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 (SOLAR)

• ClinicalTrials.gov Identifier: NCT04542070
• Recruitment Status: Completed
• First Posted: September 9, 2020
• Results First Posted: September 13, 2023
• Last Update Posted: September 13, 2023
• Sponsor: ViiV Healthcare
• Collaborator: Janssen, LP
• Information provided by (Responsible Party): ViiV Healthcare

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV Infections
• Interventions: Drug: Cabotegravir Tablets; Drug: Cabotegravir Injectable Suspension (CAB LA); Drug: Rilpivirine Tablets; Drug: Rilpivirine Injectable Suspension (RPV LA); Drug: BIKTARVY Tablets (BIK)
• Enrollment: 687

Participant Flow

Recruitment Details	The results presented are based on the primary analysis (and includes data up to Month 12 [Maintenance Phase]). Data collection is still ongoing and additional results will be provided after study completion. Any participants who successfully completed 12 months of CAB+RPV treatment in the Maintenance Phase could enter the Extension Phase and continue to have access to CAB + RPV.
Pre-assignment Details	Total 687 were enrolled out of which 681 were included in intent-to-treat exposed population (ITT-E) that is all enrolled participants who received at least one dose of investigational product (IP) during the Maintenance Phase of the study (on or after Day 1). 6 participants did not receive any dose of IP.

Arm/Group Title	Oral lead-in Phase (OLI)	Direct to Injections (D2I)	Biktarvy (BIK)
Arm/Group Description	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.	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.	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).
Period Title: Overall Study
Started [1]	175	279	227
Completed	152	255	213
Not Completed	23	24	14
Reason Not Completed
Adverse Event	10	3	1
Lack of Efficacy	1	2	0
Lost to Follow-up	3	4	2
Physician Decision	1	0	1
Withdrawal by Subject	5	8	9
Protocol Deviation	2	6	1
Protocol-Specified Withdrawal Criterion Met	1	1	0
[1] Intent-to-Treat-Exposed (ITT-E)

Baseline Characteristics

Arm/Group Title		Oral lead-in Phase (OLI)	Direct to Injections (D2I)	Biktarvy (BIK)	Total
Arm/Group Description		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.	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.	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 of all reporting groups
Overall Number of Baseline Participants		175	279	227	681
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: YEARS
	Number Analyzed	175 participants	279 participants	227 participants	681 participants
		38.5 (11.38)	39.0 (11.09)	38.6 (11.41)	38.7 (11.26)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	175 participants	279 participants	227 participants	681 participants
	Female	27 15.4%	52 18.6%	41 18.1%	120 17.6%
	Male	148 84.6%	227 81.4%	186 81.9%	561 82.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	175 participants	279 participants	227 participants	681 participants
American Indian or Alaska Native		10 5.7%	4 1.4%	2 0.9%	16 2.3%
Asian - Central/South Asian Heritage		0 0.0%	3 1.1%	0 0.0%	3 0.4%
Asian - East Asian Heritage		1 0.6%	0 0.0%	2 0.9%	3 0.4%
Asian - Japanese Heritage		4 2.3%	10 3.6%	6 2.6%	20 2.9%
Asian - South East Asian Heritage		2 1.1%	3 1.1%	3 1.3%	8 1.2%
Black or African American		40 22.9%	56 20.1%	49 21.6%	145 21.3%
Native Hawaiian or Other Pacific Islander		0 0.0%	0 0.0%	1 0.4%	1 0.1%
White - Arabic/North African Heritage		10 5.7%	5 1.8%	10 4.4%	25 3.7%
White - White/Caucasian/European Heritage		104 59.4%	194 69.5%	149 65.6%	447 65.6%
Mixed White Race		0 0.0%	0 0.0%	1 0.4%	1 0.1%
Multiple		4 2.3%	4 1.4%	4 1.8%	12 1.8%

Outcome Measures

1. Primary Outcome

Title	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
Description	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.
Time Frame	At month 12/11

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	454	227
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	1.3; (0.5 to 2.9)	0.4; (0.0 to 2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Q2M (OLI + D2I), Biktarvy (BIK)
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.2
	Estimation Comments	Difference in percentage = percentage of Q2M - percentage of BIK

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Q2M (OLI + D2I), Biktarvy (BIK)
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.
Method of Estimation	Estimation Parameter	Adjusted difference in percentage
	Estimated Value	0.9
	Confidence Interval	(2-Sided) 95%; -0.5 to 2.2
	Estimation Comments	Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.

