Trial Outcomes & Findings for A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA) (NCT NCT01910402)

NCT ID: NCT01910402

Last Updated: 2024-02-20

Results Overview

Percentage of participants with plasma human immunodeficiency virus type 1(HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL) were assessed at Week 48 using the Snapshot algorithm. Analysis was performed using a stratified analysis with Cochran-Mantel-Haenszel (CMH) weights, adjusting for Baseline plasma HIV-1 RNA ( =\<vs. \>100,000 c/mL) and CD4+ cell count (=\<350 cells per millimeter cube (cells/mm\^3) or \>350 cells/mm\^3). Intent-to-Treat Exposed (ITT-E) Population comprised of all randomized participants who received at least one dose of study medication. Percentage values are rounded off.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

499 participants

Primary outcome timeframe

Week 48

Results posted on

2024-02-20

Participant Flow

The study consists of a Screening (14-28 days), Randomized (48 weeks) and Continuation (Cont.) Phase. Participants were said to have completed the study if they completed the Randomized phase and did not enter the Cont. Phase. Participants entering the Cont. Phase were said to have completed the study if they completed both phases of the study.

A total of 499 participants were randomized to receive dolutegravir(DTG)/abacavir(ABC)/lamivudine(3TC) fixed dose combination(FDC) or combination of atazanavir(ATV), Ritonavir(RTV) and FDC of tenofovir disoproxil fumarate/emtricitabine(TDF/FTC). Two participants from each DTG/ABC/3TC and ATV+RTV+TDF/FTC groups were randomized but not treated. A total of 495 participants received at least single dose of investigational products(IP) and were included in Intent-to-Treat Exposed(ITT-E) Population.

Participant milestones

Participant milestones
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg once daily orally in the Continuation Phase until it was either locally approved or commercial supplies were available.
Randomized Phase (Up to 48 Weeks) STARTED	250	249	0
Randomized Phase (Up to 48 Weeks) ITT-E Population	248	247	0
Randomized Phase (Up to 48 Weeks) COMPLETED	206	192	0
Randomized Phase (Up to 48 Weeks) NOT COMPLETED	44	57	0
Continuation Phase(From Weeks 48 to 432) STARTED	0	0	149
Continuation Phase(From Weeks 48 to 432) COMPLETED	0	0	113
Continuation Phase(From Weeks 48 to 432) NOT COMPLETED	0	0	36

Reasons for withdrawal

Reasons for withdrawal
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg once daily orally in the Continuation Phase until it was either locally approved or commercial supplies were available.
Randomized Phase (Up to 48 Weeks) Adverse Event	10	18	0
Randomized Phase (Up to 48 Weeks) Physician Decision	1	0	0
Randomized Phase (Up to 48 Weeks) Lack of Efficacy	5	4	0
Randomized Phase (Up to 48 Weeks) Lost to Follow-up	11	13	0
Randomized Phase (Up to 48 Weeks) Withdrawal by Subject	5	7	0
Randomized Phase (Up to 48 Weeks) Randomized, but did not receive treatment	2	2	0
Randomized Phase (Up to 48 Weeks) Protocol Deviation	10	13	0
Continuation Phase(From Weeks 48 to 432) Physician Decision	0	0	1
Continuation Phase(From Weeks 48 to 432) Adverse Event	0	0	4
Continuation Phase(From Weeks 48 to 432) Withdrawal by Subject	0	0	7
Continuation Phase(From Weeks 48 to 432) Lost to Follow-up	0	0	8
Continuation Phase(From Weeks 48 to 432) Lack of Efficacy	0	0	1
Continuation Phase(From Weeks 48 to 432) Protocol Deviation	0	0	15

Baseline Characteristics

A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.	Total n=495 Participants Total of all reporting groups
Age, Continuous	38.1 Years STANDARD_DEVIATION 11.15 • n=5 Participants	37.8 Years STANDARD_DEVIATION 10.14 • n=7 Participants	37.9 Years STANDARD_DEVIATION 10.65 • n=5 Participants
Sex: Female, Male Female	248 Participants n=5 Participants	247 Participants n=7 Participants	495 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized African American/African Heritage	102 Participants n=5 Participants	108 Participants n=7 Participants	210 Participants n=5 Participants
Race/Ethnicity, Customized American Indian Or Alaskan Native	6 Participants n=5 Participants	7 Participants n=7 Participants	13 Participants n=5 Participants
Race/Ethnicity, Customized Asian - Central/South Asian Heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Asian - East Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian - South East Asian Heritage	20 Participants n=5 Participants	22 Participants n=7 Participants	42 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian Or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White - Arabic/North African Heritage	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized White - White/Caucasian/European Heritage	112 Participants n=5 Participants	104 Participants n=7 Participants	216 Participants n=5 Participants
Race/Ethnicity, Customized Mixed Race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48	82 Percentage of participants	71 Percentage of participants

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

Population: ITT-E Population

Percentage of participants with plasma HIV-1 RNA \<50 and \<400 c/mL were assessed at Baseline, Weeks 4, 12, 24 , 36 and 48 using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Baseline (Day 1)	0 Percentage of participants	0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Week 4	64 Percentage of participants	13 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Week 12	81 Percentage of participants	49 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Week 24	85 Percentage of participants	77 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Week 36	85 Percentage of participants	77 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <50 c/mL, Week 48	82 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Baseline (Day 1)	1 Percentage of participants	1 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Week 4	90 Percentage of participants	54 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Week 12	91 Percentage of participants	84 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Week 24	88 Percentage of participants	82 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Week 36	86 Percentage of participants	81 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 and <400 c/mL Over Time-Randomized Phase HIV-1 RNA <400 c/mL, Week 48	83 Percentage of participants	76 Percentage of participants

SECONDARY outcome

Timeframe: Week 96 and Week 432

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

Plasma samples were collected for quantitative analysis of HIV-1 RNA. Percentage of participants with plasma HIV-1 RNA \<50 c/mL were reported. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase Week 96, n=99	100 Percentage of participants	—
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL in Continuation Phase Week 432, n=3	100 Percentage of participants	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Change from the Baseline in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 4, n=245, 238	-2.591 Log10 copies/mL Standard Deviation 0.8015	-1.923 Log10 copies/mL Standard Deviation 0.5330
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 12, n=236, 226	-2.756 Log10 copies/mL Standard Deviation 0.8920	-2.541 Log10 copies/mL Standard Deviation 0.7373
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 24, n=225, 212	-2.789 Log10 copies/mL Standard Deviation 0.9160	-2.726 Log10 copies/mL Standard Deviation 0.8890
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 36, n=221, 204	-2.838 Log10 copies/mL Standard Deviation 0.8589	-2.772 Log10 copies/mL Standard Deviation 0.8451
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 48, n=207, 192	-2.874 Log10 copies/mL Standard Deviation 0.8035	-2.752 Log10 copies/mL Standard Deviation 0.8433

