009 10^9 cells per liter | Standard Deviation 0.02913 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 8 | 0.003 10^9 cells per liter | Standard Deviation 0.02524 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 32 | 0.003 10^9 cells per liter | Standard Deviation 0.02567 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 34 | -0.010 10^9 cells per liter | Standard Deviation 0.01 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 36 | -0.001 10^9 cells per liter | Standard Deviation 0.03325 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 38 | 0.000 10^9 cells per liter | Standard Deviation 0.01414 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 40 | 0.004 10^9 cells per liter | Standard Deviation 0.02461 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 42 | 0.000 10^9 cells per liter | Standard Deviation 0.03606 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 44 | -0.001 10^9 cells per liter | Standard Deviation 0.02271 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 46 | 0.005 10^9 cells per liter | Standard Deviation 0.02121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 48 | -0.002 10^9 cells per liter | Standard Deviation 0.02682 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 50 | -0.045 10^9 cells per liter | Standard Deviation 0.0495 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, Month 52 | 0.021 10^9 cells per liter | Standard Deviation 0.02858 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 2 | 0.017 10^9 cells per liter | Standard Deviation 0.11886 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 4 | 0.004 10^9 cells per liter | Standard Deviation 0.12341 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 8 | 0.003 10^9 cells per liter | Standard Deviation 0.14555 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 12 | -0.000 10^9 cells per liter | Standard Deviation 0.13671 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 16 | -0.002 10^9 cells per liter | Standard Deviation 0.12115 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 20 | -0.004 10^9 cells per liter | Standard Deviation 0.11308 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 22 | 0.005 10^9 cells per liter | Standard Deviation 0.00707 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 24 | -0.021 10^9 cells per liter | Standard Deviation 0.10959 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 26 | 0.014 10^9 cells per liter | Standard Deviation 0.04393 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 28 | -0.021 10^9 cells per liter | Standard Deviation 0.12165 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 30 | 0.072 10^9 cells per liter | Standard Deviation 0.09878 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 32 | -0.009 10^9 cells per liter | Standard Deviation 0.15093 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 34 | 0.083 10^9 cells per liter | Standard Deviation 0.11846 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 36 | -0.020 10^9 cells per liter | Standard Deviation 0.13447 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 38 | 0.070 10^9 cells per liter | Standard Deviation 0.21213 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 40 | -0.014 10^9 cells per liter | Standard Deviation 0.14536 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 46 | 0.020 10^9 cells per liter | Standard Deviation 0.08485 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 42 | 0.146 10^9 cells per liter | Standard Deviation 0.04933 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 44 | -0.023 10^9 cells per liter | Standard Deviation 0.12973 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 46 | 0.065 10^9 cells per liter | Standard Deviation 0.02121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 48 | -0.016 10^9 cells per liter | Standard Deviation 0.13128 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 50 | -0.085 10^9 cells per liter | Standard Deviation 0.19092 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, Month 52 | -0.020 10^9 cells per liter | Standard Deviation 0.09675 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 2 | -0.054 10^9 cells per liter | Standard Deviation 1.1875 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 4 | 0.276 10^9 cells per liter | Standard Deviation 1.4416 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 8 | 0.257 10^9 cells per liter | Standard Deviation 1.4252 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 12 | -0.153 10^9 cells per liter | Standard Deviation 1.1961 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 16 | 0.333 10^9 cells per liter | Standard Deviation 1.4322 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 20 | 0.069 10^9 cells per liter | Standard Deviation 1.2588 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 22 | -0.050 10^9 cells per liter | Standard Deviation 0.495 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 24 | 0.247 10^9 cells per liter | Standard Deviation 1.3444 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 26 | -0.700 10^9 cells per liter | Standard Deviation 0.922 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 28 | 0.369 10^9 cells per liter | Standard Deviation 1.2534 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 30 | 0.775 10^9 cells per liter | Standard Deviation 1.1147 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 32 | 0.582 10^9 cells per liter | Standard Deviation 1.5079 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 34 | -0.033 10^9 cells per liter | Standard Deviation 0.6351 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 36 | 0.197 10^9 cells per liter | Standard Deviation 1.3119 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 38 | 0.450 10^9 cells per liter | Standard Deviation 2.3335 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 40 | 0.111 10^9 cells per liter | Standard Deviation 1.4863 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 42 | 0.750 10^9 cells per liter | Standard Deviation 1.6299 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 44 | 0.016 10^9 cells per liter | Standard Deviation 1.4332 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 46 | 0.700 10^9 cells per liter | Standard Deviation 0.2828 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 48 | 0.237 10^9 cells per liter | Standard Deviation 1.363 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 50 | -2.650 10^9 cells per liter | Standard Deviation 1.2021 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, Month 52 | 0.950 10^9 cells per liter | Standard Deviation 0.6804 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 2 | 0.116 10^9 cells per liter | Standard Deviation 0.44032 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 4 | 0.150 10^9 cells per liter | Standard Deviation 0.42751 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 8 | 0.100 10^9 cells per liter | Standard Deviation 0.49306 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 12 | 0.022 10^9 cells per liter | Standard Deviation 0.61142 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, Month 16 | 0.144 10^9 cells per liter | Standard Deviation 0.50914 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 48 | 0.026 10^9 cells per liter | Standard Deviation 0.13077 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 50 | -0.085 10^9 cells per liter | Standard Deviation 0.23335 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, Month 52 | 0.198 10^9 cells per liter | Standard Deviation 0.13556 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, Month 2 | -0.197 10^9 cells per liter | Standard Deviation 0.99349 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, LTFU Month 1 | 10.80 10^9 cells per liter | Standard Deviation 25.762 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, LTFU Month 3 | 7.25 10^9 cells per liter | Standard Deviation 19.973 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, LTFU Month 6 | -8.00 10^9 cells per liter | Standard Deviation 24.503 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, LTFU Month 9 | -13.50 10^9 cells