Trial Outcomes & Findings for Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants (NCT NCT02938520)

Last Updated: 2025-12-31

Results Overview

Percentage of participants with virologic failure endpoint (HIV-1 RNA\>=50 c/mL) as per Food and Drug Administration (FDA) snapshot algorithm at Week 48 was assessed to demonstrate the noninferior antiviral activity of switching to intramuscular (IM) CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC regimen over 48 weeks in HIV-1 infected ARTexperienced participants. The HIV-1 RNA \>=50 copies/mL per snapshot algorithm was determined by the last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks) or at time of discontinuation (if discontinuation occurred prior to Week 48 for reasons other than Adverse Event).

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE3

Target enrollment

631 participants

Primary outcome timeframe

Week 48

Results posted on

2025-12-31

Participant Flow

This non-inferiority study evaluated antiviral activity of switching to intramuscular long acting carbotegravir (CAB) and rilpivirine (RPV) every 4 weeks compared to continuation of abacavir (ABC)/dolutegravir (DTG)/lamivudine (3TC) over 48 weeks in virologically suppressed participants with human immunodeficiency type 1 infection

A total of 631 participants were enrolled into the Induction Phase of the study. 566 participants were subsequently randomized. Two randomized participants did not receive study treatment. This study was conducted in 11 countries. The results presented are based on Week 48 primary analysis

Participant milestones

Participant milestones
Measure	CAB LA + RPV LA (Q4W) Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Study STARTED	283	283
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	283	283

Reasons for withdrawal

Reasons for withdrawal
Measure	CAB LA + RPV LA (Q4W) Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Overall Study On-going at the time of analysis	258	261
Overall Study Physician Decision	2	5
Overall Study Lost to Follow-up	2	2
Overall Study Withdrawal by Subject	7	7
Overall Study Protocol Violation	0	1
Overall Study Lack of Efficacy	5	3
Overall Study Adverse Event	9	4

Baseline Characteristics

Study to Evaluate the Efficacy, Safety, and Tolerability of Long-acting Intramuscular Cabotegravir and Rilpivirine for Maintenance of Virologic Suppression Following Switch From an Integrase Inhibitor in HIV-1 Infected Therapy Naive Participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA	Total n=566 Participants Total of all reporting groups
Age, Continuous	35.9 Years STANDARD_DEVIATION 10.17 • n=1000 Participants	36.0 Years STANDARD_DEVIATION 9.82 • n=1986 Participants	35.9 Years STANDARD_DEVIATION 9.99 • n=2008 Participants
Sex: Female, Male Female	63 Participants n=1000 Participants	64 Participants n=1986 Participants	127 Participants n=2008 Participants
Sex: Female, Male Male	220 Participants n=1000 Participants	219 Participants n=1986 Participants	439 Participants n=2008 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	3 Participants n=1000 Participants	6 Participants n=1986 Participants	9 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage	2 Participants n=1000 Participants	1 Participants n=1986 Participants	3 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-East Asian Heritage	1 Participants n=1000 Participants	2 Participants n=1986 Participants	3 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-South East Asian Heritage	1 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants
Race/Ethnicity, Customized Asian-Japanese Heritage	8 Participants n=1000 Participants	12 Participants n=1986 Participants	20 Participants n=2008 Participants
Race/Ethnicity, Customized Black or African American	47 Participants n=1000 Participants	56 Participants n=1986 Participants	103 Participants n=2008 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=1000 Participants	0 Participants n=1986 Participants	1 Participants n=2008 Participants
Race/Ethnicity, Customized White-Arabic/North African Heritage	5 Participants n=1000 Participants	3 Participants n=1986 Participants	8 Participants n=2008 Participants
Race/Ethnicity, Customized White-White /Caucasian/European Heritage	211 Participants n=1000 Participants	198 Participants n=1986 Participants	409 Participants n=2008 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=1000 Participants	3 Participants n=1986 Participants	7 Participants n=2008 Participants
Race/Ethnicity, Customized Missing	0 Participants n=1000 Participants	2 Participants n=1986 Participants	2 Participants n=2008 Participants

PRIMARY outcome

Timeframe: Week 48

Population: Intent-to treat exposed (ITT-E) participants included all randomized participants who received at least one dose of Investigational Product (IP) during the Maintenance Phase. Participants were analyzed according to the randomized treatment regardless of what treatment actually received.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Percentage of Participants With Virologic Failure (HIV-1 Ribonucleic Acid [RNA] >=50 Copies Per Millilter [mL]) Using Snapshot Algorithm at Week 48	2.1 Percentage of Participants	2.5 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 using FDA snapshot algorithm was assessed to demonstrate antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC. The HIV-1 RNA \<50 copies/mL per snapshot algorithm was determined by last on-treatment HIV-1 RNA measurement within the Week 48 analysis visit window (+/- 6 weeks). Participants with no data in the analysis window were classificated as non-responders.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Percentage of Participants With HIV-1 RNA <50 Copies/mL Using Snapshot Algorithm at Week 48	94 Percentage of Participants	93 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

Percentage of participants with plasma HIV-1 RNA \<200 copies/mL at Week 48 using the snapshot algorithm was assessed based on the antiviral and immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to continuation of ABC/DTG/3TC

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With HIV-1 RNA <200 Copies/mL Using Snapshot Algorithm at Week 48	94 Percentage of Participants Interval 91.0 to 97.0	94 Percentage of Participants Interval 91.0 to 97.0

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population

The CVF is defined as rebound as indicated by two consecutive plasma HIV-1-RNA levels \>=200 copies/mL after prior suppression to \<200 copies/mL.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Confirmed Virologic Failure (CVF) During the Maintenance Phase	4 Participants	3 Participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed

Plasma for quantitative HIV-1 RNA were collected at indicated time points. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Plasma HIV-1 RNA at Week 48	1.513 log10 copies/mL Standard Deviation 0.0954	1.518 log10 copies/mL Standard Deviation 0.1152

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed

Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as: HIV-1 RNA(log 10) at Week 48 minus HIV-1 RNA(log 10) at Baseline.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Plasma HIV-1 RNA at Week 48	-0.006 log10 copies/mL Standard Deviation 0.1026	0.001 log10 copies/mL Standard Deviation 0.1435

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for CD4+ Lymphocyte Count at Week 48	703.2 Cells per cubic millimeter Standard Deviation 285.75	731.2 Cells per cubic millimeter Standard Deviation 272.49

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed

Blood samples were collected and CD4+ cell count assessment by flow cyclometry was carried out to evaluate the immunologic activity of switching to IM CAB LA+RPV LA every 4 weeks compared to ABC/DTG/3TC. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value at Week 48 minus Maintenance Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for CD4+ Lymphocyte Count at Week 48	40.2 Cells per cubic millimeter Standard Deviation 195.17	79.9 Cells per cubic millimeter Standard Deviation 194.55

SECONDARY outcome

Timeframe: Day 1 up to an average of 59 weeks

Population: ITT-E Population

Data for participants who experienced disease progression to Centers for Disease Control and Prevention (CDC) Stage III or death has been presented. CDC stage is derived according to lowest post baseline CD4+ T-lympohocyte count and/or occurrence of AIDS-defining conditons (per 2014 CDC criteria).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Disease Progression	9 Participants	11 Participants

SECONDARY outcome

Timeframe: Day 1 up to an average of 59 Weeks

Population: Safety Population

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other situations as per medical or scientific judgment. Safety Population: all randomized participants who received at least 1 dose of IP during maintenance phase and assessed according to actual treatment received. All Maintenance Phase AEs was presented including AEs with start date occurring on/after date of 1st dose of randomized treatment, up to and including start date of LTFU antiretroviral therapy for participants who discontinued from Q4W arm. Non-SAE counts in \>=5% of participants within any arm is reported

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any non-SAE	252 Participants	138 Participants
Number of Participants With Non-serious Adverse Events (Non-SAEs) and Serious Adverse Events (SAEs) Any SAE	18 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Severity of adverse events (AEs) were defined as per The Division of acquired immuno deficiency syndrome (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table) Version 2.0, November 2014. Severity grades for AEs were as Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe), Grade 4 (Potentially life-threatening) and Grade 5 were all deaths related to an AE. All Maintenance Phase adverse events have been presented, which includes AEs with start date occuring on or after the date of first dose of randomized study treatment, up to and including the start date of LTFU antiretroviral therapy for participants who discontinued from the Q4W arm.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Severity of Adverse Events Grade 1	93 Participants	119 Participants
Number of Participants With Severity of Adverse Events Grade 2	143 Participants	95 Participants
Number of Participants With Severity of Adverse Events Grade 3	23 Participants	10 Participants
Number of Participants With Severity of Adverse Events Grade 4	8 Participants	1 Participants
Number of Participants With Severity of Adverse Events Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated time points.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 32, n=254, 267	89.6 Femtoliters Standard Deviation 4.69	93.6 Femtoliters Standard Deviation 5.90
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 36, n=252, 261	89.5 Femtoliters Standard Deviation 4.65	94.1 Femtoliters Standard Deviation 5.65
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 40, n=246, 255	90.3 Femtoliters Standard Deviation 4.62	94.4 Femtoliters Standard Deviation 6.09
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 44, n=256, 262	90.7 Femtoliters Standard Deviation 5.05	94.6 Femtoliters Standard Deviation 6.32
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 48, n=243, 260	91.2 Femtoliters Standard Deviation 5.21	95.4 Femtoliters Standard Deviation 6.60
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Baseline (Day 1), n=283, 283	94.8 Femtoliters Standard Deviation 4.94	94.3 Femtoliters Standard Deviation 5.69
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 4, n=279, 273	94.1 Femtoliters Standard Deviation 4.77	94.6 Femtoliters Standard Deviation 5.85
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 8, n=211, 275	92.3 Femtoliters Standard Deviation 4.86	94.6 Femtoliters Standard Deviation 5.78
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 12, n=270, 275	91.0 Femtoliters Standard Deviation 4.64	94.0 Femtoliters Standard Deviation 5.81
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 16, n=254, 265	89.9 Femtoliters Standard Deviation 4.43	94.1 Femtoliters Standard Deviation 5.78
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 20, n=255, 267	89.3 Femtoliters Standard Deviation 4.46	93.9 Femtoliters Standard Deviation 5.64
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 24, n=259, 264	89.4 Femtoliters Standard Deviation 4.33	93.8 Femtoliters Standard Deviation 5.69
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocyte Mean Corpuscular Volume Week 28, n=246, 265	89.3 Femtoliters Standard Deviation 4.64	93.5 Femtoliters Standard Deviation 5.78

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Baseline (Day 1), n=283, 283	4.59 10^12 cells per Liter Standard Deviation 0.434	4.65 10^12 cells per Liter Standard Deviation 0.412
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 4, n=279, 273	4.67 10^12 cells per Liter Standard Deviation 0.423	4.62 10^12 cells per Liter Standard Deviation 0.406
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 8, n=211, 275	4.76 10^12 cells per Liter Standard Deviation 0.435	4.67 10^12 cells per Liter Standard Deviation 0.410
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 12, n=270, 275	4.82 10^12 cells per Liter Standard Deviation 0.435	4.66 10^12 cells per Liter Standard Deviation 0.419
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 16, n=254, 265	4.87 10^12 cells per Liter Standard Deviation 0.430	4.66 10^12 cells per Liter Standard Deviation 0.407
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 20, n=255, 267	4.89 10^12 cells per Liter Standard Deviation 0.418	4.64 10^12 cells per Liter Standard Deviation 0.410
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 24, n=259, 264	4.87 10^12 cells per Liter Standard Deviation 0.418	4.67 10^12 cells per Liter Standard Deviation 0.425
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 28, n=246, 265	4.87 10^12 cells per Liter Standard Deviation 0.416	4.69 10^12 cells per Liter Standard Deviation 0.395
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 32, n=254, 267	4.83 10^12 cells per Liter Standard Deviation 0.435	4.66 10^12 cells per Liter Standard Deviation 0.418
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 36, n=252, 261	4.82 10^12 cells per Liter Standard Deviation 0.403	4.64 10^12 cells per Liter Standard Deviation 0.395
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 40, n=246, 255	4.81 10^12 cells per Liter Standard Deviation 0.407	4.63 10^12 cells per Liter Standard Deviation 0.409
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 44, n=256, 262	4.79 10^12 cells per Liter Standard Deviation 0.425	4.59 10^12 cells per Liter Standard Deviation 0.403
Absolute Values for Hematology Parameters Over Time Including Week 48: Erythrocytes Week 48, n=243, 260	4.74 10^12 cells per Liter Standard Deviation 0.443	4.59 10^12 cells per Liter Standard Deviation 0.437

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Baseline (Day 1), n=283, 283	142.5 Grams per liter Standard Deviation 13.59	143.1 Grams per liter Standard Deviation 13.51
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 4, n=279, 273	144.3 Grams per liter Standard Deviation 13.34	143.4 Grams per liter Standard Deviation 13.47
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 8, n=211, 275	143.9 Grams per liter Standard Deviation 13.84	144.7 Grams per liter Standard Deviation 13.59
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 12, n=270, 275	144.5 Grams per liter Standard Deviation 13.89	144.7 Grams per liter Standard Deviation 14.66
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 16, n=254, 265	145.3 Grams per liter Standard Deviation 13.52	144.6 Grams per liter Standard Deviation 13.88
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 20, n=255, 267	145.4 Grams per liter Standard Deviation 12.69	144.8 Grams per liter Standard Deviation 13.87
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 24, n=259, 264	145.0 Grams per liter Standard Deviation 13.14	145.3 Grams per liter Standard Deviation 14.07
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 28, n=246, 265	145.3 Grams per liter Standard Deviation 12.80	146.5 Grams per liter Standard Deviation 14.17
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 32, n=254, 267	145.1 Grams per liter Standard Deviation 13.37	146.2 Grams per liter Standard Deviation 14.80
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 36, n=252, 261	144.6 Grams per liter Standard Deviation 12.27	146.2 Grams per liter Standard Deviation 13.85
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 40, n=246, 255	145.9 Grams per liter Standard Deviation 12.32	146.2 Grams per liter Standard Deviation 13.85
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 44, n=256, 262	145.1 Grams per liter Standard Deviation 12.79	145.0 Grams per liter Standard Deviation 14.13
Absolute Values for Hematology Parameters Over Time Including Week 48: Hemoglobin Week 48, n=243, 260	143.8 Grams per liter Standard Deviation 13.56	145.4 Grams per liter Standard Deviation 14.56

