Study to Evaluate the Safety and Efficacy of Lenacapavir in Combination With Other Antiretroviral Agents in People Living With HIV (CALIBRATE)

• ClinicalTrials.gov Identifier: NCT04143594
• Recruitment Status: Completed
• First Posted: October 29, 2019
• Results First Posted: December 19, 2022
• Last Update Posted: October 10, 2023
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: HIV-1-infection
• Interventions: Drug: Oral Lenacapavir; Drug: F/TAF; Drug: Subcutaneous Lenacapavir; Drug: TAF; Drug: BIC; Drug: B/F/TAF
• Enrollment: 183

Participant Flow

Recruitment Details	Participants were enrolled at study sites in Dominican Republic, and the United States.
Pre-assignment Details	249 participants were screened.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description	Induction phase: Participants received lenacapavir (LEN) 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus emtricitabine/ tenofovir alafenamide (F/TAF) (200/25 mg) fixed-dose combination (FDC) tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous (SC) injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus bictegravir (BIC) 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Period Title: Overall Study
Started	52	53	52	26
Completed	1	0	0	6
Not Completed	51	53	52	20
Reason Not Completed
Still on study	48	42	48	18
Withdrew consent	0	6	1	1
Lost to Follow-up	2	2	3	0
Investigator's discretion	1	2	0	0
Lack of Efficacy	0	1	0	0
Protocol Violation	0	0	0	1

Baseline Characteristics

Arm/Group Title		Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF	Total
Arm/Group Description		Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.	Total of all reporting groups
Overall Number of Baseline Participants		52	53	52	25	182
Baseline Analysis Population Description		Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
		33 (9.5)	30 (8.8)	32 (12.3)	33 (11.1)	32 (10.4)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
	Female	5 9.6%	1 1.9%	6 11.5%	0 0.0%	12 6.6%
	Male	47 90.4%	52 98.1%	46 88.5%	25 100.0%	170 93.4%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Race	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
	American Indian or Alaska Native	1 1.9%	0 0.0%	0 0.0%	0 0.0%	1 0.5%
	Asian	1 1.9%	0 0.0%	1 1.9%	0 0.0%	2 1.1%
	Black	24 46.2%	24 45.3%	31 59.6%	16 64.0%	95 52.2%
	Native Hawaiian or Pacific Islander	1 1.9%	1 1.9%	0 0.0%	0 0.0%	2 1.1%
	White	23 44.2%	28 52.8%	19 36.5%	8 32.0%	78 42.9%
	Other	2 3.8%	0 0.0%	1 1.9%	1 4.0%	4 2.2%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants
Ethnicity	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
	Hispanic or Latino	25 48.1%	21 39.6%	24 46.2%	12 48.0%	82 45.1%
	Not Hispanic or Latino	27 51.9%	32 60.4%	28 53.8%	13 52.0%	100 54.9%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
Puerto Rico		1 1.9%	1 1.9%	5 9.6%	1 4.0%	8 4.4%
United States		37 71.2%	42 79.2%	37 71.2%	21 84.0%	137 75.3%
Dominican Republic		14 26.9%	10 18.9%	10 19.2%	3 12.0%	37 20.3%
Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA); Mean (Standard Deviation); Unit of measure: Log10 copies/mL
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
		4.18 (0.672)	4.35 (0.670)	4.33 (0.722)	4.35 (0.780)	4.30 (0.700)
HIV-1 RNA Categories; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
	<= 100,000 copies/mL	47 90.4%	44 83.0%	43 82.7%	21 84.0%	155 85.2%
	> 100,000 copies/mL	5 9.6%	9 17.0%	9 17.3%	4 16.0%	27 14.8%
Cluster Determinant 4+ (CD4) Cell Count; Mean (Standard Deviation); Unit of measure: cells/μL
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
		506 (297.0)	490 (209.9)	470 (221.7)	534 (260.0)	495 (246.5)
CD4 Cell Count Categories; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
	< 50 cells/μL	0 0.0%	0 0.0%	0 0.0%	0 0.0%	0 0.0%
	>= 50 to < 200 cells/μL	0 0.0%	1 1.9%	3 5.8%	0 0.0%	4 2.2%
	>= 200 to < 350 cells/μL	17 32.7%	15 28.3%	16 30.8%	4 16.0%	52 28.6%
	>= 350 to < 500 cells/μL	17 32.7%	15 28.3%	15 28.8%	11 44.0%	58 31.9%
	>= 500 cells/μL	18 34.6%	22 41.5%	18 34.6%	10 40.0%	68 37.4%
CD4 Percentage (%); Mean (Standard Deviation); Unit of measure: Percentage of CD4 cells
	Number Analyzed	52 participants	53 participants	52 participants	25 participants	182 participants
		24.2 (9.92)	24.1 (8.04)	22.7 (8.28)	26.2 (8.18)	24.0 (8.70)

