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Clinical Trial Results:
A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

Summary
EudraCT number	2012-005823-34
Trial protocol	GB IT ES PT FR
Global end of trial date	18 Aug 2022

Results information
Results version number	v2(current)
This version publication date	02 Aug 2023
First version publication date	10 Aug 2016
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

117172

ISRCTN number

US NCT number

NCT01910402

WHO universal trial number (UTN)

Sponsor organisation name

ViiV Healthcare

Sponsor organisation address

980 Great West Road, Brentford, Middlesex, United Kingdom, TW8 9GS

Public contact

GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Scientific contact

GSK Response Center, ViiV Healthcare, 1 8664357343, GSKClinicalSupportHD@gsk.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

21 Oct 2022

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

18 Aug 2022

Was the trial ended prematurely?

Main objective of the trial

To demonstrate the non-inferior antiviral activity of DTG/ABC/3TC FDC once daily compared to atazanavir (ATV) + Ritonavir (RTV) + tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) FDC each administered once daily over 48 weeks in Human Immunodeficiency Virus Type 1 (HIV-1) infected Antiretroviral Therapy (ART) naïve women

Protection of trial subjects

Not Applicable

Background therapy

Evidence for comparator

Actual start date of recruitment

22 Aug 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Russian Federation: 50

Country: Number of subjects enrolled

South Africa: 66

Country: Number of subjects enrolled

Argentina: 44

Country: Number of subjects enrolled

Thailand: 40

Country: Number of subjects enrolled

Italy: 28

Country: Number of subjects enrolled

Spain: 54

Country: Number of subjects enrolled

United States: 134

Country: Number of subjects enrolled

United Kingdom: 25

Country: Number of subjects enrolled

Mexico: 11

Country: Number of subjects enrolled

Canada: 20

Country: Number of subjects enrolled

France: 16

Country: Number of subjects enrolled

Portugal: 9

Country: Number of subjects enrolled

Puerto Rico: 2

Worldwide total number of subjects

499

EEA total number of subjects

107

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

493

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

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.

Screening details

A total of 499 participants were randomized to receive DTG/ABC/3TC FDC or combination of ATV+RTV+TDF/FTC. Two 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.

Period 1 title

Randomized phase (Up to 48 weeks)

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Dolutegravir (DTG)/ Abacavir (ABC)/ Lamivudine (3TC) fixed dose combination (FDC)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received FDC of DTG 50 mg/ABC 600 mg/3TC 300 mg tablet once daily orally

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

Arm description

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.

Arm type

Active comparator

Investigational medicinal product name

Atazanavir (ATV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

Participants received ATV 300 mg capsule once daily

Investigational medicinal product name

Tenofovir disoproxil fumarate/Emtricitabine (TDF/FTC) FDC

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received FDC of TDF 300 mg/ FTC 200 mg tablet once daily

Investigational medicinal product name

Ritonavir (RTV)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received RTV 100 mg tablet once daily

Number of subjects in period 1 ^[1]	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Started	248	247
Completed	206	192
Not completed	42	55
Physician decision	1	-
Consent withdrawn by subject	5	7
Adverse event, non-fatal	10	18
Protocol Deviation	10	13
Lost to follow-up	11	13
Lack of efficacy	5	4

Notes
[1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same.
Justification: A total of 499 participants were randomized to receive DTG/ABC/3TC FDC or combination of ATV+RTV+TDF/FTC. Two 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.

Period 2 title

Continuation Phase(From Weeks 48 to 432)

Is this the baseline period?

Allocation method

Not applicable

Blinding used

Not blinded

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

Arm description

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.

Arm type

Experimental

Investigational medicinal product name

Dolutegravir (DTG)/ Abacavir (ABC)/ Lamivudine (3TC) fixed dose combination (FDC)

Investigational medicinal product code

Other name

Pharmaceutical forms

Tablet

Routes of administration

Oral use

Dosage and administration details

Participants received FDC of DTG 50 mg/ABC 600 mg/3TC 300 mg tablet once daily orally

Number of subjects in period 2 ^[2]	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Started	149
Completed	113
Not completed	36
Adverse event, serious fatal	1
Physician decision	1
Consent withdrawn by subject	7
Adverse event, non-fatal	3
Protocol Deviation	15
Lost to follow-up	8
Lack of efficacy	1

Notes
[2] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: 149 entered from Randomized to Continuation Phase

Baseline characteristics

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Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase	Total
Number of subjects	248	247	495
Age categorical
Units: Participants
Age continuous
Units: years
arithmetic mean (standard deviation)	38.1 ( 11.15 )	37.8 ( 10.14 )	-
Gender categorical
Units: Participants
Female	248	247	495
Male	0	0	0
Race/Ethnicity, Customized
Units: Subjects
African American/African Heritage	102	108	210
American Indian Or Alaskan Native	6	7	13
Asian - Central/South Asian Heritage	2	0	2
Asian - East Asian Heritage	0	1	1
Asian - South East Asian Heritage	20	22	42
Native Hawaiian Or Other Pacific Islander	1	0	1
White - Arabic/North African Heritage	3	3	6
White - White/Caucasian/European Heritage	112	104	216
Mixed Race	2	2	4

End points

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Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

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.

Subject analysis set title

DTG 50 mg/ABC 600 mg/3TC 300 mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants received fixed dose combination (FDC) of DTG/ABC/3TC 50 milligram (mg)/600 mg/300 mg tablet once daily orally for 48 weeks in the Randomization Phase. Participants who completed 48 weeks of treatment, continued to receive DTG/ABC/3TC in the Continuation Phase until it was either locally approved or commercial supplies were available.

Subject analysis set title

ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks during Randomized Phase

Subject analysis set title

DTG 50 mg/ABC 600 mg/3TC 300 mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Subject analysis set title

ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD

Subject analysis set type

Intention-to-treat

Subject analysis set description

Participants received ATV 300 mg capsule, RTV 100 mg tablet, TDF/FTC FDC 300 mg/200 mg tablet once daily orally for 48 weeks during Randomized Phase

Primary: Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

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End point title

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

End point description

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.

End point type

Primary

End point timeframe

Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[1]	247 ^[2]
Units: Percentage of participants	82	71

Notes
[1] - ITT-E Population.
[2] - ITT-E Population.

Statistical Analysis 1

Statistical analysis description

Hypothesis was to show that the antiviral effect of the DTG/ABC/3TC FDC administered QD was non-inferior to QD ATV+RTV+TDF/FTC FDC. Non-inferiority was concluded if the lower bound of a two-sided 95% confidence interval for the difference in response rates between the two treatment arms was greater than -12%

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

non-inferiority

P-value

= 0.005 ^[3]

Method

Cochran-Mantel-Haenszel

Parameter type

Adjusted difference in proportion

Point estimate

10.5

Confidence interval

level

95%

sides

2-sided

lower limit

3.1

upper limit

17.8

Notes
[3] - If the primary and PP analyses both demonstrated non-inferiority, then as per pre-specified analysis, superiority of DTG/ABC/3TC FDC versus ATV+RTV+TDF/FTC FDC was tested in the ITT-E population at the 2-sided 5% level of significance.

Secondary: Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time-Randomized Phase

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End point title

Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time-Randomized Phase

End point description

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.

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[4]	247 ^[5]
Units: Percentage of participants
HIV-1 RNA <50 c/mL, Baseline (Day 1)	0	0
HIV-1 RNA <50 c/mL, Week 4	64	13
HIV-1 RNA <50 c/mL, Week 12	81	49
HIV-1 RNA <50 c/mL, Week 24	85	77
HIV-1 RNA <50 c/mL, Week 36	85	77
HIV-1 RNA <50 c/mL, Week 48	82	71
HIV-1 RNA <400 c/mL, Baseline (Day 1)	1	1
HIV-1 RNA <400 c/mL, Week 4	90	54
HIV-1 RNA <400 c/mL, Week 12	91	84
HIV-1 RNA <400 c/mL, Week 24	88	82
HIV-1 RNA <400 c/mL, Week 36	86	81
HIV-1 RNA <400 c/mL, Week 48	83	76

Notes
[4] - ITT-E Population
[5] - ITT-E Population

No statistical analyses for this end point

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL in Continuation Phase

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End point title

Percentage of participants with plasma HIV-1 RNA <50 c/mL in Continuation Phase

End point description

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

End point type

Secondary

End point timeframe

Week 96 and Week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[6]
Units: Percentage of participants
Week 96, n=99	100
Week 432, n=3	100

Notes
[6] - ITT-E Population.