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 96 and Week 432

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

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase Week 96, n=99	-2.911 Log10 copies/mL Standard Deviation 0.7970	—
Change From Baseline in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase Week 432, n=3	-3.107 Log10 copies/mL Standard Deviation 0.7659	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Baseline (Day 1), n=248, 247	4.481 Log10 copies/mL Standard Deviation 0.8111	4.441 Log10 copies/mL Standard Deviation 0.8023
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 4, n=245, 238	1.895 Log10 copies/mL Standard Deviation 0.6872	2.516 Log10 copies/mL Standard Deviation 0.6193
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 12, n=236, 226	1.748 Log10 copies/mL Standard Deviation 0.5458	1.908 Log10 copies/mL Standard Deviation 0.4926
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 24, n=225, 212	1.724 Log10 copies/mL Standard Deviation 0.5935	1.710 Log10 copies/mL Standard Deviation 0.4484
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 36, n=221, 204	1.666 Log10 copies/mL Standard Deviation 0.3982	1.658 Log10 copies/mL Standard Deviation 0.3362
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Randomized Phase Week 48, n=207, 192	1.619 Log10 copies/mL Standard Deviation 0.1986	1.657 Log10 copies/mL Standard Deviation 0.2743

SECONDARY outcome

Timeframe: Week 96 and Week 432

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

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase Week 96, n=99	1.591 Log10 copies/mL Standard Deviation 0.0080	—
Absolute Values in Plasma HIV-1 RNA at Indicated Time Points-Continuation Phase Week 432, n=3	1.590 Log10 copies/mL Standard Deviation 0.0000	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Change from Baseline in cluster of differentiation 4 (CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 4, n=245, 237	94.9 Cells per cubic millimeter Standard Deviation 140.02	73.7 Cells per cubic millimeter Standard Deviation 108.15
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 12, n=236, 224	143.8 Cells per cubic millimeter Standard Deviation 142.19	124.4 Cells per cubic millimeter Standard Deviation 133.60
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 24, n=226, 210	200.6 Cells per cubic millimeter Standard Deviation 162.37	163.0 Cells per cubic millimeter Standard Deviation 126.67
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 36, n=219, 204	230.7 Cells per cubic millimeter Standard Deviation 163.61	191.4 Cells per cubic millimeter Standard Deviation 167.24
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 48, n=208, 191	248.8 Cells per cubic millimeter Standard Deviation 172.01	230.7 Cells per cubic millimeter Standard Deviation 189.59

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 96, Week 432

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

Change from Baseline in cluster of differentiation 4(CD4+) cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase Week 96, n=99	286.5 Cells per cubic millimeter Standard Deviation 196.77	—
Change From Baseline in CD4+ Cell Count at Indicated Timepoints-Continuation Phase Week 432, n=3	254.7 Cells per cubic millimeter Standard Deviation 342.31	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Absolute values in CD4+ cell count were assessed at indicated time points. The Baseline value was defined as the latest pre-dose assessment (Day 1) value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 36, n=219, 204	592.8 Cells per cubic millimeter Standard Deviation 291.62	569.2 Cells per cubic millimeter Standard Deviation 299.77
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Baseline (Day 1), n=248, 247	369.7 Cells per cubic millimeter Standard Deviation 225.67	380.3 Cells per cubic millimeter Standard Deviation 223.60
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 4, n=245, 237	465.0 Cells per cubic millimeter Standard Deviation 252.51	455.1 Cells per cubic millimeter Standard Deviation 244.62
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 12, n=236, 224	509.5 Cells per cubic millimeter Standard Deviation 276.79	506.2 Cells per cubic millimeter Standard Deviation 266.84
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 24, n=226, 210	563.8 Cells per cubic millimeter Standard Deviation 303.10	542.5 Cells per cubic millimeter Standard Deviation 265.69
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Randomized Phase Week 48, n=208, 191	608.8 Cells per cubic millimeter Standard Deviation 298.95	608.5 Cells per cubic millimeter Standard Deviation 302.58

SECONDARY outcome

Timeframe: Week 96 and Week 432

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

Absolute values in CD4+ cell count were assessed at indicated time points.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase Week 96, n=99	635.3 Cells per cubic millimeter Standard Deviation 285.85	—
Absolute Values in CD4+ Cell Count at Indicated Timepoints-Continuation Phase Week 432, n=3	553.0 Cells per cubic millimeter Standard Deviation 341.63	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in carbon dioxide, electrolytes (chloride, hyperkalemia, hypernatremia, hypokalemia, hyponatremia, phosphate, potassium, sodium), lipids (cholesterol \[CHLS\], high density lipoprotein \[HDL\] CHLS direct, low density lipoprotein (LDL) CHLS calculation, LDL CHLS direct, triglycerides), glucose (hyperglycaemia, hypoglycaemia) and urea are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Laboratory parameters were assessed in Safety Population which comprised of all participants who received at least one dose of study treatment.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in bilirubin and creatinine are summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Bilirubin, Week 4, n= 244, 237	-0.8 Micromoles per liter Standard Deviation 2.59	27.2 Micromoles per liter Standard Deviation 23.15
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Bilirubin, Week 12, n= 236, 226	-0.6 Micromoles per liter Standard Deviation 2.65	22.8 Micromoles per liter Standard Deviation 16.49
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Bilirubin, Week 24, n= 225, 212	-0.2 Micromoles per liter Standard Deviation 3.06	25 Micromoles per liter Standard Deviation 18.38
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Bilirubin, Week 36, n= 219, 204	-0.2 Micromoles per liter Standard Deviation 3.01	23.8 Micromoles per liter Standard Deviation 16.31
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Bilirubin, Week 48, n= 208, 192	-0.3 Micromoles per liter Standard Deviation 3.08	23.7 Micromoles per liter Standard Deviation 17
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Creatinine, Week 4, n= 245, 237	8.4 Micromoles per liter Standard Deviation 7.057	4.89 Micromoles per liter Standard Deviation 7.109
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Creatinine, Week 12, n= 236, 226	9.2 Micromoles per liter Standard Deviation 8.288	5.83 Micromoles per liter Standard Deviation 8.357
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Creatinine, Week 24, n= 225, 212	9.16 Micromoles per liter Standard Deviation 9.983	5.8 Micromoles per liter Standard Deviation 8.063
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Creatinine, Week 36, n= 219, 204	10.08 Micromoles per liter Standard Deviation 10.473	5.37 Micromoles per liter Standard Deviation 9.013
Change From Baseline in Bilirubin and Creatinine at Indicated Timepoints Creatinine, Week 48, n= 208, 192	9.29 Micromoles per liter Standard Deviation 8.614	5.86 Micromoles per liter Standard Deviation 10.252