Outcome Measures

1. Primary Outcome

Title	Percentage of Participants With Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) < 50 Copies/mL at Week 54 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm
Description	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 54 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 54 window was between Day 323 and 413 (inclusive).
Time Frame	Week 54

Outcome Measure Data

Analysis Population Description

Full Analysis Set included all randomized participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via subcutaneous injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	52	53	52	25
Measure Type: Number; Unit of Measure: percentage of participants
	90.4	84.9	84.6	92.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7178
	Comments	P-value was from the Cochran-Mantel-Haenszel (CMH) tests stratified by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-2.6
	Confidence Interval	(2-Sided) 95%; -18.4 to 13.2
	Estimation Comments	The difference in percentage of participants between LEN-containing and the B/F/TAF groups, and its 95% confidence interval (CI) were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3900
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.1
	Confidence Interval	(2-Sided) 95%; -23.4 to 9.3
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3797
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -23.5 to 9.1
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

2. Secondary Outcome

Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 28 as Determined by the US FDA-defined Snapshot Algorithm
Description	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 28 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 28 window was between Days 176 and 231 (inclusive).
Time Frame	Week 28

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	52	53	52	25
Measure Type: Number; Unit of Measure: percentage of participants
	94.2	92.5	94.2	100.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2398
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-5.5
	Confidence Interval	(2-Sided) 95%; -15.9 to 4.8
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.1639
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.4
	Confidence Interval	(2-Sided) 95%; -18.3 to 3.4
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2307
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-5.7
	Confidence Interval	(2-Sided) 95%; -16.3 to 4.9
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

3. Secondary Outcome

Title	Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 38 as Determined by the US FDA-defined Snapshot Algorithm
Description	The percentage of participants with HIV-1 RNA < 50 copies/mL at Week 38 was analyzed using the snapshot algorithm, which defines a participant's virologic response status using only the viral load at the predefined time point within an allowed window of time, along with study drug discontinuation status. Week 24 window was between Days 232 and 322 (inclusive).
Time Frame	Week 38

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	52	53	52	25
Measure Type: Number; Unit of Measure: percentage of participants
	90.4	88.7	88.5	96.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3142
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-6.7
	Confidence Interval	(2-Sided) 95%; -20.7 to 7.3
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.3009
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.2
	Confidence Interval	(2-Sided) 95%; -21.3 to 6.8
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2859
	Comments	P-value was from the CMH tests stratified by baseline HIV-1 RNA stratum (<= 100,000 vs. > 100,000 copies/mL).
	Method	Cochran-Mantel-Haenszel
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in percentage
	Estimated Value	-7.6
	Confidence Interval	(2-Sided) 95%; -21.8 to 6.7
	Estimation Comments	The difference in percentage of participants between LEN-containing treatment groups and the B/F/TAF group, and its 95% CI were calculated based on the MH proportions adjusted by baseline HIV-1 RNA stratum (≤ 100,000 vs > 100,000 copies/mL).

