Trial Outcomes & Findings for Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO) (NCT NCT03446573)

Last Updated: 2023-07-19

Results Overview

Percentage of participants with virologic failure (plasma HIV-1 RNA \>=50 c/mL) was evaluated using FDA snapshot algorithm at Week 48. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant antiretroviral therapy (ART) prior to the visit of interest. Intent-to-treat exposed (ITT-E) Population comprises of all randomized participants who received at least one dose of study treatment either DTG + 3TC or TBR. Participants were assessed according to the treatment to which the participant was randomized. Any participant receiving a treatment randomization number was considered to be randomized.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

743 participants

Primary outcome timeframe

Week 48

Results posted on

2023-07-19

Participant Flow

This non-inferiority study evaluated antiviral activity of switching to dolutegravir (DTG) + lamivudine (3TC) fixed dose combination (FDC) once daily compared to continuation of a Tenofovir alafenamide (TAF)-based regimen (TBR) over 148 weeks in virologically suppressed participants with human immunodeficiency type 1 infection. At week 148 all participants received DTG + 3TC FDC until week 196.

A total of 743 participants were randomized to receive treatment. Two participants in the DTG+3TC group were randomized but not treated. A total of 741 participants received at least one dose of study treatment either DTG + 3TC or TBR creating the intent to treat-exposed (ITT-E) Population.

Participant milestones

Participant milestones
Measure	DTG+3TC FDC Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) less than (\<)50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg in early switch phase (Day 1 to Week 148) and continued to receive DTG/3TC FDC in late switch phase (Week 148 to Week 196).	TAF-based Regimen Participants who were on a stable TBR and had an HIV-1 RNA\<50 c/mL at the time of screening received TBR up to Week 148 in early switch phase, these participants were switched to DTG/3TC FDC in late switch phase (Week 148 to Week 196). One participant randomized to this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm (early switch phase) for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen"arm (early switch phase) for Safety because the safety profiles of TDF and TAF differ.
Early Switch Phase (Day 1 to Week 148) STARTED	371	372
Early Switch Phase (Day 1 to Week 148) ITT-E Population	369	372
Early Switch Phase (Day 1 to Week 148) COMPLETED	319	299
Early Switch Phase (Day 1 to Week 148) NOT COMPLETED	52	73
Late Switch Phase (Week 148 to Week 196) STARTED	319	298
Late Switch Phase (Week 148 to Week 196) COMPLETED	307	274
Late Switch Phase (Week 148 to Week 196) NOT COMPLETED	12	24

Reasons for withdrawal

Reasons for withdrawal
Measure	DTG+3TC FDC Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) less than (\<)50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg in early switch phase (Day 1 to Week 148) and continued to receive DTG/3TC FDC in late switch phase (Week 148 to Week 196).	TAF-based Regimen Participants who were on a stable TBR and had an HIV-1 RNA\<50 c/mL at the time of screening received TBR up to Week 148 in early switch phase, these participants were switched to DTG/3TC FDC in late switch phase (Week 148 to Week 196). One participant randomized to this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm (early switch phase) for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen"arm (early switch phase) for Safety because the safety profiles of TDF and TAF differ.
Early Switch Phase (Day 1 to Week 148) Adverse Event	23	7
Early Switch Phase (Day 1 to Week 148) Lack of Efficacy	0	6
Early Switch Phase (Day 1 to Week 148) Protocol Violation	5	6
Early Switch Phase (Day 1 to Week 148) Lost to Follow-up	4	10
Early Switch Phase (Day 1 to Week 148) Physician Decision	2	11
Early Switch Phase (Day 1 to Week 148) Withdrawal by Subject	16	33
Early Switch Phase (Day 1 to Week 148) Randomized, but did not receive treatment	2	0
Late Switch Phase (Week 148 to Week 196) Adverse Event	2	9
Late Switch Phase (Week 148 to Week 196) Lack of Efficacy	1	1
Late Switch Phase (Week 148 to Week 196) Protocol Violation	0	1
Late Switch Phase (Week 148 to Week 196) Lost to Follow-up	5	6
Late Switch Phase (Week 148 to Week 196) Physician Decision	0	1
Late Switch Phase (Week 148 to Week 196) Withdrawal by Subject	4	6

