Trial Outcomes & Findings for An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2) (NCT NCT02831764)

Last Updated: 2023-12-07

Results Overview

Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using Food and Drug Administration (FDA) Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. This endpoint was analyzed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights. Intent-To-Treat Exposed (ITT-E) Population was used which comprised of all randomized participants who received at least one dose of study treatment. Percentage values are rounded off.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

722 participants

Primary outcome timeframe

Week 48

Results posted on

2023-12-07

Participant Flow

This study is a Phase 3, randomized, double-blind, parallel group, non-inferiority study. The study consisted of double-blind phase, open-label phase and continuation phase.

Total of 722 participants were enrolled and randomized; however only 719 participants (3 participants were never dosed following randomization) were dosed in to the study to receive either dolutegravir plus lamivudine (DTG+3TC) or dolutegravir plus tenofovir/emtricitabine (DTG+TDF/FTC) creating the intent to treat-exposed (ITT-E) Population.

Participant milestones

Participant milestones
Measure	DTG + 3TC - Double-blind Phase Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.	DTG + 3TC - Open-label Phase Participants received a two-drug regimen of DTG + 3TC administered orally, once daily from Week 96 to Week 148 in an open-label phase.	DTG + TDF/FTC - Open-label Phase Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily from Week 96 to Week 148 in an open-label phase.	DTG + 3TC - Continuation Phase Participants received a DTG + 3TC administered orally, once daily from Week 148 to Week 280 in a continuation phase.
Double-blind Phase (Day1 to Week 96) STARTED	360	362	0	0	0
Double-blind Phase (Day1 to Week 96) Intent-to-Treat Exposed	360	359	0	0	0
Double-blind Phase (Day1 to Week 96) COMPLETED	319	327	0	0	0
Double-blind Phase (Day1 to Week 96) NOT COMPLETED	41	35	0	0	0
Open-label Phase (Week 96 to Week 148) STARTED	0	0	319	327	0
Open-label Phase (Week 96 to Week 148) COMPLETED	0	0	301	300	0
Open-label Phase (Week 96 to Week 148) NOT COMPLETED	0	0	18	27	0
Continuation Phase(Week 148 to Week 280) STARTED	0	0	0	0	252
Continuation Phase(Week 148 to Week 280) COMPLETED	0	0	0	0	239
Continuation Phase(Week 148 to Week 280) NOT COMPLETED	0	0	0	0	13

Reasons for withdrawal

Reasons for withdrawal
Measure	DTG + 3TC - Double-blind Phase Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.	DTG + 3TC - Open-label Phase Participants received a two-drug regimen of DTG + 3TC administered orally, once daily from Week 96 to Week 148 in an open-label phase.	DTG + TDF/FTC - Open-label Phase Participants received a three-drug regimen of DTG + TDF/FTC FDC administered orally, once daily from Week 96 to Week 148 in an open-label phase.	DTG + 3TC - Continuation Phase Participants received a DTG + 3TC administered orally, once daily from Week 148 to Week 280 in a continuation phase.
Double-blind Phase (Day1 to Week 96) Protocol specific withdrawal criteria	0	2	0	0	0
Double-blind Phase (Day1 to Week 96) Withdrawal by Subject	9	9	0	0	0
Double-blind Phase (Day1 to Week 96) Physician Decision	3	3	0	0	0
Double-blind Phase (Day1 to Week 96) Lost to Follow-up	9	7	0	0	0
Double-blind Phase (Day1 to Week 96) Adverse Event	10	6	0	0	0
Double-blind Phase (Day1 to Week 96) Lack of Efficacy	5	2	0	0	0
Double-blind Phase (Day1 to Week 96) Protocol Deviation	5	3	0	0	0
Double-blind Phase (Day1 to Week 96) Randomized, but did not receive treatment	0	3	0	0	0
Open-label Phase (Week 96 to Week 148) Adverse Event	0	0	1	6	0
Open-label Phase (Week 96 to Week 148) Lack of Efficacy	0	0	2	0	0
Open-label Phase (Week 96 to Week 148) Protocol Deviation	0	0	2	2	0
Open-label Phase (Week 96 to Week 148) Protocol-Specified Withdrawal Criteria	0	0	1	0	0
Open-label Phase (Week 96 to Week 148) Lost to Follow-up	0	0	4	7	0
Open-label Phase (Week 96 to Week 148) Physician Decision	0	0	1	3	0
Open-label Phase (Week 96 to Week 148) Withdrawal by Subject	0	0	7	9	0
Continuation Phase(Week 148 to Week 280) Protocol Deviation	0	0	0	0	1
Continuation Phase(Week 148 to Week 280) Lost to Follow-up	0	0	0	0	2
Continuation Phase(Week 148 to Week 280) Physician Decision	0	0	0	0	5
Continuation Phase(Week 148 to Week 280) Withdrawal by Subject	0	0	0	0	5

Baseline Characteristics

An Efficacy, Safety, and Tolerability Study Comparing Dolutegravir (DTG) Plus Lamivudine (3TC) With Dolutegravir Plus Tenofovir/Emtricitabine in Treatment naïve HIV Infected Participants (Gemini 2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.	Total n=719 Participants Total of all reporting groups
Age, Continuous	34.6 Years STANDARD_DEVIATION 10.72 • n=5 Participants	34.4 Years STANDARD_DEVIATION 10.35 • n=7 Participants	34.5 Years STANDARD_DEVIATION 10.53 • n=5 Participants
Sex: Female, Male Female	54 Participants n=5 Participants	46 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	306 Participants n=5 Participants	313 Participants n=7 Participants	619 Participants n=5 Participants
Race/Ethnicity, Customized American (Am) Indian or Alaska (Al.) native	21 Participants n=5 Participants	29 Participants n=7 Participants	50 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian heritage (H.)	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian H.	28 Participants n=5 Participants	26 Participants n=7 Participants	54 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian H.	6 Participants n=5 Participants	1 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Black or African Am	51 Participants n=5 Participants	35 Participants n=7 Participants	86 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White (Wt)-Arabic/North African H.	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Wt-Wt/Caucasian (Ca.)/European (Eu.) H.	237 Participants n=5 Participants	249 Participants n=7 Participants	486 Participants n=5 Participants
Race/Ethnicity, Customized Multiple	14 Participants n=5 Participants	12 Participants n=7 Participants	26 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Plasma Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/mL (c/mL) at Week 48	93 Percentage of participants Interval 90.4 to 95.7	94 Percentage of participants Interval 91.4 to 96.4

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population

Percentage of participants with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. This endpoint was analyzed using a stratified analysis with CMH weights. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 24	94 Percentage of participants Interval 91.4 to 96.4	94 Percentage of participants Interval 91.4 to 96.4

SECONDARY outcome

Timeframe: Week 96

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 96	88 Percentage of participants Interval 84.4 to 91.2	90 Percentage of participants Interval 86.5 to 92.8

SECONDARY outcome

Timeframe: Week 144

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL at Week 144	84 Percentage of participants Interval 80.4 to 87.9	84 Percentage of participants Interval 80.6 to 88.2

SECONDARY outcome

Timeframe: Up to Week 144

Population: ITT-E Population

Time of viral suppression is defined as the first viral load value \<50 c/mL. Nonparametric Kaplan-Meier method was performed. Participants who withdrew for any reason without being suppressed were censored at date of withdrawal. Participants who have not been withdrawn and have not had viral suppression at time of the analysis were censored at last viral load date. Confidence Interval (CI) was estimated using the Brookmeyer-Crowley method.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Time to Viral Suppression (HIV-1 RNA <50 c/mL) up to Week 144	29.0 Days Interval 29.0 to 55.0	29.0 Days Interval 29.0 to 57.0