4. Secondary Outcome

Title	Proportion of Participants With HIV-1 RNA < 50 Copies/mL at Week 80 as Determined by the US FDA-defined Snapshot Algorithm
Description	[Not Specified]
Time Frame	Week 80

Outcome Measure Data Not Reported

5. Secondary Outcome

Title	Change From Baseline in Log10 HIV-1 RNA at Week 28
Description	[Not Specified]
Time Frame	Baseline; Week 28

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	51	50	25
Mean (Standard Deviation); Unit of Measure: log10 copies/mL
	-2.92 (0.649)	-3.04 (0.638)	-3.01 (0.716)	-3.07 (0.774)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5755
	Comments	P-value was from analysis of variance (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.08
	Confidence Interval	(2-Sided) 95%; -0.20 to 0.37
	Estimation Comments	Difference in least squares means (Diff in LSM), and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8697
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.29
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7052
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.06
	Confidence Interval	(2-Sided) 95%; -0.23 to 0.35
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

6. Secondary Outcome

Title	Change From Baseline in Log10 HIV-1 RNA at Week 38
Description	[Not Specified]
Time Frame	Baseline; Week 38

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	51	47	25
Mean (Standard Deviation); Unit of Measure: log10 copies/mL
	-2.96 (0.639)	-3.06 (0.641)	-3.02 (0.771)	-3.04 (0.760)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8942
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.02
	Confidence Interval	(2-Sided) 95%; -0.26 to 0.30
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9058
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-0.02
	Confidence Interval	(2-Sided) 95%; -0.28 to 0.25
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.8129
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.27 to 0.35
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

7. Secondary Outcome

Title	Change From Baseline in Log10 HIV-1 RNA at Week 54
Description	[Not Specified]
Time Frame	Baseline; Week 54

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	47	47	23
Mean (Standard Deviation); Unit of Measure: log10 copies/mL
	-2.95 (0.636)	-3.12 (0.589)	-2.85 (0.840)	-3.08 (0.787)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7864
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.04
	Confidence Interval	(2-Sided) 95%; -0.25 to 0.33
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7013
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-0.05
	Confidence Interval	(2-Sided) 95%; -0.31 to 0.21
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2753
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	0.22
	Confidence Interval	(2-Sided) 95%; -0.18 to 0.62
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

8. Secondary Outcome

Title	Change From Baseline in Log10 HIV-1 RNA at Week 80
Description	[Not Specified]
Time Frame	Baseline; Week 80

Outcome Measure Data Not Reported

9. Secondary Outcome

Title	Change From Baseline in Cluster Determinant 4+ (CD4+) Cell Count at Week 28
Description	[Not Specified]
Time Frame	Baseline; Week 28

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	50	50	25
Mean (Standard Deviation); Unit of Measure: cells/µL
	172 (178.2)	158 (164.1)	206 (154.6)	163 (157.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7751
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	12
	Confidence Interval	(2-Sided) 95%; -73 to 97
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.9549
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-2
	Confidence Interval	(2-Sided) 95%; -79 to 75
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.2603
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	44
	Confidence Interval	(2-Sided) 95%; -33 to 120
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

10. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Week 38
Description	[Not Specified]
Time Frame	Baseline; Week 38

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	51	46	25
Mean (Standard Deviation); Unit of Measure: cells/µL
	195 (164.6)	219 (187.4)	210 (167.1)	232 (209.3)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.4827
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-31
	Confidence Interval	(2-Sided) 95%; -119 to 57
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.7844
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-13
	Confidence Interval	(2-Sided) 95%; -106 to 81
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6082
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	-23
	Confidence Interval	(2-Sided) 95%; -112 to 66
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

11. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Week 54
Description	[Not Specified]
Time Frame	Baseline; Week 54

Outcome Measure Data

Analysis Population Description

Participants in the Full Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	49	47	47	23
Mean (Standard Deviation); Unit of Measure: cells/µL
	206 (187.0)	212 (187.1)	220 (175.5)	193 (191.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group 1: LEN + F/TAF + TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6614
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	21
	Confidence Interval	(2-Sided) 95%; -73 to 115
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Group 2: LEN + F/TAF + BIC, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.6791
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	20
	Confidence Interval	(2-Sided) 95%; -75 to 115
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Group 3: LEN + F/TAF, Group 4: B/F/TAF
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	0.5563
	Comments	P-value was from (ANOVA) model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).
	Method	ANOVA
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	Difference in LSM
	Estimated Value	27
	Confidence Interval	(2-Sided) 95%; -65 to 120
	Estimation Comments	Difference in LSM, and its 95% CI were from ANOVA model adjusting for the baseline HIV-1 RNA level (<= 100,000 copies/mL or > 100,000 copies/mL).