Baseline Characteristics

Switch Study to Evaluate Dolutegravir Plus Lamivudine in Virologically Suppressed Human Immunodeficiency Virus Type 1 Positive Adults (TANGO)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTG+3TC FDC n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) less than (\<)50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg in early switch phase (Day 1 to Week 148) and continued to receive DTG/3TC FDC in late switch phase (Week 148 to Week 196).	TAF-based Regimen n=372 Participants Participants who were on a stable TBR and had an HIV-1 RNA\<50 c/mL at the time of screening received TBR up to Week 148 in early switch phase, these participants were switched to DTG/3TC FDC in late switch phase (Week 148 to Week 196). One participant randomized to this arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm (early switch phase) for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen"arm (early switch phase) for Safety because the safety profiles of TDF and TAF differ.	Total n=741 Participants Total of all reporting groups
Age, Continuous	40.6 Years STANDARD_DEVIATION 10.76 • n=5 Participants	40.9 Years STANDARD_DEVIATION 11.54 • n=7 Participants	40.8 Years STANDARD_DEVIATION 11.15 • n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	33 Participants n=7 Participants	58 Participants n=5 Participants
Sex: Female, Male Male	344 Participants n=5 Participants	339 Participants n=7 Participants	683 Participants n=5 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	7 Participants n=5 Participants	8 Participants n=7 Participants	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Central/South Asian Heritage (H)	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized Asian-Japanese H/East Asian H/South East Asian H	10 Participants n=5 Participants	9 Participants n=7 Participants	19 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	50 Participants n=5 Participants	58 Participants n=7 Participants	108 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/North African (NA) H	5 Participants n=5 Participants	2 Participants n=7 Participants	7 Participants n=5 Participants
Race/Ethnicity, Customized White-Arabic/NA H and white/caucasia/European H	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized White-White/caucasian/European H	292 Participants n=5 Participants	286 Participants n=7 Participants	578 Participants n=5 Participants
Race/Ethnicity, Customized Asian and White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American and White	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Cluster of differentiation 4 plus (CD4+) cell count	682.0 Cells per cubic millimeter (cells/mm^3) n=5 Participants	720.0 Cells per cubic millimeter (cells/mm^3) n=7 Participants	688.0 Cells per cubic millimeter (cells/mm^3) n=5 Participants
Baseline third agents NNRTI	51 Participants n=5 Participants	48 Participants n=7 Participants	99 Participants n=5 Participants
Baseline third agents INSTI	289 Participants n=5 Participants	296 Participants n=7 Participants	585 Participants n=5 Participants
Baseline third agents PI	29 Participants n=5 Participants	28 Participants n=7 Participants	57 Participants n=5 Participants
HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 1	255 Participants n=5 Participants	259 Participants n=7 Participants	514 Participants n=5 Participants
HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 2	94 Participants n=5 Participants	94 Participants n=7 Participants	188 Participants n=5 Participants
HIV infection by Centers for Disease Control and Prevention (CDC) classification HIV infection Stage 3	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants

PRIMARY outcome

Timeframe: Week 48

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Virologic Failure Endpoint as Per Food and Drug Administration (FDA) Snapshot Category at Week 48	0.3 Percentage of participants	0.5 Percentage of participants

SECONDARY outcome

Timeframe: Week 48

Population: ITT-E Population. Only those participants with data available at specified time points has been analyzed. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Percentage of participants with plasma HIV-1 RNA \<50 c/mL (virologic success) was evaluated using FDA snapshot algorithm at Week 48 to demonstrate the non-inferior antiviral activity of switching to DTG +3TC once daily compared to continuation of TBR over 48 weeks. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=344 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=346 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 48	93.2 Percentage of participants	93.0 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Week 24	0.3 Percentage of participants	0.8 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 96 and 144

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Percentage of participants with plasma HIV-1 RNA \>=50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 Week 96	0.3 Percentage of participants	1.1 Percentage of participants
Percentage of Participants With Virologic Failure Endpoint as Per FDA Snapshot Category at Weeks 96, 144 Week 144	0.3 Percentage of participants	1.3 Percentage of participants

SECONDARY outcome

Timeframe: Week 24

Population: ITT-E Population. Only those participants with data available at specified time points has been presented. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Week 24. The Snapshot algorithm treated all participants without HIV-1 RNA data at the visit of interest (due to missing data or discontinuation of investigational product prior to the visit window) as non-responders, as well as participants who switch their concomitant ART prior to the visit of interest. Percentage values are rounded off.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=350 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=358 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Week 24	95 Percentage of participants	96 Percentage of participants