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
CD4+ Cell Counts at Weeks 24 and 48 Week 24, n=349,345	650.4 Cells/mm^3 Standard Deviation 257.02	633.0 Cells/mm^3 Standard Deviation 287.37
CD4+ Cell Counts at Weeks 24 and 48 Week 48, n=337,340	688.1 Cells/mm^3 Standard Deviation 266.39	689.8 Cells/mm^3 Standard Deviation 308.49

SECONDARY outcome

Timeframe: Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=318 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=327 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
CD4+ Cell Counts at Week 96	734.9 Cells/mm^3 Standard Deviation 270.82	739.9 Cells/mm^3 Standard Deviation 299.80

SECONDARY outcome

Timeframe: Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=296 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=292 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
CD4+ Cell Counts at Week 144	763.8 Cells/mm^3 Standard Deviation 266.61	770.4 Cells/mm^3 Standard Deviation 332.65

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted least mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 Week 24, n=349, 345	188.8 Cells/mm^3 Standard Error 8.77	163.2 Cells/mm^3 Standard Error 9.08
Changes From Baseline in CD4+ Cell Counts at Week 24 and 48 Week 48, n=337, 340	225.7 Cells/mm^3 Standard Error 8.94	217.2 Cells/mm^3 Standard Error 9.93

SECONDARY outcome

Timeframe: Baseline and Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=318 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=327 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 96	272.0 Cells/mm^3 Standard Error 10.83	264.6 Cells/mm^3 Standard Error 11.18

SECONDARY outcome

Timeframe: Baseline and Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+ cells. Analysis was performed by flow cytometry. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error has been presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for the following covariates/factors: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, treatment and visit interaction, and Baseline CD4+ cell count and visit interaction, with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=296 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=292 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 144	301.7 Cells/mm^3 Standard Error 11.55	296.6 Cells/mm^3 Standard Error 13.55

SECONDARY outcome

Timeframe: Up to Week 144

Population: ITT-E Population

HIV-associated conditions were recorded during the study and was assessed according to the 2014 Centers for Disease Control and Prevention (CDC) Classification System for HIV Infection in Adults. Disease progressions summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrolment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrolment to Death. Participants may have more than one indicators of clinical disease progression including death, hence they may contribute to data in more than one categories.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With HIV-1 Disease Progression up to Week 144 No disease progression	356 Participants	357 Participants
Number of Participants With HIV-1 Disease Progression up to Week 144 From CDC Stage 1 to CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression up to Week 144 From CDC Stage 2 to CDC Stage 3 Event	2 Participants	1 Participants
Number of Participants With HIV-1 Disease Progression up to Week 144 From CDC Stage 3 to New CDC Stage 3 Event	1 Participants	0 Participants
Number of Participants With HIV-1 Disease Progression up to Week 144 From CDC Stage 1, 2 or 3 to Death	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: Viral Genotypic Population. Only those participants available at the specified time points were analyzed

Number of participants, who met confirmed virologic withdrawal (CVW) criteria, with treatment emergent genotypic resistance to Integrase strand transfer inhibitor (INSTI) and/or Nucleoside reverse transcriptase inhibitor (NRTI) was summarized. The Viral Genotypic Population comprised of all participants in the ITT-E population who have available on-treatment genotypic resistance data.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=7 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=3 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 INSTI Mutations	0 Participants	0 Participants
Number of Participants With Treatment-emergent Genotypic Resistance up to Week 144 Major mutations of the NRTI	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: Viral Phenotypic Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Number of participants, who met CVW criteria, with treatment emergent phenotypic resistance to INSTI and/or NRTI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results were interpreted through a proprietary algorithm (from Monogram Biosciences) and provides the overall susceptibility of the drugs (DTG, 3TC, Abacavir \[ABC\], elvitegravir \[EGV\], raltegravir \[RAL\], zidovudine \[AZT\], stavudine \[D4T\], didanosine \[DDI\]), emtricitabine \[FTC\], tenofovir disiproxil fumarate \[TDF\]). Partially sensitive and resistant cells were considered resistant in this analysis. The Viral Phenotypic Population comprised of all participants in the ITT-E population who have available on-treatment phenotypic resistance data.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=7 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=4 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, D4T, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, DDI, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, DDI, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, FTC, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, FTC, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, TDF, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, TDF, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, DTG, Sensitive, n=7,2	7 Participants	2 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, DTG, Resistant, n=7,2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, EGV, Sensitive, n=7,2	7 Participants	2 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, EGV, Resistant, n=7,2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, RAL, Sensitive, n=7,2	7 Participants	2 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 INSTI, RAL, Resistant, n=7,2	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, 3TC, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, 3TC, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, ABC, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, ABC, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, AZT, Sensitive, n=7,3	7 Participants	3 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, AZT, Resistant, n=7,3	0 Participants	0 Participants
Number of Participants With Treatment-emergent Phenotypic Resistance up to Week 144 NRTI, D4T, Sensitive, n=7,3	7 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to Week 148

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any untoward event resulting in death, life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, congenital anomaly/birth defect, any other situation according to medical or scientific judgment that may not be immediately life-threatening or result in death or hospitalization but may jeopardize the participant or may require medical or surgical intervention or protocol-defined event associated with liver injury and impaired liver function were categorized as SAE. Safety Population was used which comprised of all participants who received at least one dose of study treatment.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 Any AE	306 Participants	309 Participants
Number of Participants With Any Adverse Event (AE) and Serious AE (SAE) up to Week 148 Any SAE	39 Participants	47 Participants

SECONDARY outcome

Timeframe: Up to Week 148

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the Division of Acquired Immunodeficiency Syndrome (DAIDS) toxicity scales from Grade 1 to 5 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with adverse events by maximum grade have been presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With AEs by Maximum Severity Grades up to Week 148 Grade 1 AEs	54 Participants	54 Participants
Number of Participants With AEs by Maximum Severity Grades up to Week 148 Grade 2 AEs	211 Participants	205 Participants
Number of Participants With AEs by Maximum Severity Grades up to Week 148 Grade 3 AEs	32 Participants	43 Participants
Number of Participants With AEs by Maximum Severity Grades up to Week 148 Grade 4 AEs	7 Participants	6 Participants
Number of Participants With AEs by Maximum Severity Grades up to Week 148 Grade 5 AEs	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to Week 148

Population: Safety Population.

An AE is any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. AEs were evaluated by the investigator and graded according to the DAIDS toxicity scales from Grade 1 to 5. (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening, 5=Death). The higher the grade, the more severe the symptoms. Number of participants with drug related AEs and drug related AEs by by maximum grade have been presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Any drug related AE	69 Participants	91 Participants
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Drug related AEs with maximum toxicity Grade 1	37 Participants	53 Participants
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Drug related AEs with maximum toxicity Grade 2	26 Participants	29 Participants
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Drug related AEs with maximum toxicity Grade 3	5 Participants	8 Participants
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Drug related AEs with maximum toxicity Grade 4	1 Participants	1 Participants
Number of Participants With Any Drug Related AEs and Drug Related AEs by Maximum Grade up to Week 148 Drug related AEs with maximum toxicity Grade 5	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: Safety Population.