12. Secondary Outcome

Title	Change From Baseline in CD4+ Cell Count at Week 80
Description	[Not Specified]
Time Frame	Baseline; Week 80

Outcome Measure Data Not Reported

13. Secondary Outcome

Title	Percentage of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs)
Description	TEAEs were defined as 1 or both of any AEs leading to premature discontinuation of study drug, or any AEs with an onset date on or after the study drug start date and no later than the last exposure date after permanent discontinuation of the study drug.
Time Frame	First dose date up to 54 weeks

Outcome Measure Data

Analysis Population Description

Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	52	53	52	25
Measure Type: Number; Unit of Measure: percentage of participants
	96.2	84.9	82.7	84.0

14. Secondary Outcome

Title	Percentage of Participants Who Experienced Laboratory Abnormalities
Description	Treatment-emergent laboratory abnormalities were defined as values that increase at least 1 toxicity grade from baseline at any postbaseline visit, up to last exposure date for participants who permanently discontinued study drug, or the last available date in the database snapshot for participants who were still on treatment at the time of an interim analysis. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening.
Time Frame	First dose date up to 54 weeks

Outcome Measure Data

Analysis Population Description

Participants in the Safety Analysis Set were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
Overall Number of Participants Analyzed	52	53	52	25
Measure Type: Number; Unit of Measure: percentage of participants
Grade 1	15.4	3.8	19.2	0
Grade 2	57.7	62.3	51.9	76.0
Grade 3	11.5	20.8	17.3	24.0
Grade 4	9.6	7.5	7.7	0

15. Secondary Outcome

Title	Pharmacokinetics (PK) of TAF (Tenofovir Alafenamide)and TFV (Tenofovir): Area Under the Concentration Versus Time Curve (AUClast) on Day 1
Description	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2) and at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Outcome Measure Data

Analysis Population Description

PK Substudy Analysis Set included participants who were randomized into the study, were enrolled into the PK Substudy, had received at least 1 dose of active study drug, and had at least 1 nonmissing intensive PK substudy concentration value for any analyte of interest reported by the PK lab.

Arm/Group Title		Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:		Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed		10	14
Mean (Standard Deviation); Unit of Measure: hours*nanogram/mL (h*ng/mL)
TAF	Number Analyzed	10 participants	14 participants
		298.0 (88.0)	260.0 (63.5)
TFV	Number Analyzed	4 participants	9 participants
		27.1 (27.9)	40.5 (59.7)

16. Secondary Outcome

Title	PK of TAF and TFV (Tenofovir): Maximum Observed Concentration of Drug (Cmax) on Day 1
Description	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title		Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:		Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed		10	14
Mean (Standard Deviation); Unit of Measure: ng/mL
TAF	Number Analyzed	10 participants	14 participants
		278.8 (87.7)	318.4 (57.7)
TFV	Number Analyzed	4 participants	9 participants
		5.4 (26.5)	13.8 (160.2)

17. Secondary Outcome

Title	PK of TAF and TFV: Time (Observed Time Point) of Cmax (Tmax) on Day 1
Description	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 and 2 on Day 1.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title		Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:		Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed		10	14
Median (Inter-Quartile Range); Unit of Measure: hours
TAF	Number Analyzed	10 participants	14 participants
		0.50; (0.50 to 1.00)	0.50; (0.50 to 0.50)
TFV	Number Analyzed	4 participants	9 participants
		1.50; (1.00 to 2.02)	1.00; (0.50 to 1.17)

18. Secondary Outcome

Title	PK of TFV: Last Observed Quantifiable Concentration of the Drug (Clast) on Day 1
Description	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK sub study analysis was conducted for Group 1 and 2 on Day 1.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose on Day 1

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	4	9
Mean (Standard Deviation); Unit of Measure: ng/mL
	2.7 (23.1)	3.9 (38.0)