2. Primary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Greater >=50 Copies Per Milliliter (c/mL) at Month 12/11 - mITT-E Population
Description	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.
Time Frame	At month 12/11

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	447	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	1.1; (0.4 to 2.6)	0.4; (0.0 to 2.5)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Q2M (OLI + D2I), Biktarvy (BIK)
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.6 to 2.0
	Estimation Comments	Difference in percentage = percentage of Q2M - percentage of BIK

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Q2M (OLI + D2I), Biktarvy (BIK)
	Comments	[Not Specified]
	Type of Statistical Test	Non-Inferiority
	Comments	Non-inferiority concluded if the upper limit of a two-sided 95% confidence interval for the difference in percentage of participants with HIV-1 RNA ≥ 50 c/mL at Month 12 (OLI and BIK)/Month 11 (D2I) between the two treatment arms (Q2M - BIK) is less than 4%.
Method of Estimation	Estimation Parameter	Adjusted difference in percentage
	Estimated Value	0.7
	Confidence Interval	(2-Sided) 95%; -0.7 to 2.0
	Estimation Comments	Adjusted difference in percentage = percentage of Q2M - percentage of BIK. Based on cochran-mantel haenszel stratified analysis was adjusted for the baseline stratification factors gender at birth and baseline BMI.

3. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Less Than (<)50 c/mL at Month 12/11 - ITT-E Population
Description	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.
Time Frame	At month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	454	227
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	89.4; (86.6 to 92.3)	93.0; (89.6 to 96.3)

4. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 12/11 -mITT-E Population
Description	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.
Time Frame	At month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	447	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	90.2; (87.4 to 92.9)	92.8; (89.4 to 96.2)

5. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - ITT-E Population
Description	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.
Time Frame	At month 6/5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	454	227
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	92.7; (90.3 to 95.1)	97.8; (95.9 to 99.7)

6. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Month 6/5 - mITT-E Population
Description	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.
Time Frame	At month 6/5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	447	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	93.5; (91.2 to 95.8)	97.8; (95.8 to 99.7)

7. Secondary Outcome

Title	Number of Participants With Protocol-defined Confirmed Virologic Failure (CVF) Through Month 6/5 and 12/11
Description	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.
Time Frame	Up to month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	447	223
Measure Type: Count of Participants; Unit of Measure: Participants
Month 6/5	1 0.2%	0 0.0%
Month 12/11	2 0.4%	0 0.0%

8. Secondary Outcome

Title	Percentage of Participants With Plasma HIV-1 RNA Greater Than or Equal to (>=) 50 c/mL at Month 6/5
Description	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.
Time Frame	At month 6/5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	447	223
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of participants
	0.4; (0.1 to 1.6)	0; (0.0 to 1.6)

9. Secondary Outcome

Title	Absolute Values of HIV Viral Load
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		447	223
Mean (Standard Deviation); Unit of Measure: log10 copies per milliliter(c/mL)
Baseline (Day 1)	Number Analyzed	447 participants	223 participants
		1.5993 (0.10559)	1.5947 (0.06640)
Month 6/5	Number Analyzed	420 participants	218 participants
		1.6002 (0.09268)	1.5910 (0.01182)
Month 12/11	Number Analyzed	406 participants	201 participants
		1.6019 (0.13064)	1.5911 (0.01552)

10. Secondary Outcome

Title	Change From Baseline in HIV Viral Load
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		447	223
Mean (Standard Deviation); Unit of Measure: log10 c/mL
Baseline (Day 1)	Number Analyzed	447 participants	223 participants
		1.5993 (0.10559)	1.5947 (0.06640)
Month 6/5	Number Analyzed	420 participants	218 participants
		0.0015 (0.13997)	-0.0039 (0.06826)
Month 12/11	Number Analyzed	406 participants	201 participants
		0.0029 (0.17038)	-0.0041 (0.07172)

11. Secondary Outcome

Title	Absolute Values of Cluster of Differentiation 4 Plus (CD4+) Cell Count
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		447	222
Mean (Standard Deviation); Unit of Measure: cells per cubic millimeter(cells/mm^3)
Baseline (Day 1)	Number Analyzed	447 participants	222 participants
		670.9 (282.11)	679.4 (306.89)
Month 6/5	Number Analyzed	412 participants	212 participants
		689.1 (284.89)	673.7 (290.46)
Month 12/11	Number Analyzed	395 participants	192 participants
		711.9 (297.13)	717.3 (317.82)

12. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		447	223
Mean (Standard Deviation); Unit of Measure: cells/mm^3
Baseline (Day 1)	Number Analyzed	447 participants	223 participants
		670.9 (282.11)	679.4 (306.89)
Month 6/5	Number Analyzed	412 participants	211 participants
		20.4 (202.38)	-3.1 (197.62)
Month 12/11	Number Analyzed	395 participants	191 participants
		35.2 (219.79)	32.2 (208.29)

13. Secondary Outcome

Title	Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 12/11
Description	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.
Time Frame	Up to Month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	2	0
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI	2 100.0%	0
IN	2 100.0%	0

14. Secondary Outcome

Title	Number of Participants With Treatment-emergent Phenotypic Resistance Through Month 6/5
Description	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.
Time Frame	Up to Month 6/5

Outcome Measure Data

Analysis Population Description

Confirmed Virologic Failure (CVF) population.

