Infection, Human Immunodeficiency Virus, HIV Infections
Conditions
Keywords
bi-monthly, GSK744, injectable, long acting, maintenance, abacavir, every other month, rilpivirine, HIV-1 infection, integrase inhibitor, TMC278 LA, RPV, non-nucleoside reverse transcriptase inhibitor, LA, once monthly, GSK1265744, induction, treatment satisfication, once daily, lamivudine, adherence, TMC278, therapy-naive
Brief summary
This study is a Phase IIb, randomized, multicentre, parallel group, open-label, study having an overall objective to evaluate the antiviral activity, tolerability, and safety of two intramuscular (IM) dosing regimens of GSK744 LA plus TMC278 LA, relative to GSK744 30 milligram (mg) plus Abacavir/Lamivudine (ABC/3TC) given orally once daily (QD), in HIV-1 infected antiretroviral-naïve subjects. GSK744 is the oral formulation of GSK1265744 (cabotegravir), GSK744 LA is the long acting injectable formulation of GSK1265744 and TMC278 LA is the long acting injectable formulation of TMC278. The study will consist of three parts: an Induction Period, Maintenance Period and Extension Period. There is also a Long-Term Follow Up Period for subjects who withdraw from the study and have received at least one dose of GSK744 LA and / or TMC278 LA. In the Induction Period, eligible subjects will receive a combination of an oral regimen of 30 mg of GSK744 and 600/300 mg of ABC/3TC, once daily for 20 weeks. In the Maintenance Period, eligible subjects will be randomized 2:2:1 at Day 1 to receive an IM regimen of GSK744 LA 400 mg + TMC278 LA 600 mg every 4 weeks for 96 weeks (Q4W), an IM regimen of GSK744 LA 600 mg + TMC278 LA 900 mg every 8 weeks for 96 weeks (Q8W), or to continue on the oral Induction Period regimen of GSK744 30 mg + ABC/3TC once daily for 96 weeks (or 104 weeks if continuing on to the Extension Period). The Extension Period will allow for a collection of longer term efficacy and safety and tolerability data from subjects receiving GSK744 LA and TMC278 LA. The study will involve sufficient subjects at screening in order to ensure a total of approximately 265 subjects at the beginning of the Induction Period and approximately 225 subjects randomized into the Maintenance Period.
Interventions
DRUGCAB Oral Tablets
White to almost white oval shaped film coated 30 mg tablets for oral administration.
DRUGCAB LA
Sterile white to slightly colored suspension containing 200 mg/mL of GSK744 as free acid (GSK1265744 free acid), polysorbate 20, polyethylene glycol 3350, mannitol, and water for injection, packaged in a 3 mL USP Type I glass vial, for administration by IM injection
DRUGABC/3TC Oral tablets
ABC/3TC fixed dose combination (FDC) oral tablet, containing 600 mg of ABC (as abacavir sulfate) and 300 mg of 3TC
DRUGRPV Oral Tablets
Off-white, round, biconvex, film-coated 25 mg Rilpivirine (RPV) tablets for oral administration. Eligible subjects switching from the oral regimen to the IM regimen in the Extension Period will receive 2 weeks of RPV 25 mg once daily, from Week 102 through Week 104
OTHERHAART
Higly-active antiretroviral therapy chosen by participant based on investigator recommendations and based on availability.
DRUGRPV
Sterile white suspension containing 300 mg/mL of TMC278 as free base, poloxamer 338, sodium dihydrogen phosphate monohydrate, citric acid monohydrate, glucose monohydrate, sodium hydroxide, water for injection, packaged in a 2 mL USP Type I glass vial, for administration by IM injection.
Sponsors
Janssen Pharmaceuticals
GlaxoSmithKline
ViiV Healthcare
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects screened for this study must be HIV-1 infected and \>=18 years of age. * A female subject is eligible to enter and participate in the study if she: is of non-child-bearing potential defined as either post-menopausal (12 months of spontaneous amenorrhea and \>=45 years of age) or physically incapable of becoming pregnant with documented tubal ligation, hysterectomy or bilateral oophorectomy or; is of child-bearing potential with a negative pregnancy test at both Screening and first day of the Induction Period and agrees to use one of the following methods of contraception to avoid pregnancy 2 weeks prior to administration of IP, throughout the study, and for at least 2 weeks after discontinuation of all oral study medications and for at least 52 weeks after discontinuation of GSK744 LA and TMC278 LA: Complete abstinence from intercourse (where this is the subject's preferred and usual lifestyle); double barrier method (male condom/spermicide, male condom/diaphragm, diaphragm/spermicide); approved hormonal contraception; any intrauterine device (IUD) with published data showing that the expected failure rate is \<1% per year; male partner sterilization prior to the female subject's entry into the study, and this male is the sole partner for that subject; any other method with published data showing that the lowest expected failure rate is \<1% per year; any contraception method must be used consistently and in accordance with the approved product label. All subjects participating in the study must follow safer sexual practices including the use of effective barrier methods (e.g. male condom/spermicide) to minimize risk of HIV transmission. * HIV-1 infection as documented by Screening plasma HIV-1 RNA\>=1000 c/mL. * CD4+ cell count \>=200 cells/mm\^3 (or higher as local guidelines dictate). * ART-naive defined as having no more than 10 days of prior therapy with any antiretroviral agent following a diagnosis of HIV-1 infection. Any previous exposure to an HIV integrase inhibitor or non-nucleoside reverse transcriptase inhibitor will be exclusionary. * French subjects: In France, a subject will be eligible for inclusion in this study only if either affiliated to or a beneficiary of a social security category.
Exclusion criteria
* Women who are breastfeeding. * Any evidence at screening of an active Center for Disease and Prevention Control (CDC) Category C disease, except cutaneous Kaposi's sarcoma not requiring systemic therapy. * Subjects with known moderate to severe hepatic impairment. * Any pre-existing physical or mental condition (including substance abuse disorder) which, in the opinion of the Investigator, may interfere with the subject's ability to comply with the dosing schedule and/or protocol evaluations or which may compromise the safety of the subject. * Subject who, in the investigator's judgment, poses a significant suicide risk. Recent history of suicidal behavior and/or suicidal ideation may be considered as evidence of serious suicide risk. * The subject has a tattoo or other dermatological condition overlying the gluteus region which may interfere with interpretation of injection site reactions. * History of ongoing or clinically relevant hepatitis within the previous 6 months, including chronic Hepatitis B virus (HBV) infection (HBsAg positive). 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; subjects who are anticipated to require such therapy during the randomized portion of the study must be excluded. * History of liver cirrhosis with or without hepatitis viral co-infection. * Ongoing or clinically relevant pancreatitis. * History of the following cardiac diseases: myocardial infarction, congestive heart failure, documented hypertrophic cardiomyopathy, sustained ventricular tachycardia. * Personal or known family history of prolonged QT syndrome. * Any condition which, in the opinion of the Investigator, may interfere with the absorption, distribution, metabolism or excretion of the drug or render the subject 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 PK sampling, subjects with a history of sensitivity to heparin or heparin-induced thrombocytopenia must not be enrolled. * Current or anticipated need for chronic anti-coagulation. * Any evidence of primary resistance based on the presence of any major resistance-associated mutation in the Screening result or, if known, any historical resistance test result. * Any verified Grade 4 laboratory abnormality. * Any acute laboratory abnormality at Screening, which, in the opinion of the Investigator, would preclude the subject's participation in the study of an investigational compound. * Subject has estimated creatinine clearance \<50 mL/min via Cockcroft-Gault method. * Alanine aminotransferase (ALT) \>=5 times Upper limit of normal (ULN). Subjects with ALT \>2xULN but \<5xULN may participate in the study, if in the opinion of the Investigator and GlaxoSmithKline (GSK) medical monitor the lab abnormality will not interfere with the study procedures or compromise subject safety. * Alanine aminotransferase (ALT) \>=3xULN and bilirubin \>=1.5xULN (with \>35% direct bilirubin). * Any clinically significant finding on screening or Baseline electrocardiograph (ECG), specifically: Heart rate \<45 and \>100 beats per minute (bpm) (Males) and \<50 and \>100 bpm (Females) (100 to 110 bpm can be rechecked within 30 minutes to verify eligibility), QRS duration \>120 milliseconds (msec), QTc interval (B or F) \>450 msec; non-sustained (\>=3 consecutive beats) or sustained ventricular tachycardia; sinus pauses \>2.5 seconds; 2nd degree (Type II) or higher atrio-ventricular (AV) block; evidence of WPW (Wolff- Parkinson-White) syndrome (ventricular pre-excitation); pathologic Q waves defined as Q wave \>40msec OR depth \>0.4 mV; any significant arrhythmia (either on ECG or by history) which, in the opinion of the Investigator and GSK medical monitor, will interfere with the safety for the individual subject. * Subjects who are human leukocyte antigen (HLA)-B\*5701 positive and unable to use an alternative nucleoside reverse transcriptase inhibitor (NRTI) backbone (subjects who are HLA-B\*5701 positive may be enrolled if they use an alternative NRTI backbone that does not contain abacavir). * Exposure to an experimental drug and/or experimental vaccine within 28 days or 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is longer, prior to the first dose of IP. * Treatment with any of the following agents within 28 days of Screening; radiation therapy, cytotoxic chemotherapeutic agents, tuberculosis therapy and Immunomodulators that alter immune responses (such as systemic corticosteroids, interleukins, or interferons) * Treatment with an HIV-1 immunotherapeutic vaccine within 90 days of Screening. * Treatment with any agent, except recognized ART as allowed above, with documented activity against HIV-1 within 28 days of the first dose of IP.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Up to an average of 59 weeks | Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented. |
| Number of Participants With Post-Baseline Urinalysis Dipstick Results | Up to an average of 59 weeks | Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period. |
| Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | Week 32 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit). |
| Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | Up to Week 32 | Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL. |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | Up to 20 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. |
| Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Up to an average of 59 weeks | Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented. |
| Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Up to an average of 59 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented. |
| Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Up to an average of 59 weeks | An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to 20 weeks | Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented. |
| Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | From Day 1 up to Week 96 | Percentage of participants with HIV-1 RNA \<50 c/mL and \<200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. |
| Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | At Week 32 and Week 48 | Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL. |
| Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 | Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented. SD=0.000 is defined as following: if participants analyzed at a specific timepoint have resulted same values, then SD is considered equal with 0.000. |
| Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline. |
| Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. |
| Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value. |
| Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 | HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death. |
| Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Up to Week 32 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Up to Week 96 | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 (compared with Baseline [Week -20]) | Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Up to Week 32 | Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data. |
| Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Up to Week 32 | Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated. |
| Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Pre-dose on Weeks 16, 24 and 32 | Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented. |
| Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Pre-dose on Weeks 16, 20, 24, 28 and 32 | Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented. |
| Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Pre-dose on Weeks 16, 24 and 32 | Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented. |
| Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Pre-dose on Weeks 16, 20, 24, 28 and 32 | Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented. |
| Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC \[0-tau\]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (AUC \[0-tau\]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau). Standard Error (SE)=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000 . |
| Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0. |
| Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax. |
| Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (AUC \[0-tau\]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau). SE=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000. |
| Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0. |
| Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | Up to Week 32 | Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax. |
| Number of Participants With Treatment-emergent Phenotypic Resistance | Up to Week 32 | Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant. |
| Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Up to Week 32 | Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact \[HC\] and not injectable drug user). |
| Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Up to Week 32 | Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \<200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact \[HC\] and not injectable drug user). |
| HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | At Week 32 and Week 96 | The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks. |
| HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period) | Week 32 | The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. |
| Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Week 32 | The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented. |
| Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Week 96 | The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 96 by their score categories (0: none of the time to 6: all of the time) are presented. |
| Number of Participants With Treatment-emergent Genotypic Resistance | Up to Week 32 | Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor \[NRTI\], Non-nucleoside reverse transcriptase inhibitor \[NNRTI\], protease inhibitor \[PI\])are presented. |
| Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -8, Week -4, Day 1 | Percentage of participants with HIV-1 RNA \<200 c/mL and \<50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product. |
| Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -8, Week -4, Day 1 | Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented. |
| Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1 | Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline. |
| Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, Week -16, Week -12, Week -4, Day 1 | Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented. |
| Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1 | Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline. |
| Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to 20 Weeks | An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented. |
| Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Up to Week 20 | Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented. |
Countries
Canada, France, Germany, Spain, United States
Participant flow
Recruitment details
The study was conducted across 50 sites in five countries (United States, Canada, France, Germany and Spain). The results presented are based on final analysis, up to approximately Week 468.