Blood samples were collected up to Week 144 for assessment of hemoglobin, leukocytes, neutrophils and platelet count. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the listed hematology parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grades 1 to 4	8 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grades 2 to 4	6 Participants	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grades 3 to 4	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grade 1	2 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grade 2	4 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Hemoglobin, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grades 1 to 4	5 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grades 2 to 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grade 1	4 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Leukocytes, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grades 1 to 4	23 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grades 2 to 4	8 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grades 3 to 4	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grade 1	15 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grade 2	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grade 3	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Neutrophils, Grade 4	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grades 1 to 4	13 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grades 2 to 4	5 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grade 1	8 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grade 2	5 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities up to Week 144 Platelets, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: Safety Population

Blood samples were collected up to Week 144 for assessment of Alanine Aminotransferase (ALT), Albumin, Alkaline Phosphatase (ALP), Aspartate aminotransferase (AST), Bilirubin, Carbon dioxide (CO2), Cholesterol, Creatine kinase (CK), Creatinine, Direct Bilirubin, Glomerular filtration rate (GFR), Hypercalcemia, Hyperglycemia, Hyperkalemia, Hypernatremia, Hypocalcemia, Hypoglycemia, Hypokalemia, Hyponatremia, Low density lipid (LDL) Cholesterol, Lactate Dehydrogenase, Lipase, Phosphate, and Triglycerides. Any abnormality was graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent chemistry toxicities in any of the chemistry parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grades 1 to 4	77 Participants	71 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grades 2 to 4	30 Participants	29 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grades 3 to 4	13 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grade 1	47 Participants	42 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grade 2	17 Participants	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grade 3	6 Participants	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALT, Grade 4	7 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grades 1 to 4	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grades 2 to 4	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grades 3 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grade 2	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grades 1 to 4	10 Participants	17 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grades 2 to 4	2 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grades 3 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grade 1	8 Participants	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grade 2	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 ALP, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grades 1 to 4	71 Participants	83 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grades 2 to 4	30 Participants	32 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grades 3 to 4	15 Participants	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grade 1	41 Participants	51 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grade 2	15 Participants	18 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grade 3	8 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 AST, Grade 4	7 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grades 1 to 4	46 Participants	56 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grades 2 to 4	13 Participants	16 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grades 3 to 4	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grade 1	33 Participants	40 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grade 2	9 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grade 3	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Bilirubin, Grade 4	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grades 1 to 4	111 Participants	111 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grades 2 to 4	10 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grade 1	101 Participants	107 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grade 2	10 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CO2, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grades 1 to 4	98 Participants	50 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grades 2 to 4	23 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grades 3 to 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grade 1	75 Participants	38 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grade 2	22 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grades 1 to 4	91 Participants	83 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grades 2 to 4	49 Participants	47 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grades 3 to 4	29 Participants	28 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grade 1	42 Participants	36 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grade 2	20 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grade 3	11 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 CK, Grade 4	18 Participants	17 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grades 1 to 4	18 Participants	28 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grades 2 to 4	5 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grades 3 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grade 1	13 Participants	26 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grade 2	5 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grades 1 to 4	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grades 2 to 4	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grades 3 to 4	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grade 3	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Direct Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grades 1 to 4	198 Participants	219 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grades 2 to 4	198 Participants	219 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grades 3 to 4	20 Participants	29 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grade 2	178 Participants	190 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grade 3	20 Participants	28 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 GFR, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grades 1 to 4	4 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grades 2 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grades 3 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcemia, Grade 1	4 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypercalcaemia, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grades 1 to 4	106 Participants	86 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grades 2 to 4	49 Participants	38 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grades 3 to 4	3 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grade 1	57 Participants	48 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grade 2	46 Participants	35 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grade 3	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperglycaemia, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grades 1 to 4	7 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grades 2 to 4	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grades 3 to 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grade 1	5 Participants	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyperkalemia, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grades 1 to 4	4 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grades 2 to 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grade 1	3 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypernatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grades 1 to 4	17 Participants	21 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grades 2 to 4	6 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grades 3 to 4	1 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grade 1	11 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grade 2	5 Participants	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grade 3	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypocalcaemia, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grades 1 to 4	22 Participants	21 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grades 2 to 4	6 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grades 3 to 4	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grade 1	16 Participants	16 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grade 2	2 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grade 3	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypoglycaemia, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grades 1 to 4	9 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grades 2 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grade 1	9 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grade 2	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hypokalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grades 1 to 4	23 Participants	22 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grades 2 to 4	0 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grades 3 to 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grade 1	23 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Hyponatremia, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grades 1 to 4	66 Participants	40 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grades 2 to 4	21 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grades 3 to 4	6 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grade 1	45 Participants	27 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grade 2	15 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grade 3	6 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 LDL Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grades 1 to 4	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grades 2 to 4	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grades 3 to 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grade 1	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grade 2	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lactate Dehydrogenase, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grades 1 to 4	72 Participants	81 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grades 2 to 4	37 Participants	43 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grades 3 to 4	9 Participants	17 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grade 1	35 Participants	38 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grade 2	28 Participants	26 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grade 3	6 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Lipase, Grade 4	3 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grades 1 to 4	75 Participants	78 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grades 2 to 4	50 Participants	51 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grades 3 to 4	7 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grade 1	25 Participants	27 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grade 2	43 Participants	44 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grade 3	7 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grades 1 to 4	89 Participants	75 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grades 2 to 4	22 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grades 3 to 4	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grade 1	67 Participants	60 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grade 2	18 Participants	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grade 3	4 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities up to Week 144 Triglycerides, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Weeks 24, 48 and 96

Population: Safety Population

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 Week 48	8 Participants	8 Participants
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 Week 24	6 Participants	4 Participants
Number of Participants Who Discontinue Treatment Due to AEs Over Weeks 24, 48, 96 Week 96	10 Participants	12 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: Safety Population.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Number of Participants Who Discontinue Treatment Due to AEs Over Week 144	13 Participants	16 Participants

SECONDARY outcome

Timeframe: Baseline and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C and Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 Serum Cystatin C, Week 24, n=345,345	-0.04 Milligrams per Liter (mg/L) Standard Error 0.005	0.00 Milligrams per Liter (mg/L) Standard Error 0.005
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 Serum Cystatin C, Week 48, n=335,336	-0.05 Milligrams per Liter (mg/L) Standard Error 0.005	-0.04 Milligrams per Liter (mg/L) Standard Error 0.006
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 Serum RBP, Week 24, n=345,343	1.2 Milligrams per Liter (mg/L) Standard Error 0.42	1.4 Milligrams per Liter (mg/L) Standard Error 0.48
Change From Baseline in Renal Biomarkers-Serum Cystatin C and Serum Retinol Binding Protein (RBP) at Weeks 24, 48 Serum RBP, Week 48, n=334, 334	0.6 Milligrams per Liter (mg/L) Standard Error 0.45	-0.1 Milligrams per Liter (mg/L) Standard Error 0.42

SECONDARY outcome

Timeframe: Baseline and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum Cystatin C. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=316 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=326 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 96	-0.09 mg/L Standard Error 0.006	-0.08 mg/L Standard Error 0.005

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=301 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=304 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum Cystatin C at Week 144	-0.11 mg/L Standard Error 0.005	-0.08 mg/L Standard Error 0.006

SECONDARY outcome

Timeframe: Baseline and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood and/or urine samples were collected to perform evaluation of renal biomarkers which included Serum RBP. Baseline value is the latest pre-dose assessment. Change from Baseline was defined as value at indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=314 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=319 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum RBP at Week 96	0.557 Microgram per millimoles (ug/mmol) Standard Deviation 12.7139	2.483 Microgram per millimoles (ug/mmol) Standard Deviation 23.9105

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=294 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=289 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum RBP at Week 144	0.560 Microgram per millimoles (ug/mmol) Standard Deviation 9.5962	3.813 Microgram per millimoles (ug/mmol) Standard Deviation 10.8115