19. Secondary Outcome

Title	PK of TAF and TFV: AUClast at Weeks 16, 22, or 28
Description	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 3: LEN + F/TAF
Arm/Group Description:	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: h*ng/mL
TAF	231.2 (60.0)
TFV	173.1 (52.5)

20. Secondary Outcome

Title	PK of TAF and TFV: Cmax at Weeks 16, 22, or 28
Description	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 3: LEN + F/TAF
Arm/Group Description:	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: ng/mL
TAF	308.7 (74.7)
TFV	31.2 (51.7)

21. Secondary Outcome

Title	PK of TAF and TFV: Tmax at Weeks 16, 22, or 28
Description	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TAF and TFV were summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 3: LEN + F/TAF
Arm/Group Description:	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Median (Inter-Quartile Range); Unit of Measure: hours
TAF	0.53; (0.50 to 1.04)
TFV	1.00; (1.00 to 2.00)

22. Secondary Outcome

Title	PK of TFV: Clast at Weeks 16, 22, or 28
Description	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 15 participants in the treatment group receiving oral LEN (Treatment Group 3). Key PK parameters of TFV was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. For each participant, PK samples were taken at only one of the three possible visits: Weeks 16, 22, or 28. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 3: LEN + F/TAF
Arm/Group Description:	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: ng/mL
	22.2 (62.6)

23. Secondary Outcome

Title	PK of TAF: AUClast at Week 38
Description	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	211.5 (74.1)

24. Secondary Outcome

Title	PK of TAF: Cmax at Week 38
Description	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: ng/mL
	279.0 (67.8)

25. Secondary Outcome

Title	PK of TAF: Tmax at Week 38
Description	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). Key PK parameters of TAF was summarized for participants in the PK Sub study Analysis Set by treatment group, analyte and visit. PK substudy analysis was conducted for Group 1 at Week 38.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	11
Median (Inter-Quartile Range); Unit of Measure: hours
	0.50; (0.50 to 0.50)

26. Secondary Outcome

Title	PK of Tenofovir Diphosphate (TFV-DP): AUClast at Weeks 4, 10, 16, or 22
Description	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A peripheral blood mononuclear cell (PBMC) substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 1, 2, and 6 hours postdose

Outcome Measure Data

Analysis Population Description

The PBMC PK Substudy Analysis Set included all randomized participants who took at least 1 dose of study drug, participated in the PBMC substudy, and have at least 1 nonmissing postdose concentration value for tenofovir diphosphate (TFV-DP). The PBMC PK Substudy Analysis Set was used for PK analyses of TFV-DP.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: hours*micrometer (h*μM)
	16.2 (68.3)	21.6 (71.9)

27. Secondary Outcome

Title	PK of TFV-DP: Cmax at Weeks 4, 10, 16, or 22
Description	Cmax is defined as the maximum observed concentration of drug. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 1, 2, and 6 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	13	13
Mean (Standard Deviation); Unit of Measure: micrometer (μM)
	3.3 (37.5)	4.3 (71.8)

28. Secondary Outcome

Title	PK of TFV-DP: Tmax at Weeks 4, 10, 16, or 22
Description	Tmax is defined as the time (observed time point) of Cmax. A PBMC substudy was conducted in a total of approximately 15 participants in Treatment Groups 1 and 2. For each participant, PK samples were taken at only one of the four possible visits: Weeks 4, 10, 16, or 22. A 12-hour postdose sample was collected, if possible. The PK results were combined and summarized without regard to specific study visit within the range of prespecified study visits.
Time Frame	0 hours (Predose) and at 1, 2, and 6 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PBMC PK Substudy Analysis Set with the available data were analyzed.

Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	13	13
Median (Inter-Quartile Range); Unit of Measure: hours
	2.00; (1.00 to 6.00)	6.00; (1.00 to 6.00)

29. Secondary Outcome

Title	PK of Bictegravir (BIC): AUClast at Week 38
Description	AUClast is defined as area under the concentration versus time curve from time zero to the last quantifiable concentration. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	11
Mean (Standard Deviation); Unit of Measure: h*ng/mL
	72865.9 (31.0)

30. Secondary Outcome

Title	PK of BIC: Cmax at Week 38
Description	Cmax is defined as the maximum observed concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: ng/mL
	10180.0 (42.8)

31. Secondary Outcome

Title	PK of BIC: Tmax at Week 38
Description	Tmax is defined as the time (observed time point) of Cmax. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Median (Inter-Quartile Range); Unit of Measure: hours
	2.00; (1.00 to 3.00)

32. Secondary Outcome

Title	PK of BIC: Clast at Week 38
Description	Clast is defined as the last observable concentration of drug. A PK substudy was conducted in at least 10 participants in each of the treatment groups receiving SC LEN (Treatment Groups 1 and 2). At Week 38, samples were analyzed for BIC only in Treatment Group 2.
Time Frame	0 hours (Predose) and at 0.5, 1, 2, 3, 4, 5, 6, and 8 hours postdose

Outcome Measure Data

Analysis Population Description

Participants in the PK Substudy Analysis Set with available data were analyzed.

Arm/Group Title	Group 2: LEN + F/TAF + BIC
Arm/Group Description:	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.
Overall Number of Participants Analyzed	12
Mean (Standard Deviation); Unit of Measure: ng/mL
	8474.5 (33.3)