Pre-assignment details
Study consisted of 28 days Screening Period, 20 weeks Induction Period, 96 weeks Maintenance Period (MP), Extension Period (EP) and 52 weeks Long-Term Follow Up Period (LTFP). A total of 309 participants were enrolled in the study and entered the Induction Period, of which 288 completed and 286 were qualified and randomized into the MP.
Participants by arm
| Arm | Count |
|---|---|
| CAB 30 mg+ABC/3TC QD In induction period, all participants received an oral regimen of cabotegravir (CAB) 30 milligrams (mg) once daily (QD) plus abacavir/lamivudine (ABC/3TC) 600/300 mg QD for 20 weeks. They also received an oral dose of Rilpivirine (RPV) 25 mg tablet once daily in the last 4 weeks of the Induction Period. | 309 |
| Total | 309 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 | FG006 |
|---|---|---|---|---|---|---|---|---|
| Extension Period (Week 97 to Study End) | Adverse Event | 0 | 3 | 11 | 0 | 2 | 1 | 0 |
| Extension Period (Week 97 to Study End) | Lack of Efficacy | 0 | 0 | 0 | 0 | 1 | 0 | 0 |
| Extension Period (Week 97 to Study End) | Lost to Follow-up | 0 | 2 | 1 | 0 | 1 | 0 | 0 |
| Extension Period (Week 97 to Study End) | Physician Decision | 0 | 2 | 2 | 0 | 0 | 0 | 0 |
| Extension Period (Week 97 to Study End) | Protocol Violation | 0 | 1 | 1 | 0 | 2 | 0 | 0 |
| Extension Period (Week 97 to Study End) | Site closed | 0 | 0 | 1 | 0 | 0 | 1 | 0 |
| Extension Period (Week 97 to Study End) | Withdrawal by Subject | 0 | 7 | 9 | 0 | 2 | 0 | 0 |
| Induction Period (20 Weeks) | Adverse Event | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Lack of Efficacy | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Lost to Follow-up | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Met protocol-defined stopping criteria | 3 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Physician Decision | 1 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Protocol Violation | 2 | 0 | 0 | 0 | 0 | 0 | 0 |
| Induction Period (20 Weeks) | Withdrawal by Subject | 5 | 0 | 0 | 0 | 0 | 0 | 0 |
| Long-Term Follow-up Period (52 Weeks) | Other | 0 | 0 | 0 | 0 | 0 | 0 | 6 |
| Maintenance Period (Up to Week 96) | Adverse Event | 0 | 1 | 8 | 1 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Lack of Efficacy | 0 | 1 | 0 | 1 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Lost to Follow-up | 0 | 0 | 0 | 1 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Met protocol-defined stopping criteria | 0 | 0 | 1 | 1 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Physician Decision | 0 | 1 | 0 | 0 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Protocol Violation | 0 | 1 | 2 | 0 | 0 | 0 | 0 |
| Maintenance Period (Up to Week 96) | Withdrawal by Subject | 0 | 1 | 3 | 5 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | CAB 30 mg+ABC/3TC QD |
|---|---|
| Age, Continuous | 36.6 Years STANDARD_DEVIATION 10.39 |
| Race/Ethnicity, Customized Race African American/African Heritage | 46 Participants |
| Race/Ethnicity, Customized Race American Indian or Alaskan Native | 10 Participants |
| Race/Ethnicity, Customized Race Asian - Central/South Asian Heritage | 1 Participants |
| Race/Ethnicity, Customized Race Asian - Japanese Heritage | 1 Participants |
| Race/Ethnicity, Customized Race Asian - South East Asian Heritage | 2 Participants |
| Race/Ethnicity, Customized Race Mixed Race | 2 Participants |
| Race/Ethnicity, Customized Race Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race/Ethnicity, Customized Race White - Arabic/North African Heritage | 6 Participants |
| Race/Ethnicity, Customized Race White - White/Caucasian/European Heritage | 240 Participants |
| Sex: Female, Male Female | 27 Participants |
| Sex: Female, Male Male | 282 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk | EG006 affected / at risk |
|---|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 309 | 0 / 115 | 3 / 115 | 0 / 56 | 0 / 34 | 0 / 10 | 0 / 43 |
| other Total, other adverse events | 145 / 309 | 115 / 115 | 115 / 115 | 52 / 56 | 34 / 34 | 10 / 10 | 7 / 43 |
| serious Total, serious adverse events | 8 / 309 | 31 / 115 | 31 / 115 | 9 / 56 | 9 / 34 | 1 / 10 | 7 / 43 |
Outcome results
Primary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia.
Time frame: Up to 20 weeks
Population: Safety Population. It consists of all enrolled subjects who received at least one dose of investigational product during induction period.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | Any non-SAE | 246 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Induction Period) | Any SAE | 8 Participants |
Primary
Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period)
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. A SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect, important medical events which may require medical or surgical intervention, drug-induced liver injury with hyperbilirubinaemia. Data presented includes all post-baseline induction period and maintenance period adverse events, as well as long-term follow-up period adverse events for those participants who did not enter the extension period.
Time frame: Up to an average of 59 weeks
Population: Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of investigational product.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any non-SAE | 115 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any SAE | 9 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any non-SAE | 113 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any SAE | 8 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any non-SAE | 52 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Any Serious Adverse Event (SAE) and Any Non-serious Adverse Event (Non-SAE) (Maintenance Period) | Any SAE | 5 Participants |
Primary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters
Clinical chemistry parameters aspartate amino transferase (AST), alanine amino transferase (ALT), alkaline phosphatase (ALP), carbon dioxide(CO2) content/bicarbonate (HCO3), cholesterol, creatine kinase (CK), glucose, low density lipoprotein (LDL) cholesterol, lipase, potassium, and sodium, total bilirubin (TBIL) and triglycerides were evaluated. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Time frame: Up to an average of 59 weeks
Population: Safety Maintenance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 1 | 94 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 4 | 10 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 2 | 50 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 3 | 15 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 1 | 94 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 3 | 20 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 4 | 7 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 2 | 42 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 4 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 2 | 16 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 3 | 10 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters | Maximum toxicity Grade 1 | 44 Participants |
Primary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Toxicity was graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Time frame: Up to an average of 59 weeks
Population: Safety Maintenance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 2 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 1 | 23 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 3 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 4 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 4 | 3 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 1 | 17 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 2 | 4 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 3 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 4 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 3 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 1 | 7 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters | Maximum toxicity Grade 2 | 2 Participants |
Primary
Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Toxicity was graded according to Division of Acquired Immunodeficiency Syndrome (DAIDS) grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Data presented includes all post-baseline treatment emergent Induction Period and MP toxicities, as well as LTFP toxicities for those participants who did not enter the extension period. Number of participants with post-Baseline adverse events by maximum toxicity Grade have been presented.
Time frame: Up to an average of 59 weeks
Population: Safety Maintenance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 4 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 1 | 31 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 3 | 15 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 2 | 67 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 3 | 14 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 4 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 2 | 72 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 1 | 25 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 4 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 2 | 29 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 3 | 3 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Adverse Events by Maximum Toxicity Grade | Any AE with maximum toxicity Grade 1 | 19 Participants |
Primary
Number of Participants With Post-Baseline Urinalysis Dipstick Results
Urinalysis dipstick included urine occult blood, urine glucose, urine ketones, urine nitrite, urine protein and urine leukocyte. The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters can be read as positive, trace, 1+, 2+ and 3+ indicating proportional concentrations in the urine sample. Data presented includes all post-baseline dipstick results during Induction and Maintenance Periods, as well as LTFP for those participants who did not enter the extension period.