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in albumin is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Albumin at Indicated Timepoints Week 4, n= 245, 237	0.1 Grams per liter Standard Deviation 2.36	-0.5 Grams per liter Standard Deviation 2.59
Change From Baseline in Albumin at Indicated Timepoints Week 12, n= 236, 226	0.5 Grams per liter Standard Deviation 2.95	0.1 Grams per liter Standard Deviation 2.59
Change From Baseline in Albumin at Indicated Timepoints Week 24, n= 225, 212	1.4 Grams per liter Standard Deviation 3.2	0.8 Grams per liter Standard Deviation 2.95
Change From Baseline in Albumin at Indicated Timepoints Week 36, n= 219, 204	1.4 Grams per liter Standard Deviation 3.09	0.6 Grams per liter Standard Deviation 2.96
Change From Baseline in Albumin at Indicated Timepoints Week 48, n= 208, 192	1.7 Grams per liter Standard Deviation 3.17	1.3 Grams per liter Standard Deviation 3.04

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in creatinine clearance is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Creatinine Clearance at Indicated Time Points Week 4, n= 245, 237	-16.3 Milliliter per minute Standard Deviation 15.03	-7.5 Milliliter per minute Standard Deviation 12.91
Change From Baseline in Creatinine Clearance at Indicated Time Points Week 12, n= 236, 226	-17.3 Milliliter per minute Standard Deviation 17.01	-7 Milliliter per minute Standard Deviation 23.14
Change From Baseline in Creatinine Clearance at Indicated Time Points Week 24, n= 225, 212	-16.2 Milliliter per minute Standard Deviation 20.36	-9.1 Milliliter per minute Standard Deviation 16.88
Change From Baseline in Creatinine Clearance at Indicated Time Points Week 36, n= 219, 204	-16.8 Milliliter per minute Standard Deviation 22.35	-7.5 Milliliter per minute Standard Deviation 17.67
Change From Baseline in Creatinine Clearance at Indicated Time Points Week 48, n= 208, 192	-15.9 Milliliter per minute Standard Deviation 19.62	-7.7 Milliliter per minute Standard Deviation 18.42

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in lipase is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Lipase at Indicated Timepoints Week 4, n= 245, 237	-1.2 Units per liter Standard Deviation 15.06	-1.3 Units per liter Standard Deviation 15.81
Change From Baseline in Lipase at Indicated Timepoints Week 12, n= 236, 226	-2.2 Units per liter Standard Deviation 22.74	-2.1 Units per liter Standard Deviation 29
Change From Baseline in Lipase at Indicated Timepoints Week 24, n= 225, 212	-6 Units per liter Standard Deviation 21.05	-6 Units per liter Standard Deviation 18.57
Change From Baseline in Lipase at Indicated Timepoints Week 36, n= 219, 204	-6.3 Units per liter Standard Deviation 25.62	-6.3 Units per liter Standard Deviation 21.36
Change From Baseline in Lipase at Indicated Timepoints Week 48, n= 208, 192	-6.5 Units per liter Standard Deviation 29.63	-7.8 Units per liter Standard Deviation 20.72

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Clinical chemistry parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in Total CHLS/HDL CHLS ratio is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints Week 4, n= 1, 4	0.1264 Ratio Standard Deviation NA NA indicates standard deviation could not be calculated for a single participant	0.2159 Ratio Standard Deviation 0.60727
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints Week 12, n= 233, 223	-0.2736 Ratio Standard Deviation 1.0283	-0.1092 Ratio Standard Deviation 0.73776
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints Week 24, n= 224, 209	-0.3098 Ratio Standard Deviation 1.11093	-0.1922 Ratio Standard Deviation 0.79848
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints Week 36, n= 212, 198	-0.3286 Ratio Standard Deviation 1.01181	-0.1433 Ratio Standard Deviation 0.79498
Change From Baseline in Total CHLS/HDL CHLS Ratio at Indicated Timepoints Week 48, n= 207, 186	-0.2886 Ratio Standard Deviation 1.01415	-0.1444 Ratio Standard Deviation 1.23362

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in basophils, eosinophils, lymphocytes, monocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocytes is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Erythrocytes at Indicated Time Points Week 4, n= 243, 234	-0.04 10^12 cells per liter Standard Deviation 0.244	-0.07 10^12 cells per liter Standard Deviation 0.239
Change From Baseline in Erythrocytes at Indicated Time Points Week 12, n= 233, 220	-0.07 10^12 cells per liter Standard Deviation 0.351	-0.09 10^12 cells per liter Standard Deviation 0.308
Change From Baseline in Erythrocytes at Indicated Time Points Week 24, n= 225, 211	-0.08 10^12 cells per liter Standard Deviation 0.373	-0.09 10^12 cells per liter Standard Deviation 0.329
Change From Baseline in Erythrocytes at Indicated Time Points Week 36, n= 218, 203	-0.10 10^12 cells per liter Standard Deviation 0.384	-0.08 10^12 cells per liter Standard Deviation 0.358
Change From Baseline in Erythrocytes at Indicated Time Points Week 48, n= 207, 190	-0.10 10^12 cells per liter Standard Deviation 0.365	-0.05 10^12 cells per liter Standard Deviation 0.318

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Hematology parameters were assessed at Baseline (Day 1), Weeks 4, 12, 24, 36 and 48. Change from Baseline in hematocrit is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Hematocrit Count at Indicated Time Points Week 4, n= 243, 234	0.0003 Proportion of red blood cells in blood Standard Deviation 0.02176	-0.0042 Proportion of red blood cells in blood Standard Deviation 0.02238
Change From Baseline in Hematocrit Count at Indicated Time Points Week 12, n= 233, 220	0.0081 Proportion of red blood cells in blood Standard Deviation 0.03157	0.0000 Proportion of red blood cells in blood Standard Deviation 0.02646
Change From Baseline in Hematocrit Count at Indicated Time Points Week 24, n= 225, 211	0.0157 Proportion of red blood cells in blood Standard Deviation 0.03209	0.0051 Proportion of red blood cells in blood Standard Deviation 0.03083
Change From Baseline in Hematocrit Count at Indicated Time Points Week 36, n= 218, 203	0.0167 Proportion of red blood cells in blood Standard Deviation 0.03451	0.0062 Proportion of red blood cells in blood Standard Deviation 0.03379
Change From Baseline in Hematocrit Count at Indicated Time Points Week 48, n= 207, 190	0.0212 Proportion of red blood cells in blood Standard Deviation 0.03293	0.0107 Proportion of red blood cells in blood Standard Deviation 0.03200

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 4, Week 12, Week 24, Week 36 and Week 48

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

Hematology parameters were assessed at Baseline (Day 1), Week 4, 12, 24, 36 and Week 48. Change from Baseline in erythrocyte mean corpuscular volume (EMCV) is summarized. Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points Week 4, n= 243, 234	0.9 Femtoliter Standard Deviation 1.81	0.5 Femtoliter Standard Deviation 1.83
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points Week 12, n= 233, 220	3.4 Femtoliter Standard Deviation 2.98	1.9 Femtoliter Standard Deviation 2.94
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points Week 24, n= 225, 211	5.5 Femtoliter Standard Deviation 4.03	3.1 Femtoliter Standard Deviation 4.33
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points Week 36, n= 218, 203	6.0 Femtoliter Standard Deviation 4.04	3.1 Femtoliter Standard Deviation 5.22
Change From Baseline in Erythrocyte Mean Corpuscular Volume at Indicated Time Points Week 48, n= 207, 190	7.1 Femtoliter Standard Deviation 4.31	3.7 Femtoliter Standard Deviation 5.15

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.