SECONDARY outcome

Timeframe: Weeks 96 and 144

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Percentage of participants with plasma HIV-1 RNA \<50 c/mL was evaluated using FDA snapshot algorithm at Weeks 96 and 144.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 Week 96	85.9 Percentage of participants	79.0 Percentage of participants
Percentage of Participants With Plasma HIV-1 RNA <50 c/mL as Per Snapshot Algorithm at Weeks 96 and 144 Week 144	85.9 Percentage of participants	81.7 Percentage of participants

SECONDARY outcome

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

Population: ITT-E Population. All 741 (369+372) participants were analyzed, however only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

CD4+ cells are type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+. It was evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 Week 24, n=351, 359	21.0 Cells per cubic millimeter Interval -68.0 to 115.0	6.0 Cells per cubic millimeter Interval -87.0 to 99.0
Change From Baseline in CD4+ Cell Count at Weeks 24 and 48 Week 48, n=344, 345	22.5 Cells per cubic millimeter Interval -71.0 to 121.5	11.0 Cells per cubic millimeter Interval -98.0 to 90.0

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

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

CD4+ cells are a type of white blood cells that fight infection and as HIV infection progresses, the number of these cells declines. Blood samples were collected at specified time points to assess CD4+and evaluated by flow cytometry. Baseline value is defined as the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 Week 96, n=315, 295	61.0 Cells per cubic millimeter Interval -61.0 to 179.0	45.0 Cells per cubic millimeter Interval -80.0 to 154.0
Change From Baseline in CD4+ Cell Count at Weeks 96 and 144 Week 144, n=309, 301	36.0 Cells per cubic millimeter Interval -64.0 to 154.0	35.0 Cells per cubic millimeter Interval -60.0 to 134.0

SECONDARY outcome

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

Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio. It was assessed by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over 48 Weeks. Baseline (Day 1) values were the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable .

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 Week 24, n=346, 358	0.010 Ratio Interval -0.07 to 0.11	0.040 Ratio Interval -0.06 to 0.12
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 24 and 48 Week 48, n=342, 343	0.030 Ratio Interval -0.05 to 0.11	0.050 Ratio Interval -0.05 to 0.16

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

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

Blood samples were collected at specified time points to assess CD4+/CD8+ cell count ratio and were evaluated by flow cyclometry to evaluate the immunologic activity of switching to DTG+3TC once daily compared to continuation of TBR over Weeks 96 and 144. Baseline (Day 1) values are the actual CD4+ cell count ratio values at pre-dose Day 1. Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 Week 96, n=312, 292	0.035 Ratio Interval -0.085 to 0.14	0.080 Ratio Interval -0.05 to 0.17
Change From Baseline in CD4+/CD8+ Cell Count Ratio at Weeks 96 and 144 Week 144, n=307, 300	0.060 Ratio Interval -0.06 to 0.2	0.100 Ratio Interval -0.02 to 0.24

SECONDARY outcome

Timeframe: At Weeks 24 and 48

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable

HIV-associated conditions were recorded during the study and were assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV were: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3:Documented AIDS defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Disease progression summarize participants who had HIV infection stage 3 associated conditions or death. Indicators of clinical disease progression were defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Disease Progression at Weeks 24 and 48 From CDC Stage 1 to CDC Stage 3 Event	1 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 24 and 48 From CDC Stage 2 to CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 24 and 48 From CDC Stage 3 to new CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 24 and 48 From CDC Stage 1, 2 or 3 to Death	1 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 24 and 48 No HIV-1 disease progression	367 Participants	372 Participants