SECONDARY outcome

Timeframe: Baseline and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI (GFR-cystatin C adjusted) and Serum or Plasma GFR from creatinine adjusted using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 GFR Cystatin C adjusted, Week 24, n=345,345	3.8 Milliliter/minute/1.73 meter^2 Standard Error 0.66	0.2 Milliliter/minute/1.73 meter^2 Standard Error 0.65
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 GFR Cystatin C adjusted, Week 48, n=335,336	5.4 Milliliter/minute/1.73 meter^2 Standard Error 0.64	3.6 Milliliter/minute/1.73 meter^2 Standard Error 0.64
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 GFR creatinine adjusted, Week 24, n=346,344	-12.0 Milliliter/minute/1.73 meter^2 Standard Error 0.64	-15.4 Milliliter/minute/1.73 meter^2 Standard Error 0.59
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and Serum or Plasma GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24, 48 GFR creatinine adjusted, Week 48, n=335, 337	-12.1 Milliliter/minute/1.73 meter^2 Standard Error 0.60	-15.4 Milliliter/minute/1.73 meter^2 Standard Error 0.61

SECONDARY outcome

Timeframe: Baseline and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of renal biomarkers which included Serum GFR from cystatin C adjusted using CKD-EPI and Serum or Plasma GFR from creatinine adjusted for BSA using CKD-EPI. Baseline value is the latest pre-dose Assessment. Change from Baseline was defined as value at the indicated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 GFR Cystatin C adjusted, Week 96, n=316,326	9.1 Milliliter/minute/1.73 meter^2 Standard Deviation 18.75	9.5 Milliliter/minute/1.73 meter^2 Standard Deviation 13.95
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 96 GFR creatinine adjusted, Week 96, n=315,325	-14.2 Milliliter/minute/1.73 meter^2 Standard Deviation 12.69	-17.5 Milliliter/minute/1.73 meter^2 Standard Deviation 11.57

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 GFR Cystatin C adjusted, Week 144, n=301,304	10.3 Milliliter/minute/1.73 meter^2 Standard Deviation 18.82	10.1 Milliliter/minute/1.73 meter^2 Standard Deviation 15.50
Change From Baseline in Renal Biomarkers-Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum or Plasma GFR From Creatinine Adjusted for BSA Using CKD-EPI Method at Week 144 GFR creatinine adjusted, Week 144, n=292,292	-15.5 Milliliter/minute/1.73 meter^2 Standard Deviation 12.56	-18.2 Milliliter/minute/1.73 meter^2 Standard Deviation 11.73

SECONDARY outcome

Timeframe: Baseline and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood and samples were collected to perform evaluation of renal biomarker which included Serum or Plasma Creatinine. Baseline value is defined as the the latest pre-dose assessment. Change from Baseline was calculated as value at the inidcated time point minus Baseline value. Biomarkers were adjusted for treatment, visit, Baseline plasma HIV-1 RNA, baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 Serum or Plasma Creatinine, Week 24, n=346, 344	10.51 Micromoles per Liter (umol/L) Standard Deviation 0.548	13.53 Micromoles per Liter (umol/L) Standard Deviation 0.507
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Weeks 24, 48 Serum or Plasma Creatinine, Week 48, n=335, 337	10.32 Micromoles per Liter (umol/L) Standard Deviation 0.519	13.44 Micromoles per Liter (umol/L) Standard Deviation 0.540

SECONDARY outcome

Timeframe: Baseline and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=315 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=325 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 96	11.71 Micromoles per Liter (umol/L) Standard Error 0.563	14.75 Micromoles per Liter (umol/L) Standard Error 0.526

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=292 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=292 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Renal Biomarker-Serum or Plasma Creatinine at Week 144	12.28 Micromoles per Liter (umol/L) Standard Error 0.613	15.14 Micromoles per Liter (umol/L) Standard Error 0.583

SECONDARY outcome

Timeframe: Baseline and Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine and Serum B2M, Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Geometric mean ratio and 95% CI of geometric mean ratio have been presented. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Serum B2M, Week 24, n=344,346	0.809 Ratio Interval 0.794 to 0.824	0.882 Ratio Interval 0.867 to 0.898
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Serum B2M, Week 48, n=335,336	0.811 Ratio Interval 0.796 to 0.827	0.887 Ratio Interval 0.871 to 0.904
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine B2M, Week 24, n=124,106	0.844 Ratio Interval 0.755 to 0.944	1.129 Ratio Interval 0.974 to 1.309
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine B2M, Week 48, n=109, 103	0.917 Ratio Interval 0.804 to 1.046	1.323 Ratio Interval 1.066 to 1.642
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Albumin/Creatinine, Week 24, n=259, 251	0.907 Ratio Interval 0.844 to 0.976	1.021 Ratio Interval 0.94 to 1.109
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Albumin/Creatinine , Week 48, n=249, 240	0.911 Ratio Interval 0.835 to 0.994	0.971 Ratio Interval 0.891 to 1.058
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine B2M/Urine Creatinine , Week 24, n=122, 104	0.880 Ratio Interval 0.779 to 0.993	1.126 Ratio Interval 0.988 to 1.282
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine B2M/Urine Creatinine , Week 48, n=108, 103	0.969 Ratio Interval 0.854 to 1.099	1.307 Ratio Interval 1.077 to 1.586
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Phosphate, Week 24, n=343, 340	1.041 Ratio Interval 0.955 to 1.134	1.063 Ratio Interval 0.978 to 1.157
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Phosphate, Week 48, n=335, 332	1.121 Ratio Interval 1.031 to 1.22	1.056 Ratio Interval 0.974 to 1.144
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Protein/Creatinine, Week 24, n=263,279	0.818 Ratio Interval 0.779 to 0.859	0.991 Ratio Interval 0.941 to 1.043
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine Protein/Creatinine , Week 48, n=259, 261	0.866 Ratio Interval 0.818 to 0.917	1.007 Ratio Interval 0.954 to 1.062
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine RBP 4, Week 24, n=340, 338	0.656 Ratio Interval 0.591 to 0.729	0.824 Ratio Interval 0.738 to 0.921
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine RBP 4, Week 48, n=333, 331	0.740 Ratio Interval 0.666 to 0.822	0.819 Ratio Interval 0.73 to 0.919
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine RBP 4/Urine Creatinine, Week 24, n=338, 335	0.670 Ratio Interval 0.614 to 0.73	0.811 Ratio Interval 0.741 to 0.888
Ratio to Baseline in Renal Biomarkers-Urine and Serum Beta-2 Microglobulin (B2M), Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine, Urine RBP 4 and Urine RBP 4/Urine Creatinine at Weeks 24, 48 Urine RBP 4/Urine Creatinine, Week 48, n=331, 328	0.749 Ratio Interval 0.689 to 0.814	0.844 Ratio Interval 0.774 to 0.92

SECONDARY outcome

Timeframe: Baseline and Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood and/or urine were collected to perform evaluation of renal inflammation biomarkers: Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine. Baseline value was the latest pre-dose assessment. Change from Baseline was performed on log-transformed data. Ratio to Baseline was calculated as ratio of post-dose visit value over Baseline value. Biomarkers were Adjusted for treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age, sex, race, presence of diabetes mellitus, presence of hypertension, loge transformed Baseline biomarker value, treatment and visit interaction, and loge transformed Baseline biomarker value and visit interaction; with visit as the repeated factor.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 Urine Albumin/Creatinine, Week 96, n=239, 243	0.939 Ratio Interval 0.861 to 1.023	0.997 Ratio Interval 0.914 to 1.087
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 Urine B2M/Urine Creatinine, Week 96, n=101, 96	0.844 Ratio Interval 0.757 to 0.941	1.259 Ratio Interval 1.055 to 1.503
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 Urine Phosphate, Week 96, n=316, 322	1.156 Ratio Interval 1.064 to 1.256	1.069 Ratio Interval 0.988 to 1.156
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 Urine Protein/Creatinine, Week 96, n=251, 261	0.887 Ratio Interval 0.836 to 0.942	1.016 Ratio Interval 0.963 to 1.072
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 96 Urine RBP 4/Urine Creatinine, Week 96, n=314, 318	1.030 Ratio Interval 0.953 to 1.113	1.287 Ratio Interval 1.189 to 1.393