No statistical analyses for this end point

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Randomized Phase

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End point title

Change from Baseline in Plasma HIV-1 RNA at indicated time points-Randomized Phase

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[7]	247 ^[8]
Units: Log10 copies/mL
arithmetic mean (standard deviation)
Week 4, n=245, 238	-2.591 ( 0.8015 )	-1.923 ( 0.5330 )
Week 12, n=236, 226	-2.756 ( 0.8920 )	-2.541 ( 0.7373 )
Week 24, n=225, 212	-2.789 ( 0.9160 )	-2.726 ( 0.8890 )
Week 36, n=221, 204	-2.838 ( 0.8589 )	-2.772 ( 0.8451 )
Week 48, n=207, 192	-2.874 ( 0.8035 )	-2.752 ( 0.8433 )

Notes
[7] - ITT-E Population
[8] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Continuation Phase

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End point title

Change from Baseline in Plasma HIV-1 RNA at indicated time points-Continuation Phase

End point description

End point type

Secondary

End point timeframe

Baseline (Day 1), Week 96 and Week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[9]
Units: Log10 copies/mL
arithmetic mean (standard deviation)
Week 96, n=99	-2.911 ( 0.7970 )
Week 432, n=3	-3.107 ( 0.7659 )

Notes
[9] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Randomized Phase

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End point title

Absolute Values in Plasma HIV-1 RNA at indicated time points-Randomized Phase

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[10]	247 ^[11]
Units: Log10 copies/mL
arithmetic mean (standard deviation)
Baseline (Day 1), n=248, 247	4.481 ( 0.8111 )	4.441 ( 0.8023 )
Week 4, n=245, 238	1.895 ( 0.6872 )	2.516 ( 0.6193 )
Week 12, n=236, 226	1.748 ( 0.5458 )	1.908 ( 0.4926 )
Week 24, n=225, 212	1.724 ( 0.5935 )	1.710 ( 0.4484 )
Week 36, n=221, 204	1.666 ( 0.3982 )	1.658 ( 0.3362 )
Week 48, n=207, 192	1.619 ( 0.1986 )	1.657 ( 0.2743 )

Notes
[10] - ITT-E Population
[11] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Randomized Phase

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End point title

Change from Baseline in CD4+ cell count at indicated timepoints-Randomized Phase

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[12]	247 ^[13]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)
Week 4, n=245, 237	94.9 ( 140.02 )	73.7 ( 108.15 )
Week 12, n=236, 224	143.8 ( 142.19 )	124.4 ( 133.60 )
Week 24, n=226, 210	200.6 ( 162.37 )	163.0 ( 126.67 )
Week 36, n=219, 204	230.7 ( 163.61 )	191.4 ( 167.24 )
Week 48, n=208, 191	248.8 ( 172.01 )	230.7 ( 189.59 )

Notes
[12] - ITT-E Population
[13] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Continuation Phase

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End point title

Absolute Values in Plasma HIV-1 RNA at indicated time points-Continuation Phase

End point description

Absolute Values in plasma HIV-1 RNA were assessed at indicated time points. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)

End point type

Secondary

End point timeframe

Week 96 and Week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[14]
Units: Log10 copies/mL
arithmetic mean (standard deviation)
Week 96, n=99	1.591 ( 0.0080 )
Week 432, n=3	1.590 ( 0.0000 )

Notes
[14] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Continuation Phase

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End point title

Change from Baseline in CD4+ cell count at indicated timepoints-Continuation Phase

End point description

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

End point type

Secondary

End point timeframe

Baseline (Day 1), Week 96, Week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[15]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)
Week 96, n=99	286.5 ( 196.77 )
Week 432, n=3	254.7 ( 342.31 )

Notes
[15] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Randomized Phase

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End point title

Absolute values in CD4+ cell count at indicated timepoints-Randomized Phase

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[16]	247 ^[17]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)
Baseline (Day 1), n=248, 247	369.7 ( 225.67 )	380.3 ( 223.60 )
Week 4, n=245, 237	465.0 ( 252.51 )	455.1 ( 244.62 )
Week 12, n=236, 224	509.5 ( 276.79 )	506.2 ( 266.84 )
Week 24, n=226, 210	563.8 ( 303.10 )	542.5 ( 265.69 )
Week 36, n=219, 204	592.8 ( 291.62 )	569.2 ( 299.77 )
Week 48, n=208, 191	608.8 ( 298.95 )	608.5 ( 302.58 )

Notes
[16] - ITT-E Population
[17] - ITT-E Population

No statistical analyses for this end point

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Continuation Phase

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End point title

Absolute values in CD4+ cell count at indicated timepoints-Continuation Phase

End point description

Absolute values in CD4+ cell count were assessed at indicated time points. Only those participants with data available at indicated time points were analyzed (represented by n=X in category titles)

End point type

Secondary

End point timeframe

Week 96 and Week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[18]
Units: Cells per cubic millimeter
arithmetic mean (standard deviation)
Week 96, n=99	635.3 ( 285.85 )
Week 432, n=3	553.0 ( 341.63 )

Notes
[18] - ITT-E Population

No statistical analyses for this end point

Secondary: Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points

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End point title

Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates standard deviation could not be calculated for a single participant

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[19]	247 ^[20]
Units: Millimoles per liter
arithmetic mean (standard deviation)
Carbon Dioxide, Week 4, n= 244, 237	-0.4 ( 2.29 )	0.6 ( 2.2 )
Carbon Dioxide, Week 12, n= 236, 226	-0.2 ( 2.2 )	0.8 ( 2.19 )
Carbon Dioxide, Week 24, n= 224, 212	-0.5 ( 2.31 )	0.3 ( 2.38 )
Carbon Dioxide, Week 36, n= 219, 204	0 ( 2.34 )	0.6 ( 2.5 )
Carbon Dioxide, Week 48, n= 208, 192	-0.6 ( 2.55 )	0.4 ( 2.46 )
Chloride, Week 4, n= 245, 237	0.6 ( 2.42 )	-0.5 ( 2.68 )
Chloride, Week 12, n= 236, 226	1 ( 2.51 )	0.2 ( 2.58 )
Chloride, Week 24, n= 225, 212	0.7 ( 2.71 )	-0.1 ( 2.58 )
Chloride, Week 36, n= 219, 204	0.9 ( 2.65 )	0 ( 2.96 )
Chloride, Week 48, n= 208, 192	0.7 ( 2.42 )	0 ( 2.63 )
CHLS, Week 4, n= 1, 3	-0.1 ( 99999 )	-0.017 ( 0.446 )
CHLS, Week 12, n= 224, 221	0.298 ( 0.7492 )	-0.058 ( 0.7137 )
CHLS, Week 24, n= 218, 201	0.317 ( 0.7254 )	-0.001 ( 0.7456 )
CHLS, Week 36, n= 205, 191	0.33 ( 0.7328 )	0 ( 0.7509 )
CHLS, Week 48, n= 195, 175	0.447 ( 0.7441 )	0.109 ( 0.7647 )
Glucose, Week 12, n= 226, 224	0.3 ( 1.359 )	0.22 ( 1.234 )
Glucose, Week 24, n= 219, 204	0.17 ( 0.811 )	0.26 ( 1.248 )
Glucose, Week 36, n= 211, 196	0.17 ( 1.24 )	0.34 ( 1.753 )
Glucose, Week 48, n= 197, 180	0.18 ( 1.01 )	0.24 ( 1.377 )
HDL CHLS, Direct, Week 4, n= 1, 3	-0.1 ( 99999 )	0 ( 0.0529 )
HDL CHLS, Direct, Week 12, n= 224, 221	0.182 ( 0.3407 )	0.005 ( 0.2316 )
HDL CHLS, Direct, Week 24, n= 218, 201	0.201 ( 0.2962 )	0.053 ( 0.2819 )
HDL CHLS, Direct, Week 36, n= 205, 191	0.204 ( 0.2943 )	0.036 ( 0.2848 )
HDL CHLS, Direct, Week 48, n= 195, 175	0.231 ( 0.2911 )	0.081 ( 0.2964 )
Hyperglycaemia, Week 12, n= 226, 224	0.3 ( 1.359 )	0.22 ( 1.234 )
Hyperglycaemia, Week 24, n= 219, 204	0.17 ( 0.811 )	0.26 ( 1.248 )
Hyperglycaemia, Week 36, n= 211, 196	0.17 ( 1.24 )	0.34 ( 1.753 )
Hyperglycaemia, Week 48, n= 197, 180	0.18 ( 1.01 )	0.24 ( 1.377 )
Hyperkalemia, Week 4, n= 244, 237	-0.01 ( 0.344 )	0.12 ( 0.367 )
Hyperkalemia, Week 12, n= 236, 226	0.03 ( 0.355 )	0.1 ( 0.39 )
Hyperkalemia, Week 24, n= 224, 212	-0.04 ( 0.339 )	0.06 ( 0.372 )
Hyperkalemia, Week 36, n= 219, 204	0.03 ( 0.332 )	0.13 ( 0.387 )
Hyperkalemia, Week 48, n= 208, 192	-0.04 ( 0.346 )	0.04 ( 0.372 )
Hypernatremia, Week 4, n= 245, 237	0 ( 2.11 )	-0.5 ( 2.4 )
Hypernatremia, Week 12, n= 236, 226	0.7 ( 2.3 )	0.1 ( 2.51 )
Hypernatremia, Week 24, n= 225, 212	0.6 ( 2.3 )	0.2 ( 2.11 )
Hypernatremia, Week 36, n= 219, 204	0.9 ( 2.32 )	0.2 ( 2.5 )
Hypernatremia, Week 48, n= 208, 192	0.6 ( 2.24 )	0.5 ( 2.39 )
Hypoglycaemia, Week 12, n= 226, 224	0.3 ( 1.359 )	0.22 ( 1.234 )
Hypoglycaemia, Week 24, n= 219, 204	0.17 ( 0.811 )	0.26 ( 1.248 )
Hypoglycaemia, Week 36, n= 211, 196	0.17 ( 1.24 )	0.34 ( 1.753 )
Hypoglycaemia, Week 48, n= 197, 180	0.18 ( 1.01 )	0.24 ( 1.377 )
Hypokalemia, Week 4, n= 244, 237	-0.01 ( 0.344 )	0.12 ( 0.367 )
Hypokalemia, Week 12, n= 236, 226	0.03 ( 0.355 )	0.1 ( 0.39 )
Hypokalemia, Week 24, n= 224, 212	-0.04 ( 0.339 )	0.06 ( 0.372 )
Hypokalemia, Week 36, n= 219, 204	0.03 ( 0.332 )	0.13 ( 0.387 )
Hypokalemia, Week 48, n= 208, 192	-0.04 ( 0.346 )	0.04 ( 0.372 )
Hyponatremia, Week 4, n= 245, 237	0 ( 2.11 )	-0.5 ( 2.4 )
Hyponatremia, Week 12, n= 236, 226	0.7 ( 2.3 )	0.1 ( 2.51 )
Hyponatremia, Week 24, n= 225, 212	0.6 ( 2.3 )	0.2 ( 2.11 )
Hyponatremia, Week 36, n= 219, 204	0.9 ( 2.32 )	0.2 ( 2.5 )
Hyponatremia, Week 48, n= 208, 192	0.6 ( 2.24 )	0.5 ( 2.39 )
LDL CHLS Calculation, Week 4, n= 1, 3	0.08 ( 99999 )	-0.123 ( 0.5255 )
LDL CHLS Calculation, Week 12, n= 221, 219	0.125 ( 0.6045 )	-0.14 ( 0.6114 )
LDL CHLS Calculation, Week 24, n= 213, 201	0.111 ( 0.6209 )	-0.111 ( 0.6188 )
LDL CHLS Calculation, Week 36, n= 201, 188	0.112 ( 0.6385 )	-0.099 ( 0.6049 )
LDL CHLS Calculation, Week 48, n= 190, 175	0.213 ( 0.6499 )	-0.021 ( 0.6227 )
LDL CHLS, Direct, Week 12, n= 0, 1	88888 ( 88888 )	-0.44 ( 99999 )
LDL CHLS, Direct, Week 24, n= 1, 0	-0.64 ( 99999 )	88888 ( 88888 )
LDL CHLS, Direct, Week 36, n= 1, 0	-0.23 ( 99999 )	88888 ( 88888 )
LDL CHLS, Direct, Week 48, n= 0, 0	88888 ( 88888 )	88888 ( 88888 )
Phosphate, Week 4, n= 245, 237	0 ( 0.1461 )	-0.032 ( 0.1726 )
Phosphate, Week 12, n= 236, 226	0.02 ( 0.1694 )	0.026 ( 0.1634 )
Phosphate, Week 24, n= 225, 212	0.021 ( 0.1628 )	0.026 ( 0.1701 )
Phosphate, Week 36, n= 219, 204	0.029 ( 0.1736 )	0.009 ( 0.1675 )
Phosphate, Week 48, n= 208, 192	0.016 ( 0.1736 )	0 ( 0.1673 )
Potassium, Week 4, n= 244, 237	-0.01 ( 0.344 )	0.12 ( 0.367 )
Potassium, Week 12, n= 236, 226	0.03 ( 0.355 )	0.1 ( 0.39 )
Potassium, Week 24, n= 224, 212	-0.04 ( 0.339 )	0.06 ( 0.372 )
Potassium, Week 36, n= 219, 204	0.03 ( 0.332 )	0.13 ( 0.387 )
Potassium, Week 48, n= 208, 192	-0.04 ( 0.346 )	0.04 ( 0.372 )
Sodium, Week 4, n= 245, 237	0 ( 2.11 )	-0.5 ( 2.4 )
Sodium, Week 12, n= 236, 226	0.7 ( 2.3 )	0.1 ( 2.51 )
Sodium, Week 24, n= 225, 212	0.6 ( 2.3 )	0.2 ( 2.11 )
Sodium, Week 36, n= 219, 204	0.9 ( 2.32 )	0.2 ( 2.5 )
Sodium, Week 48, n= 208, 192	0.6 ( 2.24 )	0.5 ( 2.39 )
Triglycerides, Week 4, n= 1, 3	-0.18 ( 99999 )	0.237 ( 0.2491 )
Triglycerides, Week 12, n= 224, 221	-0.04 ( 0.6861 )	0.167 ( 0.7074 )
Triglycerides, Week 24, n= 218, 201	0.036 ( 0.7108 )	0.125 ( 0.6132 )
Triglycerides, Week 36, n= 205, 191	0.037 ( 0.6732 )	0.157 ( 0.6785 )
Triglycerides, Week 48, n= 195, 175	0.018 ( 0.8158 )	0.107 ( 0.5527 )
Urea, Week 4, n= 245, 237	-0.04 ( 1.085 )	0.1 ( 1.313 )
Urea, Week 12, n= 236, 226	0.08 ( 1.097 )	0.16 ( 1.409 )
Urea, Week 24, n= 225, 212	0.03 ( 1.187 )	0.12 ( 1.283 )
Urea, Week 36, n= 219, 204	0.08 ( 1.236 )	-0.03 ( 1.256 )
Urea, Week 48, n= 208, 192	0.1 ( 1.162 )	0.02 ( 1.179 )

