Trial Outcomes & Findings for A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed (NCT NCT04542070)

NCT ID: NCT04542070

Last Updated: 2024-06-04

Results Overview

Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 12 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

687 participants

Primary outcome timeframe

At month 12/11

Results posted on

2024-06-04

Participant Flow

The study consists in 2 periods: Maintenance Period and Extension Period. Any participants who successfully completed 12 months of CAB+RPV treatment in the Maintenance Phase had the option to enter the Extension Phase and continued to have access to CAB + RPV.

687 participants were enrolled in this study, out of which 681 were included in intent-to-treat exposed population (ITT-E).The Modified ITT-E (excluded participants due to eligibility criteria violations and GCP non-compliance) was used to primarily present the participant flow, baseline characteristics and efficacy analysis. Safety analyses were primarily presented based on Safety set, which included all participants including the ones with eligibility criteria violations and GCP non-compliance

Participant milestones

Participant milestones
Measure	Oral lead-in Phase (OLI) Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.	Direct to Injections (D2I) Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	Switch Q2M Group Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.
Maintenance Period (Day 1 - Month 12) STARTED	175	279	227	0
Maintenance Period (Day 1 - Month 12) COMPLETED	152	255	213	0
Maintenance Period (Day 1 - Month 12) NOT COMPLETED	23	24	14	0
Maintenance + Extension Period STARTED	173	274	0	0
Maintenance + Extension Period COMPLETED	150	247	0	0
Maintenance + Extension Period NOT COMPLETED	23	27	0	0
Extension Period (Month 13 - Month 27) STARTED	0	0	0	143
Extension Period (Month 13 - Month 27) COMPLETED	0	0	0	130
Extension Period (Month 13 - Month 27) NOT COMPLETED	0	0	0	13

Reasons for withdrawal

Reasons for withdrawal
Measure	Oral lead-in Phase (OLI) Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.	Direct to Injections (D2I) Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	Switch Q2M Group Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.
Maintenance Period (Day 1 - Month 12) Adverse Event	10	3	1	0
Maintenance Period (Day 1 - Month 12) Lack of Efficacy	1	2	0	0
Maintenance Period (Day 1 - Month 12) Lost to Follow-up	3	4	2	0
Maintenance Period (Day 1 - Month 12) Physician Decision	1	0	1	0
Maintenance Period (Day 1 - Month 12) Withdrawal by Subject	5	8	9	0
Maintenance Period (Day 1 - Month 12) Protocol Deviation	2	6	1	0
Maintenance Period (Day 1 - Month 12) Protocol-Specified Withdrawal Criterion Met	1	1	0	0
Maintenance + Extension Period Adverse Event	10	2	0	0
Maintenance + Extension Period Lack of Efficacy	2	2	0	0
Maintenance + Extension Period Lost to Follow-up	3	4	0	0
Maintenance + Extension Period Physician Decision	1	1	0	0
Maintenance + Extension Period Protocol Violation	2	5	0	0
Maintenance + Extension Period Protocol-specified withdrawal criterion met	1	1	0	0
Maintenance + Extension Period Withdrawal by Subject	4	12	0	0
Extension Period (Month 13 - Month 27) Adverse Event	0	0	0	4
Extension Period (Month 13 - Month 27) Lack of Efficacy	0	0	0	1
Extension Period (Month 13 - Month 27) Lost to Follow-up	0	0	0	1
Extension Period (Month 13 - Month 27) Physician Decision	0	0	0	2
Extension Period (Month 13 - Month 27) Withdrawal by Subject	0	0	0	5

Baseline Characteristics

A Study to Evaluate Efficacy and Safety of Cabotegravir (CAB) Long Acting (LA) Plus (+) Rilpivirine (RPV) LA Versus BIKTARVY® (BIK) in Participants With Human Immunodeficiency Virus (HIV)-1 Who Are Virologically Suppressed

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Oral lead-in Phase (OLI) n=175 Participants Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.	Direct to Injections (D2I) n=279 Participants Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	Total n=681 Participants Total of all reporting groups
Age, Continuous	38.5 YEARS STANDARD_DEVIATION 11.38 • n=5 Participants	39.0 YEARS STANDARD_DEVIATION 11.09 • n=7 Participants	38.6 YEARS STANDARD_DEVIATION 11.41 • n=5 Participants	38.7 YEARS STANDARD_DEVIATION 11.26 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	52 Participants n=7 Participants	41 Participants n=5 Participants	120 Participants n=4 Participants
Sex: Female, Male Male	148 Participants n=5 Participants	227 Participants n=7 Participants	186 Participants n=5 Participants	561 Participants n=4 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	10 Participants n=5 Participants	4 Participants n=7 Participants	2 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	0 Participants n=5 Participants	3 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	1 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants
Race/Ethnicity, Customized Asian - Japanese Heritage	4 Participants n=5 Participants	10 Participants n=7 Participants	6 Participants n=5 Participants	20 Participants n=4 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	2 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants
Race/Ethnicity, Customized Black or African American	40 Participants n=5 Participants	56 Participants n=7 Participants	49 Participants n=5 Participants	145 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	10 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants	25 Participants n=4 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	104 Participants n=5 Participants	194 Participants n=7 Participants	149 Participants n=5 Participants	447 Participants n=4 Participants
Race/Ethnicity, Customized Mixed White Race	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Multiple	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants

PRIMARY outcome

Timeframe: At month 12/11

Population: Intent-to-treat exposed (ITT-E) population included all randomized participants who receive at least one dose of IP during the Maintenance Phase of the study (on or after Day 1).

