Trial Outcomes & Findings for Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (NCT NCT04223778)

Last Updated: 2026-02-18

Results Overview

HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime polymerase chain reaction (PCR) assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

672 participants

Primary outcome timeframe

Week 48

Results posted on

2026-02-18

Participant Flow

Adult human immunodeficiency virus-1 (HIV-1)-infected participants receiving baseline antiretroviral therapy (ART) were enrolled. 672 participants were randomly assigned in a 1:1 ratio to either Group 1: participants switched from baseline ART to doravirine (DOR)/islatravir (ISL) on Day 1 to Week 96; or Group 2: participants continued baseline ART until Week 48 then delayed switch to DOR/ISL from Week 48 to Week 96.

Participant milestones

Participant milestones
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Overall Study STARTED	336	336
Overall Study Group 1 Participants Who Received DOR/ISL From 0-48 Weeks	336	0
Overall Study Group 1 Participants Who Received DOR/ISL From 48-96 Weeks	322	0
Overall Study Group 2 Participants Who Received Baseline ART From Weeks 0-48	0	336
Overall Study Group 2 Participants Who Delayed Switch Over to DOR/ISL Weeks 48-96	0	326
Overall Study COMPLETED	279	299
Overall Study NOT COMPLETED	57	37

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Overall Study Death	1	1
Overall Study Lost to Follow-up	4	5
Overall Study Physician Decision	10	6
Overall Study Withdrawal by Subject	35	17
Overall Study Not Reported	7	8

Baseline Characteristics

Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.	Total n=672 Participants Total of all reporting groups
Age, Continuous	45.5 Years STANDARD_DEVIATION 11.7 • n=4 Participants	45.4 Years STANDARD_DEVIATION 11.7	45.5 Years STANDARD_DEVIATION 11.7 • n=4 Participants
Sex: Female, Male Female	123 Participants n=4 Participants	126 Participants	249 Participants n=4 Participants
Sex: Female, Male Male	213 Participants n=4 Participants	210 Participants	423 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	67 Participants n=4 Participants	64 Participants	131 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	266 Participants n=4 Participants	270 Participants	536 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=4 Participants	2 Participants	5 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	4 Participants n=4 Participants	8 Participants	12 Participants n=4 Participants
Race (NIH/OMB) Asian	19 Participants n=4 Participants	19 Participants	38 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=4 Participants	2 Participants	2 Participants n=4 Participants
Race (NIH/OMB) Black or African American	88 Participants n=4 Participants	91 Participants	179 Participants n=4 Participants
Race (NIH/OMB) White	210 Participants n=4 Participants	198 Participants	408 Participants n=4 Participants
Race (NIH/OMB) More than one race	13 Participants n=4 Participants	16 Participants	29 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=4 Participants	2 Participants	4 Participants n=4 Participants
ART Regimen Stratification PI-containing regimens (including PI- and InSTI-containing regimens)	46 Participants n=4 Participants	46 Participants	92 Participants n=4 Participants
ART Regimen Stratification InSTI-based regimens (non-PI containing regimens)	174 Participants n=4 Participants	174 Participants	348 Participants n=4 Participants
ART Regimen Stratification All other non-PI- and non-InSTI containing regimens	116 Participants n=4 Participants	116 Participants	232 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 48

Population: All randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants With Human Immunodeficiency Virus (HIV)-1 Ribonucleic Acid (RNA) ≥50 Copies/mL at Week 48	0.0 Percentage of Participants	1.5 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~48 Weeks

Population: All randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants With One or More Adverse Events (AEs) up to Week 48	80.1 Percentage of Participants	70.2 Percentage of Participants

PRIMARY outcome

Timeframe: Up to ~48 Weeks

Population: All randomized participants who received at least one dose of study intervention.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 48	2.1 Percentage of Participants	0.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 48

Population: All randomized participants who received at least one dose of study intervention.

HIV-1 RNA levels in blood samples taken at each visit were measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA \<40 copies/mL or \<50 copies/mL at Week 48 is presented using the FDA Snapshot missing data approach.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48 HIV-1 RNA <40 copies/mL	94.6 Percentage of Participants	94.3 Percentage of Participants
Percentage of Participants With HIV-1 RNA <40 or <50 Copies/mL at Week 48 HIV-1 RNA <50 copies/mL	95.2 Percentage of Participants	94.3 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: The analysis population consisted of all randomized participants in Group 2 who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96 who received at least one dose of study intervention and had data available for this outcome measure. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 1 participants is a separate outcome measure and is presented later in the record.

HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 1 participants is a separate outcome measure and is presented later in the record.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=326 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 2 (Switch-Over): Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA ≥50 copies/mL	—	0.9 Percentage of Participants Interval 0.2 to 2.7
Group 2 (Switch-Over): Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA <50 copies/mL	—	89.6 Percentage of Participants Interval 85.7 to 92.7
Group 2 (Switch-Over): Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA <40 copies/mL	—	89.6 Percentage of Participants Interval 85.7 to 92.7

SECONDARY outcome

Timeframe: Week 96

Population: The analysis population consisted of all randomized participants in Group 1 who received at least one dose of study intervention and had data available for this outcome measure. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96 is a separate outcome measure and is presented earlier in the record.

HIV-1 RNA levels in blood samples taken at each visit was measured by the Abbott RealTime PCR assay with a reliable lower limit of quantification of 40 copies/mL. The percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with HIV-1 RNA ≥50 copies/mL, \<40 copies/mL, or \<50 copies/mL at Week 96 for Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96 is a separate outcome measure and is presented earlier in the record.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1: Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA ≥50 copies/mL	1.2 Percentage of Participants Interval 0.3 to 3.0	—
Group 1: Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA <40 copies/mL	86.0 Percentage of Participants Interval 81.8 to 89.5	—
Group 1: Percentage of Participants With HIV-1 RNA ≥50 Copies/mL, <40 Copies/mL or <50 Copies/mL at Week 96 HIV-1 RNA <50 copies/mL	85.7 Percentage of Participants Interval 81.5 to 89.3	—

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants who received at least one dose of study intervention and who have baseline data.

Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for baseline and 48 weeks. Baseline measurements were defined as the Day 1 value of each participant. The percentage change from baseline to Week 48 is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=313 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=311 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage Change From Baseline in CD4+ T-cell Count at Week 48	-0.7 Percentage Change Interval -4.0 to 2.6	8.7 Percentage Change Interval 5.4 to 12.0

SECONDARY outcome

Timeframe: Baseline and Week 96

Population: The analysis population consisted of all randomized participants in Group 1 who received at least one dose of study intervention and had data, including baseline data, available for this outcome measure. Per protocol, the percentage change from baseline in CD4+ T-cell count at Week 96 for Group 2 participants was not planned or conducted.

Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for baseline and 96 weeks. Baseline measurements were defined as the Day 1 value of each participant. The mean percent change from baseline to Week 96 in CD4+ T-cell count is reported for Group 1 participants. Per protocol, the mean percentage change from baseline in CD4+ T-cell count at Week 96 for Group 2 participants was not planned or conducted.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=284 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1: Percentage Change From Baseline in CD4+ T-cell Count at Week 96	4.49 Percentage Change Interval 0.56 to 8.43	—

SECONDARY outcome

Timeframe: Week 48 and Week 96

Population: The analysis population consisted of all randomized participants who received at least one dose of study intervention and had data available for this outcome measure for participants in Group 1 and participants in Group 2 who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.

Plasma CD4+ T-Cell Count was measured in cells/mm\^3 for Week 48 and Week 96. The mean percent change from Week 48 to Week 96 is reported for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL Week 48 to Week 96.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=289 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=285 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1 & Group 2 (Switch-Over): Percentage Change From Week 48 in CD4+ T-cell Count at Week 96	5.29 Percentage Change Interval 1.99 to 8.58	0.16 Percentage Change Interval -2.96 to 3.29

SECONDARY outcome

Timeframe: Week 48

Population: Participants who met the definition of confirmed virologic rebound (two consecutive \[2 to 4 weeks apart\] occurrences of HIV-1 RNA ≥200 copies/mL) at any time during the study or who discontinued study intervention for another reason and have HIV-1 RNA ≥200 copies/mL at the time of discontinuation. Participants for whom available genotypic or phenotypic data showed evidence of resistance, irrespective of viral load, were also included.

Viral drug resistance is defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrated drug resistance at Week 48 is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=336 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 48	0.0 Percentage of Participants	0.9 Percentage of Participants

SECONDARY outcome

Timeframe: Week 96

Population: Analysis population included participants with virologic rebound (2 repeated incidents of HIV-1 RNA ≥200 copies/mL, 2-4 weeks apart) or who discontinued study intervention with HIV-1 RNA ≥200 copies/mL. Participants with available data showing resistance, despite viral load, are included. Per protocol, percentage of participants with evidence of viral drug resistance associated substitutions from week 0 to week 48 for Groups 1 and 2 is a separate outcome measure reported earlier in the record.