Notes
[19] - Safety Population
[20] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in bilirubin and creatinine at indicated timepoints

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End point title

Change from Baseline in bilirubin and creatinine at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[21]	247 ^[22]
Units: Micromoles per liter
arithmetic mean (standard deviation)
Bilirubin, Week 4, n= 244, 237	-0.8 ( 2.59 )	27.2 ( 23.15 )
Bilirubin, Week 12, n= 236, 226	-0.6 ( 2.65 )	22.8 ( 16.49 )
Bilirubin, Week 24, n= 225, 212	-0.2 ( 3.06 )	25 ( 18.38 )
Bilirubin, Week 36, n= 219, 204	-0.2 ( 3.01 )	23.8 ( 16.31 )
Bilirubin, Week 48, n= 208, 192	-0.3 ( 3.08 )	23.7 ( 17 )
Creatinine, Week 4, n= 245, 237	8.4 ( 7.057 )	4.89 ( 7.109 )
Creatinine, Week 12, n= 236, 226	9.2 ( 8.288 )	5.83 ( 8.357 )
Creatinine, Week 24, n= 225, 212	9.16 ( 9.983 )	5.8 ( 8.063 )
Creatinine, Week 36, n= 219, 204	10.08 ( 10.473 )	5.37 ( 9.013 )
Creatinine, Week 48, n= 208, 192	9.29 ( 8.614 )	5.86 ( 10.252 )

Notes
[21] - Safety Population
[22] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in albumin at indicated timepoints

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End point title

Change from Baseline in albumin at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[23]	247 ^[24]
Units: Grams per liter
arithmetic mean (standard deviation)
Week 4, n= 245, 237	0.1 ( 2.36 )	-0.5 ( 2.59 )
Week 12, n= 236, 226	0.5 ( 2.95 )	0.1 ( 2.59 )
Week 24, n= 225, 212	1.4 ( 3.2 )	0.8 ( 2.95 )
Week 36, n= 219, 204	1.4 ( 3.09 )	0.6 ( 2.96 )
Week 48, n= 208, 192	1.7 ( 3.17 )	1.3 ( 3.04 )

Notes
[23] - Safety Population
[24] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points

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End point title

Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[25]	247 ^[26]
Units: International units per liter
arithmetic mean (standard deviation)
Alanine aminotransferase, Week 4, n= 245, 237	-3.3 ( 27.54 )	-3.4 ( 15.86 )
Alanine aminotransferase, Week 12, n= 236, 226	-5.2 ( 27.51 )	-2.3 ( 20.26 )
Alanine aminotransferase, Week 24, n= 225, 212	-5.4 ( 27.92 )	-3.7 ( 20.7 )
Alanine aminotransferase, Week 36, n= 219, 204	-4.9 ( 36.11 )	-5.3 ( 20.08 )
Alanine aminotransferase, Week 48, n= 208, 192	-5.7 ( 28.54 )	-1.5 ( 31.53 )
Alkaline phosphatase, Week 4, n= 245, 237	-1.5 ( 14.56 )	9.4 ( 28.69 )
Alkaline phosphatase, Week 12, n= 236, 226	-2.1 ( 17.1 )	15.1 ( 30.82 )
Alkaline phosphatase, Week 24, n= 225, 212	0.5 ( 17.86 )	22.4 ( 41.59 )
Alkaline phosphatase, Week 36, n= 219, 204	0.6 ( 19.19 )	20.4 ( 30.7 )
Alkaline phosphatase, Week 48, n= 208, 192	2.9 ( 28.05 )	21.9 ( 25.35 )
Aspartate aminotransferase, Week 4, n= 244, 237	-3.3 ( 29.8 )	-3.6 ( 18.83 )
Aspartate aminotransferase, Week 12, n= 236, 226	-6.2 ( 21.11 )	-4 ( 13.79 )
Aspartate aminotransferase, Week 24, n= 224, 212	-6.3 ( 22.44 )	-5.1 ( 13.8 )
Aspartate aminotransferase, Week 36, n= 219, 204	-6.4 ( 31.42 )	-6.5 ( 16.63 )
Aspartate aminotransferase, Week 48, n= 208, 192	-7.5 ( 22.19 )	-3.7 ( 25.28 )
Creatine Kinase, Week 4, n= 245, 237	-0.3 ( 68.72 )	35.6 ( 549.1 )
Creatine Kinase, Week 12, n= 236, 226	6.9 ( 73.7 )	7.3 ( 90.39 )
Creatine Kinase, Week 24, n= 225, 212	10.3 ( 88.66 )	5.8 ( 77.12 )
Creatine Kinase, Week 36, n= 219, 204	11.9 ( 155.68 )	7.2 ( 132.74 )
Creatine Kinase, Week 48, n= 208, 192	23.8 ( 242.66 )	3.8 ( 98.58 )

Notes
[25] - Safety Population
[26] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in creatinine clearance at indicated time points

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End point title

Change from Baseline in creatinine clearance at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[27]	247 ^[28]
Units: Milliliter per minute
arithmetic mean (standard deviation)
Week 4, n= 245, 237	-16.3 ( 15.03 )	-7.5 ( 12.91 )
Week 12, n= 236, 226	-17.3 ( 17.01 )	-7 ( 23.14 )
Week 24, n= 225, 212	-16.2 ( 20.36 )	-9.1 ( 16.88 )
Week 36, n= 219, 204	-16.8 ( 22.35 )	-7.5 ( 17.67 )
Week 48, n= 208, 192	-15.9 ( 19.62 )	-7.7 ( 18.42 )

Notes
[27] - Safety Population
[28] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints

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End point title

Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints

End point description

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. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles). 99999 indicates standard deviation could not be calculated for a single participant.