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 Urine Albumin/Creatinine, Week 144, n=230, 221	1.036 Ratio Interval 0.943 to 1.138	1.067 Ratio Interval 0.973 to 1.169
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 Urine B2M/Urine Creatinine, Week 144, n=108, 93	0.872 Ratio Interval 0.792 to 0.96	1.494 Ratio Interval 1.266 to 1.762
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 Urine Phosphate, Week 144, n=301, 301	1.083 Ratio Interval 1.0 to 1.174	1.084 Ratio Interval 0.999 to 1.175
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 Urine Protein/Creatinine, Week 144, n=236, 246	0.999 Ratio Interval 0.947 to 1.054	1.180 Ratio Interval 1.118 to 1.245
Ratio to Baseline in Renal Biomarkers- Urine Albumin/Creatinine, Urine B2M/Urine Creatinine, Urine Phosphate, Urine Protein/Creatinine and Urine RBP 4/Urine Creatinine at Week 144 Urine RBP 4/Urine Creatinine, Week 144, n=294, 289	1.159 Ratio Interval 1.083 to 1.24	1.567 Ratio Interval 1.451 to 1.694

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, PINP and CTX-1. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 Bone-ALP, Week 24, n=345, 346	0.72 Micrograms per Liter (ug/L) Standard Error 0.171	3.38 Micrograms per Liter (ug/L) Standard Error 0.244
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 Bone-ALP, Week 48, n=334, 337	1.24 Micrograms per Liter (ug/L) Standard Error 0.198	4.33 Micrograms per Liter (ug/L) Standard Error 0.268
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 Serum Osteocalcin, Week 24, n=345, 346	2.13 Micrograms per Liter (ug/L) Standard Error 0.321	6.80 Micrograms per Liter (ug/L) Standard Error 0.368
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 Serum Osteocalcin, Week 48, n=335, 336	0.40 Micrograms per Liter (ug/L) Standard Error 0.326	6.30 Micrograms per Liter (ug/L) Standard Error 0.384
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 PINP, Week 24, n=344, 346	1.7 Micrograms per Liter (ug/L) Standard Error 0.95	15.2 Micrograms per Liter (ug/L) Standard Error 1.12
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 PINP, Week 48, n=335, 337	0.4 Micrograms per Liter (ug/L) Standard Error 0.79	13.3 Micrograms per Liter (ug/L) Standard Error 1.06
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 CTX-1, Week 24, n=342, 342	0.1541 Micrograms per Liter (ug/L) Standard Error 0.01247	0.2812 Micrograms per Liter (ug/L) Standard Error 0.01406
Change From Baseline in Bone Biomarkers-Serum Bone Specific Alkaline Phosphatase (Bone-ALP), Serum Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (PINP) and Serum Type I Collagen C-Telopeptides (CTX-1) at Weeks 24, 48 CTX-1, Week 48, n=332, 333	0.1345 Micrograms per Liter (ug/L) Standard Error 0.01496	0.3388 Micrograms per Liter (ug/L) Standard Error 0.01983

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of bone biomarkers which included bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type CTX-1. Adjusted mean is the estimated mean change from Baseline in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 Bone-ALP, Week 96, n=315, 326	0.26 Micrograms per Liter (ug/L) Standard Error 0.188	2.39 Micrograms per Liter (ug/L) Standard Error 0.234
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 Serum Osteocalcin, Week 96, n=315, 326	0.13 Micrograms per Liter (ug/L) Standard Error 0.286	3.90 Micrograms per Liter (ug/L) Standard Error 0.368
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 PINP, Week 96, n=315, 325	7.0 Micrograms per Liter (ug/L) Standard Error 1.37	19.5 Micrograms per Liter (ug/L) Standard Error 1.66
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 96 CTX-1, Week 96, n=311, 318	0.0604 Micrograms per Liter (ug/L) Standard Error 0.01056	0.1787 Micrograms per Liter (ug/L) Standard Error 0.01403

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 Bone-ALP, Week 144, n=302, 305	-0.25 Micrograms per Liter (ug/L) Standard Error 0.156	1.88 Micrograms per Liter (ug/L) Standard Error 0.266
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 Serum Osteocalcin, Week 144, n=300, 304	-1.02 Micrograms per Liter (ug/L) Standard Error 0.280	2.87 Micrograms per Liter (ug/L) Standard Error 0.412
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 PINP, Week 144, n=299, 300	-0.1 Micrograms per Liter (ug/L) Standard Error 0.94	9.4 Micrograms per Liter (ug/L) Standard Error 1.39
Change From Baseline in Bone Biomarkers-Serum Bone-ALP, Serum Osteocalcin, Serum PINP and Serum Type I CTX-1 at Week 144 CTX-1, Week 144, n=291, 298	0.0505 Micrograms per Liter (ug/L) Standard Error 0.01154	0.1868 Micrograms per Liter (ug/L) Standard Error 0.01516

SECONDARY outcome

Timeframe: Baseline and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of bone biomarker serum vitamin D. Adjusted mean and standard error is presented. Adjusted mean is the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for: treatment, visit, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count (factor), age, sex (factor), race (factor), BMI (factor), smoking status (factor), current Vitamin D use (factor), Baseline biomarker value, treatment and visit interaction, and Baseline biomarker value and visit interaction; with visit as the repeated factor. Baseline value is defined as the latest pre-dose assessment. Change from Baseline was calculated as value at the indicated time point minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 Serum Vitamin D, Week 24, n=346, 344	11.2 Nanomoles per Liter (nmol/L) Standard Error 1.08	15.4 Nanomoles per Liter (nmol/L) Standard Error 1.33
Change From Baseline in Bone Biomarker-Serum Vitamin D at Weeks 24, 48 Serum Vitamin D, Week 48, n=336, 335	0.3 Nanomoles per Liter (nmol/L) Standard Error 0.92	0.4 Nanomoles per Liter (nmol/L) Standard Error 1.01

SECONDARY outcome

Timeframe: Baseline and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=312 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=326 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 96	-1.7 Nanomoles per Liter (nmol/L) Standard Error 1.01	1.3 Nanomoles per Liter (nmol/L) Standard Error 1.09

SECONDARY outcome

Timeframe: Baseline and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=303 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=303 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Bone Biomarker-Serum Vitamin D at Week 144	1.1 Nanomoles per Liter (nmol/L) Standard Error 1.20	1.4 Nanomoles per Liter (nmol/L) Standard Error 1.22

SECONDARY outcome

Timeframe: Baseline and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value is defined as the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value).