Viral drug resistance was defined as participants with confirmed HIV-1 RNA ≥400 copies/mL and/or genotypic or phenotypic analysis of data showing evidence of resistance to the study drug administered. The percentage of participants who demonstrate drug resistance at Week 96 is presented for Group 1 and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96. Per protocol, the percentage of participants with evidence of viral drug resistance-associated substitutions from week 0 to week 48 for Group 1 and Group 2 participants is a separate outcome measure and is presented earlier in the record.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=326 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Percentage of Participants With Evidence of Viral Drug Resistance-associated Substitutions at Week 96	0.0 Percentage of Participants	0.0 Percentage of Participants

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants on PI-containing regimens (including PI- and InSTI-containing regimens) who received at least one dose of study intervention and had baseline and Week 24 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=32 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=40 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Cholesterol	-12.94 mg/dL Interval -23.94 to -1.94	6.20 mg/dL Interval -2.16 to 14.56
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting HDL	-0.97 mg/dL Interval -5.94 to 4.0	0.76 mg/dL Interval -1.8 to 3.32
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting LDL Cholesterol	-7.47 mg/dL Interval -15.86 to 0.92	5.93 mg/dL Interval -1.08 to 12.93
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Non-HDL Cholesterol	-11.97 mg/dL Interval -21.83 to -2.1	5.44 mg/dL Interval -2.29 to 13.16
Change From Baseline to Week 24 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Triglycerides	-22.69 mg/dL Interval -42.92 to -2.46	-3.16 mg/dL Interval -19.81 to 13.49

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants on InSTI-based regimens (non-PI containing regimens) who received at least one dose of study intervention and had baseline and Week 24 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=130 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=135 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Cholesterol	2.98 mg/dL Interval -2.19 to 8.14	8.74 mg/dL Interval 4.25 to 13.23
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting HDL Cholesterol	0.84 mg/dL Interval -1.11 to 2.79	0.27 mg/dL Interval -1.06 to 1.6
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting LDL Cholesterol	3.21 mg/dL Interval -1.49 to 7.92	8.50 mg/dL Interval 4.27 to 12.73
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Non-HDL Cholesterol	2.14 mg/dL Interval -3.39 to 7.67	8.47 mg/dL Interval 4.05 to 12.9
Change From Baseline to Week 24 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Triglycerides	-0.97 mg/dL Interval -17.98 to 16.04	-1.56 mg/dL Interval -10.8 to 7.69

SECONDARY outcome

Timeframe: Baseline and Week 24

Population: All randomized participants on all other non-PI- and non-InSTI containing regimens, who received at least one dose of study intervention and had baseline and Week 24 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 24. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 24 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=89 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=95 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Cholesterol	7.18 mg/dL Interval -0.49 to 14.85	7.35 mg/dL Interval 2.44 to 12.25
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting HDL Cholesterol	-3.43 mg/dL Interval -6.51 to -0.36	-0.72 mg/dL Interval -3.02 to 1.58
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting LDL Cholesterol	11.33 mg/dL Interval 5.75 to 16.92	7.19 mg/dL Interval 3.35 to 11.04
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Non-HDL Cholesterol	11.07 mg/dL Interval 4.4 to 17.74	8.07 mg/dL Interval 4.1 to 12.04
Change From Baseline to Week 24 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Triglycerides	-1.16 mg/dL Interval -14.27 to 11.95	4.45 mg/dL Interval -3.89 to 12.8

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants on PI-containing regimens (including PI- and InSTI-containing regimens) who received at least one dose of study intervention and had baseline and Week 48 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on PI-containing regimens (including PI- and InSTI-containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting high density lipoprotein (HDL) cholesterol, fasting low density lipoprotein (LDL) cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=29 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=37 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Cholesterol	-15.31 mg/dL Interval -28.99 to -1.64	1.84 mg/dL Interval -5.7 to 9.38
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting HDL Cholesterol	-1.45 mg/dL Interval -6.01 to 3.11	-1.08 mg/dL Interval -3.91 to 1.75
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting LDL Cholesterol	-8.59 mg/dL Interval -19.72 to 2.54	3.37 mg/dL Interval -3.3 to 10.04
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Non-HDL Cholesterol	-13.86 mg/dL Interval -25.28 to -2.45	2.81 mg/dL Interval -4.4 to 10.01
Change From Baseline to Week 48 in Fasting Lipids in Participants on Protease Inhibitor (PI)-Containing Regimens (Including PI- and Integrase Strand Transferase Inhibitor [InSTI]-Containing Regimens) Fasting Triglycerides	-26.90 mg/dL Interval -42.31 to -11.48	2.28 mg/dL Interval -16.39 to 20.95