per liter | Standard Deviation 37.877 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Platelets, LTFU Month 12 | 0.80 10^9 cells per liter | Standard Deviation 22.709 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, LTFU Month 6 | -0.001 10^9 cells per liter | Standard Deviation 0.03764 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, LTFU Month 9 | 0.000 10^9 cells per liter | Standard Deviation 0.02 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, LTFU Month 12 | 0.010 10^9 cells per liter | Standard Deviation 0.0324 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, LTFU Month 6 | 0.038 10^9 cells per liter | Standard Deviation 0.09621 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, LTFU Month 9 | -0.031 10^9 cells per liter | Standard Deviation 0.09283 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, LTFU Month 12 | 0.008 10^9 cells per liter | Standard Deviation 0.05541 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, LTFU Month 1 | -0.006 10^9 cells per liter | Standard Deviation 0.03847 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, LTFU Month 3 | -0.042 10^9 cells per liter | Standard Deviation 0.02062 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, LTFU Month 6 | 0.015 10^9 cells per liter | Standard Deviation 0.05925 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, LTFU Month 9 | -0.041 10^9 cells per liter | Standard Deviation 0.04535 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Eosinophils, LTFU Month 12 | 0.036 10^9 cells per liter | Standard Deviation 0.0493 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, LTFU Month 12 | -0.462 10^9 cells per liter | Standard Deviation 0.51611 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, LTFU Month 1 | 0.448 10^9 cells per liter | Standard Deviation 0.47694 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, LTFU Month 3 | 0.932 10^9 cells per liter | Standard Deviation 1.35866 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, LTFU Month 6 | -0.148 10^9 cells per liter | Standard Deviation 0.90442 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Neutrophils, LTFU Month 9 | -0.238 10^9 cells per liter | Standard Deviation 0.37408 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, LTFU Month 1 | -0.020 10^9 cells per liter | Standard Deviation 0.06245 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, LTFU Month 1 | 0.316 10^9 cells per liter | Standard Deviation 0.68995 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, LTFU Month 3 | 0.215 10^9 cells per liter | Standard Deviation 0.31268 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, LTFU Month 6 | 0.018 10^9 cells per liter | Standard Deviation 0.40276 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, LTFU Month 9 | -0.013 10^9 cells per liter | Standard Deviation 0.33339 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Lymphocytes, LTFU Month 12 | 0.182 10^9 cells per liter | Standard Deviation 0.43906 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Monocytes, LTFU Month 3 | -0.007 10^9 cells per liter | Standard Deviation 0.13451 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, LTFU Month 1 | 0.740 10^9 cells per liter | Standard Deviation 1.1327 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, LTFU Month 3 | 1.100 10^9 cells per liter | Standard Deviation 1.472 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, LTFU Month 6 | -0.067 10^9 cells per liter | Standard Deviation 1.082 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, LTFU Month 9 | -0.317 10^9 cells per liter | Standard Deviation 0.5529 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Leukocytes, LTFU Month 12 | -0.240 10^9 cells per liter | Standard Deviation 0.7369 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, LTFU Month 1 | 0.004 10^9 cells per liter | Standard Deviation 0.02702 |
| DTG + RPV | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Basophils, LTFU Month 3 | 0.000 10^9 cells per liter | Standard Deviation 0.02944 |
Secondary
Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected for the analysis of hematology parameters: basophils, eosinophils, leukocytes, lymphocytes, monocytes, neutrophils and platelets. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Month 12 | -2.86 10^9 cells per liter | Standard Deviation 47.544 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Monocytes, Month 6 | 0.020 10^9 cells per liter | Standard Deviation 0.07211 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Basophils, Month 3 | -0.008 10^9 cells per liter | Standard Deviation 0.01464 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Basophils, Month 6 | -0.010 10^9 cells per liter | Standard Deviation 0.02309 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Basophils, Month 9 | -0.005 10^9 cells per liter | Standard Deviation 0.01512 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Basophils, Month 12 | -0.010 10^9 cells per liter | Standard Deviation 0.01732 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Eosinophils, Month 3 | -0.072 10^9 cells per liter | Standard Deviation 0.16307 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Eosinophils, Month 6 | -0.057 10^9 cells per liter | Standard Deviation 0.11236 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Eosinophils, Month 9 | -0.051 10^9 cells per liter | Standard Deviation 0.1004 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Eosinophils, Month 12 | -0.030 10^9 cells per liter | Standard Deviation 0.17127 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Leukocytes, Month 3 | 0.014 10^9 cells per liter | Standard Deviation 0.7669 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Leukocytes, Month 9 | 0.014 10^9 cells per liter | Standard Deviation 1.3508 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Leukocytes, Month 12 | -0.057 10^9 cells per liter | Standard Deviation 0.9343 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lymphocytes, Month 3 | 0.053 10^9 cells per liter | Standard Deviation 0.43811 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lymphocytes, Month 6 | -0.019 10^9 cells per liter | Standard Deviation 0.35435 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lymphocytes, Month 9 | 0.085 10^9 cells per liter | Standard Deviation 0.59379 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lymphocytes, Month 12 | -0.001 10^9 cells per liter | Standard Deviation 0.39121 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Monocytes, Month 3 | 0.098 10^9 cells per liter | Standard Deviation 0.08877 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Monocytes, Month 9 | -0.021 10^9 cells per liter | Standard Deviation 0.06644 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Monocytes, Month 12 | 0.004 10^9 cells per liter | Standard Deviation 0.07435 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Neutrophils, Month 3 | 0.097 10^9 cells per liter | Standard Deviation 0.47612 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Neutrophils, Month 6 | -0.295 10^9 cells per liter | Standard Deviation 0.64143 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Neutrophils, Month 9 | 0.115 10^9 cells per liter | Standard Deviation 1.20803 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Neutrophils, Month 12 | -0.034 10^9 cells per liter | Standard Deviation 0.80715 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Month 3 | -1.00 10^9 cells per liter | Standard Deviation 18.841 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Leukocytes, Month 6 | -0.386 10^9 cells per liter | Standard Deviation 0.8355 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Month 6 | -12.57 10^9 cells per liter | Standard Deviation 35.298 |
| CAB LA + RPV LA Q2M | Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Month 9 | -21.29 10^9 cells per liter | Standard Deviation 61.372 |
Secondary
Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0087 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0087 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 0.000 Log 10 copies per milliliter | Standard Deviation 0.014 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0096 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0102 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0085 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 0.003 Log 10 copies per milliliter | Standard Deviation 0.0299 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | -0.000 Log 10 copies per milliliter | Standard Deviation 0.0096 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0085 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 10 | 0.003 Log 10 copies per milliliter | Standard Deviation 0.0396 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0086 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 14 | 0.002 Log 10 copies per milliliter | Standard Deviation 0.0234 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | 0.007 Log 10 copies per milliliter | Standard Deviation 0.0529 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 18 | 0.001 Log 10 copies per milliliter | Standard Deviation 0.0235 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | 0.001 Log 10 copies per milliliter | Standard Deviation 0.0177 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 22 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0087 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | 0.011 Log 10 copies per milliliter | Standard Deviation 0.0888 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 0.020 Log 10 copies per milliliter | Standard Deviation 0.1251 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | 0.003 Log 10 copies per milliliter | Standard Deviation 0.0346 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0088 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0088 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 38 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0091 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | -0.001 Log 10 copies per milliliter | Standard Deviation 0.0091 |
| DTG + RPV | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | 0.437 Log 10 copies per milliliter | Standard Deviation 1.0696 |
| DTG + RPV | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | 0.026 Log 10 copies per milliliter | Standard Deviation 0.0581 |
| DTG + RPV | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | 0.262 Log 10 copies per milliliter | Standard Deviation 0.4338 |
| DTG + RPV | Change From Baseline in HIV-1 RNA for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
Secondary
Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Plasma samples were collected for quantitative analysis of HIV-1 RNA. Log 10 values for plasma HIV-1 RNA has been presented. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value. SD=0.0000 is defined as SD resulted below the detectable limit of the assay and approximate to 0.0000.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV-1 RNA for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | 0.000 Log 10 copies per milliliter | Standard Deviation 0 |
Secondary
Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV)
HIVDQoL includes 2 overview items and 26 domain items. The 2 overview items: Item 1: 3(excellent) to -3(extremely bad); Higher score indicates better quality of life. Item 2: -3(very much better) to 1(worse); Lower score indicates better quality of life. The Weighted Impact Score (WIS) was calculated for the 26 domain items by multiplying impact score(IS) (-3\[maximum {max.} negative impact\] to +1\[max. positive impact\] by the corresponding importance score (3 \[very important\] to 0\[not all important\]). Average Weighted Impact (AWI) score was calculated by summing individual weighted IS and dividing by the number of domain items. The ranges of WIS and average IS were from -9(max. negative) to +3(max. positive);higher score indicates positive impact. Change from Baseline was defined as post-dose visit value minus Baseline value (latest pre-treatment assessment with a non-missing value). SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
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 Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Holiday, Month 6 | -0.5 Scores on a scale | Standard Deviation 2.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Holiday, Month 12 | -0.1 Scores on a scale | Standard Deviation 2.76 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Getting out and about, Month 6 | 0.0 Scores on a scale | Standard Deviation 1.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Financial Situation, Month 12 | -0.1 Scores on a scale | Standard Deviation 2.59 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Depend on Others, Month 6 | -0.4 Scores on a scale | Standard Deviation 3.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Depend on Others, Month 12 | -0.2 Scores on a scale | Standard Deviation 2.73 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Others Fuss or Worry, Month 6 | 0.0 Scores on a scale | Standard Deviation 3 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Getting out and about, Month 12 | -0.2 Scores on a scale | Standard Deviation 2.01 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Long journey, Month 6 | 0.3 Scores on a scale | Standard Deviation 2.24 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Long journey, Month 12 | 0.4 Scores on a scale | Standard Deviation 2.45 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Others Fuss or Worry, Month 12 | 0.1 Scores on a scale | Standard Deviation 3.21 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Eat, Month 6 | 0.0 Scores on a scale | Standard Deviation 1.98 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Do Physically, Month 6 | -0.2 Scores on a scale | Standard Deviation 2.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Eat, Month 12 | 0.1 Scores on a scale | Standard Deviation 2.62 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Do Physically, Month 12 | -0.3 Scores on a scale | Standard Deviation 2.39 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Drink, Month 6 | -0.2 Scores on a scale | Standard Deviation 1.81 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Drink, Month 12 | -0.1 Scores on a scale | Standard Deviation 2.47 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Spiritual/Religious Life, Month 6 | -0.1 Scores on a scale | Standard Deviation 2.46 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Spiritual/Religious Life, Month 12 | -0.1 Scores on a scale | Standard Deviation 1.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Past, Month 6 | -0.3 Scores on a scale | Standard Deviation 2.69 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Past, Month 12 | 0.0 Scores on a scale | Standard Deviation 2.74 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Family, Month 6 | -0.1 Scores on a scale | Standard Deviation 1.38 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Family, Month 12 | -0.3 Scores on a scale | Standard Deviation 2.3 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Friends, Month 6 | -0.7 Scores on a scale | Standard Deviation 1.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Friends, Month 12 | -0.3 Scores on a scale | Standard Deviation 2.57 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Go on dates, Month 6 | -0.4 Scores on a scale | Standard Deviation 2.04 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Go on dates, Month 12 | -0.2 Scores on a scale | Standard Deviation 3.