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[29]	247 ^[30]
Units: Ratio
arithmetic mean (standard deviation)
Week 4, n= 1, 4	0.1264 ( 99999 )	0.2159 ( 0.60727 )
Week 12, n= 233, 223	-0.2736 ( 1.0283 )	-0.1092 ( 0.73776 )
Week 24, n= 224, 209	-0.3098 ( 1.11093 )	-0.1922 ( 0.79848 )
Week 36, n= 212, 198	-0.3286 ( 1.01181 )	-0.1433 ( 0.79498 )
Week 48, n= 207, 186	-0.2886 ( 1.01415 )	-0.1444 ( 1.23362 )

Notes
[29] - Safety Population
[30] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in lipase at indicated timepoints

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End point title

Change from Baseline in lipase at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[31]	247 ^[32]
Units: Units per liter
arithmetic mean (standard deviation)
Week 4, n= 245, 237	-1.2 ( 15.06 )	-1.3 ( 15.81 )
Week 12, n= 236, 226	-2.2 ( 22.74 )	-2.1 ( 29 )
Week 24, n= 225, 212	-6 ( 21.05 )	-6 ( 18.57 )
Week 36, n= 219, 204	-6.3 ( 25.62 )	-6.3 ( 21.36 )
Week 48, n= 208, 192	-6.5 ( 29.63 )	-7.8 ( 20.72 )

Notes
[31] - Safety Population
[32] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points

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End point title

Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[33]	247 ^[34]
Units: 10^9 cells per liter
arithmetic mean (standard deviation)
Basophils, Week 4, n= 241, 234	0.003 ( 0.0182 )	0.003 ( 0.0198 )
Basophils, Week 12, n= 228, 216	0.002 ( 0.0174 )	0.003 ( 0.0162 )
Basophils, Week 24, n= 221, 208	0.004 ( 0.0187 )	0.003 ( 0.0155 )
Basophils, Week 36, n= 214, 203	0.004 ( 0.0182 )	0.003 ( 0.0158 )
Basophils, Week 48, n= 206, 189	0.005 ( 0.0199 )	0.006 ( 0.0146 )
Eosinophils, Week 4, n= 241, 234	0.040 ( 0.1486 )	0.021 ( 0.1648 )
Eosinophils, Week 12, n= 228, 216	0.037 ( 0.1982 )	-0.001 ( 0.1610 )
Eosinophils, Week 24, n= 221, 208	0.028 ( 0.1927 )	0.005 ( 0.1973 )
Eosinophils, Week 36, n= 214, 203	0.048 ( 0.2244 )	0.014 ( 0.2139 )
Eosinophils, Week 48, n= 206, 189	0.030 ( 0.1744 )	0.007 ( 0.2274 )
Lymphocytes, Week 4, n= 241, 234	0.208 ( 0.4914 )	0.119 ( 0.5493 )
Lymphocytes, Week 12, n= 228, 216	0.257 ( 0.5500 )	0.156 ( 0.6690 )
Lymphocytes, Week 24, n= 221, 208	0.317 ( 0.4889 )	0.192 ( 0.5910 )
Lymphocytes, Week 36, n= 214, 203	0.362 ( 0.5199 )	0.178 ( 0.6441 )
Lymphocytes, Week 48, n= 206, 189	0.359 ( 0.5235 )	0.261 ( 0.7098 )
Monocytes, Week 4, n= 241, 234	-0.001 ( 0.1558 )	-0.015 ( 0.1391 )
Monocytes, Week 12, n= 228, 216	-0.010 ( 0.1412 )	-0.031 ( 0.1369 )
Monocytes, Week 24, n= 221, 208	0.008 ( 0.1498 )	-0.015 ( 0.1581 )
Monocytes, Week 36, n= 214, 203	-0.006 ( 0.1448 )	-0.028 ( 0.1500 )
Monocytes, Week 48, n= 206, 189	0.001 ( 0.1379 )	-0.024 ( 0.1638 )

Notes
[33] - Safety Population
[34] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in erythrocytes at indicated time points

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End point title

Change from Baseline in erythrocytes at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[35]	247 ^[36]
Units: 10^12 cells per liter
arithmetic mean (standard deviation)
Week 4, n= 243, 234	-0.04 ( 0.244 )	-0.07 ( 0.239 )
Week 12, n= 233, 220	-0.07 ( 0.351 )	-0.09 ( 0.308 )
Week 24, n= 225, 211	-0.08 ( 0.373 )	-0.09 ( 0.329 )
Week 36, n= 218, 203	-0.10 ( 0.384 )	-0.08 ( 0.358 )
Week 48, n= 207, 190	-0.10 ( 0.365 )	-0.05 ( 0.318 )

Notes
[35] - Safety Population
[36] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in hematocrit count at indicated time points

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End point title

Change from Baseline in hematocrit count at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[37]	247 ^[38]
Units: Proportion of red blood cells in blood
arithmetic mean (standard deviation)
Week 4, n= 243, 234	0.0003 ( 0.02176 )	-0.0042 ( 0.02238 )
Week 12, n= 233, 220	0.0081 ( 0.03157 )	0.0000 ( 0.02646 )
Week 24, n= 225, 211	0.0157 ( 0.03209 )	0.0051 ( 0.03083 )
Week 36, n= 218, 203	0.0167 ( 0.03451 )	0.0062 ( 0.03379 )
Week 48, n= 207, 190	0.0212 ( 0.03293 )	0.0107 ( 0.03200 )

Notes
[37] - Safety Population
[38] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in erythrocyte mean corpuscular volume at indicated time points

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End point title

Change from Baseline in erythrocyte mean corpuscular volume at indicated time points

End point description

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

End point type

Secondary

End point timeframe

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

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[39]	247 ^[40]
Units: Femtoliter
arithmetic mean (standard deviation)
Week 4, n= 243, 234	0.9 ( 1.81 )	0.5 ( 1.83 )
Week 12, n= 233, 220	3.4 ( 2.98 )	1.9 ( 2.94 )
Week 24, n= 225, 211	5.5 ( 4.03 )	3.1 ( 4.33 )
Week 36, n= 218, 203	6.0 ( 4.04 )	3.1 ( 5.22 )
Week 48, n= 207, 190	7.1 ( 4.31 )	3.7 ( 5.15 )

Notes
[39] - Safety Population
[40] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Triglycerides at Week 48

Top of page

End point title

Change from Baseline in Triglycerides at Week 48

End point description

Change from Baseline in mean triglycerides at Week 48. Baseline value defined as latest pre-dose assessment(Day1) value. Change from Baseline calculated as post-dose visit minus Baseline value. Adjusted mean is estimated mean change from Baseline in fasted triglycerides at Week48 in each arm calculated from a model adjusted for following covariates: treatment, Baseline plasma HIV-1 RNA, CD4+ cell count, age and triglycerides. Participants on lipid lowering therapy at Baseline excluded from analysis. Measurements collected after a participant initiates lipid lowering therapy were set to missing. Missing values 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, Week12 and Week36. Participants on lipid lowering therapy at Baseline excluded from analysis. Only those participants with data available at specified time points were analyzed

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	226 ^[41]	214 ^[42]
Units: Millimoles per liter
least squares mean (standard error)	0.045 ( 0.0477 )	0.070 ( 0.0477 )

Notes
[41] - Safety Population
[42] - Safety Population

Statistical Analysis 1

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

440

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.7053

Method

Multiple Imputed Dataset - MAR

Parameter type

Mean difference (final values)

Point estimate

-0.026

Confidence interval

level

95%

sides

2-sided

lower limit

-0.159

upper limit

0.107

Secondary: Change from Baseline in total cholesterol (TC)/HDL Ratio at Week 48

Top of page

End point title

Change from Baseline in total cholesterol (TC)/HDL Ratio at Week 48

End point description

Change from Baseline in mean TC/HDL ratio at Week48. Baseline value defined as latest pre-dose assessment(Day1) value. Change from Baseline calculated as post-dose visit minus Baseline value. Adjusted mean is estimated mean change from Baseline in fasted TC/HDL at Week48 in each arm calculated from a model adjusted for following covariates: treatment, Baseline plasma HIV-1 RNA, CD4+ cell count, age and TC/HDL. Participants on lipid lowering therapy at Baseline 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, Week12 and Week36. Participants on lipid lowering therapy at Baseline excluded from analysis. Only those participants with data available at specified time points were analyzed.

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	226 ^[43]	214 ^[44]
Units: Ratio
least squares mean (standard error)	-0.264 ( 0.0707 )	-0.158 ( 0.0784 )

Notes
[43] - Safety Population
[44] - Safety Population

Statistical Analysis 1

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

440

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.3165

Method

Multiple Imputed Dataset - MAR

Parameter type

Mean difference (final values)

Point estimate

-0.106

Confidence interval

level

95%

sides

2-sided

lower limit

-0.313

upper limit

0.101

Secondary: Number of Participants With AEs by maximum toxicity-Randomized Phase

Top of page

End point title

Number of Participants With AEs by maximum toxicity-Randomized Phase

End point description

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.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[45]	247 ^[46]
Units: Participants
Grade 1	79	60
Grade 2	94	91
Grade 3	18	37
Grade 4	3	9

Notes
[45] - Safety Population
[46] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in urine albumin creatinine ratio at indicated time points

Top of page

End point title

Change from Baseline in urine albumin creatinine ratio at indicated time points

End point description

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

End point type

Secondary

End point timeframe

Baseline (Day 1), Week 24 and Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[47]	247 ^[48]
Units: milligrams per millimole
arithmetic mean (standard deviation)
Week 24, n= 179, 186	-1.15 ( 16.557 )	-1.03 ( 9.091 )
Week 48, n= 170, 164	-0.68 ( 20.597 )	-0.10 ( 9.393 )

Notes
[47] - Safety Population
[48] - Safety Population

No statistical analyses for this end point

Secondary: Number of Participants With AEs by maximum toxicity-Continuation Phase

Top of page

End point title

Number of Participants With AEs by maximum toxicity-Continuation Phase

End point description

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. 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.