Adverse Events

Time Frame	Adverse Events: First dose date up to 54 weeks; All-Cause Mortality: Enrollment up to 54 weeks
Adverse Event Reporting Description	All-cause mortality: All Randomized Analysis Set included all participants who were randomized in the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug.
Arm/Group Title	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
Arm/Group Description	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus TAF 25 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily TAF 25 mg tablets from Week 80 onwards.	Induction phase: Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 300 mg tablet orally on Day 8 plus F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 to Week 28 plus LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Day 15. Maintenance phase: Participants received LEN 927 mg (309 mg/mL; 2 X 1.5 mL) via SC injection on Week 28 and every 6 months (26 weeks) thereafter plus BIC 75 mg tablets once daily orally at Week 28 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive SC LEN 927 mg injection every 6 months (26 weeks) and oral daily BIC 75 mg tablets from Week 80 onwards.	Participants received LEN 600 mg (2 X 300 mg, tablet) orally on Days 1 and 2, followed by LEN 50 mg tablets once daily orally from Day 3 and will continue up to Week 80. Participants received F/TAF (200/25 mg) FDC tablets once daily orally from Day 1 and will continue up to Week 80. Participants willing to continue the study beyond Week 80 will continue to receive oral daily LEN 50 mg tablets and oral daily F/TAF 200/25 mg FDC tablets from Week 80 onwards.	Participants received B/F/TAF (50/200/25 mg) FDC tablets once daily orally from Day 1 and throughout their participation in the study.
All-Cause Mortality
	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	0/52 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	0/26 (0.00%)
Serious Adverse Events
	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	3/52 (5.77%)	3/53 (5.66%)	4/52 (7.69%)	0/25 (0.00%)
Blood and lymphatic system disorders
Lymphadenopathy mediastinal † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Gastrointestinal disorders
Vomiting † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Infections and infestations
Escherichia infection † 1	0/52 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/25 (0.00%)
Hepatitis A † 1	0/52 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/25 (0.00%)
Perirectal abscess † 1	0/52 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/25 (0.00%)
Pneumocystis jirovecii pneumonia † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Pneumonia † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Staphylococcal infection † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Injury, poisoning and procedural complications
Poisoning † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Non-small cell lung cancer † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Uterine leiomyoma † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Psychiatric disorders
Bipolar disorder † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Major depression † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Mental disorder † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Psychotic disorder † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
Substance-induced psychotic disorder † 1	0/52 (0.00%)	1/53 (1.89%)	0/52 (0.00%)	0/25 (0.00%)
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Pleural effusion † 1	1/52 (1.92%)	0/53 (0.00%)	0/52 (0.00%)	0/25 (0.00%)
Pneumothorax † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	0/25 (0.00%)
1 Term from vocabulary, MedDRA (23.1); † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Group 1: LEN + F/TAF + TAF	Group 2: LEN + F/TAF + BIC	Group 3: LEN + F/TAF	Group 4: B/F/TAF
	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)	Affected / at Risk (%)
Total	45/52 (86.54%)	40/53 (75.47%)	36/52 (69.23%)	19/25 (76.00%)
Blood and lymphatic system disorders
Lymphadenopathy † 1	4/52 (7.69%)	4/53 (7.55%)	6/52 (11.54%)	1/25 (4.00%)
Gastrointestinal disorders
Abdominal pain † 1	4/52 (7.69%)	1/53 (1.89%)	1/52 (1.92%)	1/25 (4.00%)
Abdominal pain upper † 1	2/52 (3.85%)	0/53 (0.00%)	0/52 (0.00%)	2/25 (8.00%)
Constipation † 1	0/52 (0.00%)	0/53 (0.00%)	3/52 (5.77%)	0/25 (0.00%)
Diarrhoea † 1	3/52 (5.77%)	4/53 (7.55%)	5/52 (9.62%)	1/25 (4.00%)
Nausea † 1	10/52 (19.23%)	5/53 (9.43%)	6/52 (11.54%)	1/25 (4.00%)
Vomiting † 1	2/52 (3.85%)	1/53 (1.89%)	4/52 (7.69%)	0/25 (0.00%)
General disorders
Fatigue † 1	0/52 (0.00%)	6/53 (11.32%)	2/52 (3.85%)	1/25 (4.00%)
Injection site erythema † 1	21/52 (40.38%)	12/53 (22.64%)	0/52 (0.00%)	0/25 (0.00%)
Injection site induration † 1	8/52 (15.38%)	5/53 (9.43%)	0/52 (0.00%)	0/25 (0.00%)
Injection site inflammation † 1	10/52 (19.23%)	4/53 (7.55%)	0/52 (0.00%)	0/25 (0.00%)
Injection site nodule † 1	9/52 (17.31%)	8/53 (15.09%)	0/52 (0.00%)	0/25 (0.00%)
Injection site pain † 1	15/52 (28.85%)	10/53 (18.87%)	0/52 (0.00%)	0/25 (0.00%)
Injection site swelling † 1	16/52 (30.77%)	13/53 (24.53%)	0/52 (0.00%)	0/25 (0.00%)
Pyrexia † 1	3/52 (5.77%)	2/53 (3.77%)	2/52 (3.85%)	2/25 (8.00%)
Infections and infestations
Acarodermatitis † 1	3/52 (5.77%)	0/53 (0.00%)	1/52 (1.92%)	1/25 (4.00%)
Anal chlamydia infection † 1	0/52 (0.00%)	1/53 (1.89%)	3/52 (5.77%)	0/25 (0.00%)
Covid-19 † 1	5/52 (9.62%)	5/53 (9.43%)	5/52 (9.62%)	3/25 (12.00%)
Gonorrhoea † 1	2/52 (3.85%)	2/53 (3.77%)	3/52 (5.77%)	1/25 (4.00%)
Influenza † 1	4/52 (7.69%)	2/53 (3.77%)	5/52 (9.62%)	0/25 (0.00%)
Nasopharyngitis † 1	4/52 (7.69%)	4/53 (7.55%)	3/52 (5.77%)	0/25 (0.00%)
Onychomycosis † 1	3/52 (5.77%)	1/53 (1.89%)	2/52 (3.85%)	0/25 (0.00%)
Oropharyngeal gonococcal infection † 1	1/52 (1.92%)	1/53 (1.89%)	3/52 (5.77%)	1/25 (4.00%)
Otitis media † 1	0/52 (0.00%)	0/53 (0.00%)	1/52 (1.92%)	2/25 (8.00%)
Proctitis gonococcal † 1	0/52 (0.00%)	1/53 (1.89%)	3/52 (5.77%)	0/25 (0.00%)
Syphilis † 1	5/52 (9.62%)	4/53 (7.55%)	5/52 (9.62%)	4/25 (16.00%)
Upper respiratory tract infection † 1	2/52 (3.85%)	0/53 (0.00%)	2/52 (3.85%)	3/25 (12.00%)
Urinary tract infection † 1	1/52 (1.92%)	1/53 (1.89%)	4/52 (7.69%)	1/25 (4.00%)
Injury, poisoning and procedural complications
Ligament sprain † 1	0/52 (0.00%)	0/53 (0.00%)	0/52 (0.00%)	2/25 (8.00%)
Investigations
Weight increased † 1	2/52 (3.85%)	1/53 (1.89%)	2/52 (3.85%)	3/25 (12.00%)
Metabolism and nutrition disorders
Hypertriglyceridaemia † 1	0/52 (0.00%)	3/53 (5.66%)	0/52 (0.00%)	0/25 (0.00%)
Vitamin D deficiency † 1	0/52 (0.00%)	4/53 (7.55%)	3/52 (5.77%)	1/25 (4.00%)
Musculoskeletal and connective tissue disorders
Arthralgia † 1	2/52 (3.85%)	4/53 (7.55%)	2/52 (3.85%)	4/25 (16.00%)
Back pain † 1	1/52 (1.92%)	4/53 (7.55%)	4/52 (7.69%)	3/25 (12.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts † 1	0/52 (0.00%)	1/53 (1.89%)	3/52 (5.77%)	1/25 (4.00%)
Nervous system disorders
Dizziness † 1	3/52 (5.77%)	2/53 (3.77%)	2/52 (3.85%)	1/25 (4.00%)
Headache † 1	9/52 (17.31%)	5/53 (9.43%)	7/52 (13.46%)	3/25 (12.00%)
Psychiatric disorders
Anxiety † 1	2/52 (3.85%)	2/53 (3.77%)	3/52 (5.77%)	2/25 (8.00%)
Depression † 1	1/52 (1.92%)	6/53 (11.32%)	3/52 (5.77%)	1/25 (4.00%)
Insomnia † 1	1/52 (1.92%)	0/53 (0.00%)	2/52 (3.85%)	3/25 (12.00%)
Respiratory, thoracic and mediastinal disorders
Cough † 1	3/52 (5.77%)	1/53 (1.89%)	1/52 (1.92%)	1/25 (4.00%)
Oropharyngeal pain † 1	2/52 (3.85%)	4/53 (7.55%)	3/52 (5.77%)	0/25 (0.00%)
Rhinitis allergic † 1	0/52 (0.00%)	1/53 (1.89%)	3/52 (5.77%)	0/25 (0.00%)
Skin and subcutaneous tissue disorders
Rash † 1	1/52 (1.92%)	0/53 (0.00%)	3/52 (5.77%)	2/25 (8.00%)
Vascular disorders
Hypertension † 1	3/52 (5.77%)	3/53 (5.66%)	1/52 (1.92%)	1/25 (4.00%)
1 Term from vocabulary, MedDRA (23.1); † 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.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