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Close relationships, Month 6 | 0.4 Scores on a scale | Standard Deviation 3.1 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Close relationships, Month 12 | 0.2 Scores on a scale | Standard Deviation 3.13 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sex life, Month 6 | 0.2 Scores on a scale | Standard Deviation 2.74 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sex life, Month 12 | -0.2 Scores on a scale | Standard Deviation 2.62 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Physical appearance, Month 6 | -0.3 Scores on a scale | Standard Deviation 1.78 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Physical appearance, Month 12 | -0.2 Scores on a scale | Standard Deviation 2.28 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Self-confidence, Month 6 | 0.0 Scores on a scale | Standard Deviation 2.35 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Self-confidence, Month 12 | 0.2 Scores on a scale | Standard Deviation 2.83 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Motivation, Month 6 | -0.3 Scores on a scale | Standard Deviation 2.04 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Motivation, Month 12 | -0.3 Scores on a scale | Standard Deviation 2.85 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Stigma, Month 6 | -1.1 Scores on a scale | Standard Deviation 2.38 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Stigma, Month 12 | 0.0 Scores on a scale | Standard Deviation 3.03 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Conceal, Month 6 | -0.6 Scores on a scale | Standard Deviation 2.91 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Conceal, Month 12 | 0.3 Scores on a scale | Standard Deviation 3.04 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Future, Month 6 | 0.0 Scores on a scale | Standard Deviation 2.89 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Future, Month 12 | 0.3 Scores on a scale | Standard Deviation 3.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Financial Situation, Month 6 | -0.1 Scores on a scale | Standard Deviation 2.76 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 1, Month 6 | 0.1 Scores on a scale | Standard Deviation 0.65 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 1, Month 12 | 0.0 Scores on a scale | Standard Deviation 0.75 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 2, Month 6 | 0.0 Scores on a scale | Standard Deviation 1.11 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 2, Month 12 | 0.2 Scores on a scale | Standard Deviation 1.05 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Leisure, Month 6 | 0.1 Scores on a scale | Standard Deviation 2.2 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Leisure, Month 12 | 0.2 Scores on a scale | Standard Deviation 2.02 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Work, Month 6 | -0.3 Scores on a scale | Standard Deviation 2.07 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Work, Month 12 | -0.1 Scores on a scale | Standard Deviation 2.48 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Having Children or More Children, Month 6 | 0.3 Scores on a scale | Standard Deviation 1.86 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Having Children or More Children, Month 12 | -0.3 Scores on a scale | Standard Deviation 2.82 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sleep, Month 6 | -0.2 Scores on a scale | Standard Deviation 2.32 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sleep, Month 12 | 0.0 Scores on a scale | Standard Deviation 2.56 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Average Weighted Impact, Month 6 | -0.17 Scores on a scale | Standard Deviation 1.084 |
| CAB LA + RPV LA Q2M | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Average Weighted Impact, Month 12 | -0.07 Scores on a scale | Standard Deviation 1.69 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sex life, Month 6 | -1.3 Scores on a scale | Standard Deviation 2.8 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Holiday, Month 12 | -2.0 Scores on a scale | Standard Deviation 2.83 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 1, Month 6 | 0.4 Scores on a scale | Standard Deviation 0.53 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Getting out and about, Month 6 | -1.1 Scores on a scale | Standard Deviation 3.76 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sex life, Month 12 | -1.0 Scores on a scale | Standard Deviation 3 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Financial Situation, Month 12 | -0.6 Scores on a scale | Standard Deviation 4.61 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sleep, Month 12 | -0.4 Scores on a scale | Standard Deviation 2.7 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Depend on Others, Month 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Physical appearance, Month 6 | -1.1 Scores on a scale | Standard Deviation 2.85 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Depend on Others, Month 12 | -1.2 Scores on a scale | Standard Deviation 3.25 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 1, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Physical appearance, Month 12 | -1.4 Scores on a scale | Standard Deviation 2.23 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Getting out and about, Month 12 | -1.9 Scores on a scale | Standard Deviation 2.48 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Having Children or More Children, Month 6 | 1.3 Scores on a scale | Standard Deviation 4.27 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Long journey, Month 6 | -0.4 Scores on a scale | Standard Deviation 2.7 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Others Fuss or Worry, Month 6 | -1.6 Scores on a scale | Standard Deviation 3.36 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Self-confidence, Month 6 | -1.7 Scores on a scale | Standard Deviation 2.43 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 2, Month 6 | 0.3 Scores on a scale | Standard Deviation 1.25 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Others Fuss or Worry, Month 12 | -0.3 Scores on a scale | Standard Deviation 3.5 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Long journey, Month 12 | -2.3 Scores on a scale | Standard Deviation 2.93 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Self-confidence, Month 12 | -2.9 Scores on a scale | Standard Deviation 3.48 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Average Weighted Impact, Month 12 | -1.27 Scores on a scale | Standard Deviation 1.695 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Do Physically, Month 6 | -0.7 Scores on a scale | Standard Deviation 2.36 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Eat, Month 6 | -1.3 Scores on a scale | Standard Deviation 3.4 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Motivation, Month 6 | -0.6 Scores on a scale | Standard Deviation 2.51 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Eat, Month 12 | -1.1 Scores on a scale | Standard Deviation 2.48 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Overview Item 2, Month 12 | -0.6 Scores on a scale | Standard Deviation 1.13 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Motivation, Month 12 | -2.1 Scores on a scale | Standard Deviation 2.85 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Drink, Month 6 | -0.7 Scores on a scale | Standard Deviation 4.42 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Having Children or More Children, Month 12 | -1.5 Scores on a scale | Standard Deviation 3 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Freedom to Drink, Month 12 | -1.7 Scores on a scale | Standard Deviation 3.4 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Leisure, Month 6 | 0.9 Scores on a scale | Standard Deviation 1.46 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Spiritual/Religious Life, Month 6 | -0.5 Scores on a scale | Standard Deviation 1.22 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Stigma, Month 12 | -2.0 Scores on a scale | — |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Spiritual/Religious Life, Month 12 | -1.0 Scores on a scale | Standard Deviation 2.45 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Average Weighted Impact, Month 6 | -0.43 Scores on a scale | Standard Deviation 1.792 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Past, Month 6 | 0.7 Scores on a scale | Standard Deviation 2.21 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Conceal, Month 6 | -1.6 Scores on a scale | Standard Deviation 3.51 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Past, Month 12 | -1.3 Scores on a scale | Standard Deviation 2.21 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Do Physically, Month 12 | -1.7 Scores on a scale | Standard Deviation 2.63 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Leisure, Month 12 | -1.6 Scores on a scale | Standard Deviation 3.74 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Family, Month 6 | -0.9 Scores on a scale | Standard Deviation 2.27 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Conceal, Month 12 | -0.4 Scores on a scale | Standard Deviation 4.1 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Family, Month 12 | -1.5 Scores on a scale | Standard Deviation 2.51 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Sleep, Month 6 | 0.7 Scores on a scale | Standard Deviation 1.25 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Friends, Month 6 | -1.1 Scores on a scale | Standard Deviation 2.85 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Future, Month 6 | 1.0 Scores on a scale | Standard Deviation 2.24 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Friends, Month 12 | -2.0 Scores on a scale | Standard Deviation 2.38 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Work, Month 6 | -0.9 Scores on a scale | Standard Deviation 4.14 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Go on dates, Month 6 | -3.5 Scores on a scale | Standard Deviation 3.54 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Feelings About the Future, Month 12 | -0.9 Scores on a scale | Standard Deviation 2.85 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Go on dates, Month 12 | -3.5 Scores on a scale | Standard Deviation 3.54 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Holiday, Month 6 | -0.3 Scores on a scale | Standard Deviation 3.55 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Close relationships, Month 6 | -0.5 Scores on a scale | Standard Deviation 2.95 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Financial Situation, Month 6 | 1.1 Scores on a scale | Standard Deviation 1.46 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Close relationships, Month 12 | -0.5 Scores on a scale | Standard Deviation 2.95 |
| DTG + RPV | Change From Baseline in HIV Dependent Quality of Life (HIVDQoL - Self-completion Questionnaire Designed to Measure QoL in People Living With HIV) | Work, Month 12 | -0.7 Scores on a scale | Standard Deviation 2.75 |
Secondary
Change From Baseline in Individual Item Score of HIVTSQs
HIVTSQs is a 12 item questionnaire. The individual item scores are rated as 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. Change from Baseline is defined as post-dose value minus Baseline value. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. SD=0.00 is defined as SD resulted below the detectable limit of the assay and approximate to 0.00.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
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 Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 4, Month 6 | 0.0 Scores on a scale | Standard Deviation 0.95 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 1, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.75 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 2, Month 6 | -0.1 Scores on a scale | Standard Deviation 0.46 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 2, Month 12 | 0.0 Scores on a scale | Standard Deviation 0.34 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 3, Month 6 | -0.5 Scores on a scale | Standard Deviation 1.41 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 3, Month 12 | -0.5 Scores on a scale | Standard Deviation 1.21 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 1, Month 6 | -0.1 Scores on a scale | Standard Deviation 0.82 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 4, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 5, Month 6 | 0.1 Scores on a scale | Standard Deviation 1 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 5, Month 12 | 0.1 Scores on a scale | Standard Deviation 1.14 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 6, Month 6 | 0.1 Scores on a scale | Standard Deviation 1.13 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 6, Month 12 | 0.0 Scores on a scale | Standard Deviation 1.31 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 7, Month 6 | 0.1 Scores on a scale | Standard Deviation 0.74 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 7, Month 12 | 0.0 Scores on a scale | Standard Deviation 1.06 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 8, Month 6 | 0.2 Scores on a scale | Standard Deviation 0.93 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 8, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.95 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 9, Month 6 | -0.1 Scores on a scale | Standard Deviation 0.61 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 9, Month 12 | -0.2 Scores on a scale | Standard Deviation 0.8 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 10, Month 6 | 0.1 Scores on a scale | Standard Deviation 0.91 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 10, Month 12 | 0.1 Scores on a scale | Standard Deviation 1.03 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 11, Month 6 | 0.0 Scores on a scale | Standard Deviation 1.09 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 11, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.79 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 12, Month 6 | -1.3 Scores on a scale | Standard Deviation 1.59 |
| CAB LA + RPV LA Q2M | Change From Baseline in Individual Item Score of HIVTSQs | Item 12, Month 12 | -1.1 Scores on a scale | Standard Deviation 1.58 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 9, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 1, Month 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 7, Month 6 | 0.0 Scores on a scale | Standard Deviation 0.58 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 1, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 12, Month 6 | -0.6 Scores on a scale | Standard Deviation 1.13 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 2, Month 6 | -0.3 Scores on a scale | Standard Deviation 0.49 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 7, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.69 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 2, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 10, Month 6 | 0.3 Scores on a scale | Standard Deviation 0.76 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 3, Month 6 | 0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 8, Month 6 | 0.0 Scores on a scale | Standard Deviation 0.58 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 3, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 11, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.9 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 4, Month 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 10, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.9 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 4, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.69 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 8, Month 12 | 0.0 Scores on a scale | Standard Deviation 0.58 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 5, Month 6 | 0.3 Scores on a scale | Standard Deviation 0.49 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 12, Month 12 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 5, Month 12 | 0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 9, Month 6 | 0.0 Scores on a scale | Standard Deviation 0 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 6, Month 6 | 0.4 Scores on a scale | Standard Deviation 1.62 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 11, Month 6 | -0.1 Scores on a scale | Standard Deviation 0.38 |
| DTG + RPV | Change From Baseline in Individual Item Score of HIVTSQs | Item 6, Month 12 | 0.3 Scores on a scale | Standard Deviation 1.8 |
Secondary
Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
HIVTSQs 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 as compared to the past few weeks; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline was defined as post-dose visit value minus baseline value.