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Baseline (Day 1), n=283, 283	0.4341 Proportion of red blood cells in blood Standard Deviation 0.03889	0.4370 Proportion of red blood cells in blood Standard Deviation 0.03887
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 4, n=279, 273	0.4387 Proportion of red blood cells in blood Standard Deviation 0.03809	0.4363 Proportion of red blood cells in blood Standard Deviation 0.03832
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 8, n=211, 275	0.4382 Proportion of red blood cells in blood Standard Deviation 0.04056	0.4403 Proportion of red blood cells in blood Standard Deviation 0.03978
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 12, n=270, 275	0.4377 Proportion of red blood cells in blood Standard Deviation 0.04020	0.4373 Proportion of red blood cells in blood Standard Deviation 0.04144
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 16, n=254, 265	0.4366 Proportion of red blood cells in blood Standard Deviation 0.03769	0.4371 Proportion of red blood cells in blood Standard Deviation 0.03890
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 20, n=255, 267	0.4363 Proportion of red blood cells in blood Standard Deviation 0.03574	0.4349 Proportion of red blood cells in blood Standard Deviation 0.03839
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 24, n=259, 264	0.4351 Proportion of red blood cells in blood Standard Deviation 0.03580	0.4366 Proportion of red blood cells in blood Standard Deviation 0.03901
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 28, n=246, 265	0.4342 Proportion of red blood cells in blood Standard Deviation 0.03519	0.4374 Proportion of red blood cells in blood Standard Deviation 0.03867
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 32, n=254, 267	0.4318 Proportion of red blood cells in blood Standard Deviation 0.03623	0.4347 Proportion of red blood cells in blood Standard Deviation 0.04025
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 36, n=252, 261	0.4301 Proportion of red blood cells in blood Standard Deviation 0.03392	0.4349 Proportion of red blood cells in blood Standard Deviation 0.03774
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 40, n=246, 255	0.4328 Proportion of red blood cells in blood Standard Deviation 0.03433	0.4358 Proportion of red blood cells in blood Standard Deviation 0.03845
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 44, n=256, 262	0.4332 Proportion of red blood cells in blood Standard Deviation 0.03570	0.4328 Proportion of red blood cells in blood Standard Deviation 0.03847
Absolute Values for Hematology Parameters Over Time Including Week 48: Hematocrit Week 48, n=243, 260	0.4310 Proportion of red blood cells in blood Standard Deviation 0.03875	0.4361 Proportion of red blood cells in blood Standard Deviation 0.04156

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK at indicated timepoints.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-albumin at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Baseline (Day 1), n=283, 283	43.8 Grams per liter Standard Deviation 3.04	44.1 Grams per liter Standard Deviation 2.80
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 4, n=280, 277	43.7 Grams per liter Standard Deviation 3.03	43.8 Grams per liter Standard Deviation 2.70
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 8, n=212, 278	43.5 Grams per liter Standard Deviation 2.85	43.9 Grams per liter Standard Deviation 2.76
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 12, n=270, 276	43.7 Grams per liter Standard Deviation 3.06	44.1 Grams per liter Standard Deviation 2.87
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 16, n=255, 269	44.1 Grams per liter Standard Deviation 2.99	44.0 Grams per liter Standard Deviation 2.78
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 20, n=260, 272	44.1 Grams per liter Standard Deviation 3.11	43.9 Grams per liter Standard Deviation 2.72
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 24, n=261, 268	44.3 Grams per liter Standard Deviation 3.08	44.2 Grams per liter Standard Deviation 2.60
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 28, n=253, 268	44.4 Grams per liter Standard Deviation 3.09	44.5 Grams per liter Standard Deviation 2.66
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 32, n=255, 268	44.6 Grams per liter Standard Deviation 3.17	44.4 Grams per liter Standard Deviation 2.76
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 36, n=254, 261	44.1 Grams per liter Standard Deviation 3.05	44.3 Grams per liter Standard Deviation 2.63
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 40, n=250, 266	44.8 Grams per liter Standard Deviation 3.02	44.5 Grams per liter Standard Deviation 2.76
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 44, n=258, 263	44.7 Grams per liter Standard Deviation 2.98	44.4 Grams per liter Standard Deviation 2.71
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 48, n=247, 262	44.6 Grams per liter Standard Deviation 2.98	44.6 Grams per liter Standard Deviation 2.86

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin at indicated timepoints.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea at indicated timepoints.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-lipase at indicated timepoints.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 36, n=254, 261	31.5 Units per liter Standard Deviation 20.49	31.2 Units per liter Standard Deviation 20.03
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 40, n=250, 266	32.6 Units per liter Standard Deviation 27.07	32.1 Units per liter Standard Deviation 22.19
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 44, n=258, 263	36.3 Units per liter Standard Deviation 45.04	33.0 Units per liter Standard Deviation 24.09
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 48, n=247, 261	30.1 Units per liter Standard Deviation 20.31	32.6 Units per liter Standard Deviation 28.96
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Baseline (Day 1), n=283, 283	31.0 Units per liter Standard Deviation 21.04	30.9 Units per liter Standard Deviation 28.89
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 4, n=278, 276	31.7 Units per liter Standard Deviation 27.17	32.6 Units per liter Standard Deviation 24.73
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 8, n=211, 278	31.5 Units per liter Standard Deviation 21.15	31.3 Units per liter Standard Deviation 19.96
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 12, n=270, 276	31.4 Units per liter Standard Deviation 23.94	33.6 Units per liter Standard Deviation 23.37
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 16, n=254, 269	30.8 Units per liter Standard Deviation 22.39	32.1 Units per liter Standard Deviation 18.99
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 20, n=260, 270	31.3 Units per liter Standard Deviation 23.46	31.9 Units per liter Standard Deviation 19.13
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 24, n=260, 268	31.3 Units per liter Standard Deviation 22.60	32.2 Units per liter Standard Deviation 21.08
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 28, n=253, 268	30.3 Units per liter Standard Deviation 18.71	33.0 Units per liter Standard Deviation 22.56
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 32, n=254, 268	33.5 Units per liter Standard Deviation 35.38	33.2 Units per liter Standard Deviation 32.95

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance at indicated timepoints. Glomerular filtration rate (GFR) will be estimated by the central laboratory using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Baseline (Day 1), n=283, 283	94.3 mL/min/1.73/m^2 Standard Deviation 17.61	97.9 mL/min/1.73/m^2 Standard Deviation 17.70
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 4, n=278, 277	101.2 mL/min/1.73/m^2 Standard Deviation 16.56	96.5 mL/min/1.73/m^2 Standard Deviation 17.14
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 8, n=211, 278	104.9 mL/min/1.73/m^2 Standard Deviation 15.64	98.1 mL/min/1.73/m^2 Standard Deviation 17.46
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 12, n=270, 276	104.8 mL/min/1.73/m^2 Standard Deviation 16.08	98.6 mL/min/1.73/m^2 Standard Deviation 17.77
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 16, n=254, 269	104.2 mL/min/1.73/m^2 Standard Deviation 15.03	97.6 mL/min/1.73/m^2 Standard Deviation 16.84
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 20, n=261, 271	105.5 mL/min/1.73/m^2 Standard Deviation 15.19	98.0 mL/min/1.73/m^2 Standard Deviation 17.67
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 24, n=261, 268	105.1 mL/min/1.73/m^2 Standard Deviation 16.05	97.9 mL/min/1.73/m^2 Standard Deviation 17.33
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 28, n=253, 268	105.3 mL/min/1.73/m^2 Standard Deviation 16.18	98.8 mL/min/1.73/m^2 Standard Deviation 17.40
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 32, n=254, 268	105.1 mL/min/1.73/m^2 Standard Deviation 16.10	98.8 mL/min/1.73/m^2 Standard Deviation 17.39
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 36, n=254, 262	104.7 mL/min/1.73/m^2 Standard Deviation 15.88	98.0 mL/min/1.73/m^2 Standard Deviation 16.60
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 40, n=250, 266	104.3 mL/min/1.73/m^2 Standard Deviation 16.47	98.3 mL/min/1.73/m^2 Standard Deviation 17.25
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 44, n=258, 263	104.4 mL/min/1.73/m^2 Standard Deviation 16.73	98.9 mL/min/1.73/m^2 Standard Deviation 16.67
Absolute Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance. Week 48, n=247, 261	103.6 mL/min/1.73/m^2 Standard Deviation 16.34	96.9 mL/min/1.73/m^2 Standard Deviation 18.21

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 HDL cholesterol, Baseline (Day 1), n=268, 275	1.249 Millimoles per liter Standard Deviation 0.3761	1.302 Millimoles per liter Standard Deviation 0.3851
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 HDL cholesterol, Week 48, n=240, 239	1.359 Millimoles per liter Standard Deviation 0.4096	1.376 Millimoles per liter Standard Deviation 0.4335
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 LDL cholesterol, Baseline (Day 1), n=267, 275	2.557 Millimoles per liter Standard Deviation 0.7991	2.529 Millimoles per liter Standard Deviation 0.7870
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 LDL cholesterol, Week 48, n=238, 237	2.697 Millimoles per liter Standard Deviation 0.9158	2.472 Millimoles per liter Standard Deviation 0.7693
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 Triglycerides, Baseline (Day 1), n=268, 275	1.387 Millimoles per liter Standard Deviation 0.9142	1.294 Millimoles per liter Standard Deviation 0.7392
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 Triglycerides, Week 48, n=240, 239	1.323 Millimoles per liter Standard Deviation 0.9333	1.341 Millimoles per liter Standard Deviation 0.9059
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 Total Cholesterol, Baseline (Day 1), n=268, 275	4.44 Millimoles per liter Standard Deviation 0.928	4.42 Millimoles per liter Standard Deviation 0.986
Absolute Values for Fasting Lipid Panel Overtime Including Week 48 Total Cholesterol, Week 48, n=240, 239	4.65 Millimoles per liter Standard Deviation 1.021	4.46 Millimoles per liter Standard Deviation 0.944

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The dipstick test gives results in a semi-quantitative manner and results for urinalysis parameters (ketones, glucose, bilirubin, occult blood, nitrite and blood protein) can be read as positive, trace, 1+, 2+, 3+ and 4+ indicating proportional concentrations in the urine sample. The urine parameters were graded according to DAIDS scale where Grade 1 indicates mild (trace to 1+), Grade 2 indicates moderate (2+) and Grade 3 indicates severe (3+ or higher). Only participants with abnormal findings for urinalysis at any visit has been presented.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin,Baseline (Day 1),Trace, n=276, 276	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 1+, n=276, 276	15 Participants	22 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 2+, n=276, 276	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Baseline (Day 1), 3+, n=276, 276	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Baseline (Day 1), Trace, n=282, 282	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Baseline (Day 1), 1+, n=282, 282	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Baseline (Day 1), 2+, n=282, 282	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Baseline (Day 1), 3+, n=282, 282	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Baseline (Day 1), Trace, n=276, 276	30 Participants	29 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Baseline (Day 1), 1+, n=276, 276	4 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Baseline (Day 1), 2+, n=276, 276	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Baseline (Day 1), 3+, n=276, 276	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase,Baseline,Trace,n=276, 276	22 Participants	21 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Baseline, 1+, n=276, 276	12 Participants	14 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Baseline, 2+, n=276, 276	9 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Baseline, 3+, n=276, 276	3 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine nitrite, Baseline, positive, n=276, 276	6 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Baseline, Trace, n=276, 276	13 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Baseline, 1+, n=276, 276	5 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Baseline, 2+, n=276, 276	6 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Baseline, 3+, n=276, 276	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Baseline, Trace, n=276, 276	25 Participants	20 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Baseline, 1+, n=276, 276	4 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Baseline, 2+, n=276, 276	3 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Baseline, 3+, n=276, 276	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 4, Trace, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 4, 1+, n=278, 272	14 Participants	28 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 4, 2+, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 4, 3+, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 4, Trace, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 4, 1+, n=278, 272	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 4, 2+, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 4, 3+, n=278, 272	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 4, Trace, n=278, 272	20 Participants	21 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 4, 1+, n=278, 272	1 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 4, 2+, n=278, 272	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 4, 3+, n=278, 272	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 4, Trace,n=278, 272	19 Participants	23 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 4, 1+, n=278, 272	9 Participants	17 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 4, 2+, n=278, 272	6 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 4, 3+, n=278, 272	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine nitrite, Week 4, positive, n=278, 272	2 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 4, Trace, n=278, 272	11 Participants	13 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 4, 1+, n=278, 272	8 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 4, 2+, n=278, 272	5 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 4, 3+, n=278, 272	0 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 4, Trace, n=278, 272	12 Participants	24 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 4, 1+, n=278, 272	4 Participants	11 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 4, 2+, n=278, 272	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 4, 3+, n=278, 272	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 24, Trace, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 24, 1+, n=195, 258	7 Participants	14 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 , Urine bilirubin, Week 24, 2+, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 24, 3+, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 24, Trace, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 24, 1+, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 24, 2+, n=195, 258	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 24, 3+, n=195, 258	1 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 24, Trace, n=195, 258	13 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 24, 1+, n=195, 258	0 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 24, 2+, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 24, 3+, n=195, 258	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase,Week 24, Trace,n=195, 258	15 Participants	28 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 24, 1+, n=195, 258	8 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 24, 2+, n=195, 258	3 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 24, 3+, n=195, 258	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine nitrite, Week 24, positive, n=195, 258	4 Participants	5 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 24, Trace, n=195, 258	9 Participants	9 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 24, 1+, n=195, 258	3 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 24, 2+, n=195, 258	3 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 24, 3+, n=195, 258	1 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 24, Trace, n=195, 258	11 Participants	21 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 24, 1+, n=195, 258	4 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 24, 2+, n=195, 258	2 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 24, 3+, n=195, 258	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 48, Trace, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 48, 1+, n=261, 259	9 Participants	12 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 48, 2+, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine bilirubin, Week 48, 3+, n=261, 259	0 Participants	1 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 48, Trace, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 48, 1+, n=261, 259	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 48, 2+, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine glucose, Week 48, 3+, n=261, 259	2 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 48, Trace, n=261, 259	12 Participants	13 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 48, 1+, n=261, 259	0 Participants	4 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 48, 2+, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine ketones, Week 48, 3+, n=261, 259	0 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 48,Trace,n=261, 259	12 Participants	15 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 48, 1+, n=261, 259	5 Participants	10 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 48, 2+, n=261, 259	4 Participants	7 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine leukocyte esterase, Week 48, 3+, n=261, 259	2 Participants	2 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine nitrite, Week 48, positive, n=261, 259	2 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 48, Trace, n=261, 259	9 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 48, 1+, n=261, 259	4 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 48, 2+, n=261, 259	8 Participants	3 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine occult blood, Week 48, 3+, n=261, 259	1 Participants	0 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 48, Trace, n=261, 259	14 Participants	23 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 48, 1+, n=261, 259	5 Participants	8 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 48, 2+, n=261, 259	6 Participants	6 Participants
Number of Participants With Abnormal Urinalysis Parameter Over Time Including Week 48 Urine protein, Week 48, 3+, n=261, 259	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=8, n=261, 259	5 Participants	4 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=5, n=276, 276	36 Participants	32 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=5.5, n=276, 276	104 Participants	101 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=6, n=276, 276	66 Participants	62 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=6.5, n=276, 276	29 Participants	35 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=7, n=276, 276	27 Participants	27 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=7.5, n=276, 276	7 Participants	12 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=8, n=276, 276	4 Participants	4 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH=8.5, n=276, 276	2 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Baseline (Day 1), pH>9.0, n=276, 276	1 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=5, n=278, 272	33 Participants	41 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=5.5, n=278, 272	83 Participants	81 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=6, n=278, 272	68 Participants	71 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=6.5, n=278, 272	48 Participants	36 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=7, n=278, 272	25 Participants	22 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=7.5, n=278, 272	10 Participants	12 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=8, n=278, 272	5 Participants	5 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH=8.5, n=278, 272	6 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 4, pH>9.0, n=278, 272	0 Participants	3 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=5, n=195, 258	42 Participants	50 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=5.5, n=195, 258	55 Participants	78 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=6, n=195, 258	47 Participants	51 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=6.5, n=195, 258	19 Participants	46 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=7, n=195, 258	22 Participants	16 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=7.5, n=195, 258	4 Participants	13 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=8, n=195, 258	3 Participants	2 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH=8.5, n=195, 258	3 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 24, pH>9.0, n=195, 258	0 Participants	1 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=5, n=261, 259	54 Participants	57 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=5.5, n=261, 259	81 Participants	77 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=6, n=261, 259	50 Participants	61 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=6.5, n=261, 259	30 Participants	27 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=7, n=261, 259	24 Participants	18 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=7.5, n=261, 259	14 Participants	10 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH=8.5, n=261, 259	2 Participants	3 Participants
Number of Participants With Urine Potential of Hydrogen (pH) Over Time Including Week 48 Week 48, pH>9.0, n=261, 259	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including basophil, eosinophils, leukocytes, lymphocytes, neutrophils, monocytes, and platelets at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter including erythrocyte mean corpuscular volume at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 4, n=279, 273	-0.7 Femtoliters Standard Deviation 1.66	0.2 Femtoliters Standard Deviation 1.56
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 8, n=211, 275	-2.5 Femtoliters Standard Deviation 2.33	0.2 Femtoliters Standard Deviation 2.06
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 12, n=270, 275	-3.8 Femtoliters Standard Deviation 2.49	-0.3 Femtoliters Standard Deviation 2.48
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 16, n=254, 265	-5.1 Femtoliters Standard Deviation 2.63	-0.2 Femtoliters Standard Deviation 2.65
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 20, n=255, 267	-5.6 Femtoliters Standard Deviation 2.72	-0.5 Femtoliters Standard Deviation 2.55
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 24, n=259, 264	-5.6 Femtoliters Standard Deviation 2.85	-0.5 Femtoliters Standard Deviation 2.58
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 28, n=246, 265	-5.6 Femtoliters Standard Deviation 2.97	-0.9 Femtoliters Standard Deviation 2.52
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 32, n=254, 267	-5.3 Femtoliters Standard Deviation 3.02	-0.9 Femtoliters Standard Deviation 2.55
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 36, n=252, 261	-5.3 Femtoliters Standard Deviation 3.00	-0.6 Femtoliters Standard Deviation 2.45
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 40, n=246, 255	-4.8 Femtoliters Standard Deviation 3.02	-0.1 Femtoliters Standard Deviation 2.64
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 44, n=256, 262	-4.2 Femtoliters Standard Deviation 3.12	0.2 Femtoliters Standard Deviation 2.81
Change From Baseline for Hematology Parameters: Erythrocyte Mean Corpuscular Volume Week 48, n=243, 260	-3.7 Femtoliters Standard Deviation 3.12	1.0 Femtoliters Standard Deviation 2.93