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=454 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma Human Immunodeficiency Viruses (HIV)-1 Ribonucleic Acid (RNA) Greater Than or Equal to (>=) 50 Copies Per Milliliter (c/mL) at Month 12/11 - ITT-E Population	1.3 Percentage of participants Interval 0.5 to 2.9	0.4 Percentage of participants Interval 0.0 to 2.4

PRIMARY outcome

Timeframe: At month 12/11

Population: Modified intent-to-treat exposed (mITT-E) population included all ITT-E participants (that is all randomized participants who received at least one dose of IP during the Maintenance Phase of the study \[(on or after Day 1\])) excluding those from a GSK Investigational site where Good Clinical Practice noncompliance was observed.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population	1.1 Percentage of participants Interval 0.4 to 2.6	0.4 Percentage of participants Interval 0.0 to 2.5

SECONDARY outcome

Timeframe: At month 12/11

Population: Intent-to-treat exposed (ITT-E) population.

Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=454 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population	89.4 Percentage of participants Interval 86.6 to 92.3	93.0 Percentage of participants Interval 89.6 to 96.3

SECONDARY outcome

Timeframe: At month 12/11

Population: Modified intent-to-treat exposed (mITT-E) population

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population	90.2 Percentage of participants Interval 87.4 to 92.9	92.8 Percentage of participants Interval 89.4 to 96.2

SECONDARY outcome

Timeframe: At month 6/5

Population: Intent-to-treat exposed (ITT-E) population

Percentage of participants with plasma HIV 1 RNA \< 50 c/mL was assessed using the FDA snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=454 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population	92.7 Percentage of participants Interval 90.3 to 95.1	97.8 Percentage of participants Interval 95.9 to 99.7

SECONDARY outcome

Timeframe: At month 6/5

Population: Modified intent-to-treat exposed (mITT-E) population

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population	93.5 Percentage of participants Interval 91.2 to 95.8	97.8 Percentage of participants Interval 95.8 to 99.7

SECONDARY outcome

Timeframe: Up to month 12

Population: Modified intent-to-treat exposed (mITT-E) population

Protocol-defined confirmed virologic failure was defined as rebound as indicated by two consecutive plasma HIV-1 RNA levels \>= 200 c/mL (Day 1 values are not applicable) after prior suppression to \<200 c/mL. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at Month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Cumulative number of participants with protocol defined CVF through Month 6/5 and 12/11 has been presented.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 Month 6/5	1 Participants	0 Participants
Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11 Month 12/11	2 Participants	0 Participants

SECONDARY outcome

Timeframe: At month 6/5

Population: Modified intent-to-treat exposed (mITT-E) population

Percentage of participants with plasma HIV 1 RNA \>= 50 c/mL at month 6 was assessed using the food and drug administration (FDA) snapshot algorithm. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. The FDA snapshot algorithm defines a participant's virologic response status using only the viral load at the predefined time point within a window of time (HIV-RNA equal to or above 50 copies/mL and HIV-RNA below 50 copies/mL), along with study drug discontinuation status. The third category of the FDA snapshot ("No virologic data") is not pre-defined as an endpoint and therefore not reported separately.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5	0.4 Percentage of participants Interval 0.1 to 1.6	0 Percentage of participants Interval 0.0 to 1.6

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Logarithm to base 10 (log10) values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Absolute Values of HIV Viral Load Baseline (Day 1)	1.5993 log10 copies per milliliter(c/mL) Standard Deviation 0.10559	1.5947 log10 copies per milliliter(c/mL) Standard Deviation 0.06640
Absolute Values of HIV Viral Load Month 6/5	1.6002 log10 copies per milliliter(c/mL) Standard Deviation 0.09268	1.5910 log10 copies per milliliter(c/mL) Standard Deviation 0.01182
Absolute Values of HIV Viral Load Month 12/11	1.6019 log10 copies per milliliter(c/mL) Standard Deviation 0.13064	1.5911 log10 copies per milliliter(c/mL) Standard Deviation 0.01552

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from Baseline is defined as post-dose visit value minus Baseline value. Logarithm to base 10 values for plasma HIV-1 RNA has been presented. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in HIV Viral Load Baseline (Day 1)	1.5993 log10 c/mL Standard Deviation 0.10559	1.5947 log10 c/mL Standard Deviation 0.06640
Change From Baseline in HIV Viral Load Month 6/5	0.0015 log10 c/mL Standard Deviation 0.13997	-0.0039 log10 c/mL Standard Deviation 0.06826
Change From Baseline in HIV Viral Load Month 12/11	0.0029 log10 c/mL Standard Deviation 0.17038	-0.0041 log10 c/mL Standard Deviation 0.07172

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=222 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count Baseline (Day 1)	670.9 cells per cubic millimeter(cells/mm^3) Standard Deviation 282.11	679.4 cells per cubic millimeter(cells/mm^3) Standard Deviation 306.89
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count Month 6/5	689.1 cells per cubic millimeter(cells/mm^3) Standard Deviation 284.89	673.7 cells per cubic millimeter(cells/mm^3) Standard Deviation 290.46
Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count Month 12/11	711.9 cells per cubic millimeter(cells/mm^3) Standard Deviation 297.13	717.3 cells per cubic millimeter(cells/mm^3) Standard Deviation 317.82

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Blood samples were collected and CD4+ cell count was assessed using flow cytometry. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in CD4+ Cell Count Baseline (Day 1)	670.9 cells/mm^3 Standard Deviation 282.11	679.4 cells/mm^3 Standard Deviation 306.89
Change From Baseline in CD4+ Cell Count Month 6/5	20.4 cells/mm^3 Standard Deviation 202.38	-3.1 cells/mm^3 Standard Deviation 197.62
Change From Baseline in CD4+ Cell Count Month 12/11	35.2 cells/mm^3 Standard Deviation 219.79	32.2 cells/mm^3 Standard Deviation 208.29

SECONDARY outcome

Timeframe: Up to Month 12/11

Population: Confirmed Virologic Failure (CVF) population included all participants in the ITT-E population who met Confirmed Virologic Failure (CVF).