Time frame: At Months 6 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
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 Q2M | Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 6 | -0.19 Scores on a scale | Standard Deviation 6.419 |
| CAB LA + RPV LA Q2M | Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 12 | -0.42 Scores on a scale | Standard Deviation 6.659 |
| DTG + RPV | Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 6 | 0.71 Scores on a scale | Standard Deviation 3.773 |
| DTG + RPV | Change From Baseline in Total Treatment Satisfaction Score of HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) | Month 12 | 0.14 Scores on a scale | Standard Deviation 6.256 |
Secondary
Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of CAB LA+RPV LA Q2M. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.
Time frame: Up to End of LTFU Phase (compared with Baseline [Day1]), (approximately up to 12 months after exiting the Maintenance Phase)
Population: ITT-E Population. Only those participants with data available for specific analysis and specified time points analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 48 | -44.2 Cells per cubic millimeter | Standard Deviation 236.71 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 12 | -19.4 Cells per cubic millimeter | Standard Deviation 189.19 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 16 | 45.6 Cells per cubic millimeter | Standard Deviation 227.11 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 20 | 43.8 Cells per cubic millimeter | Standard Deviation 193.72 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 24 | 41.6 Cells per cubic millimeter | Standard Deviation 224.99 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 26 | 4.2 Cells per cubic millimeter | Standard Deviation 160.08 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 50 | -451.0 Cells per cubic millimeter | Standard Deviation 485.08 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 52 | -23.0 Cells per cubic millimeter | Standard Deviation 78.28 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 40 | 67.1 Cells per cubic millimeter | Standard Deviation 205.26 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 42 | 390.8 Cells per cubic millimeter | Standard Deviation 406.79 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 44 | 31.6 Cells per cubic millimeter | Standard Deviation 244.33 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 46 | -98.5 Cells per cubic millimeter | Standard Deviation 424.97 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 28 | -6.2 Cells per cubic millimeter | Standard Deviation 196.62 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 2 | -4.9 Cells per cubic millimeter | Standard Deviation 196.47 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 4 | 5.3 Cells per cubic millimeter | Standard Deviation 221.68 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 6 | 100.2 Cells per cubic millimeter | Standard Deviation 343.66 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 8 | -20.7 Cells per cubic millimeter | Standard Deviation 218.39 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 30 | 18.1 Cells per cubic millimeter | Standard Deviation 192.09 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 32 | -13.5 Cells per cubic millimeter | Standard Deviation 215.6 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 34 | 15.8 Cells per cubic millimeter | Standard Deviation 239.28 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | Month 36 | 0.0 Cells per cubic millimeter | Standard Deviation 195.92 |
| DTG + RPV | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 1 | -88.8 Cells per cubic millimeter | Standard Deviation 156.64 |
| DTG + RPV | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 3 | -97.8 Cells per cubic millimeter | Standard Deviation 188.52 |
| DTG + RPV | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 6 | -111.8 Cells per cubic millimeter | Standard Deviation 236.26 |
| DTG + RPV | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 9 | -103.3 Cells per cubic millimeter | Standard Deviation 87.22 |
| DTG + RPV | Change From Baseline Values for CD4+ for CAB LA + RPV LA Q2M Arm up to End of LTFU Phase | LTFU Month 12 | 28.8 Cells per cubic millimeter | Standard Deviation 209.33 |
Secondary
Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Blood samples were collected and CD4+ cell count assessment by flow cytometry was carried out to evaluate the immunologic activity of DTG + RPV arm. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from baseline value is defined as post-dose value minus baseline value.