End point type

Secondary

End point timeframe

From Weeks 48 to 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[49]
Units: Participants
Grade 1	32
Grade 2	48
Grade 3	7
Grade 4	6

Notes
[49] - Safety - Continuation Phase Population

No statistical analyses for this end point

Secondary: Number of participants with any adverse events (AEs), and serious adverse events (SAEs)-Randomized Phase

Top of page

End point title

Number of participants with any adverse events (AEs), and serious adverse events (SAEs)-Randomized Phase

End point description

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.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[50]	247 ^[51]
Units: Participants
Any AEs	195	197
Any SAEs	12	20

Notes
[50] - Safety Population
[51] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants with any AEs, and SAEs in Continuation Phase

Top of page

End point title

Number of participants with any AEs, and SAEs in Continuation Phase

End point description

End point type

Secondary

End point timeframe

From Weeks 48 to 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[52]
Units: Participants
Any AEs	93
Any SAEs	13

Notes
[52] - Safety-Continuation Phase Population

No statistical analyses for this end point

Secondary: Number of Participants with maximum post-Baseline emergent chemistry toxicities-Randomized Phase

Top of page

End point title

Number of Participants with maximum post-Baseline emergent chemistry toxicities-Randomized Phase

End point description

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.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[53]	247 ^[54]
Units: Participants
Hyperglycaemia, Grade 1	17	11
Hyperglycaemia, Grade 2	16	9
Hyperglycaemia, Grade 3	4	3
Hyperglycaemia, Grade 4	1	0
Hyperkalemia, Grade 1	1	0
Hyperkalemia, Grade 2	0	1
Hyperkalemia, Grade 3	0	0
Hyperkalemia, Grade 4	0	0
Hypernatremia, Grade 1	1	0
Hypernatremia, Grade 2	0	0
Hypernatremia, Grade 3	0	0
Hypernatremia, Grade 4	0	0
Hypoglycaemia, Grade 1	6	5
Hypoglycaemia, Grade 2	3	1
Hypoglycaemia, Grade 3	1	0
Hypoglycaemia, Grade 4	0	0
Hypokalemia, Grade 1	17	19
Hypokalemia, Grade 2	1	0
Hypokalemia, Grade 3	0	0
Hypokalemia, Grade 4	0	0
Hyponatremia, Grade 1	44	57
Hyponatremia, Grade 2	1	0
Hyponatremia, Grade 3	0	0
Hyponatremia, Grade 4	0	0
Alanine aminotransferase, Grade 1	5	7
Alanine aminotransferase, Grade 2	6	4
Alanine aminotransferase, Grade 3	1	2
Alanine aminotransferase, Grade 4	1	0
Albumin, Grade 1	3	2
Albumin, Grade 2	0	2
Albumin, Grade 3	0	0
Albumin, Grade 4	0	0
Alkaline phosphatase, Grade 1	3	14
Alkaline phosphatase, Grade 2	2	1
Alkaline phosphatase, Grade 3	0	0
Alkaline phosphatase, Grade 4	0	0
Aspartate aminotransferase, Grade 1	12	7
Aspartate aminotransferase, Grade 2	4	4
Aspartate aminotransferase, Grade 3	1	2
Aspartate aminotransferase, Grade 4	1	0
Bilirubin, Grade 1	2	52
Bilirubin, Grade 2	0	86
Bilirubin, Grade 3	0	57
Bilirubin, Grade 4	0	5
Carbon dioxide, Grade 1	65	54
Carbon dioxide, Grade 2	4	3
Carbon dioxide, Grade 3	0	0
Carbon dioxide, Grade 4	0	0
Cholesterol, Grade 1	52	31
Cholesterol, Grade 2	28	9
Cholesterol, Grade 3	4	2
Cholesterol, Grade 4	0	0
Creatine kinase, Grade 1	3	5
Creatine kinase, Grade 2	1	1
Creatine kinase, Grade 3	3	0
Creatine kinase, Grade 4	0	1
Creatinine, Grade 1	3	7
Creatinine, Grade 2	0	3
Creatinine, Grade 3	1	0
Creatinine, Grade 4	0	0
LDL cholesterol calculation, Grade 1	38	21
LDL cholesterol calculation, Grade 2	13	9
LDL cholesterol calculation, Grade 3	7	2
LDL cholesterol calculation, Grade 4	0	0
LDL cholesterol direct, Grade 1	3	1
LDL cholesterol direct, Grade 2	1	0
LDL cholesterol direct, Grade 3	0	0
LDL cholesterol direct, Grade 4	0	0
Lipase, Grade 1	12	7
Lipase, Grade 2	5	3
Lipase, Grade 3	3	2
Lipase, Grade 4	0	1
Phosphate, Grade 1	5	11
Phosphate, Grade 2	7	9
Phosphate, Grade 3	1	2
Phosphate, Grade 4	0	0
Potassium, Grade 1	18	19
Potassium, Grade 2	1	1
Potassium, Grade 3	0	0
Potassium, Grade 4	0	0
Sodium, Grade 1	45	57
Sodium, Grade 2	1	0
Sodium, Grade 3	0	0
Sodium, Grade 4	0	0
Triglycerides, Grade 1	0	0
Triglycerides, Grade 2	5	2
Triglycerides, Grade 3	2	0
Triglycerides, Grade 4	0	0
Glucose, Grade 1	22	15
Glucose, Grade 2	19	10
Glucose, Grade 3	4	3
Glucose, Grade 4	1	0

Notes
[53] - Safety Population
[54] - Safety Population

No statistical analyses for this end point

Secondary: Number of Participants With maximum post-Baseline emergent chemistry toxicities-Continuation Phase

Top of page

End point title

Number of Participants With maximum post-Baseline emergent chemistry toxicities-Continuation Phase

End point description

Number of participants with Grade1-4 emergent chemistry toxicities were assessed in Continuation Phase. Chemistry toxicities categorized into following grades as per The Division of AIDS Table for Grading 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. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

End point type

Secondary

End point timeframe

From Weeks 48 to 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[55]
Units: Participants
Hyperglycaemia, Grade 1, n=143	24
Hyperglycaemia, Grade 2, n=143	9
Hyperglycaemia, Grade 3, n=143	3
Hyperglycaemia, Grade 4, n=143	0
Hypernatremia, Grade 1, n=146	2
Hypernatremia, Grade 2, n=146	0
Hypernatremia, Grade 3, n=146	0
Hypernatremia, Grade 4, n=146	0
Hypoglycaemia, Grade 1, n=143	1
Hypoglycaemia, Grade 2, n=143	0
Hypoglycaemia, Grade 3, n=143	0
Hypoglycaemia, Grade 4, n=143	1
Hypokalemia, Grade 1, n=146	13
Hypokalemia, Grade 2, n=146	0
Hypokalemia, Grade 3, n=146	0
Hypokalemia, Grade 4, n=146	0
Hyponatremia, Grade 1, n=146	36
Hyponatremia, Grade 2, n=146	0
Hyponatremia, Grade 3, n=146	0
Hyponatremia, Grade 4, n=146	0
Alanine aminotransferase, Grade 1, n=146	7
Alanine aminotransferase, Grade 2, n=146	3
Alanine aminotransferase, Grade 3, n=146	0
Alanine aminotransferase, Grade 4, n=146	2
Alkaline phosphatase, Grade 1, n=146	5
Alkaline phosphatase, Grade 2, n=146	0
Alkaline phosphatase, Grade 3, n=146	0
Alkaline phosphatase, Grade 4, n=146	0
Aspartate aminotransferase, Grade 1, n=146	10
Aspartate aminotransferase, Grade 2, n=146	2
Aspartate aminotransferase, Grade 3, n=146	0
Aspartate aminotransferase, Grade 4, n=146	2
Bilirubin, Grade 1, n=146	4
Bilirubin, Grade 2, n=146	1
Bilirubin, Grade 3, n=146	3
Bilirubin, Grade 4, n=146	0
Carbon dioxide, Grade 1, n=146	58
Carbon dioxide, Grade 2, n=146	7
Carbon dioxide, Grade 3, n=146	0
Carbon dioxide, Grade 4, n=146	0
Cholesterol, Grade 1, n=71	9
Cholesterol, Grade 2, n=71	9
Cholesterol, Grade 3, n=71	3
Cholesterol, Grade 4, n=71	0
Creatine kinase, Grade 1, n=146	6
Creatine kinase, Grade 2, n=146	1
Creatine kinase, Grade 3, n=146	1
Creatine kinase, Grade 4, n=146	1
Creatinine, Grade 1, n=146	5
Creatinine, Grade 2, n=146	0
Creatinine, Grade 3, n=146	0
Creatinine, Grade 4, n=146	1
LDL cholesterol calculation, Grade 1, n=70	5
LDL cholesterol calculation, Grade 2, n=70	8
LDL cholesterol calculation, Grade 3, n=70	2
LDL cholesterol calculation, Grade 4, n=70	0
LDL cholesterol direct, Grade 1, n=2	1
LDL cholesterol direct, Grade 2, n=2	0
LDL cholesterol direct, Grade 3, n=2	0
LDL cholesterol direct, Grade 4, n=2	0
Lipase, Grade 1, n=146	9
Lipase, Grade 2, n=146	6
Lipase, Grade 3, n=146	1
Lipase, Grade 4, n=146	1
Phosphate, Grade 1, n=146	2
Phosphate, Grade 2, n=146	15
Phosphate, Grade 3, n=146	2
Phosphate, Grade 4, n=146	0
Potassium, Grade 1, n=146	13
Potassium, Grade 2, n=146	0
Potassium, Grade 3, n=146	0
Potassium, Grade 4, n=146	0
Sodium, Grade 1, n=146	37
Sodium, Grade 2, n=146	0
Sodium, Grade 3, n=146	0
Sodium, Grade 4, n=146	0
Triglycerides, Grade 1, n=71	0
Triglycerides, Grade 2, n=71	1
Triglycerides, Grade 3, n=71	0
Triglycerides, Grade 4, n=71	0
Glucose, Grade 1, n=143	24
Glucose, Grade 2, n=143	9
Glucose, Grade 3, n=143	3
Glucose, Grade 4, n=143	1

Notes
[55] - Safety-Continuation Phase Population

No statistical analyses for this end point

Secondary: Number of Participants with maximum post-Baseline emergent hematology toxicities-Randomized Phase

Top of page

End point title

Number of Participants with maximum post-Baseline emergent hematology toxicities-Randomized Phase

End point description

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.