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
NNRTI	1 100.0%	0
IN	1 100.0%	0

15. Secondary Outcome

Title	Number of Participants With Treatment-emergent Genotypic Resistance Through Month 12/11
Description	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.
Time Frame	Up to Month 12/11

Outcome Measure Data

Analysis Population Description

Confirmed Virologic Failure (CVF) population.

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	2	0
Measure Type: Count of Participants; Unit of Measure: Participants
M230L	1 50.0%	0
Q148R	1 50.0%	0
K101E	1 50.0%	0
G118R	1 50.0%	0

16. Secondary Outcome

Title	Number of Participants With Treatment-emergent Genotypic Resistance Through Month 6/5
Description	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.
Time Frame	Up to Month 6/5

Outcome Measure Data

Analysis Population Description

Confirmed Virologic Failure (CVF) population.

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	1	0
Measure Type: Count of Participants; Unit of Measure: Participants
M230L	1 100.0%	0
Q148R	1 100.0%	0

17. Secondary Outcome

Title	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))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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.

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		449	227
Mean (Standard Deviation); Unit of Measure: micrograms per liter (ug/L)
Serum Bone Specific Alkaline Phosphatase, Baseline (Day 1)	Number Analyzed	448 participants	227 participants
		12.7 (4.27)	12.9 (4.60)
Serum Bone Specific Alkaline Phosphatase, Month 6/5	Number Analyzed	418 participants	221 participants
		0.3 (9.89)	0.2 (2.60)
Serum Bone Specific Alkaline Phosphatase, Month 12/11	Number Analyzed	403 participants	208 participants
		0.1 (5.03)	0.5 (3.55)
Serum Osteocalcin, Baseline (Day 1)	Number Analyzed	447 participants	227 participants
		21.0 (7.35)	20.4 (7.48)
Serum Osteocalcin, Month 6/5	Number Analyzed	418 participants	219 participants
		0.4 (5.53)	-0.4 (5.11)
Serum Osteocalcin, Month 12/11	Number Analyzed	395 participants	209 participants
		0.9 (6.11)	-0.6 (5.51)
Serum Procollagen 1 N-Terminal Propeptide, Baseline (Day 1)	Number Analyzed	448 participants	226 participants
		59.1 (23.06)	59.2 (23.88)
Serum Procollagen 1 N-Terminal Propeptide, Month 6/5	Number Analyzed	420 participants	219 participants
		-1.5 (15.70)	0.1 (18.53)
Serum Procollagen 1 N-Terminal Propeptide, Month 12/11	Number Analyzed	402 participants	209 participants
		-0.7 (19.73)	0.6 (19.63)
Serum Type I Collagen C-Telopeptides, Baseline (Day 1)	Number Analyzed	449 participants	226 participants
		0.4 (0.25)	0.5 (0.25)
Serum Type I Collagen C-Telopeptides, Month 6/5	Number Analyzed	421 participants	222 participants
		-0.1 (0.23)	-0.1 (0.21)
Serum Type I Collagen C-Telopeptides, Month 12/11	Number Analyzed	405 participants	209 participants
		0.0 (0.25)	0.0 (0.22)

18. Secondary Outcome

Title	Change From Baseline in Bone Biomarkers: Serum 25-hydroxyvitamin D (Nanomoles Per Liter (Nmol/L))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		440	219
Mean (Standard Deviation); Unit of Measure: nanomoles per liter (nmol/L)
Baseline (Day 1)	Number Analyzed	440 participants	219 participants
		61.0 (34.69)	59.9 (33.30)
Month 6/5	Number Analyzed	403 participants	214 participants
		2.8 (29.24)	6.0 (34.16)
Month 12/11	Number Analyzed	393 participants	199 participants
		-2.3 (29.00)	-3.1 (26.38)

19. Secondary Outcome

Title	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])
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		448	227
Mean (Standard Deviation); Unit of Measure: milligrams per liter (mg/L)
Serum beta-2 microglobulin, Baseline (Day 1)	Number Analyzed	447 participants	227 participants
		1.8 (0.40)	1.8 (0.38)
Serum beta-2 microglobulin, Month 6/5	Number Analyzed	413 participants	223 participants
		0.0 (0.28)	0.0 (0.28)
Serum beta-2 microglobulin, Month 12/11	Number Analyzed	402 participants	208 participants
		0.0 (0.33)	0.0 (0.32)
Serum cystatin C, Baseline (Day 1)	Number Analyzed	448 participants	227 participants
		0.9 (0.13)	0.9 (0.14)
Serum cystatin C, Month 6/5	Number Analyzed	416 participants	223 participants
		0.0 (0.08)	0.0 (0.08)
Serum cystatin C, Month 12/11	Number Analyzed	404 participants	209 participants
		0.0 (0.08)	0.0 (0.08)
Serum retinol binding protein, Baseline (Day 1)	Number Analyzed	446 participants	227 participants
		51.3 (13.01)	52.2 (12.61)
Serum retinol binding protein, Month 6/5	Number Analyzed	417 participants	220 participants
		-1.0 (9.00)	-0.3 (8.75)
Serum retinol binding protein, Month 12/11	Number Analyzed	397 participants	208 participants
		-1.2 (9.24)	0.2 (9.06)
Urine beta-2 microglobulin, Baseline (Day 1)	Number Analyzed	257 participants	128 participants
		0.2 (0.34)	0.2 (0.40)
Urine beta-2 microglobulin, Month 6/5	Number Analyzed	175 participants	84 participants
		0.0 (0.40)	0.1 (0.65)
Urine beta-2 microglobulin, Month 12/11	Number Analyzed	148 participants	86 participants
		0.0 (0.24)	0.1 (0.52)