Time frame: At Months 3, 6, 9 and 12 (compared with Baseline [Day 1]) [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 3 | -24.0 Cells per cubic millimeter | Standard Deviation 118.4 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 6 | -75.4 Cells per cubic millimeter | Standard Deviation 123.71 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 9 | -27.3 Cells per cubic millimeter | Standard Deviation 150.96 |
| CAB LA + RPV LA Q2M | Change From Baseline Values for CD4+ for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Month 12 | -13.9 Cells per cubic millimeter | Standard Deviation 145.76 |
Secondary
Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc)
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 represented deterioration in satisfaction with treatment. A score of 0 represents no change. A maximum of 5 items can be missing, the missing scores were imputed with the mean of the completed item scores. If 6 or more items are missing, then the overall treatment satisfaction scale score was not computed and remained missing.
Time frame: At Month 12 (compared with Baseline [Day 1]) [Maintenance Phase]
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 Q2M | Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) | 28.0 Scores on a scale | Standard Deviation 6.78 |
| DTG + RPV | Change in Treatment Satisfaction Over Time Using the HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) | 27.7 Scores on a scale | Standard Deviation 6.97 |
Secondary
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
An adverse event 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. Number of participants with adverse events leading to permanent withdrawal has been presented.
Time frame: Up to End of Maintenance Phase (up to Month 52)
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | 1 Participants |
Secondary
Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase]
An adverse event 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. Number of participants with adverse events leading to permanent withdrawal has been presented.
Time frame: Up to Month 12 [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants Who Permanently Discontinued Treatment Due to Adverse Events for DTG + RPV Arm up to Month 12 [Maintenance Phase] | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to End of Maintenance Phase (up to Month 52)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | AST, Grade 1 | 12 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | AST, Grade 2 | 6 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | AST, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | AST, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Bilirubin, Grade 1 | 4 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Bilirubin, Grade 2 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Bilirubin, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | CO2, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | CO2, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | CO2, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Cholesterol, Grade 1 | 8 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Cholesterol, Grade 2 | 5 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Cholesterol, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatine kinase, Grade 1 | 8 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatine kinase, Grade 2 | 7 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatine kinase, Grade 3 | 6 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatine kinase, Grade 4 | 2 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatinine, Grade 1 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatinine, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Direct bilirubin, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted using CKD-EPI, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted for BSA, Grade 2 | 23 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted for BSA, Grade 3 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted for BSA, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Glucose, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | LDL cholesterol calculation, Grade 1 | 7 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | LDL cholesterol calculation, Grade 3 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Lipase, Grade 2 | 15 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Lipase, Grade 3 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Lipase, Grade 4 | 4 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Phosphate, Grade 2 | 2 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | ALT, Grade 1 | 15 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | ALT, Grade 2 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | ALT, Grade 3 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | ALT, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Bilirubin, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | CO2, Grade 1 | 13 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Cholesterol, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatinine, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Creatinine, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Direct bilirubin, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Direct bilirubin, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Direct bilirubin, Grade 3 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted using CKD-EPI, Grade 2 | 23 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted using CKD-EPI, Grade 3 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted using CKD-EPI, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | GFR from creatinine adjusted for BSA, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Glucose, Grade 1 | 21 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Glucose, Grade 2 | 20 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Glucose, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | LDL cholesterol calculation, Grade 2 | 4 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | LDL cholesterol calculation, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Lipase, Grade 1 | 10 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Phosphate, Grade 1 | 14 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Phosphate, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Phosphate, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Sodium, Grade 1 | 9 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Sodium, Grade 2 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Sodium, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Sodium, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Triglycerides, Grade 1 | 11 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Triglycerides, Grade 2 | 8 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Triglycerides, Grade 3 | 2 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Triglycerides, Grade 4 | 1 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]
Clinical chemistry toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of following clinical chemistry parameters: alanine aminotransferase (ALT), albumin, aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase, creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease epidemiology collaboration (CKD-EPI), GFR from creatinine adjusted for bovine serum albumin (BSA), glucose, low density lipoprotein (LDL) cholesterol calculation, lipase, phosphate, sodium and triglycerides. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Month 12 [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | CO2, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | CO2, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Cholesterol, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted using CKD-EPI, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted using CKD-EPI, Grade 3 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted using CKD-EPI, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted for BSA, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted for BSA, Grade 2 | 5 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted for BSA, Grade 3 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Grade 1 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | LDL cholesterol calculation, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | LDL cholesterol calculation, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | LDL cholesterol calculation, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lipase, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lipase, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Triglycerides, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Grade 1 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | ALT, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | AST, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Bilirubin, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | CO2, Grade 1 | 1 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | CO2, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Cholesterol, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Cholesterol, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Cholesterol, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatine kinase, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Creatinine, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Direct bilirubin, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Direct bilirubin, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Direct bilirubin, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Direct bilirubin, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted using CKD-EPI, Grade 2 | 5 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | GFR from creatinine adjusted for BSA, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Glucose, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | LDL cholesterol calculation, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lipase, Grade 2 | 2 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Lipase, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Phosphate, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Sodium, Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Triglycerides, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Triglycerides, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Chemistry Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Triglycerides, Grade 4 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to End of Maintenance Phase (up to Month 52)
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Platelets, Grade 1 | 2 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Platelets, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Platelets, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for CAB LA + RPV LA Q2M Arm up to End of Maintenance Phase | Platelets, Grade 4 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase]
The hematology toxicities were graded as per the DAIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table). Blood samples were collected for the analysis of the hematology parameter: platelets. Severity grades were: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening).
Time frame: Up to Month 12 [Maintenance Phase]
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Grade 2 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Maximum Post-Baseline Hematology Toxicities for DTG + RPV Arm up to Month 12 [Maintenance Phase] | Platelets, Grade 4 | 0 Participants |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm
An adverse event 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. A SAE is defined as 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 judgement.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm | Non-SAE (>=5%) | 86 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for CAB LA + RPV LA Q2M Arm | SAE | 10 Participants |
Secondary
Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm
An adverse event 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. A SAE is defined as 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 judgement.