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including erythrocytes at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline for Hematology Parameters: Erythrocytes Week 4, n=279, 273	0.08 10^12 cells per Liter Standard Deviation 0.226	-0.03 10^12 cells per Liter Standard Deviation 0.228
Change From Baseline for Hematology Parameters: Erythrocytes Week 8, n=211, 275	0.18 10^12 cells per Liter Standard Deviation 0.249	0.02 10^12 cells per Liter Standard Deviation 0.239
Change From Baseline for Hematology Parameters: Erythrocytes Week 12, n=270, 275	0.23 10^12 cells per Liter Standard Deviation 0.269	0.01 10^12 cells per Liter Standard Deviation 0.273
Change From Baseline for Hematology Parameters: Erythrocytes Week 16, n=254, 265	0.30 10^12 cells per Liter Standard Deviation 0.263	0.01 10^12 cells per Liter Standard Deviation 0.255
Change From Baseline for Hematology Parameters: Erythrocytes Week 20, n=255, 267	0.31 10^12 cells per Liter Standard Deviation 0.272	-0.01 10^12 cells per Liter Standard Deviation 0.242
Change From Baseline for Hematology Parameters: Erythrocytes Week 24, n=259, 264	0.31 10^12 cells per Liter Standard Deviation 0.254	0.02 10^12 cells per Liter Standard Deviation 0.242
Change From Baseline for Hematology Parameters: Erythrocytes Week 28, n=246, 265	0.29 10^12 cells per Liter Standard Deviation 0.248	0.04 10^12 cells per Liter Standard Deviation 0.259
Change From Baseline for Hematology Parameters: Erythrocytes Week 32, n=254, 267	0.25 10^12 cells per Liter Standard Deviation 0.283	0.01 10^12 cells per Liter Standard Deviation 0.259
Change From Baseline for Hematology Parameters: Erythrocytes Week 36, n=252, 261	0.23 10^12 cells per Liter Standard Deviation 0.263	-0.01 10^12 cells per Liter Standard Deviation 0.250
Change From Baseline for Hematology Parameters: Erythrocytes Week 40, n=246, 255	0.23 10^12 cells per Liter Standard Deviation 0.246	-0.01 10^12 cells per Liter Standard Deviation 0.239
Change From Baseline for Hematology Parameters: Erythrocytes Week 44, n=256, 262	0.21 10^12 cells per Liter Standard Deviation 0.234	-0.06 10^12 cells per Liter Standard Deviation 0.243
Change From Baseline for Hematology Parameters: Erythrocytes Week 48, n=243, 260	0.16 10^12 cells per Liter Standard Deviation 0.264	-0.06 10^12 cells per Liter Standard Deviation 0.257

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameters including hematocrit at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline for Hematology Parameters: Hematocrit Week 4, n=279, 273	0.0046 Proportion of red blood cells in blood Standard Deviation 0.02082	-0.0013 Proportion of red blood cells in blood Standard Deviation 0.02213
Change From Baseline for Hematology Parameters: Hematocrit Week 8, n=211, 275	0.0053 Proportion of red blood cells in blood Standard Deviation 0.02344	0.0026 Proportion of red blood cells in blood Standard Deviation 0.02314
Change From Baseline for Hematology Parameters: Hematocrit Week 12, n=270, 275	0.0040 Proportion of red blood cells in blood Standard Deviation 0.02383	-0.0000 Proportion of red blood cells in blood Standard Deviation 0.02618
Change From Baseline for Hematology Parameters: Hematocrit Week 16, n=254, 265	0.0035 Proportion of red blood cells in blood Standard Deviation 0.02338	-0.0003 Proportion of red blood cells in blood Standard Deviation 0.02489
Change From Baseline for Hematology Parameters: Hematocrit Week 20, n=255, 267	0.0024 Proportion of red blood cells in blood Standard Deviation 0.02335	-0.0033 Proportion of red blood cells in blood Standard Deviation 0.02323
Change From Baseline for Hematology Parameters: Hematocrit Week 24, n=259, 264	0.0021 Proportion of red blood cells in blood Standard Deviation 0.02299	-0.0012 Proportion of red blood cells in blood Standard Deviation 0.02337
Change From Baseline for Hematology Parameters: Hematocrit Week 28, n=246, 265	-0.0003 Proportion of red blood cells in blood Standard Deviation 0.02262	-0.0001 Proportion of red blood cells in blood Standard Deviation 0.02460
Change From Baseline for Hematology Parameters: Hematocrit Week 32, n=254, 267	-0.0017 Proportion of red blood cells in blood Standard Deviation 0.02607	-0.0032 Proportion of red blood cells in blood Standard Deviation 0.02503
Change From Baseline for Hematology Parameters: Hematocrit Week 36, n=252, 261	-0.0041 Proportion of red blood cells in blood Standard Deviation 0.02515	-0.0032 Proportion of red blood cells in blood Standard Deviation 0.02407
Change From Baseline for Hematology Parameters: Hematocrit Week 40, n=246, 255	-0.0014 Proportion of red blood cells in blood Standard Deviation 0.02461	-0.0017 Proportion of red blood cells in blood Standard Deviation 0.02388
Change From Baseline for Hematology Parameters: Hematocrit Week 44, n=256, 262	-0.0011 Proportion of red blood cells in blood Standard Deviation 0.02230	-0.0045 Proportion of red blood cells in blood Standard Deviation 0.02328
Change From Baseline for Hematology Parameters: Hematocrit Week 48, n=243, 260	-0.0027 Proportion of red blood cells in blood Standard Deviation 0.02571	-0.0019 Proportion of red blood cells in blood Standard Deviation 0.02572

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of hematology parameter including hemoglobin at indicated timepoints. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline was defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline for Hematology Parameters: Hemoglobin Week 48, n=243, 260	1.4 Grams per liter Standard Deviation 7.98	2.1 Grams per liter Standard Deviation 8.33
Change From Baseline for Hematology Parameters: Hemoglobin Week 4, n=279, 273	1.8 Grams per liter Standard Deviation 6.59	0.1 Grams per liter Standard Deviation 6.47
Change From Baseline for Hematology Parameters: Hemoglobin Week 8, n=211, 275	1.9 Grams per liter Standard Deviation 7.29	1.3 Grams per liter Standard Deviation 7.26
Change From Baseline for Hematology Parameters: Hemoglobin Week 12, n=270, 275	2.1 Grams per liter Standard Deviation 7.47	1.5 Grams per liter Standard Deviation 8.28
Change From Baseline for Hematology Parameters: Hemoglobin Week 16, n=254, 265	2.9 Grams per liter Standard Deviation 6.98	1.4 Grams per liter Standard Deviation 7.88
Change From Baseline for Hematology Parameters: Hemoglobin Week 20, n=255, 267	2.9 Grams per liter Standard Deviation 7.43	1.4 Grams per liter Standard Deviation 7.18
Change From Baseline for Hematology Parameters: Hemoglobin Week 24, n=259, 264	2.7 Grams per liter Standard Deviation 7.32	2.0 Grams per liter Standard Deviation 7.11
Change From Baseline for Hematology Parameters: Hemoglobin Week 28, n=246, 265	2.7 Grams per liter Standard Deviation 6.80	3.3 Grams per liter Standard Deviation 7.75
Change From Baseline for Hematology Parameters: Hemoglobin Week 32, n=254, 267	2.7 Grams per liter Standard Deviation 8.08	2.9 Grams per liter Standard Deviation 7.73
Change From Baseline for Hematology Parameters: Hemoglobin Week 36, n=252, 261	2.0 Grams per liter Standard Deviation 7.93	2.8 Grams per liter Standard Deviation 7.73
Change From Baseline for Hematology Parameters: Hemoglobin Week 40, n=246, 255	3.2 Grams per liter Standard Deviation 7.91	3.1 Grams per liter Standard Deviation 7.85
Change From Baseline for Hematology Parameters: Hemoglobin Week 44, n=256, 262	2.5 Grams per liter Standard Deviation 7.66	1.8 Grams per liter Standard Deviation 7.62

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including ALT, ALP, AST and CK. Baseline values is defined as the latest pre-treatment assessment with a non-missing value. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-albumin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 28, n=253, 268	0.5 Grams per liter Standard Deviation 2.42	0.4 Grams per liter Standard Deviation 2.32
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 4, n=280, 277	-0.1 Grams per liter Standard Deviation 2.15	-0.3 Grams per liter Standard Deviation 2.14
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 8, n=212, 278	-0.1 Grams per liter Standard Deviation 2.32	-0.3 Grams per liter Standard Deviation 2.25
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 12, n=270, 276	-0.1 Grams per liter Standard Deviation 2.38	0.0 Grams per liter Standard Deviation 2.58
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 16, n=255, 269	0.2 Grams per liter Standard Deviation 2.23	-0.1 Grams per liter Standard Deviation 2.48
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 20, n=260, 272	0.2 Grams per liter Standard Deviation 2.51	-0.2 Grams per liter Standard Deviation 2.47
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 24, n=261, 268	0.5 Grams per liter Standard Deviation 2.28	0.2 Grams per liter Standard Deviation 2.37
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 32, n=255, 268	0.7 Grams per liter Standard Deviation 2.47	0.4 Grams per liter Standard Deviation 2.60
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 36, n=254, 261	0.3 Grams per liter Standard Deviation 2.44	0.3 Grams per liter Standard Deviation 2.52
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 40, n=250, 266	0.9 Grams per liter Standard Deviation 2.42	0.5 Grams per liter Standard Deviation 2.46
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 44, n=258, 263	0.9 Grams per liter Standard Deviation 2.44	0.4 Grams per liter Standard Deviation 2.49
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Albumin Week 48, n=247, 262	0.7 Grams per liter Standard Deviation 2.40	0.5 Grams per liter Standard Deviation 2.63

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters including bilirubin, creatinine and direct bilirubin. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Baseline value is defined as the latest pre-treatment assessment with a non-missing value. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameters which includes total CO2, chloride, glucose, phosphate, potassium, sodium and urea. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-lipase. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 4, n=278, 276	1.6 Units per liter Standard Deviation 23.51	1.8 Units per liter Standard Deviation 30.92
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 8, n=211, 278	0.8 Units per liter Standard Deviation 19.07	0.4 Units per liter Standard Deviation 27.41
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 12, n=270, 276	1.3 Units per liter Standard Deviation 18.55	2.5 Units per liter Standard Deviation 29.44
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 16, n=254, 269	0.8 Units per liter Standard Deviation 20.27	1.2 Units per liter Standard Deviation 27.24
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 20, n=260, 270	1.6 Units per liter Standard Deviation 16.26	0.8 Units per liter Standard Deviation 27.96
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 24, n=260, 268	0.9 Units per liter Standard Deviation 18.74	0.9 Units per liter Standard Deviation 27.58
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 28, n=253, 268	-0.4 Units per liter Standard Deviation 16.73	1.8 Units per liter Standard Deviation 29.09
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 32, n=254, 268	2.9 Units per liter Standard Deviation 29.88	2.0 Units per liter Standard Deviation 34.42
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 36, n=254, 261	1.0 Units per liter Standard Deviation 17.45	-0.1 Units per liter Standard Deviation 28.89
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 40, n=250, 266	2.3 Units per liter Standard Deviation 22.71	0.6 Units per liter Standard Deviation 27.95
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 44, n=258, 263	5.7 Units per liter Standard Deviation 41.87	1.6 Units per liter Standard Deviation 29.05
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Lipase Week 48, n=247, 261	0.7 Units per liter Standard Deviation 16.14	1.1 Units per liter Standard Deviation 32.35

