Trial Outcomes & Findings for A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (NCT NCT05729568)

Results Overview

Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

83 participants

Primary outcome timeframe

Week 26

Results posted on

2026-04-27

Participant Flow

241 participants were screened. The study planned to enroll participants in Treatment Groups 1, 2 and 3. However, per review of the programmatic data overall and from study GS-US-536-5816 (NCT04811040), Treatment Group 2 was removed prior to dosing of all groups in the study and did not enroll any participants. Therefore, data is reported only for Treatment Groups 1 and 3.

Participants were enrolled at study sites in the United States, Puerto Rico, Australia, and Canada. Data submitted represent primary analysis performed on data collected by the Primary Completion Date and additional data collected up to Week 52 (31 Mar 2025). Complete data will be submitted within 1 year of the study completion date.

Participant milestones

Participant milestones
Measure	Extension Phase Treatment Group 3: SBR At Week 52, participants in this group will be given the option to participate in the Extension Phase to switch from oral ART to LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion, every 26 weeks at the dose specified for Treatment Group 1. Teropavimab: Administered intravenously. Zinlirvimab: Administered intravenously. Lenacapavir Tablet: Administered orally. Lenacapavir Injection: Administered subcutaneously	Randomized Phase Treatment Group 1: LEN + TAB + ZAB Participants received loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in Stay on Baseline Regimen (SBR) group continued their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.	Extension Phase: Treatment Group 1: LEN + TAB + ZAB At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will receive LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion. Teropavimab: Administered intravenously. Zinlirvimab: Administered intravenously. Lenacapavir Injection: Administered subcutaneously.
Randomized Phase STARTED	0	56	27	0
Randomized Phase COMPLETED	0	50	24	0
Randomized Phase NOT COMPLETED	0	6	3	0
Extension Phase STARTED	24	0	0	47
Extension Phase COMPLETED	0	0	0	0
Extension Phase NOT COMPLETED	24	0	0	47

Reasons for withdrawal

Reasons for withdrawal
Measure	Extension Phase Treatment Group 3: SBR At Week 52, participants in this group will be given the option to participate in the Extension Phase to switch from oral ART to LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion, every 26 weeks at the dose specified for Treatment Group 1. Teropavimab: Administered intravenously. Zinlirvimab: Administered intravenously. Lenacapavir Tablet: Administered orally. Lenacapavir Injection: Administered subcutaneously	Randomized Phase Treatment Group 1: LEN + TAB + ZAB Participants received loading dose of lenacapavir (LEN) 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg subcutaneous (SC) injection along with teropavimab (TAB) 2550 mg intravenous (IV) infusion and zinlirvimab (ZAB) 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in Stay on Baseline Regimen (SBR) group continued their baseline oral antiretroviral therapy (ART) up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.	Extension Phase: Treatment Group 1: LEN + TAB + ZAB At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL will be given the option to participate in the study extension phase. In the study extension phase, participants will receive LEN 927 mg SC, TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion. Teropavimab: Administered intravenously. Zinlirvimab: Administered intravenously. Lenacapavir Injection: Administered subcutaneously.
Randomized Phase Still on Study	0	2	1	0
Randomized Phase Randomized but Never Treated	0	3	0	0
Randomized Phase Adverse Event	0	0	1	0
Randomized Phase Investigator's Discretion	0	1	0	0
Randomized Phase Withdrew consent	0	0	1	0
Extension Phase Still On Study	24	0	0	47

Baseline Characteristics

A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Randomized Phase Treatment Group 1: LEN + TAB + ZAB n=53 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.	Total n=80 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants
Age, Categorical Between 18 and 65 years	52 Participants n=226 Participants	26 Participants n=240 Participants	78 Participants n=236 Participants
Age, Categorical >=65 years	1 Participants n=226 Participants	1 Participants n=240 Participants	2 Participants n=236 Participants
Age, Continuous	44 years STANDARD_DEVIATION 13.7 • n=226 Participants	53 years STANDARD_DEVIATION 9.6 • n=240 Participants	47 years STANDARD_DEVIATION 13.0 • n=236 Participants
Sex: Female, Male Female	8 Participants n=226 Participants	4 Participants n=240 Participants	12 Participants n=236 Participants
Sex: Female, Male Male	45 Participants n=226 Participants	23 Participants n=240 Participants	68 Participants n=236 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=226 Participants	7 Participants n=240 Participants	20 Participants n=236 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	40 Participants n=226 Participants	20 Participants n=240 Participants	60 Participants n=236 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants
Race (NIH/OMB) Asian	1 Participants n=226 Participants	1 Participants n=240 Participants	2 Participants n=236 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants
Race (NIH/OMB) Black or African American	21 Participants n=226 Participants	8 Participants n=240 Participants	29 Participants n=236 Participants
Race (NIH/OMB) White	28 Participants n=226 Participants	16 Participants n=240 Participants	44 Participants n=236 Participants
Race (NIH/OMB) More than one race	3 Participants n=226 Participants	2 Participants n=240 Participants	5 Participants n=236 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=226 Participants	0 Participants n=240 Participants	0 Participants n=236 Participants
Region of Enrollment United States	48 Participants n=226 Participants	19 Participants n=240 Participants	67 Participants n=236 Participants
Region of Enrollment Australia	2 Participants n=226 Participants	6 Participants n=240 Participants	8 Participants n=236 Participants
Region of Enrollment Puerto Rico	2 Participants n=226 Participants	1 Participants n=240 Participants	3 Participants n=236 Participants
Region of Enrollment Canada	1 Participants n=226 Participants	1 Participants n=240 Participants	2 Participants n=236 Participants
Clusters of Differentiation 4 (CD4)+ T-cell Counts	740 cells/µL STANDARD_DEVIATION 239.3 • n=226 Participants	764 cells/µL STANDARD_DEVIATION 264.9 • n=240 Participants	748 cells/µL STANDARD_DEVIATION 246.8 • n=236 Participants