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=2 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 NNRTI	2 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11 IN	2 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Month 6/5

Population: Confirmed Virologic Failure (CVF) population.

Blood samples were collected to evaluate the phenotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of phenotype, fold changes to CAB, RPV, and BIC, replication capacity of Integrase, protease, and reverse transcriptase enzymes at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=1 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 NNRTI	1 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5 IN	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Month 12/11

Population: Confirmed Virologic Failure (CVF) population.

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. No participants in the BIK arm met CVF.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=2 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 M230L	1 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 Q148R	1 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 K101E	1 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11 G118R	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Month 6/5

Population: Confirmed Virologic Failure (CVF) population.

Blood samples were collected to evaluate the genotypic resistance to CAB, RPV, BIC, FTC, and TAF. For each participant, prevalence of resistance mutations and genotypic susceptibility at the time of CVF was assessed. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. No participants in the BIK arm met CVF.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=1 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 Q148R	1 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5 M230L	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety Population included all randomly assigned participants who received at least one dose of study drug. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate bone specific biomarkers: specific alkaline phosphatase, procollagen type 1 N-propeptide, type 1 collagen cross-linked C-telopeptide, osteocalcin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=449 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Type I Collagen C-Telopeptides, Month 12/11	0.0 micrograms per liter (ug/L) Standard Deviation 0.25	0.0 micrograms per liter (ug/L) Standard Deviation 0.22
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Bone Specific Alkaline Phosphatase, Baseline (Day 1)	12.7 micrograms per liter (ug/L) Standard Deviation 4.27	12.9 micrograms per liter (ug/L) Standard Deviation 4.60
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Bone Specific Alkaline Phosphatase, Month 6/5	0.3 micrograms per liter (ug/L) Standard Deviation 9.89	0.2 micrograms per liter (ug/L) Standard Deviation 2.60
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Bone Specific Alkaline Phosphatase, Month 12/11	0.1 micrograms per liter (ug/L) Standard Deviation 5.03	0.5 micrograms per liter (ug/L) Standard Deviation 3.55
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Osteocalcin, Baseline (Day 1)	21.0 micrograms per liter (ug/L) Standard Deviation 7.35	20.4 micrograms per liter (ug/L) Standard Deviation 7.48
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Osteocalcin, Month 6/5	0.4 micrograms per liter (ug/L) Standard Deviation 5.53	-0.4 micrograms per liter (ug/L) Standard Deviation 5.11
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Osteocalcin, Month 12/11	0.9 micrograms per liter (ug/L) Standard Deviation 6.11	-0.6 micrograms per liter (ug/L) Standard Deviation 5.51
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Procollagen 1 N-Terminal Propeptide, Baseline (Day 1)	59.1 micrograms per liter (ug/L) Standard Deviation 23.06	59.2 micrograms per liter (ug/L) Standard Deviation 23.88
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Procollagen 1 N-Terminal Propeptide, Month 6/5	-1.5 micrograms per liter (ug/L) Standard Deviation 15.70	0.1 micrograms per liter (ug/L) Standard Deviation 18.53
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Procollagen 1 N-Terminal Propeptide, Month 12/11	-0.7 micrograms per liter (ug/L) Standard Deviation 19.73	0.6 micrograms per liter (ug/L) Standard Deviation 19.63
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Type I Collagen C-Telopeptides, Baseline (Day 1)	0.4 micrograms per liter (ug/L) Standard Deviation 0.25	0.5 micrograms per liter (ug/L) Standard Deviation 0.25
Change From Baseline in Bone Biomarkers: Specific Alkaline Phosphatase, Procollagen Type 1 N-Terminal Propeptide, Type 1 Collagen Cross-linked C-telopeptide, Osteocalcin (Micrograms Per Liter (ug/L)) Serum Type I Collagen C-Telopeptides, Month 6/5	-0.1 micrograms per liter (ug/L) Standard Deviation 0.23	-0.1 micrograms per liter (ug/L) Standard Deviation 0.21

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate bone specific biomarkers: serum 25-hydroxyvitamin D. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=440 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=219 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) Baseline (Day 1)	61.0 nanomoles per liter (nmol/L) Standard Deviation 34.69	59.9 nanomoles per liter (nmol/L) Standard Deviation 33.30
Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) Month 6/5	2.8 nanomoles per liter (nmol/L) Standard Deviation 29.24	6.0 nanomoles per liter (nmol/L) Standard Deviation 34.16
Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L)) Month 12/11	-2.3 nanomoles per liter (nmol/L) Standard Deviation 29.00	-3.1 nanomoles per liter (nmol/L) Standard Deviation 26.38