SECONDARY outcome

Timeframe: At Weeks 96 and 144

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable

HIV-associated conditions were recorded during the study and assessed according to the 2014 CDC Classification System for HIV Infection in Adults. CDC classification for HIV is: Stage 1: No AIDS defining condition and CD4+ T-lymphocyte count: \>=500 cells/mcL; Stage 2: No AIDS infection and CD4+ lymphocyte count: 200-499 cell/mcL and Stage 3: Documented AIDS-defining condition or CD4+ T-lymphocye count \<200 cells/mcL. Indicators of clinical disease progression is defined as: CDC Category Stage 1 at enrollment to Stage 3 event; CDC Category Stage 2 at enrollment to Stage 3 event; CDC Category Stage 3 at enrollment to New Stage 3 Event; CDC Category Stage 1, 2 or 3 at enrollment to Death.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Disease Progression at Weeks 96 and 144 Week 96, From CDC Stage 1 to CDC Stage 3 Event	2 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 96, From CDC Stage 2 to CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 96, From CDC Stage 3 to new CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 96, From CDC Stage 1, 2 or 3 to Death	2 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 96, No HIV-1 disease progression	365 Participants	372 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 144, From CDC Stage 1 to CDC Stage 3 Event	2 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 144, From CDC Stage 2 to CDC Stage 3 Event	0 Participants	1 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 144,From CDC Stage 3 to new CDC Stage 3 Event	0 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 144, From CDC Stage 1, 2 or 3 to Death	3 Participants	0 Participants
Number of Participants With Disease Progression at Weeks 96 and 144 Week 144, No HIV-1 disease progression	364 Participants	371 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: Safety Population. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Safety Population included all participants who received at least one dose of study treatment either DTG + 3TC or TBR. This population was based on the treatment the participant actually received. Number of participants with any SAE and common (\>=2%) non-SAEs are presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 Any non-SAE (>=2%)	222 Participants	204 Participants
Number of Participants With Any Serious Adverse Events (SAEs) and Common (>=2%) Non-serious Adverse Events (Non-SAEs): Up to Week 48 Any SAE	21 Participants	16 Participants

SECONDARY outcome

Timeframe: Up to Week 48

An AE is any untoward medical occurrence temporally associated with the use of a study treatment, whether or not considered related to study treatment. A SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, associated with liver injury and impaired liver function or any other important medical event as per medical or scientific judgment . Number of TDF-based regimen participants with any SAE and common (\>=2%) non-SAEs are presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 Any non-SAE (>=2%)	1 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 48 Any SAE	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 148

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 Any SAE	57 Participants	44 Participants
Number of Participants With Any SAEs and Common (>=2%) Non-SAEs: Up to Week 148 Any non-SAE (>=2%)	307 Participants	304 Participants

SECONDARY outcome

Timeframe: Up to Week 48

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

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With AEs by Their Severity Grades: Up to Week 48 Grade 1	102 Participants	94 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 48 Grade 2	170 Participants	177 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 48 Grade 3	19 Participants	15 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 48 Grade 4	3 Participants	6 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 48 Grade 5	1 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

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

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 Grade 2	1 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With AEs by Their Severity Grades: Up to Week 48 Grade 5	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 144

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With AEs by Their Severity Grades: Up to Week 144 Grade 1	57 Participants	65 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 144 Grade 2	217 Participants	208 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 144 Grade 3	50 Participants	54 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 144 Grade 4	9 Participants	8 Participants
Number of Participants With AEs by Their Severity Grades: Up to Week 144 Grade 5	3 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment. Number of participants who discontinued the treatment due to adverse events have been presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 48	13 Participants	2 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen Who Discontinued the Treatment Due to AEs: Up to Week 48	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 144

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the study treatment.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Who Discontinued the Treatment Due to AEs: Up to Week 144	23 Participants	7 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Blood samples were collected up to Week 48 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Hemoglobin, Grade 1	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Hemoglobin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Hemoglobin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Leukocytes, Grade 1	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Leukocytes, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Leukocytes, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Leukocytes, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Neutrophils, Grade 1	3 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Neutrophils, Grade 2	2 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Neutrophils, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Neutrophils, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Platelets, Grade 1	6 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Platelets, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Platelets, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 48 Platelets, Grade 4	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 36

Blood samples were collected up to the Week 36 visit for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms. Only those TDF-based regimen participants with maximum post-Baseline emergent hematology toxicities in any of the hematology parameters have been presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Hemoglobin, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Hemoglobin, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Hemoglobin, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Hemoglobin, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Leukocytes, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Leukocytes, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Leukocytes, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Leukocytes, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Neutrophils, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Neutrophils, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Neutrophils, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Neutrophils, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Platelets, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Platelets, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Platelets, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 36 Platelets, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 144