PRIMARY outcome

Timeframe: Week 26

Population: Participants in the Full Analysis Set were analyzed. The Full Analysis Set included all randomized participants who received at least one dose of the complete long acting study drug regimen (ie, SC LEN + TAB, ZAB) or continued with their baseline ART regimen.

Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 26 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 26 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 26 analysis window and i) discontinued study drug prior to or in the Week 26 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 26 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 26 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=53 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Percentage of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) ≥ 50 Copies/mL at Week 26 as Determined by the United States Food and Drug Administration (US FDA)-Defined Snapshot Algorithm	1.9 percentage of participants Interval 0.0 to 10.1	0.0 percentage of participants Interval 0.0 to 12.8

SECONDARY outcome

Timeframe: Week 52

Population: Participants in the Full Analysis Set were analyzed.

Percentage of participants with HIV-1 RNA ≥ 50 copies/mL at Week 52 was analyzed using US FDA-defined snapshot algorithm, which defines a participant's virologic outcome and included participants a) who had last available on-treatment HIV-1 RNA ≥ 50 copies/mL in the Week 52 analysis window; or b) who did not have on-treatment HIV-1 RNA data in the Week 52 analysis window and i) discontinued study drug prior to or in the Week 52 analysis window due to lack of efficacy, or ii) discontinued study drug prior to or in the Week 52 analysis window due to adverse event (AE) or death and had last available on-treatment HIV-1 RNA ≥ 50 copies/mL, or iii) discontinued study drug prior to or in the Week 52 analysis window due to reasons other than AE, death, or lack of efficacy and had the last available on-treatment HIV-1 RNA ≥ 50 copies/mL. Clopper-Pearson exact method was used to calculate the 95% confidence interval (CI) for the outcome measure of each treatment. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=53 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm	5.7 percentage of participants Interval 1.2 to 15.7	0.0 percentage of participants Interval 0.0 to 12.8

SECONDARY outcome

Timeframe: Week 26

Population: Participants in the Full Analysis Set were analyzed.

Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 26 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \< 50 copies/mL in the Week 26 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=53 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 26 as Determined by the US FDA-defined Snapshot Algorithm	96.2 percentage of participants Interval 87.0 to 99.5	96.3 percentage of participants Interval 81.0 to 99.9

SECONDARY outcome

Timeframe: Week 52

Population: Participants in the Full Analysis Set were analyzed.

Percentage of participants with HIV-1 RNA \< 50 copies/mL at Week 52 was analyzed using the US FDA-defined snapshot algorithm, which defined a participant's virologic outcome and included participants who had the last available on-treatment HIV-1 RNA \< 50 copies/mL in the Week 52 analysis window. The Clopper-Pearson exact method was used to calculate the 95% CI for the outcome measure of each treatment. Percentages were rounded off.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=53 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Percentage of Participants With HIV-1 RNA < 50 Copies/mL at Week 52 as Determined by the US FDA-defined Snapshot Algorithm	88.7 percentage of participants Interval 77.0 to 95.7	92.6 percentage of participants Interval 75.7 to 99.1

SECONDARY outcome

Timeframe: Baseline, Week 26

Population: Participant in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=52 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=26 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Change From Baseline in Clusters of Differentiation 4 (CD4) + T-cell Counts at Week 26	23 cells/µL Standard Deviation 143.4	74 cells/µL Standard Deviation 202.6

SECONDARY outcome

Timeframe: Baseline, Week 52

Population: Participant in the Full Analysis Set with available data were analyzed.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=50 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=25 Participants Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Change From Baseline in CD4+ T-cell Counts at Week 52	10 cells/μL Standard Deviation 207.8	53 cells/μL Standard Deviation 123.6

SECONDARY outcome

Timeframe: Up to approximately 6 years

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 26 predose

Population: Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed. TAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing TAB concentration value reported by the PK laboratory test. ZAB PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 non-missing ZAB concentration value reported by the PK laboratory test.

Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=52 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Trough Concentration at Week 26 Predose for TAB and ZAB TAB	41.8 µg/mL Standard Deviation 22.7	—
Trough Concentration at Week 26 Predose for TAB and ZAB ZAB	72.0 µg/mL Standard Deviation 39.2	—

SECONDARY outcome

Timeframe: Week 26 predose

Population: Participants in the LEN PK Analysis Set with available data were analyzed. LEN PK Analysis Set included all randomized participants who have received at least 1 dose of study drug, and have at least 1 nonmissing LEN concentration value reported by the PK laboratory test.

Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=52 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Trough Concentration at Week 26 Predose for LEN	20.2 ng/mL Standard Deviation 10.6	—

SECONDARY outcome

Timeframe: Week 52 predose

Population: Participants in the TAB PK Analysis Set and ZAB PK Analysis Set with available data were analyzed.

Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=49 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Trough Concentration at Week 52 Predose for TAB and ZAB TAB	43.1 ug/mL Standard Deviation 17.0	—
Trough Concentration at Week 52 Predose for TAB and ZAB ZAB	56.6 ug/mL Standard Deviation 26.8	—

SECONDARY outcome

Timeframe: Week 52 predose

Population: Participants in the LEN PK Analysis Set with available data were analyzed

Trough concentration is defined as the concentration of the drug in plasma/serum at the end of the dosing interval.

Outcome measures

Outcome measures
Measure	Randomized Phase Treatment Group 1: LEN + TAB+ ZAB n=46 Participants Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Trough Concentration at Week 52 Predose for LEN	25.8 ng/mL Standard Deviation 14.2	—

SECONDARY outcome

Timeframe: Up to approximately 6 years

AUC0-tau is defined as the partial area under the concentration versus time curve from time "0" to time "t".

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

t1/2 is defined as the terminal elimination half-life.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

Cmax is defined as the maximum observed concentration of drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

Cmax is defined as the maximum observed concentration of drug.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

Tmax is defined as the time (observed time point) of Cmax.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to approximately 6 years

Anti-TAB and anti-ZAB antibodies incidence referred to the percentage of participants who have treatment-emergent anti-TAB and anti-ZAB antibodies among all participants evaluable for anti-drug antibody (ADA) incidence.

Outcome measures

Outcome data not reported

Adverse Events

Randomized Phase Treatment Group 1: LEN + TAB + ZAB

Serious events: 1 serious events

Other events: 43 other events

Deaths: 0 deaths

Randomized Phase Treatment Group 3: SBR

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Randomized Phase Treatment Group 1: LEN + TAB + ZAB n=53 participants at risk Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 participants at risk Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Infections and infestations Perineal abscess	1.9% 1/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Scrotal abscess	1.9% 1/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pancreatic carcinoma metastatic	0.00% 0/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).

Other adverse events

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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
Publication restrictions are in place

Restriction type: OTHER

Measure	Randomized Phase Treatment Group 1: LEN + TAB + ZAB n=53 participants at risk Participants received loading dose of LEN 600 mg tablets, orally, on Day 1 and Day 2. They received LEN 927 mg SC injection along with TAB 2550 mg IV infusion and ZAB 2550 mg IV infusion on Day 1 and every 26 weeks up to Week 52 in the Randomized Phase. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL were given the option to participate in the study extension phase. In the study extension phase, participants continued to receive their randomized study drugs every 26 weeks.	Randomized Phase Treatment Group 3: SBR n=27 participants at risk Participants in SBR group continued their baseline oral ART up to Week 52. Antiretroviral therapy included drugs like bictegravir/emtricitabine/tenofovir alafenamide, darunavir/cobicistat/emtricitabine/tenofovir alafenamide, dolutegravir/abacavir lamivudine, and rilpivirine/emtricitabine/tenofovir alafenamide, administered as per standard of care. At Week 52, participants in this group with HIV-1 RNA \< 50 copies/mL and in the absence of confirmed virologic rebound throughout the Randomized Phase of the study switched from oral ART to LEN, TAB and ZAB, every 26 weeks. The participants switched to receive LEN, TAB, and ZAB every 26 weeks beginning at Week 52.
Gastrointestinal disorders Constipation	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Gastrointestinal disorders Diarrhoea	13.2% 7/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Gastrointestinal disorders Haemorrhoids	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Gastrointestinal disorders Nausea	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
General disorders Injection site erythema	20.8% 11/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
General disorders Injection site induration	13.2% 7/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
General disorders Injection site mass	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
General disorders Injection site nodule	47.2% 25/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
General disorders Injection site pain	22.6% 12/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Covid-19	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	7.4% 2/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Paronychia	0.00% 0/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	7.4% 2/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Sinusitis	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Upper respiratory tract infection	9.4% 5/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Infections and infestations Viral upper respiratory tract infection	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	3.7% 1/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	7.4% 2/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).
Respiratory, thoracic and mediastinal disorders Cough	5.7% 3/53 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).	0.00% 0/27 • All-cause Mortality and Adverse events: Up to Week 52 All-cause mortality: All Randomized Analysis Set included all participants who were randomized into the study. Adverse events: Safety Analysis Set included all participants who were randomized and received at least 1 dose of study drug (ie, study treatment, including LEN, TAB, ZAB, or continued with their baseline ART regimen).