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate renal specific biomarkers: specific serum beta-2 microglobulin, cystatin c, retinol binding protein, urine beta-2 microglobulin. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=448 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum cystatin C, Month 12/11	0.0 milligrams per liter (mg/L) Standard Deviation 0.08	0.0 milligrams per liter (mg/L) Standard Deviation 0.08
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum beta-2 microglobulin, Month 6/5	0.0 milligrams per liter (mg/L) Standard Deviation 0.28	0.0 milligrams per liter (mg/L) Standard Deviation 0.28
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum beta-2 microglobulin, Month 12/11	0.0 milligrams per liter (mg/L) Standard Deviation 0.33	0.0 milligrams per liter (mg/L) Standard Deviation 0.32
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum cystatin C, Baseline (Day 1)	0.9 milligrams per liter (mg/L) Standard Deviation 0.13	0.9 milligrams per liter (mg/L) Standard Deviation 0.14
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum cystatin C, Month 6/5	0.0 milligrams per liter (mg/L) Standard Deviation 0.08	0.0 milligrams per liter (mg/L) Standard Deviation 0.08
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum retinol binding protein, Baseline (Day 1)	51.3 milligrams per liter (mg/L) Standard Deviation 13.01	52.2 milligrams per liter (mg/L) Standard Deviation 12.61
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum retinol binding protein, Month 6/5	-1.0 milligrams per liter (mg/L) Standard Deviation 9.00	-0.3 milligrams per liter (mg/L) Standard Deviation 8.75
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum retinol binding protein, Month 12/11	-1.2 milligrams per liter (mg/L) Standard Deviation 9.24	0.2 milligrams per liter (mg/L) Standard Deviation 9.06
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Urine beta-2 microglobulin, Baseline (Day 1)	0.2 milligrams per liter (mg/L) Standard Deviation 0.34	0.2 milligrams per liter (mg/L) Standard Deviation 0.40
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Urine beta-2 microglobulin, Month 6/5	0.0 milligrams per liter (mg/L) Standard Deviation 0.40	0.1 milligrams per liter (mg/L) Standard Deviation 0.65
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Urine beta-2 microglobulin, Month 12/11	0.0 milligrams per liter (mg/L) Standard Deviation 0.24	0.1 milligrams per liter (mg/L) Standard Deviation 0.52
Change From Baseline in Renal Biomarkers: Specific Serum Beta-2 Microglobulin, Cystatin c, Retinol Binding Protein, Urine Beta-2 Microglobulin (Milligrams Per Liter [mg/L]) Serum beta-2 microglobulin, Baseline (Day 1)	1.8 milligrams per liter (mg/L) Standard Deviation 0.40	1.8 milligrams per liter (mg/L) Standard Deviation 0.38

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate renal specific biomarkers: urine phosphate. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=449 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=223 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) Baseline (Day 1)	20.0 millimoles per liter (mmol/L) Standard Deviation 14.03	18.4 millimoles per liter (mmol/L) Standard Deviation 13.10
Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) Month 6/5	-1.0 millimoles per liter (mmol/L) Standard Deviation 16.29	0.4 millimoles per liter (mmol/L) Standard Deviation 15.60
Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L)) Month 12/11	0.1 millimoles per liter (mmol/L) Standard Deviation 16.17	-0.6 millimoles per liter (mmol/L) Standard Deviation 15.16

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein 4. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=447 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=222 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) Baseline (Day 1)	114.2 microgram per liter (ug/L) Standard Deviation 111.45	100.0 microgram per liter (ug/L) Standard Deviation 82.00
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) Month 6/5	0.8 microgram per liter (ug/L) Standard Deviation 139.88	5.7 microgram per liter (ug/L) Standard Deviation 105.08
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L)) Month 12/11	-0.6 microgram per liter (ug/L) Standard Deviation 123.52	-1.2 microgram per liter (ug/L) Standard Deviation 105.26

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate renal specific biomarkers: urine retinol binding protein/creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=216 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=107 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) Baseline (Day 1)	8.6 milligram per mole (mg/mol) Standard Deviation 6.32	8.0 milligram per mole (mg/mol) Standard Deviation 5.75
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) Month 6/5	0.8 milligram per mole (mg/mol) Standard Deviation 6.00	-0.8 milligram per mole (mg/mol) Standard Deviation 7.23
Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol)) Month 12/11	-0.5 milligram per mole (mg/mol) Standard Deviation 6.41	0.0 milligram per mole (mg/mol) Standard Deviation 4.15

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Serum samples were collected to evaluate renal specific biomarkers: urine beta-2 microglobulin/ creatinine. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=182 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=88 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) Baseline (Day 1)	0.0 grams per mole (g/mol) Standard Deviation 0.03	0.0 grams per mole (g/mol) Standard Deviation 0.04
Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) Month 12/11	0.0 grams per mole (g/mol) Standard Deviation 0.02	0.0 grams per mole (g/mol) Standard Deviation 0.04
Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol)) Month 6/5	0.0 grams per mole (g/mol) Standard Deviation 0.03	0.0 grams per mole (g/mol) Standard Deviation 0.19

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Month 12/11

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=454 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 No (Baseline) to Missing ((Month 12/11))	8 Percentage of participants	6 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 Yes (Baseline) to Yes (Month 12/11)	9 Percentage of participants	9 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 Yes (Baseline) to No (Month 12/11)	5 Percentage of participants	7 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 Yes (Baseline) to Missing (Month 12/11)	2 Percentage of participants	1 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 No (Baseline) to Yes (Month 12/11)	6 Percentage of participants	8 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11 No (Baseline) to No (Month 12/11)	69 Percentage of participants	70 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at month 6/5

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

Metabolic syndrome defined as cluster of conditions that occurred together increasing one's risk of heart disease, stroke and type 2 diabetes mellitus (DM). These conditions included increased blood pressure (BP), elevated blood glucose levels, excess body fat around the waist and abnormal fasting cholesterol and triglyceride (TG) levels. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 visit and Q2M D2I participants at Month 5 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=454 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=227 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 Yes (Baseline) to Yes (Month 6/5)	9 Percentage of participants	11 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 Yes (Baseline) to No (Month 6/5)	7 Percentage of participants	6 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 Yes (Baseline) to Missing (Month 6/5)	1 Percentage of participants	0 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 No (Baseline) to Yes (Month 6/5)	5 Percentage of participants	10 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 No (Baseline) to No (Month 6/5)	74 Percentage of participants	71 Percentage of participants
Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5 No (Baseline) to Missing (Month 6/5)	5 Percentage of participants	2 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Safety population. Only those participants with data available at specified time points have been analyzed.