Change from Baseline in mean triglycerides is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted triglycerides at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=226 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=214 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Triglycerides at Week 48	0.045 Millimoles per liter Standard Error 0.0477	0.070 Millimoles per liter Standard Error 0.0477

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: Safety Population. Participants on lipid lowering therapy at Baseline were excluded from analysis. Only those participants with data available at specified time points were analyzed.

Change from Baseline in mean total cholesterol (TC)/HDL ratio is summarized at Week 48. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Adjusted mean is the estimated mean change from Baseline in fasted TC/HDL at Week 48 in each arm calculated from a model adjusted for the following covariates: treatment, Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, age and triglycerides/HDL at Baseline. Participants on lipid lowering therapy at Baseline were excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values were imputed using multiple imputation under a multivariate normal model adjusting for Baseline plasma HIV-1 RNA, Baseline CD4+ cell count, fasted triglycerides and TC/HDL ratio at Baseline, Week 12 and Week 36.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=226 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=214 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in TC/HDL Ratio at Week 48	-0.264 Ratio Standard Error 0.0707	-0.158 Ratio Standard Error 0.0784

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 24 and Week 48

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

Change from Baseline in urine albumin creatinine ratio at Week 24 and Week 48 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points Week 24, n= 179, 186	-1.15 milligrams per millimole Standard Deviation 16.557	-1.03 milligrams per millimole Standard Deviation 9.091
Change From Baseline in Urine Albumin Creatinine Ratio at Indicated Time Points Week 48, n= 170, 164	-0.68 milligrams per millimole Standard Deviation 20.597	-0.10 milligrams per millimole Standard Deviation 9.393

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Number of participants with Grade 1-4 AEs by maximum toxicity were assessed from the start of study treatment and until end of the Randomization phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With AEs by Maximum Toxicity-Randomized Phase Grade 1	79 Participants	60 Participants
Number of Participants With AEs by Maximum Toxicity-Randomized Phase Grade 2	94 Participants	91 Participants
Number of Participants With AEs by Maximum Toxicity-Randomized Phase Grade 3	18 Participants	37 Participants
Number of Participants With AEs by Maximum Toxicity-Randomized Phase Grade 4	3 Participants	9 Participants

SECONDARY outcome

Timeframe: From Weeks 48 to 432

Population: Safety - Continuation Phase Population comprised of all participants in the DTG/ABC/3TC group who received at least 1 dose of study treatment after entering the Continuation Phase

Number of participants with Grade 1-4 AEs were assessed in Continuation Phase. AEs are categorized into following grades as per The Division of Aqcuired Immuno Deficiency Syndrome (AIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With AEs by Maximum Toxicity-Continuation Phase Grade 1	32 Participants	—
Number of Participants With AEs by Maximum Toxicity-Continuation Phase Grade 2	48 Participants	—
Number of Participants With AEs by Maximum Toxicity-Continuation Phase Grade 3	7 Participants	—
Number of Participants With AEs by Maximum Toxicity-Continuation Phase Grade 4	6 Participants	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or other events that may jeopardize the participant or may require medical or surgical intervention to prevent one of the outcome listed above, liver injury and impaired liver function and grade 4 laboratory abnormalities. Number of participants with any AEs, and SAEs have been presented.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase Any AEs	195 Participants	197 Participants
Number of Participants With Any Adverse Events (AEs), and Serious Adverse Events (SAEs)-Randomized Phase Any SAEs	12 Participants	20 Participants

SECONDARY outcome

Timeframe: From Weeks 48 to 432

Population: Safety-Continuation Phase Population

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Any AEs, and SAEs in Continuation Phase Any AEs	93 Participants	—
Number of Participants With Any AEs, and SAEs in Continuation Phase Any SAEs	13 Participants	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Number of participants with Grade 1-4 emergent chemistry toxicities were assessed from the start of study treatment and end of Randomized Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hyperkalemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperglycaemia, Grade 1	17 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperglycaemia, Grade 2	16 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperglycaemia, Grade 3	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperglycaemia, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperkalemia, Grade 1	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperkalemia, Grade 2	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperkalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyperkalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypernatremia, Grade 1	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypernatremia, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypernatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypernatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypoglycaemia, Grade 1	6 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypoglycaemia, Grade 2	3 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypoglycaemia, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypoglycaemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypokalemia, Grade 1	17 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypokalemia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypokalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hypokalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyponatremia, Grade 1	44 Participants	57 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyponatremia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyponatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Hyponatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alanine aminotransferase, Grade 1	5 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alanine aminotransferase, Grade 2	6 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alanine aminotransferase, Grade 3	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alanine aminotransferase, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Albumin, Grade 1	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Albumin, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alkaline phosphatase, Grade 1	3 Participants	14 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alkaline phosphatase, Grade 2	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alkaline phosphatase, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Alkaline phosphatase, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Aspartate aminotransferase, Grade 1	12 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Aspartate aminotransferase, Grade 2	4 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Aspartate aminotransferase, Grade 3	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Aspartate aminotransferase, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Bilirubin, Grade 1	2 Participants	52 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Bilirubin, Grade 2	0 Participants	86 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Bilirubin, Grade 3	0 Participants	57 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Bilirubin, Grade 4	0 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Carbon dioxide, Grade 1	65 Participants	54 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Carbon dioxide, Grade 2	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Carbon dioxide, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Carbon dioxide, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Cholesterol, Grade 1	52 Participants	31 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Cholesterol, Grade 2	28 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Cholesterol, Grade 3	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatine kinase, Grade 1	3 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatine kinase, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatine kinase, Grade 3	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatine kinase, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatinine, Grade 1	3 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatinine, Grade 2	0 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatinine, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol calculation, Grade 1	38 Participants	21 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol calculation, Grade 2	13 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol calculation, Grade 3	7 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol calculation, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol direct, Grade 1	3 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol direct, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol direct, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase LDL cholesterol direct, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Lipase, Grade 1	12 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Lipase, Grade 2	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Lipase, Grade 3	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Lipase, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Phosphate, Grade 1	5 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Phosphate, Grade 2	7 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Phosphate, Grade 3	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Potassium, Grade 1	18 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Potassium, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Potassium, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Potassium, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Sodium, Grade 1	45 Participants	57 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Sodium, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Sodium, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Sodium, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Triglycerides, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Triglycerides, Grade 2	5 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Triglycerides, Grade 3	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Triglycerides, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Glucose, Grade 1	22 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Glucose, Grade 2	19 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Glucose, Grade 3	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Randomized Phase Glucose, Grade 4	1 Participants	0 Participants