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 LDL Cholesterol, Week 24, n=298, 309	3.8 Percentage change Standard Deviation 25.85	-7.8 Percentage change Standard Deviation 21.13
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 LDL Cholesterol, Week 48, n=297, 307	10.7 Percentage change Standard Deviation 27.54	-4.1 Percentage change Standard Deviation 20.39
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 Triglycerides,Week 24, n=299, 310	7.0 Percentage change Standard Deviation 40.45	0.5 Percentage change Standard Deviation 44.01
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 Triglycerides, Week 48, n=299, 307	7.3 Percentage change Standard Deviation 46.92	-0.3 Percentage change Standard Deviation 49.22
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 Serum or Plasma Cholesterol, Week 24, n=298, 310	5.0 Percentage change Standard Deviation 16.85	-4.5 Percentage change Standard Deviation 15.44
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 Serum or Plasma Cholesterol, Week 48, n=298, 307	9.3 Percentage change Standard Deviation 17.10	-3.3 Percentage change Standard Deviation 14.61
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 HDL Cholesterol, Direct, Week 24, n=299, 310	13.9 Percentage change Standard Deviation 25.17	7.2 Percentage change Standard Deviation 32.22
Percentage Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma High Density Lipoprotein (HDL) Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Weeks 24, 48 HDL Cholesterol, Direct, Week 48, n=299, 307	15.3 Percentage change Standard Deviation 23.75	4.0 Percentage change Standard Deviation 21.86

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 Serum or Plasma Cholesterol, Week 96, n=270, 289	0.345 Millimoles per liter Standard Error 0.0356	-0.132 Millimoles per liter Standard Error 0.0375
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 HDL Cholesterol, Direct, Week 96, n=271, 289	0.185 Millimoles per liter Standard Error 0.0160	0.071 Millimoles per liter Standard Error 0.0136
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 LDL Cholesterol, Week 96, n=270, 289	0.139 Millimoles per liter Standard Error 0.0308	-0.160 Millimoles per liter Standard Error 0.0304
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 96 Triglycerides, Week 96, n=271, 289	0.105 Millimoles per liter Standard Error 0.0488	-0.102 Millimoles per liter Standard Error 0.0365

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of fasting lipids which included Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides. Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 LDL Cholesterol, Week 144, n=263, 278	0.143 Millimoles per liter Standard Error 0.0357	-0.085 Millimoles per liter Standard Error 0.0333
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 Serum or Plasma Cholesterol, Week 144, n=263, 278	0.360 Millimoles per liter Standard Error 0.0432	-0.015 Millimoles per liter Standard Error 0.0394
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 HDL Cholesterol, Direct, Week 144, n=264, 278	0.180 Millimoles per liter Standard Error 0.0162	0.093 Millimoles per liter Standard Error 0.0136
Change From Baseline in Fasting Lipids-Serum or Plasma Cholesterol, Serum or Plasma HDL Cholesterol (Direct), Serum or Plasma LDL Cholesterol (Calculated or Direct) and Serum or Plasma Triglycerides at Week 144 Triglycerides, Week 144, n=264, 278	0.078 Millimoles per liter Standard Error 0.0448	-0.057 Millimoles per liter Standard Error 0.0430

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 24, 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Percentage change from Baseline was calculated as 100 multiplied by (\[post-dose visit value minus Baseline value\] divided by Baseline value). Lipid last observation carried forwarded (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Participants on lipid-lowering agents at Baseline were excluded.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 Total/HDL Cholesterol Ratio, Week 24, n=298, 310	-4.4 Percentage change Standard Deviation 22.53	-7.5 Percentage change Standard Deviation 17.90
Percentage Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Weeks 24, 48 Total/HDL Cholesterol Ratio, Week 48, n=298, 307	-2.8 Percentage change Standard Deviation 17.86	-4.5 Percentage change Standard Deviation 18.25

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=270 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=289 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 96	-0.113 Ratio Standard Error 0.1552	-0.395 Ratio Standard Error 0.0473

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to perform evaluation of fasting lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio. Baseline value is the latest pre-dose assessment (Day 1). Baseline value was defined as the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=263 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=278 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in Fasting Lipid-Serum or Plasma Total Cholesterol/HDL Cholesterol Ratio at Week 144	-0.245 Ratio Standard Error 0.0545	-0.359 Ratio Standard Error 0.0533

SECONDARY outcome

Timeframe: Weeks 24 and 48

Population: Safety Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Weeks 24 and 48 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 48 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 Week 24, n=313, 320	4 Percentage of participants	0 Percentage of participants
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Weeks 24, 48 Week 48, n=324, 332	4 Percentage of participants	2 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). The higher the grade, the more severe the symptoms. Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 96 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 96 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=324 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=332 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 96	6 Percentage of participants	2 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

Population: Safety Population. Only those participants available at the specified time points were analyzed.

Blood samples were collected to perform evaluation of fasting LDL cholesterol. Any abnormalities were evaluated by the investigator and graded according to DAIDS toxicity scales from Grade 1 to 4 (1=Mild, 2=Moderate, 3=Severe, 4=Potentially life threatening). Percentage of participants with Grade 2 or greater laboratory abnormalities in fasting LDL cholesterol by Week 144 have been presented. Participants without any post-Baseline fasting LDL cholesterol value prior to Week 144 or those who had Baseline lipids-lowering agents were not included. Lipid Last Observation Carried Forward (LOCF) data was used such that the last available fasted, on-treatment lipid value prior to the initiation of a lipid-lowering agent was used in place of future observed values. Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=324 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=333 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants With Grade 2 or Greater Laboratory Abnormalities in Fasting LDL Cholesterol by Week 144	6 Percentage of participants	4 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000 c/mL) and Race (White, African American/African heritage (H.), Asian other). Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Baseline CD4+ cell count Group-1, <=200,n=32,26	78 Percentage of participants	92 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Baseline CD4+ cell count Group-1, >200,n=328,333	95 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Female, n=54, 46	93 Percentage of participants	89 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Male, n=306, 313	94 Percentage of participants	95 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Age, <35,n= 209, 203	93 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Age, 35 to <50,n=115, 122	96 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Age, >=50, n=36, 34	94 Percentage of participants	91 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Baseline plasma HIV-1 RNA, <=100000,n=294,282	94 Percentage of participants	95 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Baseline plasma HIV-1 RNA, >100000,n=66, 77	92 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Race, White, n=240, 252	95 Percentage of participants	95 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Race, African American/African H., n=51, 35	90 Percentage of participants	89 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Race, Asian, n=34, 30	97 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count, Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 24 Race, Other, n=35, 42	89 Percentage of participants	93 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3 for group-1), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Baseline plasma HIV-1 RNA, <=100000,n=294,282	92 Percentage of participants	95 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Race, White, n=240, 252	96 Percentage of participants	96 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Race, Asian, n=34, 30	97 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Race, Other, n=35, 42	86 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Baseline CD4+ cell count Group-1, <=200,n=32, 26	78 Percentage of participants	96 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Baseline CD4+ cell count Group-1, >200,n=328,333	95 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Female, n=54, 46	89 Percentage of participants	87 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Male, n=306, 313	94 Percentage of participants	95 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Age, <35,n= 209,203	92 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Age, 35 to <50,n=115, 122	97 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Age, >=50, n=36, 34	89 Percentage of participants	94 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Baseline plasma HIV-1 RNA, >100000,n=66, 77	97 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 48 Race, African American/African H., n=51, 35	80 Percentage of participants	86 Percentage of participants

SECONDARY outcome

Timeframe: Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Baseline CD4+ cell count, >200,n=328,333	89 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Female, n=54, 46	81 Percentage of participants	85 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Male, n=306, 313	89 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Age, <35,n= 209, 203	88 Percentage of participants	91 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Age, 35 to <50,n=115, 122	90 Percentage of participants	89 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Age, >=50, n=36, 34	83 Percentage of participants	88 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Baseline plasma HIV-1 RNA, <=100000,n=294, 282	88 Percentage of participants	91 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Baseline plasma HIV-1 RNA, >100000,n=66, 77	86 Percentage of participants	84 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Race, White, n=240,252	92 Percentage of participants	91 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Race, African American/African H., n=51, 35	69 Percentage of participants	86 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Race, Asian, n=34, 30	88 Percentage of participants	90 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Race, Other, n=35, 42	89 Percentage of participants	83 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 96 Baseline CD4+ cell count, <=200,n=32, 26	72 Percentage of participants	85 Percentage of participants