The homeostatic model assessment (HOMA) is a method used to quantify insulin resistance. HOMA-IR is calculated as fasting insulin microunits per liter (microU/L) multiplied by fasting glucose (nmol/L) divided by 22.5. Higher HOMA-IR values indicate increased insulin resistance; values \<2 is generally regarded as normal. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=409 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=210 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) Baseline (Day 1)	2.8 HOMA-IR score Standard Deviation 4.05	3.1 HOMA-IR score Standard Deviation 5.06
Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) Month 6/5	0.3 HOMA-IR score Standard Deviation 4.11	-0.1 HOMA-IR score Standard Deviation 5.09
Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR) Month 12/11	0.2 HOMA-IR score Standard Deviation 3.99	-0.4 HOMA-IR score Standard Deviation 3.76

SECONDARY outcome

Timeframe: Up to month 12/11

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Participants who had switched from the daily oral BIK regimen to CAB + RPV, were assessed as per the preference questionnaire every two months. There were 3 preference questions included to assess the preferred treatment 1) Long-acting injectable HIV medication, 2) Daily oral HIV medication, 3) No Preference. This endpoint was only planned to be analyzed for Q2M arm only. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit. Data represented included maintenance withdrawal or Month 12/11.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=163 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=262 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M Long-acting injectable HIV medication	87 Percentage of participants	92 Percentage of participants
Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M Daily oral HIV medication	7 Percentage of participants	4 Percentage of participants
Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M No Preference	6 Percentage of participants	5 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

The HIVTSQs total treatment satisfaction score comprised of 11 items based on HIVTSQ questionnaire each graded on a scale of 0 (very dissatisfied) to 6 (very satisfied) which were summed to produce a total score range of 0-66. Higher scores represent greater treatment satisfaction. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=446 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=222 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Month 12/11	4.21 Scores on scale Standard Deviation 9.273	-1.93 Scores on scale Standard Deviation 8.045
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Baseline (Day 1)	57.88 Scores on scale Standard Deviation 7.906	58.38 Scores on scale Standard Deviation 8.229
Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs) Month 6/5	3.99 Scores on scale Standard Deviation 9.670	-0.66 Scores on scale Standard Deviation 7.417

SECONDARY outcome

Timeframe: Baseline (Day 1) and up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

The individual item scores on HIVTSQs scale were rated on a scale of 6 (very satisfied, convenient, flexible, etc.) to -6 (very dissatisfied, inconvenient, inflexible, etc.). Higher scores represent greater satisfaction with each aspect of treatment. Baseline value is defined as latest pre-treatment assessment with a non-missing value, including those from unscheduled visits. Change from baseline is defined as post-dose visit value minus baseline value. For the Q2M arm, data from the Q2M OLI participants at Month 6 and 12 visit and Q2M D2I participants at Month 5 and 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 6 and 12 visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=446 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=222 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 1=Satisfaction with current treatment), Month 12/11	0.2 Scores on scale Standard Deviation 1.07	-0.3 Scores on scale Standard Deviation 1.00
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 2=Controlled HIV), Month 12/11	0.0 Scores on scale Standard Deviation 0.70	-0.1 Scores on scale Standard Deviation 0.69
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 3=Satisfaction with side effects of present treatment), Baseline (Day 1)	5.5 Scores on scale Standard Deviation 0.91	5.5 Scores on scale Standard Deviation 1.02
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 4=Satisfaction with current treatment demands), Baseline (Day 1)	5.2 Scores on scale Standard Deviation 1.16	5.2 Scores on scale Standard Deviation 1.21
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 4=Satisfaction with current treatment demands), Month 6/5	0.4 Scores on scale Standard Deviation 1.32	-0.1 Scores on scale Standard Deviation 1.28
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 4=Satisfaction with current treatment demands), Month 12/11	0.3 Scores on scale Standard Deviation 1.33	-0.2 Scores on scale Standard Deviation 1.35
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 6=Treatment flexibility), Month 6/5	0.9 Scores on scale Standard Deviation 1.77	0.0 Scores on scale Standard Deviation 1.58
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 1=Satisfaction with current treatment), Baseline (Day 1)	5.5 Scores on scale Standard Deviation 0.86	5.6 Scores on scale Standard Deviation 0.75
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 1=Satisfaction with current treatment), Month 6/5	0.1 Scores on scale Standard Deviation 1.10	-0.2 Scores on scale Standard Deviation 0.91
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 2=Controlled HIV), Baseline (Day 1)	5.8 Scores on scale Standard Deviation 0.54	5.8 Scores on scale Standard Deviation 0.45
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 2=Controlled HIV), Month 6/5	0.0 Scores on scale Standard Deviation 0.80	-0.1 Scores on scale Standard Deviation 0.55
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 3=Satisfaction with side effects of present treatment), Month 6/5	-0.3 Scores on scale Standard Deviation 1.42	0.0 Scores on scale Standard Deviation 1.21
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 3=Satisfaction with side effects of present treatment), Month 12/11	-0.1 Scores on scale Standard Deviation 1.38	0.0 Scores on scale Standard Deviation 1.16
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 5=Treatment convenience), Baseline (Day 1)	5.0 Scores on scale Standard Deviation 1.24	5.2 Scores on scale Standard Deviation 1.16
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 5=Treatment convenience), Month 6/5	0.6 Scores on scale Standard Deviation 1.42	-0.1 Scores on scale Standard Deviation 1.30
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 5=Treatment convenience), Month 12/11	0.7 Scores on scale Standard Deviation 1.43	-0.2 Scores on scale Standard Deviation 1.33
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 6=Treatment flexibility), Baseline (Day 1)	4.7 Scores on scale Standard Deviation 1.70	4.9 Scores on scale Standard Deviation 1.55
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 6=Treatment flexibility), Month 12/11	0.9 Scores on scale Standard Deviation 1.74	-0.1 Scores on scale Standard Deviation 1.58
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 7=Satisfaction with understanding of HIV), Baseline (Day 1)	5.5 Scores on scale Standard Deviation 0.80	5.5 Scores on scale Standard Deviation 0.92
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 7=Satisfaction with understanding of HIV), Month 6/5	0.2 Scores on scale Standard Deviation 0.81	0.1 Scores on scale Standard Deviation 0.75
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 7=Satisfaction with understanding of HIV), Month 12/11	0.1 Scores on scale Standard Deviation 0.86	0.1 Scores on scale Standard Deviation 0.78
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 8=Treatment fitting in with lifestyle), Baseline (Day 1)	5.0 Scores on scale Standard Deviation 1.20	5.1 Scores on scale Standard Deviation 1.11
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 8=Treatment fitting in with lifestyle), Month 6/5	0.7 Scores on scale Standard Deviation 1.36	-0.1 Scores on scale Standard Deviation 1.26
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 8=Treatment fitting in with lifestyle), Month 12/11	0.7 Scores on scale Standard Deviation 1.31	-0.2 Scores on scale Standard Deviation 1.38
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 9=Recommendation of current treatment for HIV), Baseline (Day 1)	5.5 Scores on scale Standard Deviation 0.86	5.5 Scores on scale Standard Deviation 1.02
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 9=Recommendation of current treatment for HIV), Month 6/5	0.2 Scores on scale Standard Deviation 1.10	0.0 Scores on scale Standard Deviation 1.09
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 9=Recommendation of current treatment for HIV), Month 12/11	0.2 Scores on scale Standard Deviation 1.04	-0.1 Scores on scale Standard Deviation 1.04
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 10=Satisfaction with present treatment continuation), Baseline (Day 1)	4.9 Scores on scale Standard Deviation 1.23	4.9 Scores on scale Standard Deviation 1.28
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 10=Satisfaction with present treatment continuation), Month 6/5	0.8 Scores on scale Standard Deviation 1.54	0.0 Scores on scale Standard Deviation 1.38
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 10=Satisfaction with present treatment continuation), Month 12/11	0.9 Scores on scale Standard Deviation 1.49	-0.2 Scores on scale Standard Deviation 1.45
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 11=Ease or difficulty with current treatment), Baseline (Day 1)	5.2 Scores on scale Standard Deviation 1.10	5.3 Scores on scale Standard Deviation 1.06
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 11=Ease or difficulty with current treatment), Month 6/5	0.5 Scores on scale Standard Deviation 1.34	-0.2 Scores on scale Standard Deviation 1.20
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 11=Ease or difficulty with current treatment), Month 12/11	0.5 Scores on scale Standard Deviation 1.34	-0.3 Scores on scale Standard Deviation 1.13
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Baseline (Day 1)	5.5 Scores on scale Standard Deviation 1.02	5.6 Scores on scale Standard Deviation 0.94
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 6/5	-0.6 Scores on scale Standard Deviation 1.64	-0.1 Scores on scale Standard Deviation 0.93
Change From Baseline in Individual Item Scores Using HIVTSQs (Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 12/11	-0.5 Scores on scale Standard Deviation 1.54	-0.2 Scores on scale Standard Deviation 1.09