Blood samples were collected up to Week 144 for the analysis of hematology parameters-platelet count, neutrophils, hemoglobin and leukocytes. Any abnormality in hematology parameters are were evaluated according to the DAIDS toxicity scale from Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Platelets, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Hemoglobin, Grade 1	7 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Hemoglobin, Grade 2	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Hemoglobin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Hemoglobin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Leukocytes, Grade 1	2 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Leukocytes, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Leukocytes, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Leukocytes, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Neutrophils, Grade 1	5 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Neutrophils, Grade 2	3 Participants	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Neutrophils, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Neutrophils, Grade 4	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Platelets, Grade 1	8 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Platelets, Grade 2	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Hematology Toxicities: Up to Week 144 Platelets, Grade 3	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Blood samples were collected up to Week 48 for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted for body surface area (BSA), GFR from cystatin C adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALT, Grade 1	24 Participants	18 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALT, Grade 2	6 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALT, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALT, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Albumin, Grade 1	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Albumin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALP, Grade 1	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALP, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALP, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 ALP, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 AST, Grade 1	21 Participants	29 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 AST, Grade 2	7 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 AST, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 AST, Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Bilirubin, Grade 1	17 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Bilirubin, Grade 2	5 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Bilirubin, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CO2, Grade 1	73 Participants	70 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CO2, Grade 2	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CO2, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CO2, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Cholesterol, Grade 1	27 Participants	52 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Cholesterol, Grade 2	12 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Cholesterol, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CK, Grade 1	28 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CK, Grade 2	4 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CK, Grade 3	9 Participants	8 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 CK, Grade 4	6 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Creatinine, Grade 1	16 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Creatinine, Grade 2	3 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Creatinine, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Direct bilirubin, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Direct bilirubin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Direct bilirubin, Grade 3	8 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Direct bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from creatinine adjusted using CKD EPI,Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from creatinine adjusted using CKD EPI,Grade 2	135 Participants	83 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from creatinine adjusted using CKD EPI,Grade 3	26 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from creatinine adjusted using CKD EPI,Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from cystatin C adjusted using CKD-EPI,Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from cystatin C adjusted using CKD-EPI,Grade 2	52 Participants	66 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from cystatin C adjusted using CKD-EPI,Grade 3	5 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 GFR from cystatin C adjusted using CKD-EPI,Grade 4	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypercalcemia, Grade 1	7 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypercalcemia, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypercalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypercalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperglycemia, Grade 1	56 Participants	64 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperglycemia, Grade 2	21 Participants	19 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperglycemia, Grade 3	2 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperkalemia, Grade 1	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperkalemia, Grade 2	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperkalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyperkalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypernatremia, Grade 1	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypernatremia, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypernatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypernatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypocalcemia, Grade 1	8 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypocalcemia, Grade 2	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypocalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypocalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypoglycemia, Grade 1	5 Participants	6 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypoglycemia, Grade 2	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypoglycemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypoglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypokalemia, Grade 1	7 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypokalemia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypokalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hypokalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyponatremia, Grade 1	8 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyponatremia, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyponatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Hyponatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 LDL cholesterol, Grade 1	28 Participants	35 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 LDL cholesterol, Grade 2	13 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 LDL cholesterol, Grade 3	6 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 LDL cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Phosphate, Grade 1	38 Participants	47 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Phosphate, Grade 2	2 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Phosphate, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Triglycerides, Grade 1	34 Participants	48 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Triglycerides, Grade 2	4 Participants	11 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Triglycerides, Grade 3	4 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 48 Triglycerides, Grade 4	4 Participants	0 Participants