Time frame: Up to an average of 59 weeks
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 1+, n=1,3,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Trace, n=1,1,1 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 2+, n=1,1,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Trace, n=16,20,10 | 12 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Trace, n=1,3,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 3+, n=1,1,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 2+, n=16,20,10 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Positive, n=16,20,10 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Positive, n=1,1,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 1+, n=10,11,4 | 3 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Positive, n=17,17,7 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 3+, n=16,20,10 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 1+, n=16,20,10 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 3+, n=17,17,7 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Trace, n=10,11,4 | 5 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 2+, n=17,17,7 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Trace, n=17,17,7 | 15 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 1+, n=17,17,7 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Trace, n=20,20,8 | 8 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 3+, n=20,20,8 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 1+, n=1,1,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Positive, n=20,20,8 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Positive, n=1,3,1 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 2+, n=10,11,4 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 2+, n=20,20,8 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 3+, n=1,3,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 3+, n=10,11,4 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 2+, n=1,3,1 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Positive, n=10,11,4 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 1+, n=20,20,8 | 7 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 2+, n=16,20,10 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 3+, n=10,11,4 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Trace, n=1,1,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 1+, n=1,1,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 1+, n=1,3,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Trace, n=20,20,8 | 10 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Trace, n=10,11,4 | 6 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 1+, n=10,11,4 | 3 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 2+, n=10,11,4 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Positive, n=10,11,4 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 2+, n=1,1,1 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 3+, n=1,1,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Positive, n=1,1,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Trace, n=16,20,10 | 17 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 1+, n=16,20,10 | 3 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 3+, n=16,20,10 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Positive, n=16,20,10 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Trace, n=1,3,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 2+, n=1,3,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 3+, n=1,3,1 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Positive, n=1,3,1 | 3 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Trace, n=17,17,7 | 11 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 1+, n=17,17,7 | 4 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 2+, n=17,17,7 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 3+, n=17,17,7 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Positive, n=17,17,7 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 1+, n=20,20,8 | 8 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 2+, n=20,20,8 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 3+, n=20,20,8 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Positive, n=20,20,8 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Positive, n=1,1,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 3+, n=1,3,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 1+, n=10,11,4 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 3+, n=20,20,8 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 1+, n=20,20,8 | 3 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Trace, n=17,17,7 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, 2+, n=20,20,8 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 1+, n=1,1,1 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 1+, n=17,17,7 | 5 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Positive, n=1,3,1 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Trace, n=10,11,4 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 2+, n=17,17,7 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 2+, n=1,3,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, Trace, n=1,1,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, 3+, n=17,17,7 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 1+, n=16,20,10 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 2+, n=16,20,10 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Trace, n=16,20,10 | 8 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, 1+, n=1,3,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, 3+, n=16,20,10 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 3+, n=1,1,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Positive, n=20,20,8 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Ketones, Positive, n=16,20,10 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Glucose, 2+, n=1,1,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Protein, Positive, n=17,17,7 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Nitrite, Trace, n=1,3,1 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, Positive, n=10,11,4 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 3+, n=10,11,4 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Leukocyte, Trace, n=20,20,8 | 3 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Post-Baseline Urinalysis Dipstick Results | Urine Occult Blood, 2+, n=10,11,4 | 0 Participants |
Primary
Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than 1.0 logarithm to base 10 (log10) c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL.
Time frame: Up to Week 32
Population: ITT-ME Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Protocol Defined Virologic Failure (PDVF) Until Week 32 | 1 Participants |
Primary
Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest as non-responders. The Intent-to-Treat Maintenance Exposed (ITT-ME) Population consisted of all randomized participants who received at least one injection or one dose of investigational product during the Maintenance Period of the study (on or after Day 1 visit).
Time frame: Week 32
Population: ITT-ME Population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | 95 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | 94 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) Level Below 50 Copies/Milliliter (c/mL) at Week 32 | 91 Percentage of participants |
95% CI: [-4.8, 12.2]
95% CI: [-5.8, 11.5]
Secondary
Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry.
Time frame: At Week 32 and Week 96
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 752.3 Cells per cubic millimeter | Standard Deviation 318.02 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 748.6 Cells per cubic millimeter | Standard Deviation 253.41 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 761.3 Cells per cubic millimeter | Standard Deviation 293.07 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 750.0 Cells per cubic millimeter | Standard Deviation 271.11 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 891.3 Cells per cubic millimeter | Standard Deviation 273.32 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Absolute Value of CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 906.8 Cells per cubic millimeter | Standard Deviation 288.77 |
Secondary
Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Log10 values for HIV-1 RNA have been presented. SD=0.000 is defined as following: if participants analyzed at a specific timepoint have resulted same values, then SD is considered equal with 0.000.
Time frame: At Week 32 and Week 96
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.60 Log10 copies per milliliter | Standard Deviation 0.044 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | 1.60 Log10 copies per milliliter | Standard Deviation 0.056 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.59 Log10 copies per milliliter | Standard Deviation 0.025 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | 1.59 Log10 copies per milliliter | Standard Deviation 0 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | 1.59 Log10 copies per milliliter | Standard Deviation 0 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Absolute Value of Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.61 Log10 copies per milliliter | Standard Deviation 0.112 |
Secondary
Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+ using flow cytometry. Mean and standard deviation values for CD4+ are presented.
Time frame: Week -20, Week -16, Week -12, Week -4, Day 1
Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, n=309 | 498.9 Cells per cubic millimeter | Standard Deviation 180.67 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -16, n=304 | 630.5 Cells per cubic millimeter | Standard Deviation 235.09 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -12, n=300 | 664.2 Cells per cubic millimeter | Standard Deviation 256.57 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -4, n=292 | 702.3 Cells per cubic millimeter | Standard Deviation 269.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Cluster of Differentiation 4+ (CD4+), for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Day 1, n=291 | 690.9 Cells per cubic millimeter | Standard Deviation 261.63 |
Secondary
Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Log10 values for HIV-1 RNA have been presented.
Time frame: Week -20, Week -16, Week -12, Week -8, Week -4, Day 1
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -16, n=304 | 1.71 Log10 copies per milliliter | Standard Deviation 0.229 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -12, n=302 | 1.62 Log10 copies per milliliter | Standard Deviation 0.108 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -20, n=309 | 4.43 Log10 copies per milliliter | Standard Deviation 0.672 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -8, n=299 | 1.63 Log10 copies per milliliter | Standard Deviation 0.281 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -4, n=294 | 1.61 Log10 copies per milliliter | Standard Deviation 0.08 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Absolute Values of Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Day 1, n=291 | 1.60 Log10 copies per milliliter | Standard Deviation 0.07 |
Secondary
Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. C0 and Cmax of RPV LA (Q4W IM and Q8W IM dosing) was evaluated.
Time frame: Up to Week 32
Population: PK Concentration Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | C0 | 49.3 Nanograms per milliliter | Geometric Coefficient of Variation 41 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Cmax | 104 Nanograms per milliliter | Geometric Coefficient of Variation 47 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | C0 | 77.2 Nanograms per milliliter | Geometric Coefficient of Variation 35 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Cmax of RPV LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Cmax | 111 Nanograms per milliliter | Geometric Coefficient of Variation 40 |
Secondary
Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period)
Blood samples were collected at indicated time points for pharmacokinetic (PK) analysis of CAB LA. The PK Concentration Population included all participants who received CAB LA and/or RPV LA and underwent PK sampling during the study, and provided available CAB LA and/or RPV LA plasma concentration data.