End point type

Secondary

End point timeframe

Up to Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[56]	247 ^[57]
Units: Participants
Hemoglobin, Grade 1	7	21
Hemoglobin, Grade 2	2	3
Hemoglobin, Grade 3	1	1
Hemoglobin, Grade 4	0	0
Leukocytes, Grade 1	5	6
Leukocytes, Grade 2	1	2
Leukocytes, Grade 3	0	0
Leukocytes, Grade 4	0	0
Neutrophils, Grade 1	15	12
Neutrophils, Grade 2	7	9
Neutrophils, Grade 3	0	2
Neutrophils, Grade 4	1	1
Platelets, Grade 1	6	1
Platelets, Grade 2	0	2
Platelets, Grade 3	1	0
Platelets, Grade 4	0	0

Notes
[56] - Safety Population
[57] - Safety Population

No statistical analyses for this end point

Secondary: Number of Participants With maximum post-Baseline emergent hematology toxicities-Continuation Phase

Top of page

End point title

Number of Participants With maximum post-Baseline emergent hematology toxicities-Continuation Phase

End point description

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. Only those participants with data available at specified time points were analyzed.

End point type

Secondary

End point timeframe

From Weeks 48 to 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	146 ^[58]
Units: Participants
Hemoglobin, Grade 1	5
Hemoglobin, Grade 2	1
Hemoglobin, Grade 3	0
Hemoglobin, Grade 4	0
Leukocytes, Grade 1	2
Leukocytes, Grade 2	0
Leukocytes, Grade 3	1
Leukocytes, Grade 4	0
Neutrophils, Grade 1	10
Neutrophils, Grade 2	2
Neutrophils, Grade 3	1
Neutrophils, Grade 4	1
Platelets, Grade 1	3
Platelets, Grade 2	1
Platelets, Grade 3	0
Platelets, Grade 4	0

Notes
[58] - Safety - Continuation Phase Population

No statistical analyses for this end point

Secondary: Number of participants who withdrew from treatment due to AEs-Continuation phase

Top of page

End point title

Number of participants who withdrew from treatment due to AEs-Continuation phase

End point description

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.

End point type

Secondary

End point timeframe

From Weeks 48 to 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase
Number of subjects analysed	149 ^[59]
Units: Participants	4

Notes
[59] - Safety - Continuation Phase Population

No statistical analyses for this end point

Secondary: Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints

Top of page

End point title

Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

Baseline (Day 1), Weeks 24 and 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[60]	247 ^[61]
Units: Micrograms per liter
arithmetic mean (standard deviation)
BSAP, Week 24, n=219, 207	1.33 ( 3.934 )	6.00 ( 5.962 )
BSAP, Week 48, n=202, 184	2.64 ( 5.746 )	7.60 ( 7.144 )
Osteocalcin, Week 24, n=209, 197	3.73 ( 7.484 )	14.38 ( 22.205 )
Osteocalcin, Week 48, n=194, 178	5.15 ( 9.018 )	16.30 ( 25.043 )
PTP, Week 24, n=223, 206	10.1 ( 20.11 )	32.0 ( 27.89 )
PTP, Week 48, n=205, 186	11.2 ( 23.05 )	34.1 ( 27.28 )

Notes
[60] - Safety Population
[61] - Safety Population

No statistical analyses for this end point

Secondary: Number of participants who withdrew from treatment due to AEs-Randomized Phase

Top of page

End point title

Number of participants who withdrew from treatment due to AEs-Randomized Phase

End point description

End point type

Secondary

End point timeframe

Up to Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[62]	247 ^[63]
Units: Participants	10	17

Notes
[62] - Safety Population
[63] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in vitamin D, vitamin D2 and vitamin D3 at Week 24 and Week 48

Top of page

End point title

Change from Baseline in vitamin D, vitamin D2 and vitamin D3 at Week 24 and Week 48

End point description

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

End point type

Secondary

End point timeframe

Baseline (Day 1), Weeks 24 and 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[64]	247 ^[65]
Units: Nanomoles per liter
arithmetic mean (standard deviation)
Vitamin D, Week 24, n=223, 208	1.8 ( 24.95 )	16.3 ( 31.66 )
Vitamin D, Week 48, n=206, 186	-1.9 ( 20.63 )	8.9 ( 23.78 )
Vitamin D2, Week 24, n=223, 208	0.3 ( 6.04 )	1.0 ( 7.88 )
Vitamin D2, Week 48, n=206, 186	0.1 ( 4.71 )	0.9 ( 11.00 )
Vitamin D3, Week 24, n=223, 208	1.5 ( 24.33 )	15.2 ( 31.39 )
Vitamin D3, Week 48, n=206, 186	-1.9 ( 20.56 )	7.9 ( 21.72 )

Notes
[64] - Safety Population
[65] - Safety Population

No statistical analyses for this end point

Secondary: Change from Baseline in Type I collagen C-telopeptides at indicated timepoints

Top of page

End point title

Change from Baseline in Type I collagen C-telopeptides at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

Baseline (Day 1), Weeks 24 and 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[66]	247 ^[67]
Units: Nanograms per liter
arithmetic mean (standard deviation)
Week 24, n=221, 207	89.8 ( 173.09 )	272.4 ( 205.22 )
Week 48, n=202, 185	75.9 ( 173.73 )	267.9 ( 200.82 )

Notes
[66] - Safety Population
[67] - Safety Population

No statistical analyses for this end point

Secondary: Bone specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline

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End point title

Bone specific alkaline phosphatase, osteocalcin, procollagen 1 N-terminal propeptide, Type 1 Collagen C-Telopeptide, vitamin D ratio of Week 48 results over Baseline

End point description

Bone markers assessed at indicated timepoints. Bone specific alkaline phosphatase(BSAP), osteocalcin and procollagen 1 N-terminal propeptide(PTP), Type 1 Collagen C-Telopeptide, vitaminD ratio of Week48 results over Baseline is calculated. Bone biomarkers analyzed based on log transformed data. Estimates of adjusted mean and difference 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 transformed back to Week48/Baseline ratio for each treatment group. Adjusted difference of log-transformed change from Baseline between treatment groups is transformed back to ratio of Week48/Baseline ratio in DTG/ABC/3TC FDC to ATV+RTV+TDF/FTC FDC. Only those participants with data available at specified time points were analyzed(represented by n=X in category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[68]	247 ^[69]
Units: Ratio
number (confidence interval 95%)
BSAP, n=202, 183	1.188 (1.135 to 1.243)	1.629 (1.553 to 1.708)
PTP, n=202, 184	1.214 (1.158 to 1.272)	1.752 (1.668 to 1.840)
Osteocalcin, n=194, 178	1.282 (1.214 to 1.354)	2.039 (1.926 to 2.159)
Type 1 Collagen C-Telopeptide, n=202, 184	1.257 (1.195 to 1.323)	1.918 (1.819 to 2.023)
Vitamin D, n=206, 186	0.987 (0.940 to 1.036)	1.158 (1.101 to 1.219)

Notes
[68] - Safety Population
[69] - Safety Population

Statistical Analysis 1

Statistical analysis description

BSAP ratio of Week 48 result over Baseline

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Ratio of ratios

Point estimate

0.729

Confidence interval

level

95%

sides

2-sided

lower limit

0.683

upper limit

0.779

Statistical Analysis 5

Statistical analysis description

Vitamin D ratio of Week 48 result over Baseline

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Ratio of ratios

Point estimate

0.852

Confidence interval

level

95%

sides

2-sided

lower limit

0.794

upper limit

0.914

Statistical Analysis 4

Statistical analysis description

Type 1 Collagen C-Telopeptide ratio of Week 48 result over Baseline

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.0001

Method

ANCOVA

Parameter type

Ratio of ratios

Point estimate

0.655

Confidence interval

level

95%

sides

2-sided

lower limit

0.609

upper limit

0.706

Statistical Analysis 2

Statistical analysis description

PTP ratio of Week 48 result over Baseline

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Ratio of ratios

Point estimate

0.693

Confidence interval

level

95%

sides

2-sided

lower limit

0.647

upper limit

0.741

Statistical Analysis 3

Statistical analysis description

Osteocalcin ratio of Week 48 result over Baseline

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

ANCOVA

Parameter type

Ratio of ratios

Point estimate

0.629

Confidence interval

level

95%

sides

2-sided

lower limit

0.581

upper limit

0.68

Secondary: Change from Baseline at Week 48 in SF-12 Total Score, MCS and PCS

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End point title

Change from Baseline at Week 48 in SF-12 Total Score, MCS and PCS

End point description

SF-12 is a self-reported outcome measure assessing psychological wellness and the impact of health on an individual's everyday life. SF-12 questions make up 8 scales:Physical Functioning, Role Physical,Bodily Pain, General Health,Vitality, Social Functioning,Role Emotional, Mental Health.SF-12 total score ranges from 20 to 60 and higher score indicate a higher level of functioning. It 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 sum of all 12 items and scored onto a 0-100 scale such that a higher score indicates a better health state and functioning. Baseline value wasdefined as latest pre-dose assessment (Day 1) value. Change from Baseline was calculated as post-dose visit value minus Baseline value. Only those participants with data available at the specified time points were analyzed (represented by n=X in the category titles)