SECONDARY outcome

Timeframe: At Month 12/11

Population: Modified Intent-to-Treat Exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

HIV treatment satisfaction change questionnaire (HIVTSQc) total Score is computed with items 1-11 which were summed to produce a total score range of -33 to 33. Higher score indicated greater improvement in the satisfaction with the treatment and lower score indicated greater deterioration in treatment satisfaction. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=426 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=214 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11	26.97 Scores on scale Standard Deviation 10.135	16.89 Scores on scale Standard Deviation 14.299

SECONDARY outcome

Timeframe: At Month 12/11

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

Individual item scores were rated on a scale of +3 (much more satisfied', 'much more convenient', 'much more flexible') to -3 (much less satisfied', 'much less convenient', 'much less flexible'). Higher score indicates greater improvement, and lower score indicates greater deterioration in satisfaction with each aspect of treatment. A score of 0 represents no change. For the Q2M arm, data from the Q2M OLI participants at Month 12 visit and Q2M D2I participants at Month 11 visit were combined as the study objective was to demonstrate the non-inferior antiviral activity of (Q2M) (OLI+ D2I combined) compared to BIK. For BIK arm, data was collected at month 12 visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=427 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=214 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Individual Item Scores of HIVTSQc at Month 12/11 Item 6=Treatment flexibility	2.41 Scores on scale Standard Deviation 1.138	1.24 Scores on scale Standard Deviation 1.591
Individual Item Scores of HIVTSQc at Month 12/11 Item 1=Satisfaction with current treatment	2.56 Scores on scale Standard Deviation 1.043	1.60 Scores on scale Standard Deviation 1.417
Individual Item Scores of HIVTSQc at Month 12/11 Item 2=Controlled HIV	2.47 Scores on scale Standard Deviation 1.086	1.88 Scores on scale Standard Deviation 1.375
Individual Item Scores of HIVTSQc at Month 12/11 Item 3=Satisfaction with side effects of present treatment	2.10 Scores on scale Standard Deviation 1.388	1.63 Scores on scale Standard Deviation 1.463
Individual Item Scores of HIVTSQc at Month 12/11 Item 4=Satisfaction with current treatment demands	2.41 Scores on scale Standard Deviation 1.109	1.42 Scores on scale Standard Deviation 1.560
Individual Item Scores of HIVTSQc at Month 12/11 Item 5=Treatment convenience	2.50 Scores on scale Standard Deviation 1.070	1.38 Scores on scale Standard Deviation 1.520
Individual Item Scores of HIVTSQc at Month 12/11 Item 7=Satisfaction with understanding of HIV	2.35 Scores on scale Standard Deviation 1.065	1.94 Scores on scale Standard Deviation 1.297
Individual Item Scores of HIVTSQc at Month 12/11 Item 8=Treatment fitting in with lifestyle	2.56 Scores on scale Standard Deviation 0.994	1.43 Scores on scale Standard Deviation 1.489
Individual Item Scores of HIVTSQc at Month 12/11 Item 9=Recommendation of current treatment for HIV	2.61 Scores on scale Standard Deviation 1.065	1.73 Scores on scale Standard Deviation 1.467
Individual Item Scores of HIVTSQc at Month 12/11 Item 10=Satisfaction with present treatment continuation	2.58 Scores on scale Standard Deviation 1.093	1.22 Scores on scale Standard Deviation 1.602
Individual Item Scores of HIVTSQc at Month 12/11 Item 11=Ease or difficulty with current treatment	2.46 Scores on scale Standard Deviation 1.107	1.43 Scores on scale Standard Deviation 1.542
Individual Item Scores of HIVTSQc at Month 12/11 Item 12=Satisfaction with amount of discomfort/pain with current treatment	1.85 Scores on scale Standard Deviation 1.530	1.64 Scores on scale Standard Deviation 1.465