Time frame: Up to Month 12 [Maintenance Phase]
Population: Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm | Non-SAE (>=5%) | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Non-serious Adverse Events (Non-SAEs >=5 Percent [%] Incidence) and Serious Adverse Events (SAEs) for DTG + RPV Arm | SAE | 0 Participants |
Secondary
Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase
Confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 c/mL after prior suppression to \<200 c/mL.
Time frame: Up to End of Maintenance Phase (up to Month 52 for CAB LA+RPV LA Q2M group, up to Month 12 for DTG+RPV group)
Population: ITT-E Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase | 1 Participants |
| DTG + RPV | Number of Participants With Protocol-defined Confirmed Virologic Failure up to End of Maintenance Phase | 0 Participants |
Secondary
Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Grade 1 | 22 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Grade 2 | 53 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Grade 3 | 10 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Grade 4 | 4 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for CAB LA + RPV LA Q2M Arm | Grade 5 | 0 Participants |
Secondary
Number of Participants With Severity of Adverse Events for DTG + RPV Arm
Severity of adverse events were defined as per The Division of Acquired Immunodeficiency Syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS adverse events Grading Table). Severity grades for adverse events were Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 (all deaths related to an AE).
Time frame: Up to Month 12 [Maintenance Phase]
Population: Safety Population comprised of all participants who received at least one dose of study treatment on or after Day 1 visit. Participants were assessed according to actual treatment received.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Grade 1 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Grade 2 | 3 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Grade 3 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Grade 4 | 0 Participants |
| CAB LA + RPV LA Q2M | Number of Participants With Severity of Adverse Events for DTG + RPV Arm | Grade 5 | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Genotypic Resistance
Plasma samples were collected and analyzed for genotypic resistance from participants who met confirmed virologic withdrawal criteria.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants reporting confirmed virologic failure were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Treatment Emergent Genotypic Resistance | 0 Participants |
Secondary
Number of Participants With Treatment Emergent Phenotypic Resistance
Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria.
Time frame: Up to End of LTFU Phase (approximately up to 12 months after exiting the Maintenance Phase)
Population: Safety Population. Only those participants reporting confirmed virologic failure were analyzed.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA + RPV LA Q2M | Number of Participants With Treatment Emergent Phenotypic Resistance | 0 Participants |
Secondary
Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \<50 c/mL as per FDA snapshot algorithm at Month 12 was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M and oral DTG + RPV regimen. The HIV-1 RNA \<50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window.
Time frame: At Month 12 [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase] | 98 Percentage of participants |
| DTG + RPV | Percentage of Participants With HIV-RNA <50 c/mL as Per FDA Snapshot Algorithm at Month 12 [Maintenance Phase] | 100 Percentage of participants |
Secondary
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of CAB LA+RPV LA Q2M regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 2, 4, 6, 8, 10 and 12 [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Baseline (Day 1) | 0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 2 | 0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 4 | 1 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 6 | 0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 8 | 0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 10 | 0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for CAB LA + RPV LA Q2M Arm up to Month 12 [Maintenance Phase] | Month 12 | 0 Percentage of participants |
Secondary
Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase]
Percentage of participants with HIV-1 RNA \>=50 c/mL as per FDA snapshot algorithm over time was assessed to demonstrate the antiviral activity of DTG + RPV regimen in HIV-1 infected ART experienced participants. The HIV-1 RNA \>=50 c/mL per Snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the 12 months analysis visit window. Baseline is defined as the latest pre-dose assessment with a non-missing value, including those from unscheduled visits.
Time frame: At Baseline (Day 1) and at Months 3, 6, 9 and 12 [Maintenance Phase]
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | Baseline (Day 1) | 0.0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | Month 3 | 0.0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | Month 6 | 0.0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | Month 9 | 0.0 Percentage of participants |
| CAB LA + RPV LA Q2M | Percentage of Participants With HIV-RNA >=50 c/mL as Per FDA Snapshot Algorithm Over Time for DTG + RPV up to Month 12 [Maintenance Phase] | Month 12 | 0.0 Percentage of participants |
Secondary
Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio
Urine samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio.
Time frame: At Baseline (Day 1)
Population: Safety Population. Only those participants with data available at the specified data points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA + RPV LA Q2M | Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio | 0.7 Ratio | Standard Deviation 0.98 |
| CAB LA + RPV LA Q2M | Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio | 7.6 Ratio | Standard Deviation 4.528 |
| DTG + RPV | Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine albumin/creatinine ratio | 0.4 Ratio | Standard Deviation 0.122 |
| DTG + RPV | Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio | Urine protein/creatinine ratio | 9.1 Ratio | Standard Deviation 7.237 |
Other Pre-specified
Ctrough for RPV LA
Blood samples were collected at indicated time points for pharmacokinetic analysis of RPV LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary Pop PK analyses were not conducted.
Time frame: Pre-dose (Day 1) and Month 12 [Maintenance Phase]
Population: Pharmacokinetic Population
Other Pre-specified
Plasma Trough Concentration (Ctrough) for CAB LA
Blood samples were collected at indicated time points for pharmacokinetic analysis of CAB LA. This was a conditional secondary endpoint for which results are not available because the trough concentrations for this product are well characterized and therefore, secondary population pharmacokinetic (Pop PK) analyses were not conducted.
Time frame: Pre-dose (Day 1) and Month 12 [Maintenance Phase]
Population: Pharmacokinetic Population