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants on InSTI-based regimens (non-PI containing regimens) who received at least one dose of study intervention and had baseline and Week 48 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on InSTI-based regimens (non-PI containing regimens), excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=129 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=137 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Cholesterol	2.23 mg/dL Interval -2.7 to 7.17	4.39 mg/dL Interval -0.19 to 8.96
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting HDL Cholesterol	0.23 mg/dL Interval -1.61 to 2.08	0.13 mg/dL Interval -1.24 to 1.51
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting LDL Cholesterol	2.74 mg/dL Interval -1.27 to 6.76	3.44 mg/dL Interval -0.88 to 7.76
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Non-HDL Cholesterol	2.00 mg/dL Interval -3.16 to 7.16	4.37 mg/dL Interval -0.24 to 8.98
Change From Baseline to Week 48 in Fasting Lipids in Participants on InSTI-based Regimens (Non-PI Containing Regimens) Fasting Triglycerides	-2.29 mg/dL Interval -15.02 to 10.44	4.44 mg/dL Interval -5.6 to 14.48

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants on all other non-PI- and non-InSTI containing regimens, who received at least one dose of study intervention and had baseline and Week 48 data available for each lipid type, excluding participants who took lipid-lowering therapy during the study, per protocol.

Blood serum samples were taken at baseline and Week 48. Per protocol, this outcome analysis was conducted in participants on all other non-PI- and non-InSTI containing regimens, excluding participants who took lipid-lowering therapy during the study. The fasting lipids consisted of fasting cholesterol, fasting HDL cholesterol, fasting LDL cholesterol, fasting non-HDL cholesterol, and fasting triglycerides. The mean change from baseline to Week 48 in fasting lipids is presented.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=91 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=95 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Cholesterol	5.66 mg/dL Interval -1.38 to 12.7	4.62 mg/dL Interval 0.1 to 9.15
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting HDL Cholesterol	-3.84 mg/dL Interval -6.72 to -0.97	-1.98 mg/dL Interval -4.6 to 0.63
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting LDL Cholesterol	9.27 mg/dL Interval 4.05 to 14.49	7.30 mg/dL Interval 3.97 to 10.63
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Non-HDL Cholesterol	9.94 mg/dL Interval 4.16 to 15.73	6.61 mg/dL Interval 3.13 to 10.08
Change From Baseline to Week 48 in Fasting Lipids in Participants on All Other Non-PI- and Non-InSTI Containing Regimens Fasting Triglycerides	3.33 mg/dL Interval -9.54 to 16.21	-2.97 mg/dL Interval -12.37 to 6.43

SECONDARY outcome

Timeframe: Baseline and Week 48

Population: All randomized participants who received at least one dose of study intervention, had baseline and Week 48 data available for body weight, and received InSTI-based regimens.

Baseline measurements were defined as the Day 1 value of each participant. The change from baseline in body weight to Week 48 is presented for participants who received InSTI- based regimens.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=167 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=169 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Change From Baseline in Body Weight at Week 48 for InSTI-based Regimens (Non-PI-containing Regimens)	0.66 kg Interval -0.17 to 1.48	0.10 kg Interval -0.56 to 0.75

SECONDARY outcome

Timeframe: Up to ~96 Weeks

Population: The analysis population consisted of all randomized participants in Group 1 who received at least one dose of study intervention. Per protocol, the percentage of participants with one or more AEs for Group 2 participants is a separate outcome measure and is presented later in the record.

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants with one or more AEs for Group 2 participants is a separate outcome measure and is presented later in the record.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1: Percentage of Participants With One or More AEs up to Week 96	92.3 Percentage of Participants	—

SECONDARY outcome

Timeframe: Up to ~96 Weeks

Population: The analysis population consisted of all randomized participants in Group 1 who received at least one dose of study intervention. Per protocol, the percentage of participants who discontinued study intervention for Group 2 participants is a separate outcome measure and is presented later in the record.