20. Secondary Outcome

Title	Change From Baseline in Renal Biomarkers: Urine Phosphate (Millimoles Per Liter (mmol/L))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		449	223
Mean (Standard Deviation); Unit of Measure: millimoles per liter (mmol/L)
Baseline (Day 1)	Number Analyzed	449 participants	223 participants
		20.0 (14.03)	18.4 (13.10)
Month 6/5	Number Analyzed	414 participants	218 participants
		-1.0 (16.29)	0.4 (15.60)
Month 12/11	Number Analyzed	399 participants	205 participants
		0.1 (16.17)	-0.6 (15.16)

21. Secondary Outcome

Title	Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein 4 (Microgram Per Liter (ug/L))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		447	222
Mean (Standard Deviation); Unit of Measure: microgram per liter (ug/L)
Baseline (Day 1)	Number Analyzed	447 participants	222 participants
		114.2 (111.45)	100.0 (82.00)
Month 6/5	Number Analyzed	412 participants	217 participants
		0.8 (139.88)	5.7 (105.08)
Month 12/11	Number Analyzed	397 participants	204 participants
		-0.6 (123.52)	-1.2 (105.26)

22. Secondary Outcome

Title	Change From Baseline in Renal Biomarker: Urine Retinol Binding Protein/Creatinine (Milligram Per Mole (mg/Mol))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		216	107
Mean (Standard Deviation); Unit of Measure: milligram per mole (mg/mol)
Baseline (Day 1)	Number Analyzed	216 participants	107 participants
		8.6 (6.32)	8.0 (5.75)
Month 6/5	Number Analyzed	68 participants	40 participants
		0.8 (6.00)	-0.8 (7.23)
Month 12/11	Number Analyzed	91 participants	50 participants
		-0.5 (6.41)	0.0 (4.15)

23. Secondary Outcome

Title	Change From Baseline in Renal Biomarker: Urine Beta-2 Microglobulin/ Creatinine (Grams Per Mole (g/Mol))
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		182	88
Mean (Standard Deviation); Unit of Measure: grams per mole (g/mol)
Baseline (Day 1)	Number Analyzed	182 participants	88 participants
		0.0 (0.03)	0.0 (0.04)
Month 6/5	Number Analyzed	94 participants	44 participants
		0.0 (0.03)	0.0 (0.19)
Month 12/11	Number Analyzed	79 participants	45 participants
		0.0 (0.02)	0.0 (0.04)

24. Secondary Outcome

Title	Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 12/11
Description	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.
Time Frame	Baseline (Day 1) and at Month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	454	227
Measure Type: Number; Unit of Measure: Percentage of participants
Yes (Baseline) to Yes (Month 12/11)	9	9
Yes (Baseline) to No (Month 12/11)	5	7
Yes (Baseline) to Missing (Month 12/11)	2	1
No (Baseline) to Yes (Month 12/11)	6	8
No (Baseline) to No (Month 12/11)	69	70
No (Baseline) to Missing ((Month 12/11))	8	6

25. Secondary Outcome

Title	Change From Baseline in Percentage of Participants With Metabolic Syndrome at Month 6/5
Description	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.
Time Frame	Baseline (Day 1) and at month 6/5

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	454	227
Measure Type: Number; Unit of Measure: Percentage of participants
Yes (Baseline) to Yes (Month 6/5)	9	11
Yes (Baseline) to No (Month 6/5)	7	6
Yes (Baseline) to Missing (Month 6/5)	1	0
No (Baseline) to Yes (Month 6/5)	5	10
No (Baseline) to No (Month 6/5)	74	71
No (Baseline) to Missing (Month 6/5)	5	2

26. Secondary Outcome

Title	Change From Baseline in Homeostasis Model of Assessment-insulin Resistance (HOMA-IR)
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		409	210
Mean (Standard Deviation); Unit of Measure: HOMA-IR score
Baseline (Day 1)	Number Analyzed	409 participants	210 participants
		2.8 (4.05)	3.1 (5.06)
Month 6/5	Number Analyzed	348 participants	191 participants
		0.3 (4.11)	-0.1 (5.09)
Month 12/11	Number Analyzed	346 participants	177 participants
		0.2 (3.99)	-0.4 (3.76)