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected for the analysis of clinical chemistry parameter-creatinine clearance. GFR will be estimated by the central laboratory using the CKD-EPI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 4, n=278, 277	6.9 mL/min/1.73/m^2 Standard Deviation 10.16	-1.2 mL/min/1.73/m^2 Standard Deviation 8.72
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 8, n=211, 278	10.0 mL/min/1.73/m^2 Standard Deviation 11.83	0.2 mL/min/1.73/m^2 Standard Deviation 9.13
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 12, n=270, 276	10.7 mL/min/1.73/m^2 Standard Deviation 11.49	0.9 mL/min/1.73/m^2 Standard Deviation 9.83
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 16, n=254, 269	10.4 mL/min/1.73/m^2 Standard Deviation 11.28	-0.3 mL/min/1.73/m^2 Standard Deviation 10.23
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 20, n=261, 271	10.9 mL/min/1.73/m^2 Standard Deviation 11.45	0.3 mL/min/1.73/m^2 Standard Deviation 9.90
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 24, n=261, 268	10.5 mL/min/1.73/m^2 Standard Deviation 11.38	0.2 mL/min/1.73/m^2 Standard Deviation 9.63
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 36, n=254, 262	10.3 mL/min/1.73/m^2 Standard Deviation 11.94	0.2 mL/min/1.73/m^2 Standard Deviation 10.08
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 40, n=250, 266	10.2 mL/min/1.73/m^2 Standard Deviation 12.57	0.7 mL/min/1.73/m^2 Standard Deviation 9.19
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 44, n=258, 263	9.8 mL/min/1.73/m^2 Standard Deviation 11.61	1.4 mL/min/1.73/m^2 Standard Deviation 9.88
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 48, n=247, 261	9.5 mL/min/1.73/m^2 Standard Deviation 11.35	-0.7 mL/min/1.73/m^2 Standard Deviation 10.86
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 28, n=253, 268	10.9 mL/min/1.73/m^2 Standard Deviation 11.90	1.0 mL/min/1.73/m^2 Standard Deviation 9.90
Change From Baseline Values for Clinical Chemistry Parameter Over Time Including Week 48: Creatinine Clearance Week 32, n=254, 268	10.6 mL/min/1.73/m^2 Standard Deviation 11.45	1.1 mL/min/1.73/m^2 Standard Deviation 10.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at Baseline and at Week 48 to assess glucose and fasting lipids which included total cholesterol, high density lipoprotein (HDL)cholesterol, low density lipoprotein (LDL) cholesterol and triglycerides. Only fasting data is presented for glucose and lipids. Baseline value is defined as the last available fasting recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at Week 48 visit (if collected while fasting) minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 Glucose, Week 48, n=248, 251	0.02 Millimoles per liter Standard Deviation 1.220	0.04 Millimoles per liter Standard Deviation 0.923
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 Total Cholesterol, Week 48, n=240, 239	0.09 Millimoles per liter Standard Deviation 0.658	0.05 Millimoles per liter Standard Deviation 0.607
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 HDL cholesterol, Week 48, n=240, 239	0.109 Millimoles per liter Standard Deviation 0.2587	0.076 Millimoles per liter Standard Deviation 0.2478
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 LDL cholesterol, Week 48, n=238, 237	0.122 Millimoles per liter Standard Deviation 0.5807	-0.045 Millimoles per liter Standard Deviation 0.5384
Change From Baseline Values for Fasting Lipid Panel and Glucose Overtime Including Week 48 Triglycerides, Week 48, n=240, 239	-0.085 Millimoles per liter Standard Deviation 0.7167	0.073 Millimoles per liter Standard Deviation 0.8361

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine biomarker samples were collected for the analysis of urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine albumin/creatinine ratio, Week 4,n=199, 194	0.36 Grams per mole Standard Deviation 6.714	0.23 Grams per mole Standard Deviation 4.062
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine albumin/creatinine ratio, Week 24,n=137, 184	0.30 Grams per mole Standard Deviation 4.941	1.06 Grams per mole Standard Deviation 7.186
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine albumin/creatinine ratio, Week 48,n=181, 184	-0.53 Grams per mole Standard Deviation 17.469	0.19 Grams per mole Standard Deviation 3.944
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine protein/creatinine, Week 4, n=211, 215	-0.16 Grams per mole Standard Deviation 18.641	0.19 Grams per mole Standard Deviation 6.439
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine protein/creatinine, Week 24, n=151, 204	2.23 Grams per mole Standard Deviation 35.187	1.32 Grams per mole Standard Deviation 12.171
Change From Baseline Values in Urine Albumin/Creatinine Ratio and Urine Protein/Creatinine Ratio Over Time Including Week 48 Urine protein/creatinine, Week 48, n=194, 197	-1.86 Grams per mole Standard Deviation 21.898	0.26 Grams per mole Standard Deviation 8.180

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine biomarker samples were collected for the analysis of urine creatinine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine Creatinine Over Time Including Week 48 Week 4, n=277, 272	-519.5 Micromoles per liter Standard Deviation 9558.55	-429.0 Micromoles per liter Standard Deviation 9540.31
Change From Baseline Values in Urine Creatinine Over Time Including Week 48 Week 24, n=193, 258	-597.4 Micromoles per liter Standard Deviation 9405.95	-17.1 Micromoles per liter Standard Deviation 9575.04
Change From Baseline Values in Urine Creatinine Over Time Including Week 48 Week 48, n=260, 258	-1359.2 Micromoles per liter Standard Deviation 9059.43	-505.4 Micromoles per liter Standard Deviation 8873.05

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine biomarker samples were collected for the analysis of urine phosphate. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine Phosphate Over Time Including Week 48 Week 24, n=192, 260	0.585 Micromoles per liter Standard Deviation 19.2777	-0.689 Micromoles per liter Standard Deviation 16.9500
Change From Baseline Values in Urine Phosphate Over Time Including Week 48 Week 4, n=275, 273	1.842 Micromoles per liter Standard Deviation 18.4414	-0.693 Micromoles per liter Standard Deviation 18.4830
Change From Baseline Values in Urine Phosphate Over Time Including Week 48 Week 48, n=259, 258	0.043 Micromoles per liter Standard Deviation 17.3741	0.304 Micromoles per liter Standard Deviation 16.7073

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed.

Urine biomarker samples were collected for the analysis of urine retinol binding protein. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine Retinol Binding Protein Over Time Including Week 48	-0.33 Nanomoles per liter Standard Deviation 0.938	-0.24 Nanomoles per liter Standard Deviation 0.932

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine biomarker samples were collected for the analysis of urine specific gravity. Urine specific gravity is a measure of the concentration of solutes in the urine and provides information on the kidney's ability to concentrate urine. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value. The urine specific gravity was measured as the ratio of urine density compared with water density.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 Week 4, n=271, 266	-0.0004 Ratio of urine density to water density Standard Deviation 0.00837	-0.0005 Ratio of urine density to water density Standard Deviation 0.00798
Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 Week 24, n=191, 252	-0.0001 Ratio of urine density to water density Standard Deviation 0.00805	-0.0002 Ratio of urine density to water density Standard Deviation 0.00825
Change From Baseline Values in Urine Specific Gravity Over Time Including Week 48 Week 48, n=255, 252	-0.0009 Ratio of urine density to water density Standard Deviation 0.00784	-0.0007 Ratio of urine density to water density Standard Deviation 0.00783

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 4, 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine samples were collected for analysis of urine pH. pH is calculated on a scale of 0 to 14, values on the scale refer to the degree of alkalinity or acidity. A pH of 7 is neutral. A pH of less than 7 is acidic and a pH of greater than 7 is basic. Normal urine has a slightly acidic pH (5.0-6.0). Baseline value is defined as the last available recorded value up to and including the date of first Maintenance Phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values in Urine pH Over Time Including Week 48 Week 4, n=271, 266	0.12 pH Standard Deviation 0.833	0.01 pH Standard Deviation 0.884
Change From Baseline Values in Urine pH Over Time Including Week 48 Week 24, n=191, 252	-0.01 pH Standard Deviation 0.889	-0.07 pH Standard Deviation 0.910
Change From Baseline Values in Urine pH Over Time Including Week 48 Week 48, n=255, 252	0.01 pH Standard Deviation 0.926	-0.10 pH Standard Deviation 0.988

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. All Maintenance Phase adverse events (start date occurring on or after the date of first dose of randomized study treatment) leading to withdrawal have been presented.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants Who Discontinued or Withdrawn Due to AEs Over Time Including Week 48	9 Participants	4 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at Baseline and at Week 48 to assess fasting lipids which included total cholesterol, HDL cholesterol, LDL cholesterol and triglycerides. Baseline value is defined as the last available recorded fasting value up to and including the date of first Maintenance Phase dose of IP. Percentage change from baseline is calculated as: value at Week 48 (if collected while fasting) minus Baseline value divided by Baseline value multiplied by 100.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 Cholesterol, Week 48, Overall, n=240, 239	5.09 Millimoles per liter Standard Deviation 15.695	2.32 Millimoles per liter Standard Deviation 14.456
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 HDL cholesterol, Week 48, Overall, n=240, 239	15.448 Millimoles per liter Standard Deviation 78.5208	7.361 Millimoles per liter Standard Deviation 20.3088
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 LDL cholesterol, Week 48, Overall, n=238, 237	7.048 Millimoles per liter Standard Deviation 29.2139	0.462 Millimoles per liter Standard Deviation 23.9648
Percentage Change From Baseline in Fasting Lipids Overtime Including Week 48 Triglycerides, Week 48, Overall, n=240, 239	2.633 Millimoles per liter Standard Deviation 44.1663	14.252 Millimoles per liter Standard Deviation 62.2823

SECONDARY outcome

Timeframe: Week 48

Population: CVF Population. Only those participants with data available at the specified data points were analyzed.

Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Phenotypic Resistance data for following drugs :CAB,dolutegravir(DTG),elvitegravir (EVG), raltegravir(RAL),delavirdine(DLV),efavirenz(EFV),etravirine(ETR),nevirapine(NVP),RPV,lamivudine(3TC),abacavir(ABC),emtricitabine(FTC),tenofovir(TDF),zidovudine(ZDV),stavudine(d4T),didanosine(ddI),atazanavir(ATV),darunavir(DRV),fosamprenavir(FPV),indinavir(IDV),lopinavir(LPV),nelfinavir(NFV),ritonavir(RTV), saquinavir(SQV) and tipranavir (TPV) in participants meeting CVF criteria is presented.Phenotypic resistance, partially sensitive, and Sensitive were defined based on fold change(FC) value from Monogram as:resistance (FC\>clinical higher cutoff/biologic cutoff),partially sensitive (FC=clinical higher cutoff and \> clinical lower cutoff),sensitive(FC\<=clinical lower cutoff/biologic cutoff). The CVF population comprised of all participants in ITT-E population who met CVF criteria

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=3 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=3 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, CAB, sensitive	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, CAB, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, CAB, resistant	3 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, DTG, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, EVG, sensitive	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, EVG, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, EVG, resistant	3 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, RAL, sensitive	0 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, RAL, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 INI, RAL, resistant	3 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, DLV, sensitive	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, DLV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, DLV, resistant	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, EFV, sensitive	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, EFV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, EFV, resistant	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, sensitive	2 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, partially sensitive	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, ETR, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, NVP, sensitive	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, NVP, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, NVP, resistant	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, RPV, sensitive	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, RPV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NNRTI, RPV, resistant	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, 3TC, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, 3TC, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, 3TC, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ABC, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, FTC, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, FTC, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, FTC, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, sensitive	1 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, partially sensitive	2 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, TDF, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ZDV, sensitive	2 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ZDV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ZDV, resistant	1 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, d4T, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, d4T, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, d4T, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 NRTI, ddI, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, ATV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, ATV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, ATV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, DRV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, FPV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, IDV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, IDV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, IDV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, LPV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, NFV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, NFV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, NFV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, RTV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, RTV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, RTV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, partially sensitive	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, SQV, resistant	0 Participants	0 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, sensitive	3 Participants	3 Participants
Number of Participants With Phenotypic Resistance Through Week 48 PI, TPV, resistant	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Week 48

Population: CVF Population. Only those participants with data available at the specified data points were analyzed.

Plasma samples were collected and analyzed from participants who met confirmed virologic withdrawal criteria. Genotypic Resistance data for the following drugs: DTG, EVG, RAL, DLV, EFV, ETR, NVP, RPV, 3TC, ABC, FTC, TDF, ZDV, d4T, ddI, ATV, DRV, FPV, IDV, LPV, NFV, RTV, SQV and TPV in participants meeting CVF criteria has been presented.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=3 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=3 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, sensitive	2 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, FPV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, IDV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, sensitive	1 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, resistant	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, resistance possible	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, DTG, sensitive	1 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EVG, resistant	2 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, RAL, sensitive	1 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, DLV, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, EFV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 INI, EFV, resistance possible	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, EFV, sensitive	2 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, ETR, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, resistance possible	1 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, NVP, sensitive	2 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, resistant	3 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, RPV, sensitive	0 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, 3TC, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NNRTI, 3TC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, 3TC, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ABC, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, FTC, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, TDF, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ZDV, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, d4T, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 NRTI, ddI, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, ATV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, DRV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, LPV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, NFV, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, RTV, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, resistance possible	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, SQV/r, sensitive	3 Participants	3 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, resistant	0 Participants	0 Participants
Number of Participants With Genotypic Resistance Through Week 48 PI, TPV/r, resistance possible	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48

Population: PK Population.

AUC values are Bayesian pharmacokinetic (PK) parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for CAB LA. The PK Population includes all participants who received CAB and / or RPV and undergo PK sampling during the study, and provide CAB and /or RPV plasma concentration data.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=278 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Area Under the Curve (AUC) for CAB LA	2517.40 Hours*micrograms per milliliter Interval 2439.876 to 2597.394	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48; 1 Week post-dose at Weeks 5, 41, 2 hours post-dose at Weeks 4 and 48

Population: PK Population.