SECONDARY outcome

Timeframe: From Month 2/1 up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

The PIN questionnaire was used to explore the dimension scores based on 4 dimensions including acceptance of injection site reactions (ISRs), Bother from ISRs, Leg movement and Sleep categories. Domain scores were calculated as a mean of all items with the domain. The PIN response options range from 1 (totally acceptable) to 5 (not at all acceptable). This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=163 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=271 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Bother of ISRs, Month 2/1	1.58 Scores on scale Standard Deviation 0.568	1.60 Scores on scale Standard Deviation 0.583
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Bother of ISRs, Month 6/5	0.01 Scores on scale Standard Deviation 0.528	-0.03 Scores on scale Standard Deviation 0.590
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Bother of ISRs, Month 12/11	0.08 Scores on scale Standard Deviation 0.594	-0.04 Scores on scale Standard Deviation 0.583
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Leg Movement, Month 2/1	1.93 Scores on scale Standard Deviation 1.013	1.83 Scores on scale Standard Deviation 0.913
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Leg Movement, Month 6/5	-0.14 Scores on scale Standard Deviation 0.779	-0.22 Scores on scale Standard Deviation 0.868
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Leg Movement, Month 12/11	-0.18 Scores on scale Standard Deviation 0.859	-0.24 Scores on scale Standard Deviation 0.817
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Sleep, Month 2/1	1.83 Scores on scale Standard Deviation 0.936	1.87 Scores on scale Standard Deviation 0.965
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Sleep, Month 6/5	-0.01 Scores on scale Standard Deviation 0.915	-0.16 Scores on scale Standard Deviation 0.869
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Sleep, Month 12/11	-0.07 Scores on scale Standard Deviation 0.948	-0.17 Scores on scale Standard Deviation 0.870
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Acceptance, Month 2/1	2.02 Scores on scale Standard Deviation 1.017	2.05 Scores on scale Standard Deviation 0.949
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Acceptance, Month 6/5	-0.14 Scores on scale Standard Deviation 0.906	-0.13 Scores on scale Standard Deviation 0.879
Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M Acceptance, Month 12/11	-0.20 Scores on scale Standard Deviation 0.873	-0.26 Scores on scale Standard Deviation 0.856

SECONDARY outcome

Timeframe: From Month 2/1 up to Month 12

Population: Modified intent-to-treat exposed (mITT-E) population. Only those participants with data available at specified time points have been analyzed.

The PIN questionnaire was used to explore the individual item scores based on anxiety before, pain, satisfaction, anxiety after and willingness categories. The items in the scale are rated on a 5-point scale and questions are phrased in such a way as to ensure that 1 is very dissatisfied and 5 was very satisfied. This endpoint was only planned to be analyzed for Q2M arm. Month 2/1 refers to the Month 2 (OLI and BIK) visit/Month 1 (DTI) visit. Month 6/5 refers to the Month 6 (OLI and BIK) visit/Month 5 (DTI) visit. Month 12/11 refers to the Month 12 (OLI and BIK) visit/Month 11 (DTI) visit.

Outcome measures

Outcome measures
Measure	Q2M (OLI + D2I) n=163 Participants Participants with HIV-1 who started OLI were administered with Cabotegravir and Rilpivirine (CAB + RPV) tablets orally for one month. At the month 1 visit, the last dose of oral 30 mg CAB + 25 mg RPV tablets were given, followed by the first 600 mg CAB LA + 900 mg RPV LA intramuscular injection, and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections every 2 months (Q2M) until Month 12. Participants with HIV-1 who started with D2I, received the first injection of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading dose at Day 1 followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and 3 followed by Q2M until Month 11.	Biktarvy (BIK) n=271 Participants Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety After, Month 2/1	1.8 Scores on scale Standard Deviation 1.12	1.7 Scores on scale Standard Deviation 0.96
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety After, Month 12/11	-0.24 Scores on scale Standard Deviation 0.947	-0.16 Scores on scale Standard Deviation 0.850
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Willingness, Month 6/5	0.01 Scores on scale Standard Deviation 0.716	-0.08 Scores on scale Standard Deviation 0.794
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety Before, Month 2/1	1.9 Scores on scale Standard Deviation 1.02	1.9 Scores on scale Standard Deviation 1.02
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety Before, Month 6/5	-0.14 Scores on scale Standard Deviation 1.021	-0.22 Scores on scale Standard Deviation 1.000
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety Before, Month 12/11	-0.28 Scores on scale Standard Deviation 0.973	-0.22 Scores on scale Standard Deviation 0.914
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Pain, Month 2/1	1.8 Scores on scale Standard Deviation 0.88	2.0 Scores on scale Standard Deviation 0.93
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Pain, Month 6/5	0.09 Scores on scale Standard Deviation 0.907	-0.03 Scores on scale Standard Deviation 0.935
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Pain, Month 12/11	0.13 Scores on scale Standard Deviation 0.995	0.02 Scores on scale Standard Deviation 0.943
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Satisfaction, Month 2/1	1.7 Scores on scale Standard Deviation 0.90	1.6 Scores on scale Standard Deviation 0.81
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Satisfaction, Month 6/5	-0.06 Scores on scale Standard Deviation 0.837	0.00 Scores on scale Standard Deviation 0.867
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Satisfaction, Month 12/11	-0.12 Scores on scale Standard Deviation 0.861	-0.11 Scores on scale Standard Deviation 0.830
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Anxiety After, Month 6/5	-0.14 Scores on scale Standard Deviation 0.994	-0.04 Scores on scale Standard Deviation 0.916
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Willingness, Month 2/1	1.4 Scores on scale Standard Deviation 0.76	1.4 Scores on scale Standard Deviation 0.78
Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M Willingness, Month 12/11	-0.01 Scores on scale Standard Deviation 0.744	-0.10 Scores on scale Standard Deviation 0.742