Time frame: Up to Week 32
Population: PK Concentration Population
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | C0 | 1.43 Micrograms per milliliter | Geometric Coefficient of Variation 54 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Cmax | 3.55 Micrograms per milliliter | Geometric Coefficient of Variation 56 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | C0 | 2.35 Micrograms per milliliter | Geometric Coefficient of Variation 32 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Average Initial Concentration (C0) and Maximum Plasma Concentration (Cmax) of CAB LA (Q4W IM and Q8W IM Dosing) (Maintenance Period) | Cmax | 3.50 Micrograms per milliliter | Geometric Coefficient of Variation 39 |
Secondary
Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as post-baseline value minus Baseline value.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 264.4 Cells per cubic millimeter | Standard Deviation 247.84 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 257.5 Cells per cubic millimeter | Standard Deviation 192.25 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 263.7 Cells per cubic millimeter | Standard Deviation 217.74 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 270.6 Cells per cubic millimeter | Standard Deviation 210.99 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 32 | 346.1 Cells per cubic millimeter | Standard Deviation 219.59 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in CD4+ at Week 32 and Week 96 (Maintenance Period) | Week 96 | 369.9 Cells per cubic millimeter | Standard Deviation 226.6 |
Secondary
Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -4, Day 1
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -16, n=304 | 131.7 Cells per cubic millimeter | Standard Deviation 172.69 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -12, n=300 | 164.5 Cells per cubic millimeter | Standard Deviation 174.61 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -4, n=292 | 201.5 Cells per cubic millimeter | Standard Deviation 195.53 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in CD4+, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Day 1, n=291 | 188.7 Cells per cubic millimeter | Standard Deviation 186.69 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.4 Grams per Liter | Standard Deviation 3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 1.0 Grams per Liter | Standard Deviation 2.76 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.9 Grams per Liter | Standard Deviation 2.9 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.9 Grams per Liter | Standard Deviation 2.87 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.1 Grams per Liter | Standard Deviation 2.8 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.2 Grams per Liter | Standard Deviation 2.61 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Albumin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Week -16, n=306 | 0.2 Grams per Liter (G/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Week -12, n=301 | 0.7 Grams per Liter (G/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Week -8, n=297 | 1.4 Grams per Liter (G/L) | Standard Deviation 2.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Week -4, n=292 | 1.7 Grams per Liter (G/L) | Standard Deviation 2.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Albumin (Induction Period) | Day 1, n=287 | 1.9 Grams per Liter (G/L) | Standard Deviation 2.8 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 32 | -1.2 Units per Liter | Standard Deviation 33.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 96 | 3.5 Units per Liter | Standard Deviation 22 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 32 | -4.4 Units per Liter | Standard Deviation 15.4 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 96 | -0.8 Units per Liter | Standard Deviation 14.73 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 32 | -3.9 Units per Liter | Standard Deviation 14.7 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase at Week 32 and Week 96 (Maintenance Period) | Week 96 | -2.3 Units per Liter | Standard Deviation 14.21 |
Secondary
Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameter: Lipase at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Week -16, n=306 | 3.3 Units per Liter (U/L) | Standard Deviation 20 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Week -12, n=301 | 0.8 Units per Liter (U/L) | Standard Deviation 15.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Week -8, n=297 | 2.8 Units per Liter (U/L) | Standard Deviation 24.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Week -4, n=292 | 2.1 Units per Liter (U/L) | Standard Deviation 23.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameter: Lipase (Induction Period) | Day 1, n=288 | -1.2 Units per Liter (U/L) | Standard Deviation 17.7 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 96 | -3.1 International Units per Liter | Standard Deviation 15.59 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 32 | 51.4 International Units per Liter | Standard Deviation 651 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 96 | -1.0 International Units per Liter | Standard Deviation 15.45 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 96 | 1.8 International Units per Liter | Standard Deviation 19.19 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 32 | -2.8 International Units per Liter | Standard Deviation 12.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 96 | 21.1 International Units per Liter | Standard Deviation 490 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 32 | -2.4 International Units per Liter | Standard Deviation 13.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 32 | -1.2 International Units per Liter | Standard Deviation 14.6 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 32 | -2.7 International Units per Liter | Standard Deviation 13.5 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 32 | -2.2 International Units per Liter | Standard Deviation 14.5 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 32 | -3.8 International Units per Liter | Standard Deviation 15 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 32 | 93.4 International Units per Liter | Standard Deviation 446.9 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 96 | -2.2 International Units per Liter | Standard Deviation 14.42 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 96 | -3.4 International Units per Liter | Standard Deviation 15.64 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 96 | -4.0 International Units per Liter | Standard Deviation 9.31 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 96 | 13.7 International Units per Liter | Standard Deviation 153.92 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 32 | -5.0 International Units per Liter | Standard Deviation 19.5 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 96 | -2.8 International Units per Liter | Standard Deviation 12.34 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALP, Week 32 | -1.3 International Units per Liter | Standard Deviation 11.6 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 96 | -13.9 International Units per Liter | Standard Deviation 227.98 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | CK, Week 32 | 38.8 International Units per Liter | Standard Deviation 394.9 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 96 | -8.8 International Units per Liter | Standard Deviation 32.57 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | ALT, Week 96 | -2.7 International Units per Liter | Standard Deviation 22.17 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK at Week 32 and Week 96 (Maintenance Period) | AST, Week 32 | -8.3 International Units per Liter | Standard Deviation 30.6 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALT, Week -16, n=306 | 0.4 International Units per Liter (IU/L) | Standard Deviation 33.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALT, Week -8, n=297 | -0.5 International Units per Liter (IU/L) | Standard Deviation 16.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALT, Week -4, n=292 | 1.5 International Units per Liter (IU/L) | Standard Deviation 50.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | AST, Week -12, n=301 | -2.2 International Units per Liter (IU/L) | Standard Deviation 13.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALT, Week -12, n=301 | -1.3 International Units per Liter (IU/L) | Standard Deviation 14.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALT, Day 1, n=287 | -1.2 International Units per Liter (IU/L) | Standard Deviation 18 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALP, Week -16, n=306 | -2.1 International Units per Liter (IU/L) | Standard Deviation 12 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALP, Week -12, n=301 | -2.6 International Units per Liter (IU/L) | Standard Deviation 11 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALP, Week -8, n=297 | -1.2 International Units per Liter (IU/L) | Standard Deviation 13 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALP, Week -4, n=292 | 0.1 International Units per Liter (IU/L) | Standard Deviation 15.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | ALP, Day 1, n=287 | 0.1 International Units per Liter (IU/L) | Standard Deviation 14.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | AST, Week -16, n=306 | 0.3 International Units per Liter (IU/L) | Standard Deviation 33.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | AST, Week -8, n=296 | -1.7 International Units per Liter (IU/L) | Standard Deviation 15.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | AST, Week -4, n=292 | -0.0 International Units per Liter (IU/L) | Standard Deviation 30.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | AST, Day 1, n=286 | -1.0 International Units per Liter (IU/L) | Standard Deviation 25.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | CK, Week -16, n=306 | 19.0 International Units per Liter (IU/L) | Standard Deviation 345.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | CK, Week -12, n=301 | 29.4 International Units per Liter (IU/L) | Standard Deviation 485.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | CK, Week -8, n=297 | 26.3 International Units per Liter (IU/L) | Standard Deviation 529.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | CK, Week -4, n=292 | 33.2 International Units per Liter (IU/L) | Standard Deviation 434.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: ALT, ALP, AST and CK (Induction Period) | CK, Day 1, n=287 | 69.9 International Units per Liter (IU/L) | Standard Deviation 1164.7 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | CO2, Day 1, n=286 | -0.8 Millimoles per Liter (mmol/L) | Standard Deviation 2.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Chloride, Week -16, n=306 | 0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Chloride, Week -12, n=301 | 0.5 Millimoles per Liter (mmol/L) | Standard Deviation 2.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Glucose, Week -16, n=255 | 0.07 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Potassium, Week -12, n=301 | -0.03 Millimoles per Liter (mmol/L) | Standard Deviation 0.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Urea, Week -4, n=292 | -0.12 Millimoles per Liter (mmol/L) | Standard Deviation 1.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Urea, Day 1, n=287 | 0.00 Millimoles per Liter (mmol/L) | Standard Deviation 1.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | CO2, Week -16, n=306 | 0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | CO2, Week -12, n=301 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | CO2, Week -8, n=296 | 0.4 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | CO2, Week -4, n=292 | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Chloride, Week -8, n=297 | 0.6 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Chloride, Week -4, n=292 | 0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Chloride, Day 1, n=287 | 0.2 Millimoles per Liter (mmol/L) | Standard Deviation 2.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Cholesterol, Week -16, n=255 | 0.21 Millimoles per Liter (mmol/L) | Standard Deviation 0.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Cholesterol, Week -12, n=236 | 0.19 Millimoles per Liter (mmol/L) | Standard Deviation 0.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Cholesterol, Week -8, n=235 | 0.27 Millimoles per Liter (mmol/L) | Standard Deviation 0.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Cholesterol, Week -4, n=282 | 0.34 Millimoles per Liter (mmol/L) | Standard Deviation 0.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Cholesterol, Day 1, n=285 | 0.34 Millimoles per Liter (mmol/L) | Standard Deviation 0.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Glucose, Week -12, n=236 | 0.16 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Glucose, Week -8, n=235 | 0.08 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Glucose, Week -4, n=281 | 0.06 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Glucose, Day 1, n=282 | -0.01 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Potassium, Week -16, n=306 | -0.05 Millimoles per Liter (mmol/L) | Standard Deviation 0.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Potassium, Week -8, n=296 | 0.03 Millimoles per Liter (mmol/L) | Standard Deviation 0.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Potassium, Week -4, n=292 | 0.03 Millimoles per Liter (mmol/L) | Standard Deviation 0.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Potassium, Day 1, n=286 | 0.03 Millimoles per Liter (mmol/L) | Standard Deviation 0.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Sodium, Week -16, n=306 | -0.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Sodium, Week -12, n=301 | 0.1 Millimoles per Liter (mmol/L) | Standard Deviation 1.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Sodium, Week -8, n=297 | 0.2 Millimoles per Liter (mmol/L) | Standard Deviation 1.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Sodium, Week -4, n=292 | 0.4 Millimoles per Liter (mmol/L) | Standard Deviation 2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Sodium, Day 1, n=287 | 0.3 Millimoles per Liter (mmol/L) | Standard Deviation 1.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Triglyceride, Week -16, n=3 | -0.69 Millimoles per Liter (mmol/L) | Standard Deviation 0.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Triglyceride, Week -12, n=2 | -0.37 Millimoles per Liter (mmol/L) | Standard Deviation 0.