SECONDARY outcome

Timeframe: From Weeks 48 to 432

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

Number of participants with grades 1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hyperglycaemia, hypernatremia, hypoglycaemia, hypokalemia, hyponatremia, alanine aminotransferase, albumin, alkaline phosphatase, aspartate aminotransferase, bilirubin, carbon dioxide, cholesterol, creatine kinase, creatinine, LDL cholesterol calculation, LDL cholesterol direct, lipase, phosphate, potassium, sodium, triglycerides and glucose.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Cholesterol, Grade 4, n=71	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatine kinase, Grade 1, n=146	6 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyperglycaemia, Grade 1, n=143	24 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyperglycaemia, Grade 2, n=143	9 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyperglycaemia, Grade 3, n=143	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyperglycaemia, Grade 4, n=143	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypernatremia, Grade 1, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypernatremia, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypernatremia, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypernatremia, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypoglycaemia, Grade 1, n=143	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypoglycaemia, Grade 2, n=143	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypoglycaemia, Grade 3, n=143	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypoglycaemia, Grade 4, n=143	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypokalemia, Grade 1, n=146	13 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypokalemia, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypokalemia, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hypokalemia, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyponatremia, Grade 1, n=146	36 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyponatremia, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyponatremia, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Hyponatremia, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alanine aminotransferase, Grade 1, n=146	7 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alanine aminotransferase, Grade 2, n=146	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alanine aminotransferase, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alanine aminotransferase, Grade 4, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alkaline phosphatase, Grade 1, n=146	5 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alkaline phosphatase, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alkaline phosphatase, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Alkaline phosphatase, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Aspartate aminotransferase, Grade 1, n=146	10 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Aspartate aminotransferase, Grade 2, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Aspartate aminotransferase, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Aspartate aminotransferase, Grade 4, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Bilirubin, Grade 1, n=146	4 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Bilirubin, Grade 2, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Bilirubin, Grade 3, n=146	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Bilirubin, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Carbon dioxide, Grade 1, n=146	58 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Carbon dioxide, Grade 2, n=146	7 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Carbon dioxide, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Carbon dioxide, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Cholesterol, Grade 1, n=71	9 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Cholesterol, Grade 2, n=71	9 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Cholesterol, Grade 3, n=71	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatine kinase, Grade 2, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatine kinase, Grade 3, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatine kinase, Grade 4, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatinine, Grade 1, n=146	5 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatinine, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatinine, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Creatinine, Grade 4, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol calculation, Grade 1, n=70	5 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol calculation, Grade 2, n=70	8 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol calculation, Grade 3, n=70	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol calculation, Grade 4, n=70	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol direct, Grade 1, n=2	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol direct, Grade 2, n=2	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol direct, Grade 3, n=2	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase LDL cholesterol direct, Grade 4, n=2	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Lipase, Grade 1, n=146	9 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Lipase, Grade 2, n=146	6 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Lipase, Grade 3, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Lipase, Grade 4, n=146	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Phosphate, Grade 1, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Phosphate, Grade 2, n=146	15 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Phosphate, Grade 3, n=146	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Phosphate, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Potassium, Grade 1, n=146	13 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Potassium, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Potassium, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Potassium, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Sodium, Grade 1, n=146	37 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Sodium, Grade 2, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Sodium, Grade 3, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Sodium, Grade 4, n=146	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Triglycerides, Grade 1, n=71	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Triglycerides, Grade 2, n=71	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Triglycerides, Grade 3, n=71	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Triglycerides, Grade 4, n=71	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Glucose, Grade 1, n=143	24 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Glucose, Grade 2, n=143	9 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Glucose, Grade 3, n=143	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Chemistry Toxicities-Continuation Phase Glucose, Grade 4, n=143	1 Participants	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

Number of participants with Grade 1-4 emergent hematology toxicities were assessed from the start of study treatment and end of Randomized Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Hemoglobin, Grade 1	7 Participants	21 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Hemoglobin, Grade 2	2 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Hemoglobin, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Leukocytes, Grade 1	5 Participants	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Leukocytes, Grade 2	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Leukocytes, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Leukocytes, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Neutrophils, Grade 1	15 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Neutrophils, Grade 2	7 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Neutrophils, Grade 3	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Neutrophils, Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Platelets, Grade 1	6 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Platelets, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Platelets, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Randomized Phase Platelets, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: From Weeks 48 to 432

Population: Safety - Continuation Phase Population. Only those participants with data available at specified time points were analyzed.

Number of participants with Grade 1-4 emergent hematology toxicities were assessed in Continuation Phase. Hematology toxicities were categorized into following grades as per The Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS AE Grading Table)- Grade 1- mild, Grade 2- moderate; Grade 3- severe and Grade 4- potentially life-threatening. Higher the grade, more severe the symptoms. Data has been reported for clinical chemistry parameters including hemoglobin, leukocytes, neutrophils and platelets.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=146 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Hemoglobin, Grade 1	5 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Hemoglobin, Grade 2	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Hemoglobin, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Hemoglobin, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Leukocytes, Grade 1	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Leukocytes, Grade 2	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Leukocytes, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Leukocytes, Grade 4	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Neutrophils, Grade 1	10 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Neutrophils, Grade 2	2 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Neutrophils, Grade 3	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Neutrophils, Grade 4	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Platelets, Grade 1	3 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Platelets, Grade 2	1 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Platelets, Grade 3	0 Participants	—
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities-Continuation Phase Platelets, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population

An AE is defined as any untoward medical occurrence in a participant temporally associated with the use of a medicinal product (MP), whether or not considered related to the MP. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of an MP. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, is an important medical event that jeopardizes the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in the above definition, or is associated with liver injury and impaired liver function.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants Who Withdrew From Treatment Due to AEs-Randomized Phase	10 Participants	17 Participants

SECONDARY outcome

Timeframe: From Weeks 48 to 432

Population: Safety - Continuation Phase Population

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=149 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants Who Withdrew From Treatment Due to AEs-Continuation Phase	4 Participants	—