27. Secondary Outcome

Title	Percentage of Participants With Treatment Preference as Assessed Using Preference Questionnaire at Month 12/11 - Q2M
Description	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.
Time Frame	Up to month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Oral lead-in Phase (OLI)	Direct to Injections (D2I)
Arm/Group Description:	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.	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.
Overall Number of Participants Analyzed	163	262
Measure Type: Number; Unit of Measure: Percentage of participants
Long-acting injectable HIV medication	87	92
Daily oral HIV medication	7	4
No Preference	6	5

28. Secondary Outcome

Title	Change From Baseline in Total Treatment Satisfaction Score Using HIV Treatment Satisfaction Status Questionnaire (HIVTSQs)
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		446	222
Mean (Standard Deviation); Unit of Measure: Scores on scale
Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		57.88 (7.906)	58.38 (8.229)
Month 6/5	Number Analyzed	436 participants	220 participants
		3.99 (9.670)	-0.66 (7.417)
Month 12/11	Number Analyzed	410 participants	213 participants
		4.21 (9.273)	-1.93 (8.045)

29. Secondary Outcome

Title	Change From Baseline in Individual Item Scores Using HIVTSQs
Description	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.
Time Frame	Baseline (Day 1) and up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		446	222
Mean (Standard Deviation); Unit of Measure: Scores on scale
(Item 1=Satisfaction with current treatment), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.5 (0.86)	5.6 (0.75)
(Item 1=Satisfaction with current treatment), Month 6/5	Number Analyzed	436 participants	220 participants
		0.1 (1.10)	-0.2 (0.91)
(Item 1=Satisfaction with current treatment), Month 12/11	Number Analyzed	410 participants	213 participants
		0.2 (1.07)	-0.3 (1.00)
(Item 2=Controlled HIV), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.8 (0.54)	5.8 (0.45)
(Item 2=Controlled HIV), Month 6/5	Number Analyzed	436 participants	220 participants
		0.0 (0.80)	-0.1 (0.55)
(Item 2=Controlled HIV), Month 12/11	Number Analyzed	410 participants	213 participants
		0.0 (0.70)	-0.1 (0.69)
(Item 3=Satisfaction with side effects of present treatment), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.5 (0.91)	5.5 (1.02)
(Item 3=Satisfaction with side effects of present treatment), Month 6/5	Number Analyzed	436 participants	220 participants
		-0.3 (1.42)	0.0 (1.21)
(Item 3=Satisfaction with side effects of present treatment), Month 12/11	Number Analyzed	410 participants	213 participants
		-0.1 (1.38)	0.0 (1.16)
(Item 4=Satisfaction with current treatment demands), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.2 (1.16)	5.2 (1.21)
(Item 4=Satisfaction with current treatment demands), Month 6/5	Number Analyzed	435 participants	220 participants
		0.4 (1.32)	-0.1 (1.28)
(Item 4=Satisfaction with current treatment demands), Month 12/11	Number Analyzed	410 participants	213 participants
		0.3 (1.33)	-0.2 (1.35)
(Item 5=Treatment convenience), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.0 (1.24)	5.2 (1.16)
(Item 5=Treatment convenience), Month 6/5	Number Analyzed	436 participants	220 participants
		0.6 (1.42)	-0.1 (1.30)
(Item 5=Treatment convenience), Month 12/11	Number Analyzed	410 participants	213 participants
		0.7 (1.43)	-0.2 (1.33)
(Item 6=Treatment flexibility), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		4.7 (1.70)	4.9 (1.55)
(Item 6=Treatment flexibility), Month 6/5	Number Analyzed	436 participants	220 participants
		0.9 (1.77)	0.0 (1.58)
(Item 6=Treatment flexibility), Month 12/11	Number Analyzed	410 participants	213 participants
		0.9 (1.74)	-0.1 (1.58)
(Item 7=Satisfaction with understanding of HIV), Baseline (Day 1)	Number Analyzed	446 participants	222 participants
		5.5 (0.80)	5.5 (0.92)
(Item 7=Satisfaction with understanding of HIV), Month 6/5	Number Analyzed	436 participants	220 participants
		0.2 (0.81)	0.1 (0.75)
(Item 7=Satisfaction with understanding of HIV), Month 12/11	Number Analyzed	410 participants	213 participants
		0.1 (0.86)	0.1 (0.78)
(Item 8=Treatment fitting in with lifestyle), Baseline (Day 1)	Number Analyzed	445 participants	221 participants
		5.0 (1.20)	5.1 (1.11)
(Item 8=Treatment fitting in with lifestyle), Month 6/5	Number Analyzed	434 participants	218 participants
		0.7 (1.36)	-0.1 (1.26)
(Item 8=Treatment fitting in with lifestyle), Month 12/11	Number Analyzed	408 participants	212 participants
		0.7 (1.31)	-0.2 (1.38)
(Item 9=Recommendation of current treatment for HIV), Baseline (Day 1)	Number Analyzed	444 participants	221 participants
		5.5 (0.86)	5.5 (1.02)
(Item 9=Recommendation of current treatment for HIV), Month 6/5	Number Analyzed	433 participants	218 participants
		0.2 (1.10)	0.0 (1.09)
(Item 9=Recommendation of current treatment for HIV), Month 12/11	Number Analyzed	408 participants	212 participants
		0.2 (1.04)	-0.1 (1.04)
(Item 10=Satisfaction with present treatment continuation), Baseline (Day 1)	Number Analyzed	445 participants	221 participants
		4.9 (1.23)	4.9 (1.28)
(Item 10=Satisfaction with present treatment continuation), Month 6/5	Number Analyzed	434 participants	218 participants
		0.8 (1.54)	0.0 (1.38)
(Item 10=Satisfaction with present treatment continuation), Month 12/11	Number Analyzed	409 participants	212 participants
		0.9 (1.49)	-0.2 (1.45)
(Item 11=Ease or difficulty with current treatment), Baseline (Day 1)	Number Analyzed	445 participants	221 participants
		5.2 (1.10)	5.3 (1.06)
(Item 11=Ease or difficulty with current treatment), Month 6/5	Number Analyzed	434 participants	218 participants
		0.5 (1.34)	-0.2 (1.20)
(Item 11=Ease or difficulty with current treatment), Month 12/11	Number Analyzed	409 participants	212 participants
		0.5 (1.34)	-0.3 (1.13)
(Item 12=Satisfaction with amount of discomfort/pain with current treatment), Baseline (Day 1)	Number Analyzed	445 participants	221 participants
		5.5 (1.02)	5.6 (0.94)
(Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 6/5	Number Analyzed	434 participants	218 participants
		-0.6 (1.64)	-0.1 (0.93)
(Item 12=Satisfaction with amount of discomfort/pain with current treatment), Month 12/11	Number Analyzed	409 participants	212 participants
		-0.5 (1.54)	-0.2 (1.09)