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Triglyceride, Week -8, n=2 | 0.29 Millimoles per Liter (mmol/L) | Standard Deviation 0.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Triglyceride, Week -4, n=278 | 0.20 Millimoles per Liter (mmol/L) | Standard Deviation 0.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Triglyceride, Day 1, n=278 | -0.00 Millimoles per Liter (mmol/L) | Standard Deviation 0.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Urea, Week -16, n=306 | -0.06 Millimoles per Liter (mmol/L) | Standard Deviation 1.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Urea, Week -12, n=301 | -0.08 Millimoles per Liter (mmol/L) | Standard Deviation 1.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea (Induction Period) | Urea, Week -8, n=297 | -0.09 Millimoles per Liter (mmol/L) | Standard Deviation 1.1 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including Total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 32 | 0.8 Micromoles per Liter | Standard Deviation 4.4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 32 | 2.7 Micromoles per Liter | Standard Deviation 8.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 96 | 0.0 Micromoles per Liter | Standard Deviation 3.78 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 96 | 3.11 Micromoles per Liter | Standard Deviation 8.515 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 96 | 4.27 Micromoles per Liter | Standard Deviation 8.73 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 32 | 0.4 Micromoles per Liter | Standard Deviation 3.6 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 96 | -0.3 Micromoles per Liter | Standard Deviation 4.11 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 32 | 3.8 Micromoles per Liter | Standard Deviation 8.7 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 96 | 4.42 Micromoles per Liter | Standard Deviation 6.105 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Creatinine, Week 32 | 2.7 Micromoles per Liter | Standard Deviation 6.1 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 96 | -1.1 Micromoles per Liter | Standard Deviation 4.25 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine at Week 32 and Week 96 (Maintenance Period) | Total Bilirubin, Week 32 | -0.6 Micromoles per Liter | Standard Deviation 4.4 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total Bilirubin and Creatinine at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Total Bilirubin, Day 1, n=287 | -0.3 Micromoles per Liter (umol/L) | Standard Deviation 4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Total Bilirubin, Week -16, n=305 | -0.6 Micromoles per Liter (umol/L) | Standard Deviation 4.5 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Total Bilirubin, Week -12, n=301 | -0.9 Micromoles per Liter (umol/L) | Standard Deviation 4 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Total Bilirubin, Week -8, n=297 | -1.0 Micromoles per Liter (umol/L) | Standard Deviation 4.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Total Bilirubin, Week -4, n=292 | -0.5 Micromoles per Liter (umol/L) | Standard Deviation 4.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Creatinine, Week -16, n=306 | 2.6 Micromoles per Liter (umol/L) | Standard Deviation 7.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Creatinine, Week -12, n=301 | 1.5 Micromoles per Liter (umol/L) | Standard Deviation 7.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Creatinine, Week -8, n=297 | 1.6 Micromoles per Liter (umol/L) | Standard Deviation 7.8 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Creatinine, Week -4, n=292 | 3.5 Micromoles per Liter (umol/L) | Standard Deviation 8.7 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total Bilirubin and Creatinine (Induction Period) | Creatinine, Day 1, n=287 | 4.6 Micromoles per Liter (umol/L) | Standard Deviation 9.1 |
Secondary
Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of clinical chemistry parameters including total CO2, chloride, cholesterol, glucose, potassium, sodium, triglyceride and urea at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 32 | -0.2 Millimoles per Liter | Standard Deviation 2.2 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 96 | 0.11 Millimoles per Liter | Standard Deviation 0.378 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 32 | 0.08 Millimoles per Liter | Standard Deviation 0.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 96 | 0.084 Millimoles per Liter | Standard Deviation 0.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 32 | 0.37 Millimoles per Liter | Standard Deviation 0.6 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 32 | 0.15 Millimoles per Liter | Standard Deviation 1.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 96 | 0.12 Millimoles per Liter | Standard Deviation 0.729 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 32 | 0.01 Millimoles per Liter | Standard Deviation 0.3 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 96 | -0.8 Millimoles per Liter | Standard Deviation 2.88 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 96 | 0.09 Millimoles per Liter | Standard Deviation 1.393 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 32 | -0.8 Millimoles per Liter | Standard Deviation 2.1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 96 | -0.1 Millimoles per Liter | Standard Deviation 2.32 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 96 | -0.1 Millimoles per Liter | Standard Deviation 1.85 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 32 | 0.13 Millimoles per Liter | Standard Deviation 1 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 96 | 0.554 Millimoles per Liter | Standard Deviation 0.6724 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 32 | 0.4 Millimoles per Liter | Standard Deviation 2 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 96 | 0.731 Millimoles per Liter | Standard Deviation 0.738 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 96 | 0.11 Millimoles per Liter | Standard Deviation 0.667 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 96 | -0.04 Millimoles per Liter | Standard Deviation 0.408 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 96 | -0.4 Millimoles per Liter | Standard Deviation 2.07 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 32 | -0.05 Millimoles per Liter | Standard Deviation 0.3 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 96 | 0.080 Millimoles per Liter | Standard Deviation 1.4964 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 32 | -0.3 Millimoles per Liter | Standard Deviation 2.4 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 96 | -0.01 Millimoles per Liter | Standard Deviation 1.23 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 32 | -0.1 Millimoles per Liter | Standard Deviation 1.8 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 32 | -1.5 Millimoles per Liter | Standard Deviation 2.4 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 32 | -0.00 Millimoles per Liter | Standard Deviation 1.7 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 32 | 0.23 Millimoles per Liter | Standard Deviation 1.4 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 32 | 0.47 Millimoles per Liter | Standard Deviation 0.7 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 96 | -1.1 Millimoles per Liter | Standard Deviation 2.64 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 96 | -0.4 Millimoles per Liter | Standard Deviation 2.53 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 32 | 0.03 Millimoles per Liter | Standard Deviation 0.7 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 96 | 0.12 Millimoles per Liter | Standard Deviation 1.461 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 32 | -1.1 Millimoles per Liter | Standard Deviation 2.4 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 32 | 0.1 Millimoles per Liter | Standard Deviation 2.1 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 32 | 0.25 Millimoles per Liter | Standard Deviation 0.5 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 32 | -0.05 Millimoles per Liter | Standard Deviation 0.6 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 32 | -0.04 Millimoles per Liter | Standard Deviation 0.2 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 32 | 0.0 Millimoles per Liter | Standard Deviation 1.7 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 32 | 0.06 Millimoles per Liter | Standard Deviation 0.7 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Urea, Week 32 | -0.01 Millimoles per Liter | Standard Deviation 1.4 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Total CO2, Week 96 | -0.1 Millimoles per Liter | Standard Deviation 2.47 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Chloride, Week 96 | 0.3 Millimoles per Liter | Standard Deviation 2.12 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Cholesterol, Week 96 | 0.348 Millimoles per Liter | Standard Deviation 0.649 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Glucose, Week 96 | 0.02 Millimoles per Liter | Standard Deviation 0.745 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Potassium, Week 96 | -0.03 Millimoles per Liter | Standard Deviation 0.314 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Sodium, Week 96 | -0.4 Millimoles per Liter | Standard Deviation 1.96 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Clinical Chemistry Parameters: Total CO2, Chloride, Cholesterol, Glucose, Potassium, Sodium, Triglyceride and Urea at Week 32 and Week 96 (Maintenance Period) | Triglycerides, Week 96 | 0.197 Millimoles per Liter | Standard Deviation 0.4972 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.026 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.0114 Proportion of red blood cells in blood | Standard Deviation 0.0288 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.027 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.0134 Proportion of red blood cells in blood | Standard Deviation 0.03125 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.01 Proportion of red blood cells in blood | Standard Deviation 0.027 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Hematocrit at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.0124 Proportion of red blood cells in blood | Standard Deviation 0.02748 |
Secondary
Change From Baseline in Hematology Parameter: Hematocrit (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hematocrit at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Week -12, n=302 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.023 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Week -16, n=304 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.022 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Week -8, n=298 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.024 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Week -4, n=290 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.025 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hematocrit (Induction Period) | Day 1, n=290 | 0.00 Proportion of red blood cells in blood | Standard Deviation 0.025 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 2.0 Grams per Liter | Standard Deviation 8.56 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 3.9 Grams per Liter | Standard Deviation 8.95 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.8 Grams per Liter | Standard Deviation 8.45 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 4.3 Grams per Liter | Standard Deviation 9.92 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 32 | 1.7 Grams per Liter | Standard Deviation 8.38 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Hemoglobin at Week 32 and Week 96 (Maintenance Period) | Week 96 | 4.1 Grams per Liter | Standard Deviation 8.11 |
Secondary
Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Hemoglobin at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Week -16, n=304 | 0.8 Grams per Liter | Standard Deviation 6.94 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Week -12, n=302 | 2.0 Grams per Liter | Standard Deviation 7.07 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Week -8, n=298 | 2.5 Grams per Liter | Standard Deviation 7.42 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Week -4, n=290 | 3.3 Grams per Liter | Standard Deviation 7.95 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Hemoglobin (Induction Period) | Day 1, n=290 | 3.1 Grams per Liter | Standard Deviation 7.96 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 32 | 2.5 Femtoliters | Standard Deviation 1.97 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.1 Femtoliters | Standard Deviation 2.99 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 32 | 2.3 Femtoliters | Standard Deviation 2.54 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.3 Femtoliters | Standard Deviation 2.54 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 32 | 7.1 Femtoliters | Standard Deviation 2.88 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume at Week 32 and Week 96 (Maintenance Period) | Week 96 | 5.3 Femtoliters | Standard Deviation 3.14 |
Secondary
Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Mean Corpuscle Volume at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Week -16, n=304 | 1.0 Femtoliters | Standard Deviation 1.52 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Week -12, n=302 | 2.1 Femtoliters | Standard Deviation 1.9 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Week -8, n=298 | 3.1 Femtoliters | Standard Deviation 2.49 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Week -4, n=290 | 4.0 Femtoliters | Standard Deviation 2.47 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Mean Corpuscle Volume (Induction Period) | Day 1, n=290 | 4.4 Femtoliters | Standard Deviation 2.57 |
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.12 10^12 cells per Liter | Standard Deviation 0.294 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.03 10^12 cells per Liter | Standard Deviation 0.286 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 32 | 0.02 10^12 cells per Liter | Standard Deviation 0.278 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 96 | 0.14 10^12 cells per Liter | Standard Deviation 0.31 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 32 | -0.20 10^12 cells per Liter | Standard Deviation 0.296 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count at Week 32 and Week 96 (Maintenance Period) | Week 96 | -0.13 10^12 cells per Liter | Standard Deviation 0.293 |
Secondary
Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period)
Blood samples were collected for the analysis of hematology parameter: Red Blood Cell count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Week -16, n=304 | -0.05 10^12 cells per Liter | Standard Deviation 0.242 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Week -12, n=302 | -0.07 10^12 cells per Liter | Standard Deviation 0.254 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Week -8, n=298 | -0.10 10^12 cells per Liter | Standard Deviation 0.266 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Week -4, n=290 | -0.10 10^12 cells per Liter | Standard Deviation 0.284 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameter: Red Blood Cell Count (Induction Period) | Day 1, n=290 | -0.14 10^12 cells per Liter | Standard Deviation 0.289 |
Secondary
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period)
Blood samples were collected for the analysis of hematology parameters including Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet count and WBC count at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: Safety Maintenance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 96 | 0.015 10^9 cells per Liter | Standard Deviation 0.1461 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 96 | 0.325 10^9 cells per Liter | Standard Deviation 0.6356 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 32 | 0.93 10^9 cells per Liter | Standard Deviation 1.67 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 96 | -0.009 10^9 cells per Liter | Standard Deviation 0.1685 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 32 | 0.34 10^9 cells per Liter | Standard Deviation 0.661 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 96 | 0.381 10^9 cells per Liter | Standard Deviation 1.306 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 96 | 0.72 10^9 cells per Liter | Standard Deviation 1.545 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 32 | -0.02 10^9 cells per Liter | Standard Deviation 0.152 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 32 | 0.00 10^9 cells per Liter | Standard Deviation 0.012 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 32 | 18.7 10^9 cells per Liter | Standard Deviation 38.28 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 32 | 0.59 10^9 cells per Liter | Standard Deviation 1.505 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 96 | 21.9 10^9 cells per Liter | Standard Deviation 40.07 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 96 | 0.004 10^9 cells per Liter | Standard Deviation 0.0139 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 32 | 0.01 10^9 cells per Liter | Standard Deviation 0.146 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 32 | 0.34 10^9 cells per Liter | Standard Deviation 1.489 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 32 | 0.23 10^9 cells per Liter | Standard Deviation 1.985 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 32 | -0.03 10^9 cells per Liter | Standard Deviation 0.144 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 96 | 0.290 10^9 cells per Liter | Standard Deviation 0.6793 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 32 | 0.81 10^9 cells per Liter | Standard Deviation 2.881 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 96 | 0.000 10^9 cells per Liter | Standard Deviation 0.0204 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 96 | -0.014 10^9 cells per Liter | Standard Deviation 0.1781 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 32 | 20.6 10^9 cells per Liter | Standard Deviation 44.93 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 96 | 21.1 10^9 cells per Liter | Standard Deviation 41.49 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 32 | 0.26 10^9 cells per Liter | Standard Deviation 0.694 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 32 | -0.00 10^9 cells per Liter | Standard Deviation 0.022 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 96 | 0.515 10^9 cells per Liter | Standard Deviation 1.62 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 96 | 0.82 10^9 cells per Liter | Standard Deviation 1.786 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 96 | 0.021 10^9 cells per Liter | Standard Deviation 0.1013 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 96 | 0.006 10^9 cells per Liter | Standard Deviation 0.0157 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 96 | 0.783 10^9 cells per Liter | Standard Deviation 1.0747 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Basophils, Week 32 | 0.00 10^9 cells per Liter | Standard Deviation 0.01 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 32 | -0.01 10^9 cells per Liter | Standard Deviation 0.143 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 32 | 0.48 10^9 cells per Liter | Standard Deviation 0.635 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 32 | -0.00 10^9 cells per Liter | Standard Deviation 0.144 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 32 | 11.6 10^9 cells per Liter | Standard Deviation 33.33 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 32 | 1.41 10^9 cells per Liter | Standard Deviation 1.529 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Total Neutrophils, Week 32 | 0.94 10^9 cells per Liter | Standard Deviation 1.365 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Eosinophils, Week 96 | -0.013 10^9 cells per Liter | Standard Deviation 0.1528 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Lymphocytes, Week 96 | 0.534 10^9 cells per Liter | Standard Deviation 0.5408 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Monocytes, Week 96 | -0.005 10^9 cells per Liter | Standard Deviation 0.1443 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | Platelet count, Week 96 | 15.3 10^9 cells per Liter | Standard Deviation 39.28 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelet Count and WBC Count at Week 32 and Week 96 (Maintenance Period) | WBC count, Week 96 | 1.31 10^9 cells per Liter | Standard Deviation 1.144 |
Secondary
Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period)
Blood samples were collected for the analysis of hematology parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets count and WBC at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as value at post-baseline visit minus value at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: Safety Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Basophils, Week -16, n=303 | 0.00 Giga cells per Liter | Standard Deviation 0.016 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Basophils, Week -12, n=298 | 0.00 Giga cells per Liter | Standard Deviation 0.019 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Basophils, Week -8, n=297 | 0.00 Giga cells per Liter | Standard Deviation 0.015 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Lymphocytes, Week -4, n=290 | 0.30 Giga cells per Liter | Standard Deviation 0.574 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Lymphocytes, Day 1, n=290 | 0.14 Giga cells per Liter | Standard Deviation 0.565 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Monocytes, Week -4, n=290 | -0.00 Giga cells per Liter | Standard Deviation 0.132 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Monocytes, Day 1, n=290 | 0.00 Giga cells per Liter | Standard Deviation 0.143 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Platelet count, Week -8, n=297 | 21.1 Giga cells per Liter | Standard Deviation 37 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Platelet count, Week -4, n=290 | 23.0 Giga cells per Liter | Standard Deviation 35.02 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Platelet count, Day 1, n=290 | 22.2 Giga cells per Liter | Standard Deviation 35.32 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Total Neutrophils, Week -16, n=303 | 0.04 Giga cells per Liter | Standard Deviation 1.185 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Total Neutrophils, Week -8, n=297 | 0.20 Giga cells per Liter | Standard Deviation 1.286 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Total Neutrophils, Week -4, n=290 | 0.31 Giga cells per Liter | Standard Deviation 1.429 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Total Neutrophils, Day 1, n=290 | 0.38 Giga cells per Liter | Standard Deviation 1.515 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Basophils, Week -4, n=290 | 0.00 Giga cells per Liter | Standard Deviation 0.016 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Basophils, Day 1, n=290 | 0.00 Giga cells per Liter | Standard Deviation 0.019 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Eosinophils, Week -16, n=303 | 0.01 Giga cells per Liter | Standard Deviation 0.131 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Eosinophils, Week -12, n=298 | 0.01 Giga cells per Liter | Standard Deviation 0.123 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Eosinophils, Week -8, n=297 | 0.02 Giga cells per Liter | Standard Deviation 0.127 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Eosinophils, Week -4, n=290 | 0.02 Giga cells per Liter | Standard Deviation 0.136 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Eosinophils, Day 1, n=290 | 0.03 Giga cells per Liter | Standard Deviation 0.161 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Lymphocytes, Week -16, n=303 | 0.24 Giga cells per Liter | Standard Deviation 0.541 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Lymphocytes, Week -12, n=298 | 0.28 Giga cells per Liter | Standard Deviation 0.573 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Lymphocytes, Week -8, n=297 | 0.30 Giga cells per Liter | Standard Deviation 0.541 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Monocytes, Week -16, n=303 | -0.00 Giga cells per Liter | Standard Deviation 0.129 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Monocytes, Week -12, n=298 | 0.00 Giga cells per Liter | Standard Deviation 0.139 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Monocytes, Week -8, n=297 | -0.00 Giga cells per Liter | Standard Deviation 0.135 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Platelet count, Week -16, n=302 | 14.4 Giga cells per Liter | Standard Deviation 31.56 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Platelet count, Week -12, n=300 | 18.2 Giga cells per Liter | Standard Deviation 32.53 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | Total Neutrophils, Week -12, n=298 | 0.22 Giga cells per Liter | Standard Deviation 1.391 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | WBC, Week -16, n=303 | 0.31 Giga cells per Liter | Standard Deviation 1.318 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | WBC, Week -12, n=298 | 0.52 Giga cells per Liter | Standard Deviation 1.522 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | WBC, Week -8, n=297 | 0.54 Giga cells per Liter | Standard Deviation 1.46 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | WBC, Week -4, n=290 | 0.64 Giga cells per Liter | Standard Deviation 1.594 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Hematology Parameters: Basophil, Eosinophils, Lymphocytes, Total Neutrophils, Monocytes, Platelets Count and White Blood Cells (WBC) Count (Induction Period) | WBC, Day 1, n=290 | 0.57 Giga cells per Liter | Standard Deviation 1.713 |
Secondary
Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period)
Plasma samples for quantitative HIV-1 RNA analysis were collected at indicated time points during Maintenance Period. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
Time frame: At Week 32 and Week 96 (compared with Baseline [Week -20])
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | -2.78 Log10 copies per milliliter | Standard Deviation 0.61 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | -2.77 Log10 copies per milliliter | Standard Deviation 0.602 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | -2.88 Log10 copies per milliliter | Standard Deviation 0.709 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | -2.89 Log10 copies per milliliter | Standard Deviation 0.713 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 96 | -2.77 Log10 copies per milliliter | Standard Deviation 0.582 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Change From Baseline in Plasma HIV-1 RNA at Week 32 and Week 96 (Maintenance Period) | Week 32 | -2.73 Log10 copies per milliliter | Standard Deviation 0.561 |
Secondary
Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Plasma samples for quantitative HIV-1 RNA were collected at indicated time points. Baseline (Week -20) refers to the last available value up to and including the date of first induction period dosing with CAB 30 mg plus ABC/3TC. Change from Baseline was defined as: HIV-1 RNA(log 10) at post-baseline visit minus HIV-1 RNA(log 10) at Baseline.
Time frame: Baseline (Week -20) and Week -16, Week -12, Week -8, Week -4, Day 1
Population: ITT-E Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -16, n=304 | -2.72 Log10 copies per milliliter | Standard Deviation 0.572 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -12, n=302 | -2.80 Log10 copies per milliliter | Standard Deviation 0.64 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -8, n=299 | -2.79 Log10 copies per milliliter | Standard Deviation 0.665 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Week -4, n=294 | -2.81 Log10 copies per milliliter | Standard Deviation 0.647 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Change From Baseline in Plasma HIV-1 RNA, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Day 1, n=291 | -2.82 Log10 copies per milliliter | Standard Deviation 0.645 |
Secondary
Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Time frame: Pre-dose on Weeks 16, 20, 24, 28 and 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 16, n=78 | 2.2703 Micrograms per milliliter | Standard Deviation 0.92102 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 20, n=77 | 2.3861 Micrograms per milliliter | Standard Deviation 0.76176 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 24, n=78 | 2.6342 Micrograms per milliliter | Standard Deviation 1.29093 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 28, n=82 | 2.4365 Micrograms per milliliter | Standard Deviation 0.8642 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of CAB LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 32, n=85 | 2.4715 Micrograms per milliliter | Standard Deviation 0.89893 |
Secondary
Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q4W IM dosing) which were considered for the assessment of steady state are presented.