AUC values are Bayesian PK parameter estimates obtained from a population PK meta-analysis of the data collected from studies 201584 and 201585# NCT02951052. Blood samples from the current study 201584 were collected at indicated time points to analyse concentration in plasma for RPV LA

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=278 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
AUC for RPV LA	63989.13 Hours*nanograms per milliliter Interval 61489.692 to 66590.156	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: PK population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for PK analysis of CAB LA.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=278 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 48, n=197	3.1325 Microgram per milliliter Interval 2.9454 to 3.3315	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 8, n=250	1.5616 Microgram per milliliter Interval 1.4508 to 1.6808	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 12, n=237	2.0141 Microgram per milliliter Interval 1.899 to 2.1362	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 16, n=215	2.0960 Microgram per milliliter Interval 1.974 to 2.2255	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 20, n=233	2.1739 Microgram per milliliter Interval 2.058 to 2.2963	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 24, n=227	2.3827 Microgram per milliliter Interval 2.2731 to 2.4976	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 28, n=220	2.4683 Microgram per milliliter Interval 2.3421 to 2.6013	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 32, n=219	2.6729 Microgram per milliliter Interval 2.5339 to 2.8196	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 36, n=215	2.8590 Microgram per milliliter Interval 2.7096 to 3.0165	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 40, n=210	2.9378 Microgram per milliliter Interval 2.7872 to 3.0966	—
Plasma Trough Concentration (Ctrough) for CAB LA Evaluable Pre-dose, Week 44, n=217	3.0133 Microgram per milliliter Interval 2.8739 to 3.1595	—

SECONDARY outcome

Timeframe: Pre-dose at Weeks 8, 12, 16, 20, 24, 28, 32, 36, 40, 44 and 48

Population: PK Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Blood samples were collected at indicated time points for PK analysis of RPV LA.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=278 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Ctrough for RPV LA Evaluable Pre-dose, Week 12, n=236	46.86 Nanograms per milliliter Interval 43.82 to 50.12	—
Ctrough for RPV LA Evaluable Pre-dose, Week 16, n=217	50.01 Nanograms per milliliter Interval 47.06 to 53.15	—
Ctrough for RPV LA Evaluable Pre-dose, Week 20, n=233	52.76 Nanograms per milliliter Interval 49.79 to 55.91	—
Ctrough for RPV LA Evaluable Pre-dose, Week 24, n=228	55.56 Nanograms per milliliter Interval 52.48 to 58.82	—
Ctrough for RPV LA Evaluable Pre-dose, Week 28, n=220	59.46 Nanograms per milliliter Interval 55.43 to 63.79	—
Ctrough for RPV LA Evaluable Pre-dose, Week 32, n=220	66.88 Nanograms per milliliter Interval 62.95 to 71.05	—
Ctrough for RPV LA Evaluable Pre-dose, Week 36, n=215	69.09 Nanograms per milliliter Interval 64.9 to 73.55	—
Ctrough for RPV LA Evaluable Pre-dose, Week 40, n=210	75.71 Nanograms per milliliter Interval 71.38 to 80.29	—
Ctrough for RPV LA Evaluable Pre-dose, Week 44, n=216	77.96 Nanograms per milliliter Interval 73.87 to 82.28	—
Ctrough for RPV LA Evaluable Pre-dose, Week 48, n=197	82.38 Nanograms per milliliter Interval 77.82 to 87.22	—
Ctrough for RPV LA Evaluable Pre-dose, Week 8, n=251	41.23 Nanograms per milliliter Interval 38.74 to 43.88	—

SECONDARY outcome

Timeframe: Week 41- 1 Week post dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples will be collected at indicated time points for PK analysis of CAB LA.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=236 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Maximum Concentration (Cmax) in Plasma for CAB LA Evaluable at Week 41	4.0334 Micrograms per milliliter Interval 3.8488 to 4.2269	—

SECONDARY outcome

Timeframe: Week 41- 1 Week post dose

Population: PK Population. Only those participants with data available at the specified data points were analyzed.

Blood samples will be collected at indicated time points for PK analysis of RPV LA.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=236 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Cmax in Plasma for RPV LA Evaluable at Week 41	106.3 Nanograms per milliliter Interval 101.03 to 111.28	—

SECONDARY outcome

Timeframe: Weeks 5 and at Weeks 41 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=270 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Bother of ISRs, Week 48	-0.14 Scores on a scale Standard Deviation 0.639	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Leg movement, Week 41	-0.58 Scores on a scale Standard Deviation 0.880	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Leg movement, Week 48	-0.63 Scores on a scale Standard Deviation 0.964	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Sleep, Week 41	-0.57 Scores on a scale Standard Deviation 0.925	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Sleep, Week 48	-0.58 Scores on a scale Standard Deviation 1.033	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Acceptance, Week 41	-0.36 Scores on a scale Standard Deviation 0.959	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Acceptance, Week 48	-0.40 Scores on a scale Standard Deviation 0.943	—
Change From Week 5 in Dimension Scores Using Perception of Injection Questionnaire (PIN)-Last Observation Carried Forward (LOCF) Bother of ISRs, Week 41	-0.14 Scores on a scale Standard Deviation 0.551	—

SECONDARY outcome

Timeframe: Weeks 5, 41 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

PIN questionnaire explores bother of pain at injection site and injection site reactions (ISR),anxiety before and after injection, willingness to receive HIV injectable treatment, following visit and satisfaction with mode of treatment administration of individuals receiving injection and perceptions associated with receiving injections.This measure contains 21 items: pain at injection site, local site reactions, impact on functioning and willingness to pursue injectable treatment outside clinical trial. Scores range from 1 to 5; questions are phrased to ensure that 1:most favorable perception of vaccination, and 5:most unfavorable.Dimension scores include bother from ISR, leg movement, sleep and acceptability.Score of a domain is calculated as mean of all items with domain.Higher scores represent worse perception of injection.LOCF was primary method of analysis.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 5, totally acceptable, n=270	47 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions,Week 5, very acceptable, n=270	29 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 5, moderate, n=270	16 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 5, little acceptable, n=270	6 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 5, not at all, n=270	3 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 5, totally acceptable, n=270	33 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 5, very acceptable, n=270	28 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 5, moderate acceptable, n=270	24 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 5, little acceptable, n=270	11 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 5, not at all acceptable, n=270	5 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, week 41, totally, n=276	57 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 41, very acceptable, n=276	29 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 41, moderate, n=276	11 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 41, little acceptable, n=276	3 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 41, not at all, n=276	1 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 41, totally acceptable, n=276	45 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 41, very acceptable, n=276	35 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 41, moderate acceptable, n=276	14 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 41, little acceptable, n=276	4 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 41, not at all acceptable, n=276	1 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, week 48, totally, n=278	55 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 48, very acceptable, n=278	31 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 48, moderate, n=278	11 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 48, little acceptable, n=278	2 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Local reactions, Week 48, not at all, n=278	1 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 48, totally acceptable, n=278	49 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 48, very acceptable, n=278	35 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 48, moderate acceptable, n=278	12 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 48 little acceptable, n=278	3 Percentage of participants	—
Percentage of Participants With Extremely or Very Acceptable Pain and Local Reaction: Acceptability Score on PIN Questionnaire Pain, Week 48, not at all acceptable, n=278	1 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 24 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The HATQoL questionnaire was used to assess health related QoL (HRQoL). It comprises of three dimensions: life satisfaction (LISAT), medication worries (MEDWO) and disclosure worries (DISWO). For LISAT domain, each question is scored as 1-5, where 5 corresponds to satisfaction 'all of time' and 1 as 'none of time'. Total score for the LISAT domain (sum of item scores for questions 1a to 1d) is transformed to a 0-100 scale using formula:\[100 divided by (20 minus 4)\]\*(raw total score for LISAT minus 4). Higher the LISAT score, greater satisfaction to life. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire Week 24, n=252, 253	0.4 Scores on a scale Interval -1.3 to 2.1	-0.8 Scores on a scale Interval -2.5 to 0.9
Change From Baseline in Life Satisfaction (LISAT) Using HIV/AIDs-targeted Quality of Life (HATQoL) Questionnaire Week 48, n=253, 258	0.9 Scores on a scale Interval -0.8 to 2.6	0.0 Scores on a scale Interval -1.6 to 1.7

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the MEDWO domain, each question is scored as 1-5, where 5 is associated with medication worry 'none of the time' and 1 as 'all of the time'. The total score for the MEDWO domain (sum of item scores for questions 2a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for MEDWO minus 5). Higher MEDWO scores correspond to lower medication worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in HIV Medication, MEDWO Using HATQoL Week 24, n=252, 253	3.2 Scores on a scale Interval 1.6 to 4.7	1.4 Scores on a scale Interval -0.1 to 3.0
Change From Baseline in HIV Medication, MEDWO Using HATQoL Week 48, n=253, 258	1.4 Scores on a scale Interval -0.3 to 3.1	1.3 Scores on a scale Interval -0.4 to 3.0

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The HATQoL questionnaire was used to assess HRQoL. It comprises of three dimensions: LISAT, MEDWO and DISWO. For the DISWO domain, each question is scored as 1-5, where 5 is associated with disclosure worry 'none of the time' and 1 as 'all of the time'. The total score for the DISWO domain (sum of item scores for questions 3a to 3e) is transformed to a 0-100 scale using formula: \[100 divided by (25 minus 5)\]\* (raw total score for DISWO minus 5). Higher DISWO total scores correspond to lower disclosure worries. Transformed dimension score for each domain was summarized and analyzed. LOCF was used as primary method of analysis. Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in DISWO Using HATQoL Week 24, n=252, 253	-0.8 Scores on a scale Interval -3.9 to 2.3	0.5 Scores on a scale Interval -2.6 to 3.6
Change From Baseline in DISWO Using HATQoL Week 48, n=253, 258	-3.6 Scores on a scale Interval -6.6 to -0.6	1.1 Scores on a scale Interval -1.9 to 4.0

SECONDARY outcome

Timeframe: Baseline and at Weeks 24 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

The SF-12 questionnaire consists of 7 questions which measures degree of general health status and mental health distress. Each question is scored 0-5, except for question 2 scored 0-3. HRQoL using SF-12 for physical component summary (PCS) and mental component summary (MCS) were assessed for two treatment groups.Missing component scores was imputed using LOCF.PCS/MCS are calculated using computer software purchased from QualityMetric (http://www.qualitymetric.com).The higher the score, the better will be the health status.Measure type was considered as mean for adjusted mean and dispersion measure as 95% CI. Baseline value is defined as the last available recorded value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) MCS, Week 24, n=251, 253	-0.045 Scores on a scale Interval -0.963 to 0.874	-1.066 Scores on a scale Interval -1.98 to -0.151
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) MCS, Week 48, n=252, 258	-0.013 Scores on a scale Interval -0.973 to 0.947	-1.116 Scores on a scale Interval -2.065 to -0.167
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) PCS, Week 24, n=251, 253	-0.019 Scores on a scale Interval -0.568 to 0.531	-0.201 Scores on a scale Interval -0.748 to 0.347
Change From Baseline in Health Status Using 12-item Short Form Survey (SF-12) PCS, Week 48, n=252, 258	-0.294 Scores on a scale Interval -0.881 to 0.293	-0.126 Scores on a scale Interval -0.706 to 0.455

SECONDARY outcome

Timeframe: Baseline and at Weeks 4b, 24 and 44

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

HIVTSQs (status version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range of 0 to 66. Higher the score, greater improvement in satisfaction with treatment; lower score, greater the deterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value. Adjusted mean and 95% CI of adjusted mean values has been presented.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 Week 4b, n=257, 0	0.2 Scores on a scale Interval -0.5 to 1.0	—
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 Week 24, n=257, 253	1.6 Scores on a scale Interval 0.8 to 2.5	-0.5 Scores on a scale Interval -1.4 to 0.3
Change From Baseline in Total Treatment Satisfaction Using HIV Treatment Satisfaction Questionnaire (HIVTSQs) at Weeks 4b, 24 and 44 Week 44, n=257, 256	1.3 Scores on a scale Interval 0.5 to 2.1	0.5 Scores on a scale Interval -0.3 to 1.4

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed

HIVTSQc (change version) total treatment satisfaction score is computed with 1-11 items. Items 1-11 are summed to produce score with possible range:-33 to 33. Higher scores represent greater improvement in treatment satisfaction compared to satisfaction with treatment received during the induction phase; lower scores representedeterioration in satisfaction with treatment. A score of 0 represents no change. LOCF was primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=263 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=266 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change in Treatment Satisfaction Over Time Using HIVTSQc at Week 48	29.6 Scores on a scale Standard Error 0.49	25.5 Scores on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline and at Weeks 4b, 24 and 44

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

HIVTSQs (status version) is a 12 item questionnaire. The individual item scores are ratedas 6 (very satisfied, convenient, flexible, etc.) to 0 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater treatment satisfaction as compared to the past few weeks. LOCF was used as primary method of analysis. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as the value at the post-dose visit minus the Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 1; Week 4b, n=257, 0	-0.0 Scores on a scale Standard Deviation 0.91	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 1; Week 24, n=257, 255	0.1 Scores on a scale Standard Deviation 0.96	-0.0 Scores on a scale Standard Deviation 0.95
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 1; Week 44, n=257, 258	0.0 Scores on a scale Standard Deviation 1.02	0.0 Scores on a scale Standard Deviation 0.93
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 2; Week 4b, n=257, 0	0.0 Scores on a scale Standard Deviation 0.61	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 2; Week 24, n=257, 255	-0.0 Scores on a scale Standard Deviation 0.62	-0.0 Scores on a scale Standard Deviation 0.87
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 2; Week 44, n=257, 258	-0.1 Scores on a scale Standard Deviation 0.61	0.1 Scores on a scale Standard Deviation 0.62
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 3; Week 4b, n=257, 0	0.2 Scores on a scale Standard Deviation 1.02	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 3; Week 24, n=257, 255	-0.1 Scores on a scale Standard Deviation 1.21	-0.0 Scores on a scale Standard Deviation 1.16
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 3; Week 44, n=257, 258	-0.0 Scores on a scale Standard Deviation 1.35	0.1 Scores on a scale Standard Deviation 1.22
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 4; Week 4b, n=257, 0	0.1 Scores on a scale Standard Deviation 1.02	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 4; Week 24, n=257, 255	0.1 Scores on a scale Standard Deviation 1.03	-0.0 Scores on a scale Standard Deviation 1.14
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 4; Week 44, n=257, 258	0.0 Scores on a scale Standard Deviation 1.08	0.1 Scores on a scale Standard Deviation 1.10
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 5; Week 4b, n=257, 0	0.1 Scores on a scale Standard Deviation 0.98	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 5; Week 24, n=257, 255	0.4 Scores on a scale Standard Deviation 1.22	-0.1 Scores on a scale Standard Deviation 1.05
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 5; Week 44, n=257, 258	0.3 Scores on a scale Standard Deviation 1.28	0.0 Scores on a scale Standard Deviation 1.06
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 6; Week 4b, n=257, 0	0.1 Scores on a scale Standard Deviation 1.40	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 6; Week 24, n=257, 255	0.3 Scores on a scale Standard Deviation 1.47	-0.1 Scores on a scale Standard Deviation 1.63
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 6; Week 44, n=257, 258	0.3 Scores on a scale Standard Deviation 1.70	0.2 Scores on a scale Standard Deviation 1.48
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 7; Week 4b, n=257, 0	0.0 Scores on a scale Standard Deviation 0.83	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 7; Week 24, n=257, 255	0.0 Scores on a scale Standard Deviation 0.79	0.0 Scores on a scale Standard Deviation 1.02
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 7; Week 44, n=257, 258	0.1 Scores on a scale Standard Deviation 0.85	0.1 Scores on a scale Standard Deviation 0.95
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 8; Week 4b, n=257, 0	-0.0 Scores on a scale Standard Deviation 1.06	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 8; Week 24, n=257, 255	0.2 Scores on a scale Standard Deviation 1.22	-0.0 Scores on a scale Standard Deviation 1.11
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 8; Week 44, n=257, 258	0.2 Scores on a scale Standard Deviation 1.27	0.1 Scores on a scale Standard Deviation 1.16
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 9; Week 4b, n=257, 0	-0.1 Scores on a scale Standard Deviation 0.85	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 9; Week 24, n=257, 255	0.0 Scores on a scale Standard Deviation 0.78	-0.1 Scores on a scale Standard Deviation 1.11
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 9; Week 44, n=257, 258	0.0 Scores on a scale Standard Deviation 0.85	0.0 Scores on a scale Standard Deviation 1.01
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 10; Week 4b, n=257, 0	-0.1 Scores on a scale Standard Deviation 1.16	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 10; Week 24, n=257, 256	0.4 Scores on a scale Standard Deviation 1.28	-0.1 Scores on a scale Standard Deviation 1.35
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 10; Week 44, n=257, 259	0.4 Scores on a scale Standard Deviation 1.33	-0.0 Scores on a scale Standard Deviation 1.20
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 11; Week 4b, n=257, 0	-0.0 Scores on a scale Standard Deviation 1.02	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 11; Week 24, n=257, 255	0.2 Scores on a scale Standard Deviation 1.18	-0.1 Scores on a scale Standard Deviation 0.99
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 11; Week 44, n=257, 258	0.1 Scores on a scale Standard Deviation 1.18	0.0 Scores on a scale Standard Deviation 0.97
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 12; Week 4b, n=257, 0	-0.0 Scores on a scale Standard Deviation 0.99	—
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 12; Week 24, n=257, 255	-0.4 Scores on a scale Standard Deviation 1.26	0.1 Scores on a scale Standard Deviation 1.19
Change From Baseline in Individual Item Scores of HIVTSQs at Weeks 4b, 24 and 44 Item 12; Week 44, n=257, 258	-0.5 Scores on a scale Standard Deviation 1.20	0.1 Scores on a scale Standard Deviation 1.29