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE up to Week 96 is reported for Group 1 participants. Per protocol, the percentage of participants who discontinued study intervention for Group 2 participants is a separate outcome measure and is presented later in the record.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=336 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1: Percentage of Participants Who Discontinued Study Intervention Due to an AE up to Week 96	5.7 Percentage of Participants	—

SECONDARY outcome

Timeframe: Weeks 48-96 (up to ~48 weeks)

Population: The analysis population consisted of all randomized participants who received at least one dose of study intervention for participants in Group 1 and participants in Group 2 who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who experienced at least one AE from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=322 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=326 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1 & Group 2 (Switch-Over): Percentage of Participants With One or More AEs From Week 48 to Week 96	73.0 Percentage of Participants	76.4 Percentage of Participants

SECONDARY outcome

Timeframe: Weeks 48-96 (up to ~48 weeks)

An AE was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The percentage of participants who discontinued study intervention due to an AE from Week 48 up to Week 96 is reported for Group 1 participants and Group 2 participants who delayed switch over from baseline ART to DOR/ISL from Week 48 to Week 96.

Outcome measures

Outcome measures
Measure	Group 1: Doravirine/Islatravir (DOR/ISL) n=322 Participants Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline Antiretroviral Therapy (ART) n=326 Participants Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Group 1 & Group 2 (Switch-Over): Percentage of Participants Who Discontinued Study Intervention Due to an AE From Week 48 to Week 96	3.7 Percentage of Participants	2.5 Percentage of Participants

Adverse Events

Group 1: DOR/ISL Weeks 0-48

Serious events: 16 serious events

Other events: 85 other events

Deaths: 0 deaths

Group 1: DOR/ISL Weeks 48-End of Trial

Serious events: 13 serious events

Other events: 115 other events

Deaths: 1 deaths

Group 2: Baseline ART Weeks 0-48

Serious events: 15 serious events

Other events: 52 other events

Deaths: 1 deaths

Group 2: DOR/ISL Weeks 48-End of Trial

Serious events: 12 serious events

Other events: 120 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Group 1: DOR/ISL Weeks 0-48 n=336 participants at risk Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 1: DOR/ISL Weeks 48-End of Trial n=322 participants at risk Participants who were previously treated with continuous baseline antiretroviral therapy (ART) received DOR/ISL, a fixed dose combination (FDC) of 100 mg doravirine (DOR)/0.75 mg islatravir (ISL) orally once daily for 96 weeks.	Group 2: Baseline ART Weeks 0-48 n=336 participants at risk Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.	Group 2: DOR/ISL Weeks 48-End of Trial n=326 participants at risk Participants received continuous baseline ART for 48 weeks. Continuing participants delayed switch over from baseline ART to DOR/ISL, fixed dose combination of 100 mg DOR/0.75 mg ISL orally once daily, from Week 48 to Week 96, a total DOR/ISL treatment duration of 48 Weeks.
Infections and infestations COVID-19	5.4% 18/336 • Number of events 19 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	13.0% 42/322 • Number of events 42 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	4.5% 15/336 • Number of events 16 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	17.5% 57/326 • Number of events 60 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.
Injury, poisoning and procedural complications Accidental overdose	7.1% 24/336 • Number of events 28 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	1.2% 4/322 • Number of events 4 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	0.89% 3/336 • Number of events 4 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	2.5% 8/326 • Number of events 12 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.
Investigations CD4 lymphocytes decreased	0.60% 2/336 • Number of events 2 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	14.0% 45/322 • Number of events 47 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	0.00% 0/336 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	12.0% 39/326 • Number of events 41 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.
Investigations Lymphocyte count decreased	0.00% 0/336 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	20.2% 65/322 • Number of events 70 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	0.00% 0/336 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	13.5% 44/326 • Number of events 46 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.
Musculoskeletal and connective tissue disorders Osteopenia	3.0% 10/336 • Number of events 10 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	0.62% 2/322 • Number of events 2 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	5.7% 19/336 • Number of events 19 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	2.1% 7/326 • Number of events 7 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.
Nervous system disorders Headache	10.7% 36/336 • Number of events 41 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	3.7% 12/322 • Number of events 14 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	4.8% 16/336 • Number of events 17 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.	4.3% 14/326 • Number of events 14 • Up to approximately 49 months All-cause mortality (ACM): all randomized participants; AEs: all randomized participants who received at least one dose of study treatment. ACM and AEs have been reported separately for Weeks 0-48 and Weeks 48 - End of Trial. Per protocol, pregnancy-related AEs, and infant serious adverse events were collected on pregnant participants enrolled in the study. They are included by the arms in which the participants were enrolled.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp and Dohme LLC

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
Publication restrictions are in place

Restriction type: OTHER