SECONDARY outcome

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

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

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints BSAP, Week 24, n=219, 207	1.33 Micrograms per liter Standard Deviation 3.934	6.00 Micrograms per liter Standard Deviation 5.962
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints BSAP, Week 48, n=202, 184	2.64 Micrograms per liter Standard Deviation 5.746	7.60 Micrograms per liter Standard Deviation 7.144
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints Osteocalcin, Week 24, n=209, 197	3.73 Micrograms per liter Standard Deviation 7.484	14.38 Micrograms per liter Standard Deviation 22.205
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints Osteocalcin, Week 48, n=194, 178	5.15 Micrograms per liter Standard Deviation 9.018	16.30 Micrograms per liter Standard Deviation 25.043
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints PTP, Week 24, n=223, 206	10.1 Micrograms per liter Standard Deviation 20.11	32.0 Micrograms per liter Standard Deviation 27.89
Change From Baseline in Bone Specific Alkaline Phosphatase, Osteocalcin and Procollagen 1 N-terminal Propeptide at Indicated Timepoints PTP, Week 48, n=205, 186	11.2 Micrograms per liter Standard Deviation 23.05	34.1 Micrograms per liter Standard Deviation 27.28

SECONDARY outcome

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

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

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in Type I collagen C-telopeptides (T-1 CCT) is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints Week 24, n=221, 207	89.8 Nanograms per liter Standard Deviation 173.09	272.4 Nanograms per liter Standard Deviation 205.22
Change From Baseline in Type I Collagen C-telopeptides at Indicated Timepoints Week 48, n=202, 185	75.9 Nanograms per liter Standard Deviation 173.73	267.9 Nanograms per liter Standard Deviation 200.82

SECONDARY outcome

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

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

Bone markers were assessed at Baseline (Day 1), Weeks 24, 48. Change from Baseline in vitamin D, vitamin D2 and vitamin D3 is summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D2, Week 48, n=206, 186	0.1 Nanomoles per liter Standard Deviation 4.71	0.9 Nanomoles per liter Standard Deviation 11.00
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D, Week 24, n=223, 208	1.8 Nanomoles per liter Standard Deviation 24.95	16.3 Nanomoles per liter Standard Deviation 31.66
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D, Week 48, n=206, 186	-1.9 Nanomoles per liter Standard Deviation 20.63	8.9 Nanomoles per liter Standard Deviation 23.78
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D2, Week 24, n=223, 208	0.3 Nanomoles per liter Standard Deviation 6.04	1.0 Nanomoles per liter Standard Deviation 7.88
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D3, Week 24, n=223, 208	1.5 Nanomoles per liter Standard Deviation 24.33	15.2 Nanomoles per liter Standard Deviation 31.39
Change From Baseline in Vitamin D, Vitamin D2 and Vitamin D3 at Week 24 and Week 48 Vitamin D3, Week 48, n=206, 186	-1.9 Nanomoles per liter Standard Deviation 20.56	7.9 Nanomoles per liter Standard Deviation 21.72

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

Bone markers were assessed at indicated timepoints. Bone specific alkaline phosphatase (BSAP), osteocalcin and procollagen 1 N-terminal propeptide (PTP), Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline is calculated. Bone biomarkers were analyzed based on log transformed data. Estimates of adjusted mean and difference were calculated from an Analysis of covariance (ANCOVA) model adjusting for age, baseline viral load Baseline CD4+ cell count, Baseline biomarker level, body mass index category, smoking status and baseline Vitamin D use. Adjusted mean of log-transformed change from Baseline are transformed back to Week 48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to the ratio of Week 48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline BSAP, n=202, 183	1.188 Ratio Interval 1.135 to 1.243	1.629 Ratio Interval 1.553 to 1.708
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline PTP, n=202, 184	1.214 Ratio Interval 1.158 to 1.272	1.752 Ratio Interval 1.668 to 1.84
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline Osteocalcin, n=194, 178	1.282 Ratio Interval 1.214 to 1.354	2.039 Ratio Interval 1.926 to 2.159
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline Type 1 Collagen C-Telopeptide, n=202, 184	1.257 Ratio Interval 1.195 to 1.323	1.918 Ratio Interval 1.819 to 2.023
Bone Specific Alkaline Phosphatase, Osteocalcin, Procollagen 1 N-terminal Propeptide, Type 1 Collagen C-Telopeptide, Vitamin D Ratio of Week 48 Results Over Baseline Vitamin D, n=206, 186	0.987 Ratio Interval 0.94 to 1.036	1.158 Ratio Interval 1.101 to 1.219

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

The 12-Item Short Form Health Survey (SF-12) is 12 item abbreviated form of SF-36 survey. SF-12 questions make up 8 scales: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, Mental Health. SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. SF-12 total score was calculated by a clinician scoring 12-question survey filled by participants. Transformed physical component summary score (PCS) and transformed mental component summary score (MCS) are derived using the sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and better functioning. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS Total Score, Week 48, n=205, 192	0.0 Score on a scale Standard Deviation 5.15	0.1 Score on a scale Standard Deviation 5.66
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS MCS, Week 48, n=205, 192	2.397 Score on a scale Standard Deviation 10.5232	2.329 Score on a scale Standard Deviation 9.9782
Change From Baseline at Week 48 in SF-12 Total Score, MCS and PCS PCS, Week 48, n=205, 192	1.905 Score on a scale Standard Deviation 8.6309	1.444 Score on a scale Standard Deviation 8.3938

SECONDARY outcome

Timeframe: Weeks 4, 12, 24 and 48

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

The HIV treatment satisfaction questionnaire (HIVTSQ) is a 10-item self-reported scale that measures overall satisfaction with treatment and by specific domains e.g. convenience, flexibility. The HIVTSQ items are summed up to produce a treatment satisfaction total score (0 to 60) and an individual satisfaction rating for each item (0 to 6) and two subscales: general satisfaction/clinical and lifestyle/ease subscales. The higher the score, the greater the improvement in treatment satisfaction as compared to the past few weeks. A smaller score represents a decline in treatment satisfaction compared to the past few weeks. Statistical analysis was performed based on Wilcoxon rank sum test.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
HIVTSQs Total Score at Indicated Timepoints Week 4, n=243, 239	54.0 Score on a scale Standard Deviation 6.37	51.9 Score on a scale Standard Deviation 8.53
HIVTSQs Total Score at Indicated Timepoints Week 12, n=236, 226	56.1 Score on a scale Standard Deviation 5.38	53.6 Score on a scale Standard Deviation 7.67
HIVTSQs Total Score at Indicated Timepoints Week 24, n=225, 211	56.8 Score on a scale Standard Deviation 4.55	54.3 Score on a scale Standard Deviation 7.27
HIVTSQs Total Score at Indicated Timepoints Week 48, n=206, 191	57.0 Score on a scale Standard Deviation 4.38	55.4 Score on a scale Standard Deviation 6.00