End point type

Secondary

End point timeframe

Baseline (Day 1) and Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[70]	247 ^[71]
Units: Score on a scale
arithmetic mean (standard deviation)
Total Score, Week 48, n=205, 192	0.0 ( 5.15 )	0.1 ( 5.66 )
MCS, Week 48, n=205, 192	2.397 ( 10.5232 )	2.329 ( 9.9782 )
PCS, Week 48, n=205, 192	1.905 ( 8.6309 )	1.444 ( 8.3938 )

Notes
[70] - ITT-E Population
[71] - ITT-E Population

No statistical analyses for this end point

Secondary: HIVTSQs Total Score at indicated timepoints

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End point title

HIVTSQs Total Score at indicated timepoints

End point description

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

End point type

Secondary

End point timeframe

Weeks 4, 12, 24 and 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[72]	247 ^[73]
Units: Score on a scale
arithmetic mean (standard deviation)
Week 4, n=243, 239	54.0 ( 6.37 )	51.9 ( 8.53 )
Week 12, n=236, 226	56.1 ( 5.38 )	53.6 ( 7.67 )
Week 24, n=225, 211	56.8 ( 4.55 )	54.3 ( 7.27 )
Week 48, n=206, 191	57.0 ( 4.38 )	55.4 ( 6.00 )

Notes
[72] - ITT-E Population
[73] - ITT-E Population

Statistical Analysis 1

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.016 ^[74]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[74] - Week 4

Statistical Analysis 4

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.007 ^[75]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[75] - Week 48

Statistical Analysis 3

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.002 ^[76]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[76] - Week 24

Statistical Analysis 2

Comparison groups

DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase v ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase

Number of subjects included in analysis

495

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001 ^[77]

Method

Wilcoxon (Mann-Whitney)

Confidence interval

Notes
[77] - Week 12

Secondary: Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups

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End point title

Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48 by subgroups

End point description

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

End point type

Secondary

End point timeframe

Week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	248 ^[78]	247 ^[79]
Units: Percentage of participants
Age, <50 Years, n=212, 212	80	71
Age, >=50 Years, n=36, 35	92	74
Race, White, n=115, 107	86	80
Race, Non-White, n=133,140	78	64
Race, African-American/African Heritage, n=102,108	74	67
Non-African-American/African Heritage, n=146, 139	88	75
BPHR, <1000, n=5, 10	60	80
BPHR, 1000 to <10,000, n=66, 62	83	77
BPHR, 10,000 to <50,000, n=83, 81	84	74
BPHR, 50,000 to <=100,000, n=25, 28	80	64
BPHR, >100,000, n=69, 66	80	64
BCCC, <200, n=64, 49	81	69
BCCC, >=200, n=184, 198	82	72
BCCC, <50, n=9, 15	67	60
BCCC, 50 to <200, n=55, 34	84	74
BCCC, 200 to <350, n=66, 74	89	73
BCCC, 350 to <500, n=56, 65	79	74
BCCC, >=500, n=62, 59	77	68
CDC category, A, n=210, 208	81	71
CDC category, B, n=27, 30	81	77
CDC category, C, n=11, 9	91	56
HIV-1 subtype: B vs Non-B, B, n=95, 111	80	69
HIV-1 subtype: B vs Non-B, non-B, n=140, 131	84	73
Argentina, n=24, 20	92	80
Canada, n=11, 9	91	89
France, n=7, 8	100	75
Italy, n=17, 11	88	64
Mexico, n=6, 5	100	60
Portugal, n=4, 5	75	60
Puerto Rico, n=0, 2	99999	100
Russia, n=28, 22	89	82
South Africa, n=33, 33	67	76
Spain, n=23, 31	70	77
Thailand, n=19, 21	95	52
United States, n=62, 69	74	67
United Kingdom, n=14, 11	93	64

Notes
[78] - ITT-E Population
[79] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with post-Baseline HIV-1 disease progression-Randomized Phase

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End point title

Number of participants with post-Baseline HIV-1 disease progression-Randomized Phase

End point description

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. Only those participants who experienced a disease progression to CDC Class C or death were analyzed.

End point type

Secondary

End point timeframe

Up to week 48

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	7 ^[80]	7 ^[81]
Units: Participants
CDC Class A to CDC Class C	5	4
CDC Class B to CDC Class C	1	2
CDC Class C to new CDC Class C	0	0
CDC Class A, B or C to Death	1	1

Notes
[80] - ITT-E Population
[81] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of participants with post-Baseline HIV-1 disease progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

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End point title

Number of participants with post-Baseline HIV-1 disease progression for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

End point description

End point type

Secondary

End point timeframe

Up to week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD
Number of subjects analysed	9 ^[82]
Units: Participants
CDC Class A to CDC Class C	6
CDC Class B to CDC Class C	1
CDC Class C to new CDC Class C	0
CDC Class A, B or C to Death	2

Notes
[82] - ITT-E Population

No statistical analyses for this end point

Secondary: Number of Participants with treatment emergent resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

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End point title

Number of Participants with treatment emergent resistances for DTG 50 mg/ABC 600 mg/3TC 300 mg QD (Randomized + Continuation Phase)

End point description

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

End point type

Secondary

End point timeframe

Up to week 432

End point values	DTG 50 mg/ABC 600 mg/3TC 300 mg QD
Number of subjects analysed	8 ^[83]
Units: Participants
INSTI; n= 6	0
NNRTI; n=8	1
NRTI; n=8	1
PI; n=8	0

Notes
[83] - On-treatment Genotypic Resistance Population

No statistical analyses for this end point

Secondary: Number of Participants with treatment emergent resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase)

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End point title

Number of Participants with treatment emergent resistances for ATV 300 mg+RTV 100 mg+TDF 300 mg/FTC 200mg QD (Randomized Phase) ^[84]

End point description

End point type

Secondary

End point timeframe

Up to week 48

Notes
[84] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: This endpoint is only reporting on a subset of the arms that are contained in the baseline period.

End point values	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Number of subjects analysed	4
Units: Participants
INSTI; n= 3	1
NNRTI; n=4	0
NRTI; n=4	1
PI; n=4	0

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All-cause mortality, Serious adverse events (SAEs) and non-SAEs were collected up to Week 48 for Randomized Phase; from Weeks 48 to 432 for Continuation Phase.

Adverse event reporting additional description

All-Cause Mortality, SAEs and non-SAEs reported for Safety Population for Randomized Phase comprised all randomized participants who received atleast one dose of study treatment. Safety-ContinuationPopulation for ContinuationPhase comprised of all participants in DTG/ABC/3TCgroup who received at least 1 dose of study treatment in ContinuationPhase.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

25.0

Reporting group title

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

Reporting group description

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.

Reporting group title

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

Reporting group description

Participants received DTG 50 mg/ABC 600 mg/3TC 300 mg QD in the Continuation Phase until it was either locally approved or commercial supplies were available.

Reporting group title

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

Reporting group description

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.