SECONDARY outcome

Timeframe: Baseline and at Weeks 8, 24 and 48

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

ACCEPT questionnaire is generic medication acceptance measure assessing how participants weigh advantages and disadvantages of long-term medication. It consists 25 items, capturing six dimensions. 3 questions focusing on general acceptance of study medication were analyzed. Items scores are rated as 1-5 :1-totally disagree,2-somewhat disagree,3-somewhat agree,4-totally agree and 5-I don't know. The acceptance domain score (ranging from 0 to 100) is calculated using the following formula:100\*(mean of recoded items in dimension minus 1) divided by 2.LOCF was primary method of analysis. Measure type is mean for adjusted mean and dispersion measure: 95% CI. Baseline value is defined as the last available value up to and including the date of first Maintenance phase dose of IP. Change from Baseline value is calculated as value at post-dose visit minus Baseline value.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 8, n=253, 256	3.3 Scores on a scale Interval 0.8 to 5.8	1.2 Scores on a scale Interval -1.3 to 3.6
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 24, 255, 261	3.7 Scores on a scale Interval 1.1 to 6.4	1.1 Scores on a scale Interval -1.5 to 3.7
Change From Baseline in Treatment Acceptance at Weeks 8, 24 and 48 Using "General Acceptance" Dimension of the Chronic Treatment Acceptance (ACCEPT) Questionnaire Week 48, n=255, 262	3.0 Scores on a scale Interval 0.4 to 5.6	0.8 Scores on a scale Interval -1.7 to 3.4

SECONDARY outcome

Timeframe: Weeks 4b, 5, 40 and 41

Population: ITT-E Population. Only those participants with data available at the specified data points were analyzed.

The NRS questionnaire is used to assess the tolerability of injections in CAB LA+RPV LA arm only. The questionnaire consists of one single question and will assess maximum level of pain experienced with the most recent injections ranking from no pain (0) to extreme pain (10). Missing scores was imputed using LOCF.

Outcome measures

Outcome measures
Measure	CAB LA + RPV LA (Q4W) n=263 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 40	0.8 Scores on a scale Standard Deviation 2.72	—
Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 41	0.4 Scores on a scale Standard Deviation 2.69	—
Change From 4b in Tolerability of Injection at Weeks 5, 40 and 41 Using Numeric Rating Scale (NRS) Within CAB LA+RPV LA Arm Week 5	1.8 Scores on a scale Standard Deviation 2.78	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to Week 48

Population: PK Population. This was an exploratory Outcome Measure. Data will not be analyzed and reported.

Blood samples were planned to be collected at indicated time points for PK analysis of CAB LA and RPV LA. Demographic parameters including, but not limited to, age, sex, race, body weight, body mass index, and relevant laboratory parameters were planned to be evaluated as potential predictors of inter subject variability for pharmacokinetic parameters.

Outcome measures

Outcome data not reported

Adverse Events

CAB LA+RPV LA (Q4W)

Serious events: 18 serious events

Other events: 252 other events

Deaths: 0 deaths

ABC/ DTG/ 3TC

Serious events: 12 serious events

Other events: 138 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Reponse Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER

Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 44, n=258, 263	67.7 International units per liter Standard Deviation 18.59	68.2 International units per liter Standard Deviation 18.62
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 48, n=247, 262	66.4 International units per liter Standard Deviation 17.95	67.7 International units per liter Standard Deviation 18.15
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 28, n=253, 268	24.8 International units per liter Standard Deviation 16.50	21.7 International units per liter Standard Deviation 10.61
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 32, n=256, 268	37.1 International units per liter Standard Deviation 233.23	20.7 International units per liter Standard Deviation 6.42
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 36, n=255, 261	23.0 International units per liter Standard Deviation 12.44	22.4 International units per liter Standard Deviation 17.37
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 40, n=250, 266	23.1 International units per liter Standard Deviation 12.22	21.0 International units per liter Standard Deviation 6.51
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 44, n=258, 263	24.4 International units per liter Standard Deviation 15.66	21.9 International units per liter Standard Deviation 13.25
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST Week 48, n=247, 262	22.3 International units per liter Standard Deviation 10.98	23.5 International units per liter Standard Deviation 42.49
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 28, n=253, 268	252.7 International units per liter Standard Deviation 673.98	194.5 International units per liter Standard Deviation 506.24
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 32, n=256, 268	175.8 International units per liter Standard Deviation 223.16	160.0 International units per liter Standard Deviation 176.09
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 28, n=253, 268	22.5 International units per liter Standard Deviation 19.78	19.6 International units per liter Standard Deviation 10.73
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 32, n=256, 268	38.5 International units per liter Standard Deviation 293.55	19.0 International units per liter Standard Deviation 11.56
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 36, n=255, 261	20.3 International units per liter Standard Deviation 13.92	21.2 International units per liter Standard Deviation 31.68
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 40, n=250, 266	20.9 International units per liter Standard Deviation 17.32	19.5 International units per liter Standard Deviation 12.35
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 44, n=258, 263	22.2 International units per liter Standard Deviation 27.14	19.8 International units per liter Standard Deviation 17.43
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 48, n=247, 262	20.1 International units per liter Standard Deviation 21.78	19.7 International units per liter Standard Deviation 16.58
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Baseline (Day 1), n=283, 283	66.5 International units per liter Standard Deviation 22.06	67.1 International units per liter Standard Deviation 22.98
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 4, n=281, 277	66.2 International units per liter Standard Deviation 19.56	65.5 International units per liter Standard Deviation 17.07
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 8, n=212, 278	66.8 International units per liter Standard Deviation 18.82	66.3 International units per liter Standard Deviation 17.49
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 12, n=270, 276	66.8 International units per liter Standard Deviation 19.80	66.1 International units per liter Standard Deviation 17.23
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 16, n=255, 269	66.7 International units per liter Standard Deviation 19.96	66.1 International units per liter Standard Deviation 17.89
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 20, n=260, 272	67.6 International units per liter Standard Deviation 19.11	65.6 International units per liter Standard Deviation 16.71
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 24, n=261, 268	67.1 International units per liter Standard Deviation 19.68	66.1 International units per liter Standard Deviation 17.96
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 28, n=253, 268	67.4 International units per liter Standard Deviation 20.05	67.5 International units per liter Standard Deviation 18.07
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 32, n=256, 268	68.0 International units per liter Standard Deviation 22.17	66.6 International units per liter Standard Deviation 17.65
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 36, n=255, 261	69.5 International units per liter Standard Deviation 26.86	68.3 International units per liter Standard Deviation 20.19
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALP, Week 40, n=250, 266	67.4 International units per liter Standard Deviation 18.94	67.7 International units per liter Standard Deviation 18.30
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 36, n=254, 261	219.0 International units per liter Standard Deviation 507.30	215.2 International units per liter Standard Deviation 460.38
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 40, n=250, 266	220.5 International units per liter Standard Deviation 507.68	149.5 International units per liter Standard Deviation 115.14
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 44, n=258, 263	254.0 International units per liter Standard Deviation 477.19	181.9 International units per liter Standard Deviation 428.28
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 48, n=247, 262	185.5 International units per liter Standard Deviation 227.54	323.6 International units per liter Standard Deviation 2637.27
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Baseline (Day 1), n=283, 283	28.7 International units per liter Standard Deviation 125.27	19.5 International units per liter Standard Deviation 14.76
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 4, n=281, 277	25.1 International units per liter Standard Deviation 64.74	17.9 International units per liter Standard Deviation 11.10
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 8, n=212, 278	20.8 International units per liter Standard Deviation 17.43	18.4 International units per liter Standard Deviation 11.34
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 12, n=270, 276	21.4 International units per liter Standard Deviation 16.94	19.2 International units per liter Standard Deviation 11.29
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 16, n=255, 269	21.6 International units per liter Standard Deviation 17.61	20.3 International units per liter Standard Deviation 13.34
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 20, n=260, 272	25.8 International units per liter Standard Deviation 72.51	19.6 International units per liter Standard Deviation 15.78
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) ALT, Week 24, n=261, 268	23.9 International units per liter Standard Deviation 31.14	19.1 International units per liter Standard Deviation 11.91
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Baseline (Day 1), n=283, 283	28.8 International units per liter Standard Deviation 90.66	22.5 International units per liter Standard Deviation 14.80
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 4, n=281, 277	25.1 International units per liter Standard Deviation 32.67	20.9 International units per liter Standard Deviation 8.47
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 8, n=212, 278	23.6 International units per liter Standard Deviation 20.85	20.5 International units per liter Standard Deviation 6.26
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 12, n=270, 276	22.8 International units per liter Standard Deviation 10.38	21.0 International units per liter Standard Deviation 8.14
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 16, n=255, 269	23.0 International units per liter Standard Deviation 10.71	22.8 International units per liter Standard Deviation 14.03
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 20, n=260, 272	25.3 International units per liter Standard Deviation 32.64	22.7 International units per liter Standard Deviation 23.48
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) AST, Week 24, n=261, 268	25.9 International units per liter Standard Deviation 25.16	21.2 International units per liter Standard Deviation 9.73
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Baseline (Day 1), n=283, 283	197.8 International units per liter Standard Deviation 291.21	199.8 International units per liter Standard Deviation 482.84
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 4, n=280, 277	230.2 International units per liter Standard Deviation 447.94	173.0 International units per liter Standard Deviation 220.54
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 8, n=212, 278	258.0 International units per liter Standard Deviation 928.82	152.9 International units per liter Standard Deviation 146.05
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 12, n=270, 276	201.8 International units per liter Standard Deviation 348.13	182.6 International units per liter Standard Deviation 387.61
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 16, n=255, 269	179.7 International units per liter Standard Deviation 248.71	234.0 International units per liter Standard Deviation 576.62
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 20, n=260, 272	215.7 International units per liter Standard Deviation 539.34	258.9 International units per liter Standard Deviation 1109.04
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST) and Creatinine Kinase (CK) CK, Week 24, n=261, 268	248.6 International units per liter Standard Deviation 628.44	183.1 International units per liter Standard Deviation 368.02

Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 28, n=253, 268	10.4 Micromoles per liter Standard Deviation 5.67	8.6 Micromoles per liter Standard Deviation 3.90
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 32, n=256, 268	10.5 Micromoles per liter Standard Deviation 7.86	8.7 Micromoles per liter Standard Deviation 3.95
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 36, n=255, 260	9.9 Micromoles per liter Standard Deviation 6.35	8.5 Micromoles per liter Standard Deviation 3.42
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 40, n=250, 266	10.2 Micromoles per liter Standard Deviation 5.26	8.5 Micromoles per liter Standard Deviation 3.52
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 44, n=258, 263	10.3 Micromoles per liter Standard Deviation 5.15	8.8 Micromoles per liter Standard Deviation 3.78
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 48, n=247, 262	10.3 Micromoles per liter Standard Deviation 5.23	8.9 Micromoles per liter Standard Deviation 3.71
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Baseline (Day 1), n=283, 283	2.3 Micromoles per liter Standard Deviation 1.32	2.2 Micromoles per liter Standard Deviation 1.09
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 4, n=277, 277	2.4 Micromoles per liter Standard Deviation 1.47	2.1 Micromoles per liter Standard Deviation 1.08
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 8, n=212, 278	2.4 Micromoles per liter Standard Deviation 1.17	2.1 Micromoles per liter Standard Deviation 0.93
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 12, n=269, 273	2.5 Micromoles per liter Standard Deviation 1.26	2.1 Micromoles per liter Standard Deviation 0.91
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 16, n=254, 268	2.4 Micromoles per liter Standard Deviation 1.46	2.1 Micromoles per liter Standard Deviation 0.95
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 20, n=260, 272	2.4 Micromoles per liter Standard Deviation 1.54	2.1 Micromoles per liter Standard Deviation 0.90
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 24, n=260, 266	2.3 Micromoles per liter Standard Deviation 1.20	2.1 Micromoles per liter Standard Deviation 0.96
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 28, n=253, 268	2.5 Micromoles per liter Standard Deviation 1.29	2.1 Micromoles per liter Standard Deviation 0.94
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 32, n=256, 268	2.5 Micromoles per liter Standard Deviation 3.48	2.1 Micromoles per liter Standard Deviation 0.94
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 36, n=255, 260	2.4 Micromoles per liter Standard Deviation 2.24	2.0 Micromoles per liter Standard Deviation 0.89
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 40, n=249, 266	2.3 Micromoles per liter Standard Deviation 1.29	2.1 Micromoles per liter Standard Deviation 0.98
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 44, n=258, 263	2.4 Micromoles per liter Standard Deviation 1.34	2.1 Micromoles per liter Standard Deviation 0.95
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 48, n=247, 262	2.3 Micromoles per liter Standard Deviation 1.26	2.2 Micromoles per liter Standard Deviation 1.00
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Baseline (Day 1), n=283, 283	89.00 Micromoles per liter Standard Deviation 16.061	85.80 Micromoles per liter Standard Deviation 15.660
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 4, n=280, 277	82.99 Micromoles per liter Standard Deviation 15.599	86.43 Micromoles per liter Standard Deviation 14.655
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 8, n=212, 278	79.50 Micromoles per liter Standard Deviation 14.103	85.50 Micromoles per liter Standard Deviation 15.925
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 12, n=270, 276	79.25 Micromoles per liter Standard Deviation 14.433	84.63 Micromoles per liter Standard Deviation 15.155
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 16, n=255, 269	79.58 Micromoles per liter Standard Deviation 14.509	85.18 Micromoles per liter Standard Deviation 14.997
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 20, n=261, 272	78.50 Micromoles per liter Standard Deviation 13.966	85.02 Micromoles per liter Standard Deviation 15.488
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 24, n=262, 268	79.10 Micromoles per liter Standard Deviation 15.340	85.05 Micromoles per liter Standard Deviation 14.690
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 28, n=253, 268	78.79 Micromoles per liter Standard Deviation 14.741	84.38 Micromoles per liter Standard Deviation 15.023
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 32, n=255, 268	78.89 Micromoles per liter Standard Deviation 14.558	84.50 Micromoles per liter Standard Deviation 15.047
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 36, n=254, 262	79.58 Micromoles per liter Standard Deviation 14.973	84.75 Micromoles per liter Standard Deviation 14.352
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 40, n=250, 266	79.50 Micromoles per liter Standard Deviation 15.615	84.70 Micromoles per liter Standard Deviation 14.808
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 44, n=258, 263	80.04 Micromoles per liter Standard Deviation 15.401	83.90 Micromoles per liter Standard Deviation 14.604
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 48, n=247, 262	79.95 Micromoles per liter Standard Deviation 15.613	90.88 Micromoles per liter Standard Deviation 87.655
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Baseline (Day 1), n=283, 283	9.3 Micromoles per liter Standard Deviation 5.12	9.4 Micromoles per liter Standard Deviation 4.68
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 4, n=281, 277	10.7 Micromoles per liter Standard Deviation 6.37	8.9 Micromoles per liter Standard Deviation 4.40
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 8, n=212, 278	10.1 Micromoles per liter Standard Deviation 4.62	8.8 Micromoles per liter Standard Deviation 3.85
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 12, n=270, 276	10.5 Micromoles per liter Standard Deviation 5.45	8.6 Micromoles per liter Standard Deviation 3.53
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 16, n=255, 269	10.6 Micromoles per liter Standard Deviation 5.49	8.7 Micromoles per liter Standard Deviation 3.74
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 20, n=260, 272	10.3 Micromoles per liter Standard Deviation 5.29	8.5 Micromoles per liter Standard Deviation 3.40
Absolute Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 24, n=261, 268	10.0 Micromoles per liter Standard Deviation 5.09	8.9 Micromoles per liter Standard Deviation 3.86

Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 4, n=281, 277	3.7 International units per liter Standard Deviation 49.90	-1.4 International units per liter Standard Deviation 11.14
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 8, n=212, 278	1.0 International units per liter Standard Deviation 14.28	-0.9 International units per liter Standard Deviation 11.86
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 12, n=270, 276	1.0 International units per liter Standard Deviation 15.80	-0.1 International units per liter Standard Deviation 13.27
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 16, n=255, 269	1.2 International units per liter Standard Deviation 16.61	1.5 International units per liter Standard Deviation 13.99
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 20, n=260, 272	5.3 International units per liter Standard Deviation 72.80	0.2 International units per liter Standard Deviation 17.04
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 24, n=261, 268	3.3 International units per liter Standard Deviation 30.00	-0.4 International units per liter Standard Deviation 12.75
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 28, n=253, 268	1.9 International units per liter Standard Deviation 18.82	0.2 International units per liter Standard Deviation 12.72
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 32, n=256, 268	18.1 International units per liter Standard Deviation 293.85	-0.4 International units per liter Standard Deviation 13.08
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 36, n=255, 261	-0.1 International units per liter Standard Deviation 14.10	1.7 International units per liter Standard Deviation 32.63
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 40, n=250, 266	0.6 International units per liter Standard Deviation 17.42	0.0 International units per liter Standard Deviation 14.84
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 44, n=258, 263	1.7 International units per liter Standard Deviation 27.55	0.8 International units per liter Standard Deviation 16.75
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALT, Week 48, n=247, 262	-0.2 International units per liter Standard Deviation 22.91	0.1 International units per liter Standard Deviation 18.81
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 4, n=281, 277	0.3 International units per liter Standard Deviation 11.04	-1.3 International units per liter Standard Deviation 15.74
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 8, n=212, 278	0.6 International units per liter Standard Deviation 10.41	-0.5 International units per liter Standard Deviation 17.00
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 12, n=270, 276	1.4 International units per liter Standard Deviation 12.71	-0.7 International units per liter Standard Deviation 17.40
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 16, n=255, 269	0.8 International units per liter Standard Deviation 10.34	-0.3 International units per liter Standard Deviation 17.99
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 20, n=260, 272	1.5 International units per liter Standard Deviation 10.20	-1.1 International units per liter Standard Deviation 17.35
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 24, n=261, 268	1.2 International units per liter Standard Deviation 9.57	-0.7 International units per liter Standard Deviation 17.03
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 28, n=253, 268	1.4 International units per liter Standard Deviation 10.57	0.6 International units per liter Standard Deviation 17.28
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 32, n=256, 268	1.9 International units per liter Standard Deviation 15.42	-0.3 International units per liter Standard Deviation 18.11
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 36, n=255, 261	3.3 International units per liter Standard Deviation 20.31	1.3 International units per liter Standard Deviation 20.90
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 40, n=250, 266	1.8 International units per liter Standard Deviation 9.84	0.7 International units per liter Standard Deviation 18.50
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 44, n=258, 263	1.4 International units per liter Standard Deviation 11.00	1.2 International units per liter Standard Deviation 17.62
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK ALP, Week 48, n=247, 262	1.1 International units per liter Standard Deviation 12.75	0.7 International units per liter Standard Deviation 17.54
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 4, n=281, 277	1.5 International units per liter Standard Deviation 24.47	-1.6 International units per liter Standard Deviation 14.58
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 8, n=212, 278	0.7 International units per liter Standard Deviation 19.90	-2.0 International units per liter Standard Deviation 14.13
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 12, n=270, 276	-0.3 International units per liter Standard Deviation 10.74	-1.5 International units per liter Standard Deviation 15.34
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 16, n=255, 269	-0.1 International units per liter Standard Deviation 11.31	1.0 International units per liter Standard Deviation 16.68
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 20, n=260, 272	2.3 International units per liter Standard Deviation 32.28	0.2 International units per liter Standard Deviation 26.46
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 24, n=261, 268	2.8 International units per liter Standard Deviation 24.22	-1.5 International units per liter Standard Deviation 16.00
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 28, n=253, 268	1.7 International units per liter Standard Deviation 15.85	-0.9 International units per liter Standard Deviation 16.99
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 32, n=256, 268	14.0 International units per liter Standard Deviation 233.48	-1.9 International units per liter Standard Deviation 14.68
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 36, n=255, 261	-0.1 International units per liter Standard Deviation 12.22	-0.2 International units per liter Standard Deviation 22.03
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 40, n=250, 266	0.2 International units per liter Standard Deviation 13.31	-1.5 International units per liter Standard Deviation 15.24
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST, Week 44, n=258, 263	1.3 International units per liter Standard Deviation 16.49	-0.5 International units per liter Standard Deviation 18.31
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK AST Week 48, n=247, 262	-0.8 International units per liter Standard Deviation 11.88	0.8 International units per liter Standard Deviation 44.70
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 4, n=280, 277	31.1 International units per liter Standard Deviation 456.63	-27.0 International units per liter Standard Deviation 523.89
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 8, n=212, 278	53.5 International units per liter Standard Deviation 907.83	-46.6 International units per liter Standard Deviation 499.91
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 12, n=270, 276	1.2 International units per liter Standard Deviation 420.32	-17.2 International units per liter Standard Deviation 605.92
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 16, n=255, 269	-18.0 International units per liter Standard Deviation 316.74	40.2 International units per liter Standard Deviation 746.32
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 20, n=260, 272	19.2 International units per liter Standard Deviation 536.70	57.3 International units per liter Standard Deviation 1208.73
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 24, n=261, 268	47.3 International units per liter Standard Deviation 635.42	-19.6 International units per liter Standard Deviation 605.13
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 28, n=253, 268	49.9 International units per liter Standard Deviation 669.37	-8.5 International units per liter Standard Deviation 705.35
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 32, n=256, 268	-24.5 International units per liter Standard Deviation 298.70	-42.5 International units per liter Standard Deviation 509.77
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 36, n=254, 261	14.7 International units per liter Standard Deviation 515.62	12.2 International units per liter Standard Deviation 674.76
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 40, n=250, 266	24.8 International units per liter Standard Deviation 544.72	-51.7 International units per liter Standard Deviation 497.70
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 44, n=258, 263	54.8 International units per liter Standard Deviation 526.28	-20.1 International units per liter Standard Deviation 652.24
Change From Baseline in Clinical Chemistry Parameters Over Time Including Week 48: ALT, ALP, AST and CK CK, Week 48, n=247, 262	-17.8 International units per liter Standard Deviation 309.33	121.1 International units per liter Standard Deviation 2682.33

Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 4, n=281, 277	1.4 Micromoles per liter Standard Deviation 4.74	-0.3 Micromoles per liter Standard Deviation 3.77
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 8, n=212, 278	0.9 Micromoles per liter Standard Deviation 4.04	-0.5 Micromoles per liter Standard Deviation 4.17
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 12, n=270, 276	1.2 Micromoles per liter Standard Deviation 4.15	-0.7 Micromoles per liter Standard Deviation 4.51
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 16, n=255, 269	1.2 Micromoles per liter Standard Deviation 4.30	-0.3 Micromoles per liter Standard Deviation 3.61
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 20, n=260, 272	1.1 Micromoles per liter Standard Deviation 4.14	-0.7 Micromoles per liter Standard Deviation 4.02
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 24, n=261, 268	0.8 Micromoles per liter Standard Deviation 4.12	-0.4 Micromoles per liter Standard Deviation 3.85
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 28, n=253, 268	1.2 Micromoles per liter Standard Deviation 4.41	-0.7 Micromoles per liter Standard Deviation 3.75
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 32, n=256, 268	1.3 Micromoles per liter Standard Deviation 6.44	-0.6 Micromoles per liter Standard Deviation 4.05
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 36, n=255, 260	0.6 Micromoles per liter Standard Deviation 5.36	-0.7 Micromoles per liter Standard Deviation 4.28
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 40, n=250, 266	0.9 Micromoles per liter Standard Deviation 4.31	-0.8 Micromoles per liter Standard Deviation 4.32
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 44, n=258, 263	1.2 Micromoles per liter Standard Deviation 4.34	-0.4 Micromoles per liter Standard Deviation 4.28
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Bilirubin, Week 48, n=247, 262	1.1 Micromoles per liter Standard Deviation 4.18	-0.3 Micromoles per liter Standard Deviation 4.17
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 4, n=277, 277	0.2 Micromoles per liter Standard Deviation 1.40	-0.1 Micromoles per liter Standard Deviation 1.33
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 8, n=212, 278	0.2 Micromoles per liter Standard Deviation 1.30	-0.1 Micromoles per liter Standard Deviation 1.19
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 12, n=269, 273	0.2 Micromoles per liter Standard Deviation 1.22	0.0 Micromoles per liter Standard Deviation 1.22
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 16, n=254, 268	0.2 Micromoles per liter Standard Deviation 1.44	-0.1 Micromoles per liter Standard Deviation 1.14
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 20, n=260, 272	0.2 Micromoles per liter Standard Deviation 1.57	-0.1 Micromoles per liter Standard Deviation 1.14
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 24, n=260, 266	0.1 Micromoles per liter Standard Deviation 1.46	-0.1 Micromoles per liter Standard Deviation 1.10
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 28, n=253, 268	0.2 Micromoles per liter Standard Deviation 1.26	-0.1 Micromoles per liter Standard Deviation 1.22
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 32, n=256, 268	0.3 Micromoles per liter Standard Deviation 3.39	-0.1 Micromoles per liter Standard Deviation 1.08
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 36, n=255, 260	0.1 Micromoles per liter Standard Deviation 2.18	-0.1 Micromoles per liter Standard Deviation 1.16
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 40, n=249, 266	0.1 Micromoles per liter Standard Deviation 1.42	-0.1 Micromoles per liter Standard Deviation 1.26
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 44, n=258, 263	0.2 Micromoles per liter Standard Deviation 1.41	-0.1 Micromoles per liter Standard Deviation 1.19
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Direct bilirubin, Week 48, n=247, 262	0.0 Micromoles per liter Standard Deviation 1.41	0.0 Micromoles per liter Standard Deviation 1.19
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 4, n=280, 277	-6.07 Micromoles per liter Standard Deviation 9.696	0.61 Micromoles per liter Standard Deviation 7.635
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 8, n=212, 278	-9.25 Micromoles per liter Standard Deviation 9.936	-0.24 Micromoles per liter Standard Deviation 8.838
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 12, n=270, 276	-9.89 Micromoles per liter Standard Deviation 9.703	-1.20 Micromoles per liter Standard Deviation 8.710
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 16, n=255, 269	-9.75 Micromoles per liter Standard Deviation 9.572	-0.33 Micromoles per liter Standard Deviation 8.964
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 20, n=261, 272	-10.10 Micromoles per liter Standard Deviation 9.839	-0.68 Micromoles per liter Standard Deviation 8.700
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 24, n=262, 268	-9.73 Micromoles per liter Standard Deviation 9.499	-0.75 Micromoles per liter Standard Deviation 8.327
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 28, n=253, 268	-10.34 Micromoles per liter Standard Deviation 9.731	-1.33 Micromoles per liter Standard Deviation 8.892
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 32, n=255, 268	-9.77 Micromoles per liter Standard Deviation 9.166	-1.26 Micromoles per liter Standard Deviation 9.243
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 36, n=254, 262	-9.57 Micromoles per liter Standard Deviation 9.712	-0.74 Micromoles per liter Standard Deviation 8.565
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 40, n=250, 266	-9.60 Micromoles per liter Standard Deviation 10.656	-1.10 Micromoles per liter Standard Deviation 7.875
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 44, n=258, 263	-9.02 Micromoles per liter Standard Deviation 9.562	-1.91 Micromoles per liter Standard Deviation 8.306
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48: Bilirubin, Direct Bilirubin and Creatinine Creatinine, Week 48, n=247, 262	-8.97 Micromoles per liter Standard Deviation 9.742	5.00 Micromoles per liter Standard Deviation 85.535