SECONDARY outcome

Timeframe: Week 48

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

Percentage of participants with plasma HIV-1 RNA \<50 copies/mL at Week 48 by subgroups (age, race, country, Baseline plasma HIV-1 RNA \[BPHR\], Baseline CD4+ cell count \[BCCC\], Baseline Centers for Disease Control and Prevention \[CDC\] category and HIV-1 subtype) were assessed using the Snapshot algorithm (Missing, Switch or Discontinuation = Failure). Analysis was performed using a stratified analysis with CMH weights, adjusting for Baseline plasma HIV-1 RNA ( =\<versus \[vs\]. \>100,000 c/mL) and CD4+ cell count (=\<350 cells/mm\^3 or \>350 cells/mm\^3). Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Race, White, n=115, 107	86 Percentage of participants	80 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Age, <50 Years, n=212, 212	80 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Age, >=50 Years, n=36, 35	92 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Race, Non-White, n=133,140	78 Percentage of participants	64 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Race, African-American/African Heritage, n=102,108	74 Percentage of participants	67 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Non-African-American/African Heritage, n=146, 139	88 Percentage of participants	75 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BPHR, <1000, n=5, 10	60 Percentage of participants	80 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BPHR, 1000 to <10,000, n=66, 62	83 Percentage of participants	77 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BPHR, 10,000 to <50,000, n=83, 81	84 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BPHR, 50,000 to <=100,000, n=25, 28	80 Percentage of participants	64 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BPHR, >100,000, n=69, 66	80 Percentage of participants	64 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, <200, n=64, 49	81 Percentage of participants	69 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, >=200, n=184, 198	82 Percentage of participants	72 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, <50, n=9, 15	67 Percentage of participants	60 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, 50 to <200, n=55, 34	84 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, 200 to <350, n=66, 74	89 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, 350 to <500, n=56, 65	79 Percentage of participants	74 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups BCCC, >=500, n=62, 59	77 Percentage of participants	68 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups CDC category, A, n=210, 208	81 Percentage of participants	71 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups CDC category, B, n=27, 30	81 Percentage of participants	77 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups CDC category, C, n=11, 9	91 Percentage of participants	56 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups HIV-1 subtype: B vs Non-B, B, n=95, 111	80 Percentage of participants	69 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups HIV-1 subtype: B vs Non-B, non-B, n=140, 131	84 Percentage of participants	73 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Argentina, n=24, 20	92 Percentage of participants	80 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Canada, n=11, 9	91 Percentage of participants	89 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups France, n=7, 8	100 Percentage of participants	75 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Italy, n=17, 11	88 Percentage of participants	64 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Mexico, n=6, 5	100 Percentage of participants	60 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Portugal, n=4, 5	75 Percentage of participants	60 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Puerto Rico, n=0, 2	—	100 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Russia, n=28, 22	89 Percentage of participants	82 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups South Africa, n=33, 33	67 Percentage of participants	76 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Spain, n=23, 31	70 Percentage of participants	77 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups Thailand, n=19, 21	95 Percentage of participants	52 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups USA, n=62, 69	74 Percentage of participants	67 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 Copies/mL at Week 48 by Subgroups United Kingdom, n=14, 11	93 Percentage of participants	64 Percentage of participants

SECONDARY outcome

Timeframe: Up to week 48

Population: ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed.

Number of participants with post-Baseline HIV-1disease progression were assessed during study period. The CDC Classification System for HIV Infection is the medical classification system used by the United States Centers for Disease Control and Prevention (CDC) to classify HIV disease and infection. The clinical categories of HIV infection are defined as follows: Category A: Mildly symptomatic, Category B: Moderately symptomatic, Category C: Severely symptomatic. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. Only those participants available at the specified time points were analyzed. Different participants may have been analyzed at different time points, so the overall number of participants analyzed reflects everyone in the ITT population.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=7 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=7 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase CDC Class A to CDC Class C	5 Participants	4 Participants
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase CDC Class B to CDC Class C	1 Participants	2 Participants
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase CDC Class C to new CDC Class C	0 Participants	0 Participants
Number of Participants With Post-Baseline HIV-1 Disease Progression-Randomized Phase CDC Class A, B or C to Death	1 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to week 432

Population: ITT-E Population, only those participants who experienced a disease progression to CDC Class C or death were analyzed

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=9 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) CDC Class A to CDC Class C	6 Participants	—
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) CDC Class B to CDC Class C	1 Participants	—
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) CDC Class C to new CDC Class C	0 Participants	—
Number of Participants With Post-Baseline HIV-1 Disease Progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) CDC Class A, B or C to Death	2 Participants	—

SECONDARY outcome

Timeframe: Up to week 432

Population: On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

Number of participants, who meet confirmed virologic withdrawal criteria, with treatment emergent genotypic resistance to integrase strand transfer inhibitor (INSTI), Non-nucleoside reverse transcriptase inhibitor (NNRTI), nucleoside reverse transcriptase inhibitor (NRTI), protease inhibitors (PI) will be summarized. The Baseline value was defined as the latest pre-dose assessment (Day 1) value. On-treatment Genotypic Resistance Population comprised of all participants in the ITTE population with available On-treatment genotypic resistance data at the time confirmed virologic withdrawal criterion was met.

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=8 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) INSTI; n= 6	0 Participants	—
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) NNRTI; n=8	1 Participants	—
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) NRTI; n=8	1 Participants	—
Number of Participants With Treatment Emergent Resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase) PI; n=8	0 Participants	—

SECONDARY outcome

Timeframe: Up to week 48

Population: On-treatment Genotypic Resistance Population. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

Outcome measures

Outcome measures
Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=4 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) INSTI; n= 3	1 Participants	—
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) NNRTI; n=4	0 Participants	—
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) NRTI; n=4	1 Participants	—
Number of Participants With Treatment Emergent Resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) PI; n=4	0 Participants	—

Adverse Events

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase

Serious events: 12 serious events

Other events: 138 other events

Deaths: 1 deaths

ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Serious events: 20 serious events