Time frame: Pre-dose on Weeks 16, 20, 24, 28 and 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 16, n=78 | 66.92 Nanograms per milliliter | Standard Deviation 25.986 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 24, n=78 | 76.84 Nanograms per milliliter | Standard Deviation 27.976 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 28, n=83 | 80.84 Nanograms per milliliter | Standard Deviation 31.297 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 32, n=85 | 90.34 Nanograms per milliliter | Standard Deviation 34.549 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q4W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 20, n=77 | 74.55 Nanograms per milliliter | Standard Deviation 29.156 |
Secondary
Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of RPV LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for RPV LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Time frame: Pre-dose on Weeks 16, 24 and 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 16, n=87 | 41.94 Nanograms per milliliter | Standard Deviation 17.575 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 24, n=85 | 47.97 Nanograms per milliliter | Standard Deviation 22.341 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Ctrough of RPV LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 32, n=83 | 57.24 Nanograms per milliliter | Standard Deviation 22.926 |
Secondary
HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period)
The HIVTSQ(c) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from +3 ('much more satisfied', 'much more convenient', 'much more flexible', etc.) to -3 ('much less satisfied', 'much less convenient', 'much less flexible', etc.). Items 1 to 12 (excluding Items 7b and 9b) are summed to produce a Total Treatment Satisfaction Score (change) with a possible range of -33 to +33. The higher the score, the greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment.
Time frame: Week 32
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period) | 30.9 Scores on a scale | Standard Deviation 7.56 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period) | 28.9 Scores on a scale | Standard Deviation 8.53 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | HIV Treatment Satisfaction Questionnaire - Change Version (HIVTSQ[c]) Total Score at Week 32 (Maintenance Period) | 20.5 Scores on a scale | Standard Deviation 14.09 |
Secondary
HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period)
The HIVTSQ(s) was developed to evaluate treatments for HIV and participant satisfaction. It has total 14 items and each items are scored from 6 (very satisfied) to 0 (very dissatisfied). Items 1 to 12 are summed to produce the Total Treatment Satisfaction Score with a possible range of 0 to 72. Higher scores represent greater treatment satisfaction as compared to the past few weeks.
Time frame: At Week 32 and Week 96
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 32 | 68.4 Scores on a scale | Standard Deviation 4.48 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 96 | 68.4 Scores on a scale | Standard Deviation 4.34 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 32 | 66.6 Scores on a scale | Standard Deviation 6.47 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 96 | 67.0 Scores on a scale | Standard Deviation 5.2 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 32 | 65.1 Scores on a scale | Standard Deviation 5.83 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | HIV Treatment Satisfaction Questionnaire - Status Version (HIVTSQ[s]) Total Score at Week 32 and Week 96 (Maintenance Period) | Week 96 | 63.5 Scores on a scale | Standard Deviation 9.75 |
Secondary
Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening. The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to 20 Weeks
Population: Safety Maintenance Population. It consisted of all participants who entered the Maintenance period and received at least one dose of IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 1 | 27 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 2 | 15 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 3 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 4 | 1 Participants |
Secondary
Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 32
Population: Safety Maintenance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 1 | 35 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 2 | 65 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 3 | 14 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 4 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 4 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 1 | 29 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 3 | 13 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 2 | 69 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 4 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 2 | 22 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 3 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 32 (Maintenance Period) | Grade 1 | 23 Participants |
Secondary
Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period)
An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Adverse events were evaluated by the investigator and graded according to the DAIDS toxicity grading, where Grade 1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.
Time frame: Up to Week 96
Population: Safety Maintenance Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 1 | 23 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 4 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 2 | 71 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 3 | 19 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 2 | 74 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 3 | 18 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 4 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 1 | 21 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 4 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 1 | 24 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 2 | 26 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With AEs by Their Severity Grades Over Week 96 (Maintenance Period) | Grade 3 | 4 Participants |
Secondary
Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period)
HIV-associated conditions were recorded during the study and was assessed according to the Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. The clinical categories of HIV infection as per CDC system are class A=Asymptomatic HIV infection or lymphadenopathy or acute HIV infection; class B=symptomatic non-acquired immunodeficiency syndrome (AIDS) conditions and class C=AIDS indicator conditions. Number of participants experiencing disease progression is presented, where disease progression is defined as the progression from Baseline HIV disease status as follows: CDC class A at Baseline to CDC class C event; CDC Class B at Baseline to CDC Class C event; CDC Class C at Baseline to new CDC Class C event; and CDC class A, B or C at Baseline to death.
Time frame: At Week 32 and Week 96
Population: ITT-ME Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 32 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 32 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 96 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 96 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 32 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 96 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 96 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 32 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1 to CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 2 to CDC Stage 3 Event, Week 96 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 1, 2 or 3 to Death, Week 32 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV-1 Disease Progression Over Week 32 and Week 96 (Maintenance Period) | From CDC Stage 3 to New CDC Stage 3 Event, Week 96 | 0 Participants |
Secondary
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 32 by their score categories (0: none of the time to 6: all of the time) are presented.
Time frame: Week 32
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 6 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 3 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 5 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 4 | 7 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 2 | 3 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 6 | 10 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 1 | 12 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 0 | 80 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 4 | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 3 | 6 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 1 | 35 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 5 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 2 | 17 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 0 | 40 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 2 | 16 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 2 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 5 | 4 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 6 | 6 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 1 | 43 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 4 | 3 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 5 | 4 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 6 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 0 | 73 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 1 | 14 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 3 | 6 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 4 | 1 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 0 | 33 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 3 | 5 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 6 | 3 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 3 | 3 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 2 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 4 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 3 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 5 | 12 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 0 | 29 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 1 | 12 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 0 | 16 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 6 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 2 | 2 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item E, score 1 | 13 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 5 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 32 (Maintenance Period) | Item F, Score 4 | 3 Participants |
Secondary
Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period)
The HIVMQ was developed to assess participant reported medication adherence. It has 6 items (a, b, c, d, e, f). Item E (How often do you find it inconvenient or difficult to take/receive medication as recommended?) and Item F (How much pain/discomfort have experienced with this medication?). Each of these 2 items are scored from 0 (none of the time) to 6 (all of the time). The higher the score, the greater the adherence to medication. Number of participants with HIVMQ Item E and F Scores at Week 96 by their score categories (0: none of the time to 6: all of the time) are presented.
Time frame: Week 96
Population: Analysis was performed on the participants that received exclusively an oral regimen during the 96-weeks period \[CAB 30mg+ABC/3TC QD (Induction Period and Maintenance Period) group\], as pre-specified in Protocol.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 2 | 3 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 3 | 2 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 2 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 3 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 5 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 6 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 0 | 18 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 1 | 10 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 4 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 5 | 9 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item E, score 6 | 3 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 0 | 3 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 1 | 8 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With HIV Medication Questionnaire (HIVMQ) Item E and F Scores at Week 96 (Maintenance Period) | Item F, Score 4 | 0 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Clinical chemistry parameters AST, ALT, ALP, CO2/HCO3, cholesterol, CK, glucose, LDL cholesterol, lipase, potassium, and sodium, total TBIL and triglycerides were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the chemistry parameters have been presented.
Time frame: Up to 20 weeks
Population: Safety Population
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 3 | 16 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 1 | 130 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 2 | 50 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Clinical Chemistry Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 4 | 5 Participants |
Secondary
Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Hematology parameters hemoglobin, platelet count, total neutrophils and white blood cell count were evaluated. Laboratory toxicities were graded according to DAIDS grading criteria, where Grade 1-mild, Grade 2-moderate, Grade 3-severe, Grade 4-potentially life-threatening. Number of participants with any time post-baseline maximum emergent toxicities in any of the hematology parameters have been presented.
Time frame: Up to Week 20
Population: Safety Population. It consists of all enrolled subjects who received at least one dose of IP.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 2 | 4 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 3 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 1 | 26 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Maximum Post-Baseline Emergent Toxicities for Hematology Parameters, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | Maximum toxicity Grade 4 | 3 Participants |
Secondary
Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \< 200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL.
Time frame: At Week 32 and Week 48
Population: ITT-ME Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 32 | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 48 | 2 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 32 | 0 Participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 48 | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 32 | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Protocol Defined Virologic Failure at Week 32 and Week 48 (Maintenance Period) | Week 48 | 1 Participants |
Secondary
Number of Participants With Treatment-emergent Genotypic Resistance
Plasma samples were collected to assess treatment emergent Genotypic Resistance for participants who had confirmed virologic failure. Number of participants who had any Integrase Inhibitor (INI) mutations or major mutations of other classes (Nucleoside reverse transcriptase inhibitor \[NRTI\], Non-nucleoside reverse transcriptase inhibitor \[NNRTI\], protease inhibitor \[PI\])are presented.
Time frame: Up to Week 32
Population: On-trt Genotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment genotypic resistance data, at time of protocol defined virologic failure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Genotypic Resistance | INI mutations | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Genotypic Resistance | Major mutations of other classes | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Genotypic Resistance | Major mutations of other classes | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Genotypic Resistance | INI mutations | 0 Participants |
Secondary
Number of Participants With Treatment-emergent Phenotypic Resistance
Plasma samples were collected for drug resistance testing. Number of participants, with treatment emergent phenotypic resistance to INI, NNRTI, NRTI and/or PI were summarized. Overall susceptibility of the drug was categorized as sensitive, partially sensitive and resistant.
Time frame: Up to Week 32
Population: On-trt Phenotypic Resistance Population consisted of all participants in the ITT-E Population with available On-treatment phynotypic resistance data, at time of protocol defined virologic failure.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Sensitive | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Partially sensitive | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Resistant | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Resistant | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Sensitive | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Partially sensitive | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Sensitive | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Partially sensitive | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Sensitive | 1 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Partially sensitive | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Resistant | 0 Participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Resistant | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Partially sensitive | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Sensitive | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Sensitive | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Sensitive | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | INI, Resistant | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Partially sensitive | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Partially sensitive | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Resistant | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NNRTI, Resistant | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Sensitive | 1 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | NRTI, Partially sensitive | 0 Participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Number of Participants With Treatment-emergent Phenotypic Resistance | PI, Resistant | 0 Participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period)
Percentage of participants with HIV-1 RNA \<200 c/mL and \<50 c/mL for oral dose of CAB 30 mg plus ABC/3TC during Induction Period was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. The Intent-to-Treat Exposed (ITT-E) Population consisted of all randomized participants who received at least one dose of investigational product.