Serious adverse events	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Total subjects affected by serious adverse events
subjects affected / exposed	12 / 248 (4.84%)	13 / 149 (8.72%)	20 / 247 (8.10%)
number of deaths (all causes)	1	1	0
number of deaths resulting from adverse events
Vascular disorders
Hypertensive emergency
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Iliac artery stenosis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
subjects affected / exposed	0 / 248 (0.00%)	2 / 149 (1.34%)	2 / 247 (0.81%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Death
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 0
Reproductive system and breast disorders
Endometriosis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Rectocele
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Asthma
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Panic attack
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Intentional self-injury
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute psychosis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Major depression
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Investigations
Blood creatinine increased
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Ankle fracture
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Thermal burn
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 0
Lower limb fracture
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cardiac disorders
Acute myocardial infarction
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute coronary syndrome
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Nervous system disorders
Amnesia
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cerebrovascular accident
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Transient ischaemic attack
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Loss of consciousness
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ischaemic stroke
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Nausea
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Abdominal pain
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Hepatitis acute
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis chronic
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Hepatotoxicity
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cholecystitis
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
Skin ulcer
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Angioedema
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic foot
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 4	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Ureterolithiasis
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Scleroderma
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Osteonecrosis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Infections and infestations
Arthritis infective
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Bacteraemia
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Cellulitis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	2 / 247 (0.81%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Herpes simplex
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Otitis media chronic
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Pneumocystis jirovecii pneumonia
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Lower respiratory tract infection
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Malaria
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Meningitis viral
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Mastoiditis
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Acute hepatitis C
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 248 (0.00%)	2 / 149 (1.34%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Diabetic foot infection
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 248 (0.00%)	1 / 149 (0.67%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Diabetic ketoacidosis
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	1 / 247 (0.40%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0
Electrolyte imbalance
subjects affected / exposed	1 / 248 (0.40%)	0 / 149 (0.00%)	0 / 247 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Randomized Phase	DTG 50 mg/ABC 600 mg/3TC 300 mg QD-Continuation Phase	ATV 300mg+RTV 100 mg+TDF 300 mg/FTC 200 mg QD-Randomized Phase
Total subjects affected by non serious adverse events
subjects affected / exposed	132 / 248 (53.23%)	30 / 149 (20.13%)	160 / 247 (64.78%)
Nervous system disorders
Headache
subjects affected / exposed	29 / 248 (11.69%)	12 / 149 (8.05%)	32 / 247 (12.96%)
occurrences all number	49	18	38
Dizziness
subjects affected / exposed	13 / 248 (5.24%)	0 / 149 (0.00%)	15 / 247 (6.07%)
occurrences all number	16	0	15
General disorders and administration site conditions
Fatigue
subjects affected / exposed	8 / 248 (3.23%)	0 / 149 (0.00%)	15 / 247 (6.07%)
occurrences all number	10	0	16
Gastrointestinal disorders
Dyspepsia
subjects affected / exposed	9 / 248 (3.63%)	0 / 149 (0.00%)	25 / 247 (10.12%)
occurrences all number	17	0	29
Diarrhoea
alternative dictionary used: MedDRA 25.0
subjects affected / exposed	23 / 248 (9.27%)	8 / 149 (5.37%)	32 / 247 (12.96%)
occurrences all number	24	8	37
Nausea
subjects affected / exposed	46 / 248 (18.55%)	0 / 149 (0.00%)	49 / 247 (19.84%)
occurrences all number	53	0	63
Abdominal pain
subjects affected / exposed	7 / 248 (2.82%)	0 / 149 (0.00%)	17 / 247 (6.88%)
occurrences all number	7	0	20
Vomiting
subjects affected / exposed	15 / 248 (6.05%)	0 / 149 (0.00%)	18 / 247 (7.29%)
occurrences all number	16	0	42
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	10 / 248 (4.03%)	0 / 149 (0.00%)	26 / 247 (10.53%)
occurrences all number	11	0	27
Hepatobiliary disorders
Jaundice
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	14 / 247 (5.67%)
occurrences all number	0	0	14
Hyperbilirubinaemia
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	13 / 247 (5.26%)
occurrences all number	0	0	16
Ocular icterus
subjects affected / exposed	0 / 248 (0.00%)	0 / 149 (0.00%)	18 / 247 (7.29%)
occurrences all number	0	0	21
Skin and subcutaneous tissue disorders
Rash
subjects affected / exposed	13 / 248 (5.24%)	0 / 149 (0.00%)	21 / 247 (8.50%)
occurrences all number	14	0	23
Pruritus
subjects affected / exposed	13 / 248 (5.24%)	0 / 149 (0.00%)	8 / 247 (3.24%)
occurrences all number	17	0	8
Musculoskeletal and connective tissue disorders
Back pain
subjects affected / exposed	12 / 248 (4.84%)	0 / 149 (0.00%)	18 / 247 (7.29%)
occurrences all number	12	0	19
Arthralgia
subjects affected / exposed	14 / 248 (5.65%)	0 / 149 (0.00%)	12 / 247 (4.86%)
occurrences all number	19	0	15
Infections and infestations
Urinary tract infection
subjects affected / exposed	13 / 248 (5.24%)	9 / 149 (6.04%)	17 / 247 (6.88%)
occurrences all number	14	11	17
Nasopharyngitis
subjects affected / exposed	15 / 248 (6.05%)	0 / 149 (0.00%)	14 / 247 (5.67%)
occurrences all number	18	0	16
Upper respiratory tract infection
subjects affected / exposed	18 / 248 (7.26%)	13 / 149 (8.72%)	21 / 247 (8.50%)
occurrences all number	21	19	24

More information

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Were there any global substantial amendments to the protocol? Yes

12 Aug 2013

Amendment No. 01: This amendment includes the removal of the Child-Pugh Classification due to its unsuitability for use in participants with no known hepatic impairment. Other minor clarifications and corrections have been incorporated, including an update to Figure 2, Virologic Criteria for Subject Management at Week 24, to differentiate between the two scenarios for re-testing HIV-1 RNA levels.

11 Aug 2014

Amendment No. 2: Changes made to the UK country specific information on study duration (Appendix 5) to comply with requests from the UK MHRA. The medical monitor contact information has also been updated.

19 Jun 2018

Amendment No. 3: Changes were made to the protocol to manage and mitigate risks following identification of a potential safety issue related to neural tube defect in infants born to women with exposure to dolutegravir at the time of conception. i. The Risk Assessment table (Section 1.3.1.) was updated to include language regarding risk and mitigation of neural tube defects. ii. Inclusion criterion #2 (Section 4.2.) was updated to exclude the double barrier method of contraception, and refer to the Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential. iii. The withdrawal criteria (Section 4.5.) were updated to include a reminder that females of reproductive potential who change their minds and desire to be pregnant, or who state they no longer are willing to comply with the approved pregnancy avoidance methods, should also be withdrawn from the study. iv. The Time and Events table (Section 6.1.) was updated to include a reminder for investigators to check at every visit that females of reproductive potential are avoiding pregnancy. v. Appendix 6 was added: Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential. vi. Administrative updates were made.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

None reported

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Clinical trials

Clinical Trial Results: A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

Primary: Percentage of participants with plasma HIV-1 RNA <50 copies/mL at Week 48

Secondary: Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time-Randomized Phase

Secondary: Percentage of participants with plasma HIV-1 RNA <50 and <400 c/mL over time-Randomized Phase

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL in Continuation Phase

Secondary: Percentage of participants with plasma HIV-1 RNA <50 c/mL in Continuation Phase

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Randomized Phase

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Randomized Phase

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Continuation Phase

Secondary: Change from Baseline in Plasma HIV-1 RNA at indicated time points-Continuation Phase

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Randomized Phase

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Randomized Phase

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Randomized Phase

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Randomized Phase

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Continuation Phase

Secondary: Absolute Values in Plasma HIV-1 RNA at indicated time points-Continuation Phase

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Continuation Phase

Secondary: Change from Baseline in CD4+ cell count at indicated timepoints-Continuation Phase

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Randomized Phase

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Randomized Phase

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Continuation Phase

Secondary: Absolute values in CD4+ cell count at indicated timepoints-Continuation Phase

Secondary: Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points

Secondary: Change from Baseline in carbon dioxide, electrolytes, lipids, glucose, urea at indicated time points

Secondary: Change from Baseline in bilirubin and creatinine at indicated timepoints

Secondary: Change from Baseline in bilirubin and creatinine at indicated timepoints

Secondary: Change from Baseline in albumin at indicated timepoints

Secondary: Change from Baseline in albumin at indicated timepoints

Secondary: Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points

Secondary: Change from Baseline in alanine aminotransferase, alkaline phosphatase, aspartate aminotransferase, creatine kinase at indicated time points

Secondary: Change from Baseline in creatinine clearance at indicated time points

Secondary: Change from Baseline in creatinine clearance at indicated time points

Secondary: Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints

Secondary: Change from Baseline in total CHLS/HDL CHLS ratio at indicated timepoints

Secondary: Change from Baseline in lipase at indicated timepoints

Secondary: Change from Baseline in lipase at indicated timepoints

Secondary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points

Secondary: Change from Baseline in basophils, eosinophils, lymphocytes, monocytes at indicated time points

Secondary: Change from Baseline in erythrocytes at indicated time points

Secondary: Change from Baseline in erythrocytes at indicated time points

Secondary: Change from Baseline in hematocrit count at indicated time points

Secondary: Change from Baseline in hematocrit count at indicated time points

Secondary: Change from Baseline in erythrocyte mean corpuscular volume at indicated time points

Secondary: Change from Baseline in erythrocyte mean corpuscular volume at indicated time points

Secondary: Change from Baseline in Triglycerides at Week 48

Secondary: Change from Baseline in Triglycerides at Week 48

Secondary: Change from Baseline in total cholesterol (TC)/HDL Ratio at Week 48

Secondary: Change from Baseline in total cholesterol (TC)/HDL Ratio at Week 48

Secondary: Number of Participants With AEs by maximum toxicity-Randomized Phase

Secondary: Number of Participants With AEs by maximum toxicity-Randomized Phase

Secondary: Change from Baseline in urine albumin creatinine ratio at indicated time points

Secondary: Change from Baseline in urine albumin creatinine ratio at indicated time points

Secondary: Number of Participants With AEs by maximum toxicity-Continuation Phase

Secondary: Number of Participants With AEs by maximum toxicity-Continuation Phase

Secondary: Number of participants with any adverse events (AEs), and serious adverse events (SAEs)-Randomized Phase

Secondary: Number of participants with any adverse events (AEs), and serious adverse events (SAEs)-Randomized Phase

Secondary: Number of participants with any AEs, and SAEs in Continuation Phase

Secondary: Number of participants with any AEs, and SAEs in Continuation Phase

Secondary: Number of Participants with maximum post-Baseline emergent chemistry toxicities-Randomized Phase

Secondary: Number of Participants with maximum post-Baseline emergent chemistry toxicities-Randomized Phase

Secondary: Number of Participants With maximum post-Baseline emergent chemistry toxicities-Continuation Phase

Secondary: Number of Participants With maximum post-Baseline emergent chemistry toxicities-Continuation Phase

Secondary: Number of Participants with maximum post-Baseline emergent hematology toxicities-Randomized Phase

Secondary: Number of Participants with maximum post-Baseline emergent hematology toxicities-Randomized Phase

Secondary: Number of Participants With maximum post-Baseline emergent hematology toxicities-Continuation Phase

Secondary: Number of Participants With maximum post-Baseline emergent hematology toxicities-Continuation Phase

Secondary: Number of participants who withdrew from treatment due to AEs-Continuation phase

Secondary: Number of participants who withdrew from treatment due to AEs-Continuation phase

Secondary: Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints

Secondary: Change from Baseline in bone specific alkaline phosphatase, osteocalcin and procollagen 1 N-terminal propeptide at indicated timepoints

Clinical Trial Results:
A Phase IIIb, randomized, open-label study of the safety and efficacy of dolutegravir/abacavir/lamivudine once daily compared to atazanavir and ritonavir plus tenofovir/emtricitabine once daily in HIV-1 infected antiretroviral therapy naïve women