SECONDARY outcome

Timeframe: Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

Percentage of participants by subgroups (by age, gender, Baseline CD4+ cell count, Baseline HIV-1 RNA, race) with HIV-1 RNA\<50 c/mL was obtained using FDA Snapshot algorithm. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Data was presented by subgroups: age (\<35, 35 to \<50, \>=50 years); gender (males and females), Baseline CD4+ cell count (\<=200 cells/mm\^3, \>200 cells/mm\^3), Baseline HIV-1 RNA (\<=100000, \>100000) and Race (White, African American/African H., Asian and other). Percentage values are rounded-off.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Female, n=54, 46	78 Percentage of participants	83 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Race, African American/African H., n=51, 35	65 Percentage of participants	74 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Race, Asian, n=34, 30	85 Percentage of participants	83 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Race, Other, n=35, 42	89 Percentage of participants	79 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Baseline CD4+ cell count, <=200,n=32, 26	75 Percentage of participants	69 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Baseline CD4+ cell count, >200,n=328,333	85 Percentage of participants	86 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Male, n=306, 313	85 Percentage of participants	85 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Age, <35,n= 209, 203	83 Percentage of participants	83 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Age, 35 to <50,n=115, 122	86 Percentage of participants	85 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Age, >=50, n=36, 34	83 Percentage of participants	88 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Baseline plasma HIV-1 RNA, <=100000,n=294, 282	84 Percentage of participants	85 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Baseline plasma HIV-1 RNA, >100000,n=66, 77	86 Percentage of participants	81 Percentage of participants
Percentage of Participants by Subgroups (by Age, Gender, Baseline CD4+ Cell Count Baseline HIV-1 RNA, Race) With Plasma HIV-1 RNA <50 c/mL at Week 144 Race, White, n=240,252	88 Percentage of participants	87 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 24

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Baseline CD4+ cell count,>200, n=320, 319	189.91 Cells/mm^3 Standard Error 9.362	167.35 Cells/mm^3 Standard Error 9.362
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Baseline plasma HIV-1 RNA,<=100000, n=283,273	186.01 Cells/mm^3 Standard Error 9.948	148.21 Cells/mm^3 Standard Error 10.134
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Baseline plasma HIV-1 RNA,>100000, n=66,72	193.90 Cells/mm^3 Standard Error 20.811	220.71 Cells/mm^3 Standard Error 19.814
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Baseline CD4+ cell count,<=200, n=29, 26	167.95 Cells/mm^3 Standard Error 31.308	106.23 Cells/mm^3 Standard Error 32.990
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Age group, <35,n= 201, 193	190.12 Cells/mm^3 Standard Error 11.829	151.13 Cells/mm^3 Standard Error 12.050
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Age group-1, 35 to <50, n=113, 119	180.50 Cells/mm^3 Standard Error 15.733	190.40 Cells/mm^3 Standard Error 15.404
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Age group-1, >=50, n=35, 33	198.74 Cells/mm^3 Standard Error 28.411	133.21 Cells/mm^3 Standard Error 29.120
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Female, n=52, 42	213.58 Cells/mm^3 Standard Error 23.225	153.92 Cells/mm^3 Standard Error 25.910
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Male, n=297, 303	183.41 Cells/mm^3 Standard Error 9.719	164.18 Cells/mm^3 Standard Error 9.631
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Race group, White, n=236, 243	186.48 Cells/mm^3 Standard Error 10.932	167.44 Cells/mm^3 Standard Error 10.790
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Race group, African Am/African H., n=48, 34	195.18 Cells/mm^3 Standard Error 24.222	151.93 Cells/mm^3 Standard Error 28.784
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Race group, Asian, n=33, 28	154.03 Cells/mm^3 Standard Error 29.438	141.24 Cells/mm^3 Standard Error 31.703
Changes From Baseline in CD4+ Cell Counts at Week 24 by Subgroups Race group, Other, n=32, 40	222.21 Cells/mm^3 Standard Error 29.681	160.20 Cells/mm^3 Standard Error 26.627

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=x in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from Analysis of Covariance (ANCOVA) model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Age group-2, <50,n= 305, 308	226.4 Cells/mm^3 Standard Error 10.09	217.8 Cells/mm^3 Standard Error 10.03
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Female, n=48, 41	236.2 Cells/mm^3 Standard Error 25.35	263.6 Cells/mm^3 Standard Error 27.50
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Race group, White, n=230, 244	225.5 Cells/mm^3 Standard Error 11.62	214.2 Cells/mm^3 Standard Error 11.30
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Race group, Other, n=32, 38	270.2 Cells/mm^3 Standard Error 31.15	232.6 Cells/mm^3 Standard Error 28.67
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Baseline plasma HIV-1 RNA,<=100000, n=273,271	215.6 Cells/mm^3 Standard Error 10.67	208.7 Cells/mm^3 Standard Error 10.71
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Baseline plasma HIV-1 RNA,>100000, n=64,69	261.8 Cells/mm^3 Standard Error 22.27	248.7 Cells/mm^3 Standard Error 21.30
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Baseline CD4+ cell count,<=200, n=28, 25	210.9 Cells/mm^3 Standard Error 33.42	153.2 Cells/mm^3 Standard Error 35.29
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Baseline CD4+ cell count,>200, n=309, 315	225.8 Cells/mm^3 Standard Error 10.00	221.7 Cells/mm^3 Standard Error 9.89
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Age group-1, <35,n= 193, 191	234.2 Cells/mm^3 Standard Error 12.67	201.7 Cells/mm^3 Standard Error 12.72
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Age group-1, 35 to <50, n=112, 117	212.7 Cells/mm^3 Standard Error 16.59	244.2 Cells/mm^3 Standard Error 16.31
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Age group-1, >=50, n=32, 32	209.1 Cells/mm^3 Standard Error 31.20	203.9 Cells/mm^3 Standard Error 31.06
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Age group-2, >=50, n= 32, 32	208.5 Cells/mm^3 Standard Error 31.27	204.1 Cells/mm^3 Standard Error 31.14
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Male, n=289, 299	222.8 Cells/mm^3 Standard Error 10.33	210.0 Cells/mm^3 Standard Error 10.17
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Race group, African Am/African H., n=42, 31	201.2 Cells/mm^3 Standard Error 27.16	239.0 Cells/mm^3 Standard Error 31.64
Changes From Baseline in CD4+ Cell Counts at Week 48 by Subgroups Race group, Asian, n=33, 27	204.9 Cells/mm^3 Standard Error 30.90	189.3 Cells/mm^3 Standard Error 33.88