Other events: 164 other events

Deaths: 0 deaths

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase

Serious events: 13 serious events

Other events: 30 other events

Deaths: 1 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

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

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alanine aminotransferase, Week 4, n= 245, 237	-3.3 International units per liter Standard Deviation 27.54	-3.4 International units per liter Standard Deviation 15.86
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alanine aminotransferase, Week 12, n= 236, 226	-5.2 International units per liter Standard Deviation 27.51	-2.3 International units per liter Standard Deviation 20.26
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alanine aminotransferase, Week 24, n= 225, 212	-5.4 International units per liter Standard Deviation 27.92	-3.7 International units per liter Standard Deviation 20.7
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alanine aminotransferase, Week 36, n= 219, 204	-4.9 International units per liter Standard Deviation 36.11	-5.3 International units per liter Standard Deviation 20.08
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alanine aminotransferase, Week 48, n= 208, 192	-5.7 International units per liter Standard Deviation 28.54	-1.5 International units per liter Standard Deviation 31.53
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alkaline phosphatase, Week 4, n= 245, 237	-1.5 International units per liter Standard Deviation 14.56	9.4 International units per liter Standard Deviation 28.69
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alkaline phosphatase, Week 12, n= 236, 226	-2.1 International units per liter Standard Deviation 17.1	15.1 International units per liter Standard Deviation 30.82
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alkaline phosphatase, Week 24, n= 225, 212	0.5 International units per liter Standard Deviation 17.86	22.4 International units per liter Standard Deviation 41.59
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alkaline phosphatase, Week 36, n= 219, 204	0.6 International units per liter Standard Deviation 19.19	20.4 International units per liter Standard Deviation 30.7
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Alkaline phosphatase, Week 48, n= 208, 192	2.9 International units per liter Standard Deviation 28.05	21.9 International units per liter Standard Deviation 25.35
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Aspartate aminotransferase, Week 4, n= 244, 237	-3.3 International units per liter Standard Deviation 29.8	-3.6 International units per liter Standard Deviation 18.83
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Aspartate aminotransferase, Week 12, n= 236, 226	-6.2 International units per liter Standard Deviation 21.11	-4 International units per liter Standard Deviation 13.79
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Aspartate aminotransferase, Week 24, n= 224, 212	-6.3 International units per liter Standard Deviation 22.44	-5.1 International units per liter Standard Deviation 13.8
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Aspartate aminotransferase, Week 36, n= 219, 204	-6.4 International units per liter Standard Deviation 31.42	-6.5 International units per liter Standard Deviation 16.63
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Aspartate aminotransferase, Week 48, n= 208, 192	-7.5 International units per liter Standard Deviation 22.19	-3.7 International units per liter Standard Deviation 25.28
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Creatine Kinase, Week 4, n= 245, 237	-0.3 International units per liter Standard Deviation 68.72	35.6 International units per liter Standard Deviation 549.1
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Creatine Kinase, Week 12, n= 236, 226	6.9 International units per liter Standard Deviation 73.7	7.3 International units per liter Standard Deviation 90.39
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Creatine Kinase, Week 24, n= 225, 212	10.3 International units per liter Standard Deviation 88.66	5.8 International units per liter Standard Deviation 77.12
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Creatine Kinase, Week 36, n= 219, 204	11.9 International units per liter Standard Deviation 155.68	7.2 International units per liter Standard Deviation 132.74
Change From Baseline in Alanine Aminotransferase, Alkaline Phosphatase, Aspartate Aminotransferase, Creatine Kinase at Indicated Time Points Creatine Kinase, Week 48, n= 208, 192	23.8 International units per liter Standard Deviation 242.66	3.8 International units per liter Standard Deviation 98.58

Measure	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase n=248 Participants Participants received fixed dose combination (FDC) of DTG 50 milligram (mg)/ABC 600 mg/3TC 300 mg tablet once daily orally for 48 weeks in the Randomization Phase.	ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase n=247 Participants Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF 300 mg/ FTC 200 mg FDC tablet once daily orally for 48 weeks during Randomized Phase.
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Basophils, Week 4, n= 241, 234	0.003 10^9 cells per liter Standard Deviation 0.0182	0.003 10^9 cells per liter Standard Deviation 0.0198
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Basophils, Week 12, n= 228, 216	0.002 10^9 cells per liter Standard Deviation 0.0174	0.003 10^9 cells per liter Standard Deviation 0.0162
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Basophils, Week 24, n= 221, 208	0.004 10^9 cells per liter Standard Deviation 0.0187	0.003 10^9 cells per liter Standard Deviation 0.0155
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Basophils, Week 36, n= 214, 203	0.004 10^9 cells per liter Standard Deviation 0.0182	0.003 10^9 cells per liter Standard Deviation 0.0158
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Basophils, Week 48, n= 206, 189	0.005 10^9 cells per liter Standard Deviation 0.0199	0.006 10^9 cells per liter Standard Deviation 0.0146
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Eosinophils, Week 4, n= 241, 234	0.040 10^9 cells per liter Standard Deviation 0.1486	0.021 10^9 cells per liter Standard Deviation 0.1648
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Eosinophils, Week 12, n= 228, 216	0.037 10^9 cells per liter Standard Deviation 0.1982	-0.001 10^9 cells per liter Standard Deviation 0.1610
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Eosinophils, Week 24, n= 221, 208	0.028 10^9 cells per liter Standard Deviation 0.1927	0.005 10^9 cells per liter Standard Deviation 0.1973
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Eosinophils, Week 36, n= 214, 203	0.048 10^9 cells per liter Standard Deviation 0.2244	0.014 10^9 cells per liter Standard Deviation 0.2139
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Eosinophils, Week 48, n= 206, 189	0.030 10^9 cells per liter Standard Deviation 0.1744	0.007 10^9 cells per liter Standard Deviation 0.2274
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Lymphocytes, Week 4, n= 241, 234	0.208 10^9 cells per liter Standard Deviation 0.4914	0.119 10^9 cells per liter Standard Deviation 0.5493
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Lymphocytes, Week 12, n= 228, 216	0.257 10^9 cells per liter Standard Deviation 0.5500	0.156 10^9 cells per liter Standard Deviation 0.6690
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Lymphocytes, Week 24, n= 221, 208	0.317 10^9 cells per liter Standard Deviation 0.4889	0.192 10^9 cells per liter Standard Deviation 0.5910
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Lymphocytes, Week 36, n= 214, 203	0.362 10^9 cells per liter Standard Deviation 0.5199	0.178 10^9 cells per liter Standard Deviation 0.6441
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Lymphocytes, Week 48, n= 206, 189	0.359 10^9 cells per liter Standard Deviation 0.5235	0.261 10^9 cells per liter Standard Deviation 0.7098
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Monocytes, Week 4, n= 241, 234	-0.001 10^9 cells per liter Standard Deviation 0.1558	-0.015 10^9 cells per liter Standard Deviation 0.1391
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Monocytes, Week 12, n= 228, 216	-0.010 10^9 cells per liter Standard Deviation 0.1412	-0.031 10^9 cells per liter Standard Deviation 0.1369
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Monocytes, Week 24, n= 221, 208	0.008 10^9 cells per liter Standard Deviation 0.1498	-0.015 10^9 cells per liter Standard Deviation 0.1581
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Monocytes, Week 36, n= 214, 203	-0.006 10^9 cells per liter Standard Deviation 0.1448	-0.028 10^9 cells per liter Standard Deviation 0.1500
Change From Baseline in Basophils, Eosinophils, Lymphocytes, Monocytes at Indicated Time Points Monocytes, Week 48, n= 206, 189	0.001 10^9 cells per liter Standard Deviation 0.1379	-0.024 10^9 cells per liter Standard Deviation 0.1638