Time frame: Week -20, Week -16, Week -12, Week -8, Week -4, Day 1
Population: ITT-E Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Week -20 | 0 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Week -8 | 89 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Week -4 | 92 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Week -16 | 72 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Week -12 | 90 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<50 c/mL, Day 1 | 91 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Week -20 | 0 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Week -16 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Week -12 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Week -8 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Week -4 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA <200 c/mL and <50 c/mL, for Oral Dose of CAB 30 mg Plus ABC/3TC (Induction Period) | HIV-1 RNA<200 c/mL, Day 1 | 94 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period)
Percentage of participants with HIV-1 RNA \<50 c/mL and \<200 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders.
Time frame: From Day 1 up to Week 96
Population: ITT-ME Population
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 96 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 64 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 4 | 99 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 40 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 56 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 36 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Day 1 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 4 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 8 | 98 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 12 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 16 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 20 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 24 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 28 | 90 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 32 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 40 | 92 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 44 | 93 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 48 | 92 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 56 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 72 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 80 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 88 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 96 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Day 1 | 100 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 8 | 99 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 12 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 16 | 98 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 20 | 98 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 24 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 28 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 32 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 36 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 44 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 48 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 64 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 72 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 80 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 88 | 96 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 32 | 95 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 36 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 40 | 91 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 44 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 36 | 93 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 48 | 91 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 56 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 64 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 72 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 80 | 87 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 44 | 91 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 88 | 86 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 96 | 87 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 80 | 88 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Day 1 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 4 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 48 | 92 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 8 | 99 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 12 | 98 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 24 | 96 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 16 | 98 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 40 | 92 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 56 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 16 | 96 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 20 | 97 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Day 1 | 99 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 4 | 98 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 64 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 8 | 97 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 96 | 87 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 12 | 97 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 88 | 86 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 28 | 95 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 20 | 97 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 24 | 94 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 72 | 90 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 28 | 92 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 32 | 94 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 12 | 98 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 16 | 89 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 36 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 32 | 91 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 56 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 40 | 86 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 72 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 12 | 98 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 44 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 56 | 86 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 4 | 93 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 48 | 89 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 36 | 89 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 28 | 91 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 28 | 86 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 64 | 86 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 40 | 86 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 16 | 93 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 72 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 88 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 8 | 95 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 80 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 64 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 80 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 88 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 44 | 89 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 32 | 91 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 96 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 24 | 91 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 24 | 93 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Day 1 | 98 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Week 20 | 91 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 4 | 96 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<50 c/mL, Day 1 | 98 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 20 | 93 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 96 | 84 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 8 | 95 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL and <200 c/mL Over Week 96 (Maintenance Period) | HIV-1 RNA<200 c/mL, Week 48 | 89 Percentage of participants |
Secondary
Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period)
Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as well as participants who switch their concomitant ART prior to the visit of interest, as non-responders. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact \[HC\] and not injectable drug user).
Time frame: Up to Week 32
Population: ITT-ME Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 88 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 89 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 94 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-Non-White, n=22,21,17 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 100 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 49 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 87 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 86 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0 | 100 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 97 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-White, n=93,94,39 | 95 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 96 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 88 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA<1000 c/mL, n=0,3,1 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-Non-White, n=22,21,17 | 95 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 39 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 92 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 94 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 84 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 92 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 100 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-White, n=93,94,39 | 94 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 92 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 71 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 94 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA<1000 c/mL, n=0,3,1 | 100 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-White, n=93,94,39 | 95 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 92 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 90 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 88 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Race-Non-White, n=22,21,17 | 82 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 24 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 50 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 90 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 94 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 80 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Plasma HIV-1 RNA Level <50 c/mL Over Week 32 by Subgroups (Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 92 Percentage of participants |
Secondary
Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period)
Virologic failure was defined as any of the following: (1) Non-response as indicated by a less than a 1.0 log10 c/mL decrease in plasma HIV-1 RNA after 4 weeks of starting the Induction Period, which is subsequently confirmed, unless the plasma HIV-1 RNA is \< 400 c/mL; (2) Rebound as indicated by two consecutive plasma HIV-1 RNA levels \>=200 c/mL after prior suppression to \<200 c/mL; (3) Rebound as indicated by two consecutive plasma HIV-1 RNA that are \> 0.5 log10 c/mL increase in plasma HIV-1 RNA from the nadir value on study, where the lowest HIV-1 RNA value is \>=200 c/mL. Data is presented for following subgroups: Baseline plasma HIV-1 RNA levels, Baseline CD4+ cell count, Race and HIV Risk factor (Homosexual contact \[HC\] and not injectable drug user).
Time frame: Up to Week 32
Population: ITT-ME Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 3 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 2 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-Non-White, n=22,21,17 | 5 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 6 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 9 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 0 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 13 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 11 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 3 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 14 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-White, n=93,94,39 | 4 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 12 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0 | 0 Percentage of participants |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ cell count <200 cells/mm^3, n=3,2,0 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 1 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA<1000 c/mL, n=0,3,1 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-White, n=93,94,39 | 1 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-Non-White, n=22,21,17 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 1 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 4 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 1 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 0 Percentage of participants |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline plasma HIV-1 RNA >=200000 c/mL, n=7,15,5 | 20 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | HC and not injectable drug user, n=98,90,40 | 5 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | No HC and not injectable drug user, n=17,25,16 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA<100000 c/mL, n=99,87,49 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 c/mL, n=16,28,7 | 29 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA<1000 c/mL, n=0,3,1 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to<10000c/mL, n=26,25,13 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 1000 to <50000c/mL, n=50,42,25 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA 50000 to<100000c/mL,n=23,17,10 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline HIV-1 RNA>=100000 to<200000c/mL,n=9,13,2 | 50 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count 200 to<350cells/mm^3,n=30,23,8 | 13 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Baseline CD4+ count >=350 cells/mm^3, n=82,90,48 | 2 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-White, n=93,94,39 | 0 Percentage of participants |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Percentage of Participants With Protocol Defined Virologic Failure (PDVF) at Week 32 by Subgroups(Maintenance Period) | Race-Non-White, n=22,21,17 | 12 Percentage of participants |
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: area under plasma concentration-time curve from time zero to the end of dosing interval (AUC \[0-tau\]) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (AUC \[0-tau\]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau). Standard Error (SE)=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000 .
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA | 0.00 Change in log odds | Standard Error 0.001 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA | 0.00 Change in log odds | Standard Error 0 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA | 0.00 Change in log odds | Standard Error 0.002 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA | 0.00 Change in log odds | Standard Error 0 |
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | 0.64 Change in log odds | Standard Error 0.837 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | 0.00 Change in log odds | Standard Error 0.025 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | 2.39 Change in log odds | Standard Error 1.903 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | 0.01 Change in log odds | Standard Error 0.039 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | 0.39 Change in log odds | Standard Error 0.528 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | -0.01 Change in log odds | Standard Error 0.02 |
Secondary
Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between pharmacodynamics response (HIV-1 RNA\<50 c/mL) at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is HIV-1 RNA\<50 c/mL (success) and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=98, 97,0 | -0.01 Change in log odds | Standard Error 0.174 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=97,96,0 | 0.00 Change in log odds | Standard Error 0.01 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=98, 97,0 | 1.64 Change in log odds | Standard Error 1.707 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Pharmacodynamic Response (HIV-1 RNA<50 c/mL) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=97,96,0 | 0.01 Change in log odds | Standard Error 0.027 |
Secondary
Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period)
Blood samples were collected at indicated time points for PK analysis of CAB LA. Ctrough is the lowest concentration reached by a drug before the next dose is administered. Ctrough for CAB LA (Q8W IM dosing) which were considered for the assessment of steady state are presented.
Time frame: Pre-dose on Weeks 16, 24 and 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 16, n=87 | 1.6902 Micrograms per milliliter | Standard Deviation 0.80471 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 24, n=86 | 1.6051 Micrograms per milliliter | Standard Deviation 0.78254 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Trough Concentration (Ctrough) of CAB LA (Q8W IM Dosing) Used for Assessment of Steady State (Maintenance Period) | Week 32, n=84 | 1.5330 Micrograms per milliliter | Standard Deviation 0.70822 |
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: AUC (0-tau) of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (AUC \[0-tau\]). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter AUC (0-tau). SE=0.000 is defined as following: if for all participants was resulted same value for the specific timepoint, then SE is equal with 0.000.
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA | 0.00 Change in log odds | Standard Error 0 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA | -0.00 Change in log odds | Standard Error 0.001 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA | -0.00 Change in log odds | Standard Error 0.002 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (AUC[0-tau]) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA | -0.00 Change in log odds | Standard Error 0 |
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Average C0 of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (Average C0). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Average C0.
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | -1.01 Change in log odds | Standard Error 1.014 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | -0.00 Change in log odds | Standard Error 0.027 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | -2.39 Change in log odds | Standard Error 1.903 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | -0.01 Change in log odds | Standard Error 0.039 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=101,104,49 | -0.01 Change in log odds | Standard Error 0.038 |
| CAB 30 mg+ABC/3TC QD (Induction Period and Maintenance Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Average C0) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=100,108, 50 | -0.53 Change in log odds | Standard Error 0.796 |
Secondary
Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period)
Logistic regression was used to examine the correlation between virologic failure at Week 32 and plasma PK parameter: Cmax of CAB LA and RPV LA per arm using MSDF (Missing, Switch or Discontinuation = Failure) algorithm. Estimates were obtained from logistic statistical model where the dependent variable is virologic failure and the independent variable is PK parameter (Cmax). Slopes and standard error are presented. Estimated effect represents the change in log odds for a one-unit increase in the PK parameter Cmax.
Time frame: Up to Week 32
Population: PK Concentration Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=98, 97,0 | -0.45 Change in log odds | Standard Error 0.509 |
| CAB LA 600 mg+RPV LA 900 mg IM-Q8W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=97,96,0 | -0.00 Change in log odds | Standard Error 0.012 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | RPV LA, n=97,96,0 | -0.01 Change in log odds | Standard Error 0.027 |
| CAB LA 400 mg+RPV LA 600 mg IM-Q4W (Maintenance and Extension Period) | Virologic Failure (From MSDF Algorithm) in Relation With PK Parameter (Cmax) of CAB LA and RPV LA at Week 32 (Maintenance Period) | CAB LA, n=98, 97,0 | -1.64 Change in log odds | Standard Error 1.707 |