30. Secondary Outcome

Title	HIV Treatment Satisfaction Change Questionnaire (HIVTSQc) Total Score at Month 12/11
Description	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.
Time Frame	At Month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	426	214
Mean (Standard Deviation); Unit of Measure: Scores on scale
	26.97 (10.135)	16.89 (14.299)

31. Secondary Outcome

Title	Individual Item Scores of HIVTSQc at Month 12/11
Description	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.
Time Frame	At Month 12/11

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Q2M (OLI + D2I)	Biktarvy (BIK)
Arm/Group Description:		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.	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).
Overall Number of Participants Analyzed		427	214
Mean (Standard Deviation); Unit of Measure: Scores on scale
Item 1=Satisfaction with current treatment	Number Analyzed	427 participants	214 participants
		2.56 (1.043)	1.60 (1.417)
Item 2=Controlled HIV	Number Analyzed	425 participants	214 participants
		2.47 (1.086)	1.88 (1.375)
Item 3=Satisfaction with side effects of present treatment	Number Analyzed	426 participants	214 participants
		2.10 (1.388)	1.63 (1.463)
Item 4=Satisfaction with current treatment demands	Number Analyzed	426 participants	214 participants
		2.41 (1.109)	1.42 (1.560)
Item 5=Treatment convenience	Number Analyzed	426 participants	214 participants
		2.50 (1.070)	1.38 (1.520)
Item 6=Treatment flexibility	Number Analyzed	426 participants	214 participants
		2.41 (1.138)	1.24 (1.591)
Item 7=Satisfaction with understanding of HIV	Number Analyzed	425 participants	214 participants
		2.35 (1.065)	1.94 (1.297)
Item 8=Treatment fitting in with lifestyle	Number Analyzed	425 participants	214 participants
		2.56 (0.994)	1.43 (1.489)
Item 9=Recommendation of current treatment for HIV	Number Analyzed	425 participants	214 participants
		2.61 (1.065)	1.73 (1.467)
Item 10=Satisfaction with present treatment continuation	Number Analyzed	424 participants	214 participants
		2.58 (1.093)	1.22 (1.602)
Item 11=Ease or difficulty with current treatment	Number Analyzed	425 participants	214 participants
		2.46 (1.107)	1.43 (1.542)
Item 12=Satisfaction with amount of discomfort/pain with current treatment	Number Analyzed	425 participants	214 participants
		1.85 (1.530)	1.64 (1.465)