• The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
• The study has been completed at all study sites for at least 2 years

Results Point of Contact

• Name/Title: Gilead Clinical Study Information Center
• Organization: Gilead Sciences
• Phone: 1-833-445-3230 (GILEAD-0)
• EMail: GileadClinicalTrials@gilead.com

Publications:

Gupta SK, Berhe M, Crofoot G, et al. Long-Acting Subcutaneous Lenacapavir Dosed Every 6 Months as part of a Combination Regimen in Treatment-Naïve People with HIV: Interim 16-week Results of a Randomized, Open-label, Phase 2 Induction-Maintenance Study (CALIBRATE)

VanderVeen, L, Margot N, Naik V, et al. Interim Resistance Analysis of Long-Acting Lenacapavir in Treatment-Naïve People with HIV at 28 Weeks (CALIBRATE)

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Harris P, Henderson R, Hayward P. Highlights from the 11th IAS Conference on Science. Lancet HIV. 2021 Aug;8(8):e459. doi: 10.1016/S2352-3018(21)00161-2. No abstract available.

• Responsible Party: Gilead Sciences
• ClinicalTrials.gov Identifier: NCT04143594
• Other Study ID Numbers: GS-US-200-4334
• First Submitted: October 28, 2019
• First Posted: October 29, 2019
• Results First Submitted: September 29, 2022
• Results First Posted: December 19, 2022
• Last Update Posted: October 10, 2023