Adverse Events

Oral lead-in Phase (OLI)

Serious events: 11 serious events

Other events: 156 other events

Deaths: 0 deaths

Direct to Injections (D2I)

Serious events: 10 serious events

Other events: 257 other events

Deaths: 0 deaths

Biktarvy (BIK)

Serious events: 15 serious events

Other events: 77 other events

Deaths: 1 deaths

Switch Q2M Group

Serious events: 5 serious events

Other events: 76 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Oral lead-in Phase (OLI) n=175 participants at risk Participants with human immunodeficiency viruses (HIV)-1 who chose oral lead in (OLI) received oral 30 milligram (mg) Cabotegravir (CAB) tablet + 25 mg Rilpivirine (RPV) tablet once daily (QD) for one month. At the month 1 visit, the last dose of oral CAB + RPV was given, followed by the first 600 mg CAB long-acting (LA) + 900 mg RPV LA intramuscular injection (IM), and second injection of CAB LA 600 mg + RPV LA 900 mg at month 2, and then subsequent injections once every 2 months (Q2M) until Month 12 (Maintenance Phase). The participants had the option to continue the regimen in the Extension Phase.	Direct to Injections (D2I) n=279 participants at risk Participants with HIV-1 who chose direct to injections (D2I) received the first injections of 600 mg CAB LA + 900 mg RPV LA, IM as initial loading doses at Day 1 one month, followed by second and third subsequent injections (CAB LA 600 mg + RPV LA 900 mg) at month 1 and month 3 followed by Q2M until Month 11. The participants had the option to continue the regimen in the Extension Phase.	Biktarvy (BIK) n=227 participants at risk Participants with HIV-1 received BIK tablet orally until month 12. BIK was a fixed dose combination of 50 mg Bictegravir (BIC) + 200 mg Emtricitabine (FTC) + 25 mg Tenofovir alafenamide (TAF).	Switch Q2M Group n=145 participants at risk Eligible participants with HIV-1 who received BIK tablet orally switched treatment after month 12 (Extension Phase) to CAB LA 600 mg + RPV LA 900 mg regimen, administered once every 2 months.
General disorders Injection site pain	60.6% 106/175 • Number of events 106 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	65.2% 182/279 • Number of events 182 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.44% 1/227 • Number of events 2 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	37.9% 55/145 • Number of events 55 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Injection site nodule	9.7% 17/175 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	9.3% 26/279 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Injection site swelling	8.6% 15/175 • Number of events 15 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	9.7% 27/279 • Number of events 27 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Pyrexia	5.7% 10/175 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	9.3% 26/279 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	3.5% 8/227 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Injection site discomfort	9.7% 17/175 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	9.3% 26/279 • Number of events 26 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Fatigue	9.7% 17/175 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	5.0% 14/279 • Number of events 14 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	2.6% 6/227 • Number of events 7 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
General disorders Injection site induration	11.4% 20/175 • Number of events 20 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	6.1% 17/279 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Infections and infestations COVID-19	19.4% 34/175 • Number of events 34 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	17.9% 50/279 • Number of events 50 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	16.7% 38/227 • Number of events 38 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	14.5% 21/145 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Infections and infestations Nasopharyngitis	4.6% 8/175 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	9.0% 25/279 • Number of events 25 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	4.4% 10/227 • Number of events 13 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Infections and infestations Syphilis	4.6% 8/175 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	8.2% 23/279 • Number of events 23 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	4.0% 9/227 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Nervous system disorders Headache	9.7% 17/175 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	12.5% 35/279 • Number of events 35 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	5.3% 12/227 • Number of events 12 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Gastrointestinal disorders Diarrhoea	4.6% 8/175 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	7.5% 21/279 • Number of events 21 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	4.0% 9/227 • Number of events 9 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Musculoskeletal and connective tissue disorders Back pain	5.7% 10/175 • Number of events 10 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	6.1% 17/279 • Number of events 17 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.
Musculoskeletal and connective tissue disorders Arthralgia	4.6% 8/175 • Number of events 8 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	5.7% 16/279 • Number of events 16 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/227 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.	0.00% 0/145 • All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected up to end of Extension Phase (approximately Month 27). AEs are reported based on Safety set population, which included all randomized participants who received at least one dose of study drug, based on the study phase they were included in. The Safety set included all participants irrespective of eligibility criteria violation and GCP non-compliance, since they received at least a study intervention dose.

Additional Information

GSK Response Center

ViiV Healthcare

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