32. Secondary Outcome

Title	Change From Month 2/1 in Dimension Scores Using Perception of Injection (PIN) Questionnaire - Q2M
Description	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.
Time Frame	From Month 2/1 up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Oral lead-in Phase (OLI)	Direct to Injections (D2I)
Arm/Group Description:		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.	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.
Overall Number of Participants Analyzed		163	271
Mean (Standard Deviation); Unit of Measure: Scores on scale
Bother of ISRs, Month 2/1	Number Analyzed	163 participants	271 participants
		1.58 (0.568)	1.60 (0.583)
Bother of ISRs, Month 6/5	Number Analyzed	160 participants	263 participants
		0.01 (0.528)	-0.03 (0.590)
Bother of ISRs, Month 12/11	Number Analyzed	152 participants	255 participants
		0.08 (0.594)	-0.04 (0.583)
Leg Movement, Month 2/1	Number Analyzed	163 participants	270 participants
		1.93 (1.013)	1.83 (0.913)
Leg Movement, Month 6/5	Number Analyzed	160 participants	262 participants
		-0.14 (0.779)	-0.22 (0.868)
Leg Movement, Month 12/11	Number Analyzed	152 participants	254 participants
		-0.18 (0.859)	-0.24 (0.817)
Sleep, Month 2/1	Number Analyzed	163 participants	270 participants
		1.83 (0.936)	1.87 (0.965)
Sleep, Month 6/5	Number Analyzed	160 participants	262 participants
		-0.01 (0.915)	-0.16 (0.869)
Sleep, Month 12/11	Number Analyzed	152 participants	254 participants
		-0.07 (0.948)	-0.17 (0.870)
Acceptance, Month 2/1	Number Analyzed	163 participants	271 participants
		2.02 (1.017)	2.05 (0.949)
Acceptance, Month 6/5	Number Analyzed	160 participants	263 participants
		-0.14 (0.906)	-0.13 (0.879)
Acceptance, Month 12/11	Number Analyzed	152 participants	255 participants
		-0.20 (0.873)	-0.26 (0.856)

33. Secondary Outcome

Title	Change From Month 2/1 in Individual Item Scores Using PIN Questionnaire- Q2M
Description	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.
Time Frame	From Month 2/1 up to Month 12

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title		Oral lead-in Phase (OLI)	Direct to Injections (D2I)
Arm/Group Description:		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.	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.
Overall Number of Participants Analyzed		163	271
Mean (Standard Deviation); Unit of Measure: Scores on scale
Anxiety Before, Month 2/1	Number Analyzed	163 participants	271 participants
		1.9 (1.02)	1.9 (1.02)
Anxiety Before, Month 6/5	Number Analyzed	160 participants	263 participants
		-0.14 (1.021)	-0.22 (1.000)
Anxiety Before, Month 12/11	Number Analyzed	152 participants	255 participants
		-0.28 (0.973)	-0.22 (0.914)
Pain, Month 2/1	Number Analyzed	163 participants	271 participants
		1.8 (0.88)	2.0 (0.93)
Pain, Month 6/5	Number Analyzed	160 participants	263 participants
		0.09 (0.907)	-0.03 (0.935)
Pain, Month 12/11	Number Analyzed	152 participants	255 participants
		0.13 (0.995)	0.02 (0.943)
Satisfaction, Month 2/1	Number Analyzed	163 participants	271 participants
		1.7 (0.90)	1.6 (0.81)
Satisfaction, Month 6/5	Number Analyzed	160 participants	263 participants
		-0.06 (0.837)	0.00 (0.867)
Satisfaction, Month 12/11	Number Analyzed	152 participants	255 participants
		-0.12 (0.861)	-0.11 (0.830)
Anxiety After, Month 2/1	Number Analyzed	163 participants	271 participants
		1.8 (1.12)	1.7 (0.96)
Anxiety After, Month 6/5	Number Analyzed	160 participants	263 participants
		-0.14 (0.994)	-0.04 (0.916)
Anxiety After, Month 12/11	Number Analyzed	152 participants	255 participants
		-0.24 (0.947)	-0.16 (0.850)
Willingness, Month 2/1	Number Analyzed	162 participants	271 participants
		1.4 (0.76)	1.4 (0.78)
Willingness, Month 6/5	Number Analyzed	157 participants	263 participants
		0.01 (0.716)	-0.08 (0.794)
Willingness, Month 12/11	Number Analyzed	151 participants	254 participants
		-0.01 (0.744)	-0.10 (0.742)