Measure	CAB LA + RPV LA (Q4W) n=283 Participants Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up (LTFU) period.	ABC/ DTG/ 3TC n=283 Participants During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 4, n=280, 276	0.6 Millimoles per liter Standard Deviation 2.67	0.2 Millimoles per liter Standard Deviation 2.32
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 8, n=212, 278	0.2 Millimoles per liter Standard Deviation 2.51	-0.1 Millimoles per liter Standard Deviation 2.24
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 12, n=270, 276	0.2 Millimoles per liter Standard Deviation 2.56	-0.1 Millimoles per liter Standard Deviation 2.26
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 16, n=255, 269	0.4 Millimoles per liter Standard Deviation 2.55	-0.1 Millimoles per liter Standard Deviation 2.72
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 20, n=260, 272	0.3 Millimoles per liter Standard Deviation 2.52	0.1 Millimoles per liter Standard Deviation 2.38
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 24, n=261, 268	0.6 Millimoles per liter Standard Deviation 2.84	0.4 Millimoles per liter Standard Deviation 2.56
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 28, n=253, 268	0.5 Millimoles per liter Standard Deviation 2.51	0.4 Millimoles per liter Standard Deviation 2.39
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 32, n=255, 268	0.5 Millimoles per liter Standard Deviation 2.72	0.3 Millimoles per liter Standard Deviation 2.37
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 36, n=253, 261	0.7 Millimoles per liter Standard Deviation 2.54	0.2 Millimoles per liter Standard Deviation 2.35
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 40, n=249, 265	0.4 Millimoles per liter Standard Deviation 2.53	0.2 Millimoles per liter Standard Deviation 2.61
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 44, n=257, 263	0.4 Millimoles per liter Standard Deviation 2.71	0.1 Millimoles per liter Standard Deviation 2.37
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 CO2, Week 48, n=247, 262	0.0 Millimoles per liter Standard Deviation 2.70	0.0 Millimoles per liter Standard Deviation 2.27
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 4, n=280, 277	0.0 Millimoles per liter Standard Deviation 2.13	0.5 Millimoles per liter Standard Deviation 2.17
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 8, n=212, 278	0.0 Millimoles per liter Standard Deviation 2.05	0.3 Millimoles per liter Standard Deviation 2.14
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 12, n=270, 276	0.0 Millimoles per liter Standard Deviation 2.10	0.4 Millimoles per liter Standard Deviation 2.16
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 16, n=255, 269	-0.2 Millimoles per liter Standard Deviation 2.32	0.3 Millimoles per liter Standard Deviation 2.39
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 20, n=260, 272	-0.3 Millimoles per liter Standard Deviation 2.49	0.4 Millimoles per liter Standard Deviation 2.15
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 24, n=261, 268	-0.2 Millimoles per liter Standard Deviation 2.40	0.2 Millimoles per liter Standard Deviation 2.47
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 28, n=253, 268	-0.2 Millimoles per liter Standard Deviation 2.21	0.1 Millimoles per liter Standard Deviation 2.18
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 32, n=255, 268	-0.2 Millimoles per liter Standard Deviation 2.37	0.3 Millimoles per liter Standard Deviation 2.34
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 36, n=254, 261	-0.1 Millimoles per liter Standard Deviation 2.46	0.4 Millimoles per liter Standard Deviation 2.37
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 40, n=250, 266	0.1 Millimoles per liter Standard Deviation 2.35	0.4 Millimoles per liter Standard Deviation 2.20
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 44, n=258, 263	0.1 Millimoles per liter Standard Deviation 2.40	0.7 Millimoles per liter Standard Deviation 2.23
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Chloride, Week 48, n=247, 262	0.0 Millimoles per liter Standard Deviation 2.23	0.3 Millimoles per liter Standard Deviation 2.09
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 4, n=279, 277	0.032 Millimoles per liter Standard Deviation 0.1865	0.014 Millimoles per liter Standard Deviation 0.1771
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 8, n=212, 278	-0.016 Millimoles per liter Standard Deviation 0.1834	0.017 Millimoles per liter Standard Deviation 0.1855
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 12, n=270, 276	-0.010 Millimoles per liter Standard Deviation 0.1825	0.009 Millimoles per liter Standard Deviation 0.1772
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 16, n=255, 269	0.000 Millimoles per liter Standard Deviation 0.1789	0.017 Millimoles per liter Standard Deviation 0.1892
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 20, n=260, 272	-0.029 Millimoles per liter Standard Deviation 0.1932	0.016 Millimoles per liter Standard Deviation 0.1764
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 24, n=261, 268	-0.001 Millimoles per liter Standard Deviation 0.1907	0.011 Millimoles per liter Standard Deviation 0.1852
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 28, n=253, 268	-0.007 Millimoles per liter Standard Deviation 0.1894	0.019 Millimoles per liter Standard Deviation 0.1882
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 32, n=255, 268	-0.004 Millimoles per liter Standard Deviation 0.1806	0.005 Millimoles per liter Standard Deviation 0.2092
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 36, n=254, 261	-0.006 Millimoles per liter Standard Deviation 0.1798	0.021 Millimoles per liter Standard Deviation 0.1965
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 40, n=250, 266	-0.011 Millimoles per liter Standard Deviation 0.1851	0.015 Millimoles per liter Standard Deviation 0.1753
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 44, n=258, 263	-0.004 Millimoles per liter Standard Deviation 0.1824	0.020 Millimoles per liter Standard Deviation 0.1801
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Phosphate, Week 48, n=247, 262	-0.007 Millimoles per liter Standard Deviation 0.1784	0.020 Millimoles per liter Standard Deviation 0.2333
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 4, n=280, 277	0.15 Millimoles per liter Standard Deviation 0.334	0.06 Millimoles per liter Standard Deviation 0.368
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 8, n=212, 278	0.10 Millimoles per liter Standard Deviation 0.348	0.08 Millimoles per liter Standard Deviation 0.346
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 12, n=270, 276	0.09 Millimoles per liter Standard Deviation 0.352	0.05 Millimoles per liter Standard Deviation 0.305
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 16, n=255, 269	0.10 Millimoles per liter Standard Deviation 0.321	0.04 Millimoles per liter Standard Deviation 0.314
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 20, n=260, 272	0.09 Millimoles per liter Standard Deviation 0.374	0.04 Millimoles per liter Standard Deviation 0.364
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 24, n=261, 268	0.12 Millimoles per liter Standard Deviation 0.353	0.07 Millimoles per liter Standard Deviation 0.309
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 28, n=253, 268	0.08 Millimoles per liter Standard Deviation 0.341	0.08 Millimoles per liter Standard Deviation 0.350
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 32, n=255, 268	0.09 Millimoles per liter Standard Deviation 0.334	0.06 Millimoles per liter Standard Deviation 0.345
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 36, n=254, 261	0.10 Millimoles per liter Standard Deviation 0.353	0.08 Millimoles per liter Standard Deviation 0.347
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 40, n=250, 266	0.07 Millimoles per liter Standard Deviation 0.347	0.06 Millimoles per liter Standard Deviation 0.345
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 44, n=258, 263	0.08 Millimoles per liter Standard Deviation 0.353	0.06 Millimoles per liter Standard Deviation 0.338
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Potassium, Week 48, n=247, 262	0.01 Millimoles per liter Standard Deviation 0.343	0.03 Millimoles per liter Standard Deviation 0.496
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 4, n=280, 277	0.3 Millimoles per liter Standard Deviation 2.25	0.2 Millimoles per liter Standard Deviation 1.95
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 8, n=212, 278	0.1 Millimoles per liter Standard Deviation 1.98	0.1 Millimoles per liter Standard Deviation 1.92
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 12, n=270, 276	0.3 Millimoles per liter Standard Deviation 1.84	0.1 Millimoles per liter Standard Deviation 1.89
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 16, n=255, 269	0.2 Millimoles per liter Standard Deviation 2.10	0.3 Millimoles per liter Standard Deviation 2.21
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 20, n=260, 272	0.2 Millimoles per liter Standard Deviation 2.08	0.4 Millimoles per liter Standard Deviation 1.79
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 24, n=261, 268	0.2 Millimoles per liter Standard Deviation 2.02	0.2 Millimoles per liter Standard Deviation 2.12
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 28, n=253, 268	0.2 Millimoles per liter Standard Deviation 1.88	0.4 Millimoles per liter Standard Deviation 1.82
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 32, n=255, 268	0.3 Millimoles per liter Standard Deviation 2.13	0.3 Millimoles per liter Standard Deviation 2.02
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 36, n=254, 261	0.2 Millimoles per liter Standard Deviation 2.16	0.4 Millimoles per liter Standard Deviation 1.94
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 40, n=250, 266	0.1 Millimoles per liter Standard Deviation 2.08	0.4 Millimoles per liter Standard Deviation 2.13
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 44, n=258, 263	0.3 Millimoles per liter Standard Deviation 2.30	0.4 Millimoles per liter Standard Deviation 2.01
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Sodium, Week 48, n=247, 262	0.2 Millimoles per liter Standard Deviation 2.11	0.3 Millimoles per liter Standard Deviation 1.72
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 4, n=280, 277	0.04 Millimoles per liter Standard Deviation 1.292	-0.05 Millimoles per liter Standard Deviation 1.240
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 8, n=212, 278	0.04 Millimoles per liter Standard Deviation 1.315	-0.05 Millimoles per liter Standard Deviation 1.278
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 12, n=270, 276	-0.01 Millimoles per liter Standard Deviation 1.287	0.04 Millimoles per liter Standard Deviation 1.340
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 16, n=255, 269	0.02 Millimoles per liter Standard Deviation 1.394	0.01 Millimoles per liter Standard Deviation 1.171
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 20, n=260, 272	-0.07 Millimoles per liter Standard Deviation 1.359	0.04 Millimoles per liter Standard Deviation 1.190
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 24, n=261, 268	0.09 Millimoles per liter Standard Deviation 1.459	-0.08 Millimoles per liter Standard Deviation 1.154
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 28, n=253, 268	0.02 Millimoles per liter Standard Deviation 1.412	0.02 Millimoles per liter Standard Deviation 1.230
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 32, n=255, 268	0.16 Millimoles per liter Standard Deviation 1.364	-0.03 Millimoles per liter Standard Deviation 1.330
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 36, n=254, 261	0.05 Millimoles per liter Standard Deviation 1.451	0.04 Millimoles per liter Standard Deviation 1.265
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 40, n=250, 266	0.07 Millimoles per liter Standard Deviation 1.466	0.05 Millimoles per liter Standard Deviation 1.312
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 44, n=258, 263	0.12 Millimoles per liter Standard Deviation 1.361	0.03 Millimoles per liter Standard Deviation 1.290
Change From Baseline Values for Clinical Chemistry Parameters Over Time Including Week 48 Urea, Week 48, n=247, 262	0.09 Millimoles per liter Standard Deviation 1.362	0.06 Millimoles per liter Standard Deviation 2.189

Measure	CAB LA+RPV LA (Q4W) n=283 participants at risk Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period.	ABC/ DTG/ 3TC n=283 participants at risk During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Hepatobiliary disorders Bile duct stone	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Hepatitis A	1.1% 3/283 • Number of events 3 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Vascular disorders Peripheral ischaemia	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Reproductive system and breast disorders Priapism	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Anogenital warts	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Pyelonephritis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Pyrexia	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Rectal fissure	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Adenocarcinoma of colon	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Anal abscess	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Anal fistula	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Musculoskeletal and connective tissue disorders Arthritis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Breast cancer	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Bronchitis pneumococcal	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Hepatobiliary disorders Cholecystitis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Colitis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Metabolism and nutrition disorders Diabetic ketoacidosis	0.35% 1/283 • Number of events 2 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Psychiatric disorders Drug abuse	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Enterocolitis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Gastroenteritis	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Hepatobiliary disorders Hydrocholecystis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Kaposi's sarcoma	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Laceration	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Large intestine perforation	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Vascular disorders Peripheral artery thrombosis	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Road traffic accident	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Psychiatric disorders Suicide attempt	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Systemic inflammatory response syndrome	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Injury, poisoning and procedural complications Tibia fracture	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Umbilical hernia	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Viral infection	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Investigations Weight decreased	0.35% 1/283 • Number of events 1 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.

Measure	CAB LA+RPV LA (Q4W) n=283 participants at risk Participants who received ABC/DTG/3TC for 20 Weeks (Week \[-20\] to Day 1) in the Induction Phase and who have an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at Week (-4) entered Maintenance Phase (Day 1 to Week 100) to begin oral therapy with CAB 30 milligram (mg) + RPV 25 mg once daily for 4 Weeks. At Week 4b visit, participants received last dose of oral CAB + RPV and first dose CAB LA 600 mg + RPV LA 900 mg injections. Participants received intramuscular (IM) injections of CAB LA 400 mg and RPV LA 600 mg at Week 8 and every four weeks (Q4W) through Week 100. After completion of Maintenance Phase, participants who chose to enter Extension Phase will continue to receive both CAB LA and RPV LA. Participants withdrawn from study treatment who received at least one CAB LA+RPV LA injection were required to enter a 52-week long term follow-up period.	ABC/ DTG/ 3TC n=283 participants at risk During Maintenance Phase (Day 1 to Week 100), participants continued to receive ABC/DTG/3TC. After completion of Maintenance Phase, participants who chose to enter the Extension Phase have the option to complete the study or switch to CAB LA+RPV LA
Metabolism and nutrition disorders Vitamin D deficiency	8.1% 23/283 • Number of events 23 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	4.6% 13/283 • Number of events 13 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Musculoskeletal and connective tissue disorders Back pain	7.8% 22/283 • Number of events 26 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	4.6% 13/283 • Number of events 14 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Nausea	5.7% 16/283 • Number of events 17 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	3.9% 11/283 • Number of events 12 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Gastroenteritis	5.3% 15/283 • Number of events 18 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	3.5% 10/283 • Number of events 10 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Pyrexia	7.4% 21/283 • Number of events 33 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	1.4% 4/283 • Number of events 4 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Pharyngitis	5.3% 15/283 • Number of events 16 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	3.2% 9/283 • Number of events 9 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Injection site swelling	8.1% 23/283 • Number of events 38 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Haemorrhoids	5.7% 16/283 • Number of events 18 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	1.1% 3/283 • Number of events 4 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Nervous system disorders Dizziness	5.3% 15/283 • Number of events 17 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	1.1% 3/283 • Number of events 3 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Injection site pruritus	5.7% 16/283 • Number of events 25 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Injection site pain	80.2% 227/283 • Number of events 1879 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Nasopharyngitis	19.8% 56/283 • Number of events 92 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	17.0% 48/283 • Number of events 70 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Upper respiratory tract infection	13.4% 38/283 • Number of events 50 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	9.9% 28/283 • Number of events 35 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Nervous system disorders Headache	13.8% 39/283 • Number of events 48 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	7.4% 21/283 • Number of events 24 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Gastrointestinal disorders Diarrhoea	11.3% 32/283 • Number of events 40 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	8.8% 25/283 • Number of events 30 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
Infections and infestations Influenza	8.8% 25/283 • Number of events 27 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	7.1% 20/283 • Number of events 22 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Injection site nodule	15.5% 44/283 • Number of events 86 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.
General disorders Injection site induration	13.4% 38/283 • Number of events 82 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.	0.00% 0/283 • Non-serious AEs and SAEs were collected up to an average of 59 weeks. AEs and SAEs were collected in Safety population.