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Baseline plasma HIV-1 RNA,>100000, n=59,67	312.1 Cells/mm^3 Standard Error 26.37	297.4 Cells/mm^3 Standard Error 24.59
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Baseline CD4+ cell count,<=200, n=25, 23	229.4 Cells/mm^3 Standard Error 40.41	202.9 Cells/mm^3 Standard Error 42.00
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Race group, White, n=221, 234	272.1 Cells/mm^3 Standard Error 13.49	258.3 Cells/mm^3 Standard Error 13.14
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Race group, African Am/African H., n=35, 30	246.3 Cells/mm^3 Standard Error 33.90	303.7 Cells/mm^3 Standard Error 36.61
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Race group, Other, n=31, 36	312.0 Cells/mm^3 Standard Error 36.01	278.9 Cells/mm^3 Standard Error 33.56
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Baseline plasma HIV-1 RNA,<=100000, n=259,260	257.9 Cells/mm^3 Standard Error 12.47	257.5 Cells/mm^3 Standard Error 12.45
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Baseline CD4+ cell count,>200, n=293, 304	272.3 Cells/mm^3 Standard Error 11.73	269.4 Cells/mm^3 Standard Error 11.50
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Age group-1, <35,n= 186, 187	266.0 Cells/mm^3 Standard Error 14.74	257.7 Cells/mm^3 Standard Error 14.68
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Age group-1, 35 to <50, n=101, 110	273.6 Cells/mm^3 Standard Error 19.95	286.8 Cells/mm^3 Standard Error 19.22
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Age group-1, >=50, n=31, 30	265.8 Cells/mm^3 Standard Error 36.14	233.1 Cells/mm^3 Standard Error 36.61
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Female, n=44, 40	312.7 Cells/mm^3 Standard Error 30.12	307.6 Cells/mm^3 Standard Error 31.67
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Male, n=274, 287	261.4 Cells/mm^3 Standard Error 12.07	259.3 Cells/mm^3 Standard Error 11.81
Changes From Baseline in CD4+ Cell Counts at Week 96 by Subgroups Race group, Asian, n=31, 27	224.0 Cells/mm^3 Standard Error 36.31	264.0 Cells/mm^3 Standard Error 38.57

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is the latest pre-dose assessment (Day 1). Change from Baseline was defined as value at the indicated time point minus Baseline value. Adjusted mean and standard error is presented for subgroups (Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, Age group, Gender and race). For each subgroup, adjusted mean is the estimated mean change from Baseline in each arm calculated from ANCOVA model adjusting for the following covariates/factors: treatment, Baseline plasma HIV-1 RNA (factor), Baseline CD4+ cell count, subgroup, and treatment and relevant subgroup interaction. For CD4+ cell count subgroup, Baseline CD4+ cell count group is included as a factor only.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Race group, Other, n=31, 32	355.0 Cells/mm^3 Standard Error 39.84	240.7 Cells/mm^3 Standard Error 39.35
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Baseline plasma HIV-1 RNA,<=100000, n=241,234	286.8 Cells/mm^3 Standard Error 14.36	277.8 Cells/mm^3 Standard Error 14.58
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Baseline plasma HIV-1 RNA,>100000, n=55,58	338.2 Cells/mm^3 Standard Error 30.34	354.7 Cells/mm^3 Standard Error 29.35
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Baseline CD4+ cell count,<=200, n=25, 19	264.8 Cells/mm^3 Standard Error 44.91	208.9 Cells/mm^3 Standard Error 51.25
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Baseline CD4+ cell count,>200, n=271, 273	300.3 Cells/mm^3 Standard Error 13.54	297.9 Cells/mm^3 Standard Error 13.48
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Age group, <35,n=171, 159	302.9 Cells/mm^3 Standard Error 17.05	277.1 Cells/mm^3 Standard Error 17.65
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Age group-1, 35 to <50, n=95, 103	292.8 Cells/mm^3 Standard Error 22.82	329.2 Cells/mm^3 Standard Error 22.02
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Age group-1, >=50, n=30, 30	274.1 Cells/mm^3 Standard Error 40.71	250.0 Cells/mm^3 Standard Error 40.60
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Female, n=40, 37	355.0 Cells/mm^3 Standard Error 34.93	381.8 Cells/mm^3 Standard Error 36.37
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Male, n=256, 255	287.7 Cells/mm^3 Standard Error 13.81	279.6 Cells/mm^3 Standard Error 13.85
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Race group, White, n=202, 211	300.0 Cells/mm^3 Standard Error 15.61	296.5 Cells/mm^3 Standard Error 15.29
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Race group, African Am/African H., n=34, 24	256.4 Cells/mm^3 Standard Error 38.04	377.6 Cells/mm^3 Standard Error 45.25
Changes From Baseline in CD4+ Cell Counts at Week 144 by Subgroups Race group, Asian, n=29, 25	258.5 Cells/mm^3 Standard Error 41.57	245.4 Cells/mm^3 Standard Error 44.36

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has 1 question assessing each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. The health state is defined by combining the levels of answers from each of the 5 questions. Each health state is referred to in terms of a 5 digit code. Health state 5 digit code is translated into utility score, which is valued up to 1 (perfect health) with lower values meaning worse state. EQ-5D-5L utility score ranges from -0.281 to 1. Higher scores indicate better health. MMRM was run on LOCF dataset. Baseline was the latest pre-dose assessment and change from Baseline=post-dose value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 Week 4, n=359, 355	0.0111 Scores on a scale Standard Error 0.00326	0.0130 Scores on a scale Standard Error 0.00510
Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 Week 24, n=360, 358	0.0207 Scores on a scale Standard Error 0.00310	0.0203 Scores on a scale Standard Error 0.00347
Change From Baseline in European Quality of Life [EuroQoL] - 5 Dimensions - 5 Levels (EQ-5D-5L) Utility Score at Weeks 4, 24, 48 Week 48, n=360, 358	0.0189 Scores on a scale Standard Error 0.00362	0.0208 Scores on a scale Standard Error 0.00342

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=358 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in EQ-5D-5L Utility Score at Week 96	0.0168 Scores on a scale Standard Error 0.00339	0.0171 Scores on a scale Standard Error 0.00424

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=358 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in EQ-5D-5L Utility Score at Week 144	0.0210 Scores on a scale Standard Error 0.00346	0.0131 Scores on a scale Standard Error 0.00441

SECONDARY outcome

Timeframe: Baseline (Day 1) and Weeks 4, 24, 48

Population: ITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X in the category titles).

EQ-5D-5L questionnaire provided a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). MMRM was run on the LOCF dataset, using the observed margins (OM) option. Baseline was the latest pre-dose assessment value and change from Baseline=post-dose value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=360 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=359 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48 Week 4, n=358, 355	1.8 Scores on a scale Standard Error 0.50	3.1 Scores on a scale Standard Error 0.41
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48 Week 24, n=359, 358	3.9 Scores on a scale Standard Error 0.43	4.5 Scores on a scale Standard Error 0.48
Change From Baseline in EuroQol - 5 Dimensions - 5 Levels (EQ-5D-5L) Thermometer Scores at Weeks 4, 24, 48 Week 48, n=359, 358	4.0 Scores on a scale Standard Error 0.43	4.6 Scores on a scale Standard Error 0.48

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 96

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=359 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=358 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 96	4.4 Scores on a scale Standard Error 0.45	5.1 Scores on a scale Standard Error 0.52

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 144

Population: ITT-E Population. Only those participants available at the specified time points were analyzed.

Outcome measures

Outcome measures
Measure	DTG + 3TC - Double-blind Phase n=359 Participants Participants received a two-drug regimen of DTG + 3TC administered orally, once daily for 96 weeks in a double-blind phase.	DTG + TDF/FTC - Double-blind Phase n=358 Participants Participants received a three-drug regimen of DTG + TDF/FTC fixed dose combination (FDC) administered orally, once daily for 96 weeks in a double-blind phase.
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 144	4.8 Scores on a scale Standard Error 0.44	4.5 Scores on a scale Standard Error 0.51

Adverse Events

DTG + 3TC - Double-blind Phase + Open-label Phase

Serious events: 39 serious events

Other events: 273 other events

Deaths: 2 deaths

DTG + TDF/FTC - Double-blind Phase + Open-label Phase

Serious events: 47 serious events

Other events: 276 other events

Deaths: 1 deaths

DTG + 3TC - Continuation Phase

Serious events: 9 serious events

Other events: 45 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

Restriction type: OTHER