Adverse Events

Time Frame	All cause mortality, non-serious adverse events (Non-SAEs) and serious adverse events (SAEs) were collected maximum up to 12 months.
Adverse Event Reporting Description	Safety population included all randomly assigned participants who received at least one dose of study drug.
Arm/Group Title	Oral lead-in Phase (OLI)		Direct to Injections (D2I)		Biktarvy (BIK)
Arm/Group Description	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.		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.		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).
All-Cause Mortality
	Oral lead-in Phase (OLI)		Direct to Injections (D2I)		Biktarvy (BIK)
	Affected / at Risk (%)		Affected / at Risk (%)		Affected / at Risk (%)
Total	0/175 (0.00%)		0/279 (0.00%)		1/227 (0.44%)
Serious Adverse Events
	Oral lead-in Phase (OLI)		Direct to Injections (D2I)		Biktarvy (BIK)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/175 (6.29%)		10/279 (3.58%)		15/227 (6.61%)
Cardiac disorders
Acute myocardial infarction † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Atrial fibrillation † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Gastrointestinal disorders
Anorectal disorder † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
General disorders
Injection site pain † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Pyrexia † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Hepatobiliary disorders
Cholecystitis † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Infections and infestations
Cellulitis † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
COVID-19 † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	1/227 (0.44%)	1
Respiratory tract infection † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Anal abscess † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Appendicitis † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
COVID-19 pneumonia † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Herpes simplex meningitis † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Herpes simplex meningoencephalitis † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Pyelonephritis † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Tonsillitis † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Tuberculosis † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Injury, poisoning and procedural complications
Abdominal injury † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Overdose † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	1/227 (0.44%)	1
Road traffic accident † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	2/227 (0.88%)	2
Contusion † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Joint dislocation † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Radius fracture † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Skin abrasion † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Skin laceration † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Ulna fracture † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Investigations
Blood creatine phosphokinase increased † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Alanine aminotransferase increased † 1	2/175 (1.14%)	2	1/279 (0.36%)	1	0/227 (0.00%)	0
Metabolism and nutrition disorders
Obesity † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Musculoskeletal and connective tissue disorders
Bursitis † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Back pain † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Intervertebral disc protrusion † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bladder transitional cell carcinoma † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Glioblastoma multiforme † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Nervous system disorders
Syncope † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Brain injury † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Encephalopathy † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Haemorrhagic transformation stroke † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Product Issues
Device breakage † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Psychiatric disorders
Drug abuse † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Substance abuse † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Renal and urinary disorders
Acute kidney injury † 1	0/175 (0.00%)	0	0/279 (0.00%)	0	1/227 (0.44%)	1
Urinary retention † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
Skin and subcutaneous tissue disorders
Angioedema † 1	1/175 (0.57%)	1	0/279 (0.00%)	0	0/227 (0.00%)	0
Surgical and medical procedures
Abortion induced † 1	0/175 (0.00%)	0	1/279 (0.36%)	1	0/227 (0.00%)	0
1 Term from vocabulary, v24.1; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Oral lead-in Phase (OLI)		Direct to Injections (D2I)		Biktarvy (BIK)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	130/175 (74.29%)		217/279 (77.78%)		77/227 (33.92%)
Gastrointestinal disorders
Diarrhoea † 1	8/175 (4.57%)	11	19/279 (6.81%)	19	9/227 (3.96%)	9
General disorders
Injection site pain † 1	104/175 (59.43%)	506	178/279 (63.80%)	887	1/227 (0.44%)	2
Injection site nodule † 1	17/175 (9.71%)	28	25/279 (8.96%)	56	0/227 (0.00%)	0
Injection site swelling † 1	14/175 (8.00%)	40	26/279 (9.32%)	43	0/227 (0.00%)	0
Pyrexia † 1	10/175 (5.71%)	14	22/279 (7.89%)	32	8/227 (3.52%)	8
Injection site discomfort † 1	15/175 (8.57%)	56	24/279 (8.60%)	65	0/227 (0.00%)	0
Fatigue † 1	16/175 (9.14%)	19	14/279 (5.02%)	18	6/227 (2.64%)	7
Injection site induration † 1	17/175 (9.71%)	42	16/279 (5.73%)	33	0/227 (0.00%)	0
Infections and infestations
COVID-19 † 1	32/175 (18.29%)	33	41/279 (14.70%)	43	38/227 (16.74%)	38
Nasopharyngitis † 1	8/175 (4.57%)	11	18/279 (6.45%)	22	10/227 (4.41%)	13
Syphilis † 1	8/175 (4.57%)	9	19/279 (6.81%)	19	9/227 (3.96%)	10
Nervous system disorders
Headache † 1	16/175 (9.14%)	17	33/279 (11.83%)	43	12/227 (5.29%)	12
1 Term from vocabulary, v24.1; † Indicates events were collected by systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

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.

Results Point of Contact

• Name/Title: GSK Response Center
• Organization: ViiV Healthcare
• Phone: 866-435-7343
• EMail: GSKClinicalSupportHD@gsk.com

Publications:

Karver TS, Pascual-Bernaldez M, Berni A, Hnoosh A, Castagna A, Messiaen P, Puerto MJG, Bloch M, Adachi E, Sinclair G, Felizarta F, Angel JB, Sutton K, Sutherland-Phillips D, D'Amico R, Kerrigan D. Factors Associated with Health Care Providers' Preference for Forgoing an Oral Lead-In Phase When Initiating Long-Acting Injectable Cabotegravir and Rilpivirine in the SOLAR Clinical Trial. AIDS Patient Care STDS. 2023 Jan;37(1):53-59. doi: 10.1089/apc.2022.0168.

• Responsible Party: ViiV Healthcare
• ClinicalTrials.gov Identifier: NCT04542070
• Other Study ID Numbers: 213500
• First Submitted: September 1, 2020
• First Posted: September 9, 2020
• Results First Submitted: July 12, 2023
• Results First Posted: September 13, 2023
• Last Update Posted: September 13, 2023