SECONDARY outcome

Timeframe: Up to Week 36

samples were collected up to the Week 36 visit for the analysis of clinical chemistry parameters: alanine aminotransferase (ALT), albumin, alkaline phosphate (ALP), aspartate aminotransferase (AST), bilirubin, carbon dioxide (CO2), cholesterol, creatinine kinase (CK), creatinine, direct bilirubin, glomerular filtration rate (GFR) from creatinine adjusted using chronic kidney disease-epidemiology collaboration (CKD-EPI), GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, low density lipoprotein (LDL) cholesterol, phosphate and triglycerides. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALT, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALT, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALT, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALT, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Albumin, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Albumin, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Albumin, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Albumin, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALP, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALP, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALP, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 ALP, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 AST, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 AST, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 AST, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 AST, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Bilirubin, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Bilirubin, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Bilirubin, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Bilirubin, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CO2, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CO2, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CO2, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CO2, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Cholesterol, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Cholesterol, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Cholesterol, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Cholesterol, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CK, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CK, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CK, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 CK, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Creatinine, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Creatinine, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Creatinine, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Creatinine, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Direct bilirubin, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Direct bilirubin, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Direct bilirubin, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Direct bilirubin, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from creatinine adjusted using CKD EPI,Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from creatinine adjusted using CKD EPI,Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from creatinine adjusted using CKD EPI,Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from creatinine adjusted using CKD EPI,Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from cystatin C adjusted using CKD-EPI,Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from cystatin C adjusted using CKD-EPI,Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from cystatin C adjusted using CKD-EPI,Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 GFR from cystatin C adjusted using CKD-EPI,Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypercalcemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypercalcemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypercalcemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypercalcemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperglycemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperglycemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperglycemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperglycemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperkalemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperkalemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperkalemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyperkalemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypernatremia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypernatremia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypernatremia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypernatremia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypocalcemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypocalcemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypocalcemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypocalcemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypoglycemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypoglycemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypoglycemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypoglycemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypokalemia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypokalemia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypokalemia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hypokalemia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyponatremia, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyponatremia, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyponatremia, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Hyponatremia, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 LDL cholesterol, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 LDL cholesterol, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 LDL cholesterol, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 LDL cholesterol, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Phosphate, Grade 1	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Phosphate, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Phosphate, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Phosphate, Grade 4	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Triglycerides, Grade 1	1 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Triglycerides, Grade 2	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Triglycerides, Grade 3	0 Participants	—
Number of Participants Randomized to TBR Arm Receiving TDF-based Regimen With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 36 Triglycerides, Grade 4	0 Participants	—

SECONDARY outcome

Timeframe: Up to Week 144

Blood samples were collected up to Week 144 for the analysis of clinical chemistry parameters: ALT, albumin, ALP, AST, bilirubin, CO2, cholesterol, CK, creatinine, direct bilirubin, GFR from creatinine adjusted for BSA, GFR from cystatin C adjusted using CKD-EPI, hypercalcemia, hyperglycemia, hyperkalemia, hypernatremia, hypocalcemia, hypoglycemia, hypokalemia, hyponatremia, LDL cholesterol, phosphate triglycerides and lactate dehydrogenase. Any abnormality in clinical chemistry parameters were evaluated according to the DAIDS toxicity scale From Grade 1 to 4: Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe) and Grade 4 (Potentially life-threatening). The higher the grade, the more severe the symptoms.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Lactate Dehydrogenase Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypokalemia, Grade 1	10 Participants	7 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypokalemia, Grade 2	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypokalemia, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypokalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyponatremia, Grade 1	21 Participants	26 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyponatremia, Grade 2	0 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyponatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyponatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 LDL cholesterol, Grade 1	41 Participants	56 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 LDL cholesterol, Grade 2	19 Participants	24 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 LDL cholesterol, Grade 3	8 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 LDL cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Phosphate, Grade 1	61 Participants	71 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Phosphate, Grade 2	3 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Phosphate, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Phosphate, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Triglycerides, Grade 1	60 Participants	77 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Triglycerides, Grade 2	6 Participants	15 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Triglycerides, Grade 3	6 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Triglycerides, Grade 4	4 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Lactate Dehydrogenase Grade 1	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Lactate Dehydrogenase Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Lactate Dehydrogenase Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypoglycemia, Grade 2	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypoglycemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypoglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CO2, Grade 3	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CO2, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Cholesterol, Grade 1	42 Participants	70 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALT, Grade 1	55 Participants	49 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALT, Grade 2	11 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALT, Grade 3	5 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALT, Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Albumin, Grade 1	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Albumin, Grade 2	2 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Albumin, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Albumin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALP, Grade 1	6 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALP, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALP, Grade 3	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 ALP, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 AST, Grade 1	34 Participants	45 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 AST, Grade 2	13 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 AST, Grade 3	3 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 AST, Grade 4	3 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Bilirubin, Grade 1	24 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Bilirubin, Grade 2	9 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Bilirubin, Grade 3	3 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CO2, Grade 1	110 Participants	97 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CO2, Grade 2	2 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypocalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Cholesterol, Grade 2	26 Participants	34 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Cholesterol, Grade 3	1 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Cholesterol, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CK, Grade 1	41 Participants	30 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CK, Grade 2	12 Participants	13 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CK, Grade 3	12 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 CK, Grade 4	10 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Creatinine, Grade 1	21 Participants	12 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Creatinine, Grade 2	5 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Creatinine, Grade 3	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Creatinine, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Direct bilirubin, Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Direct bilirubin, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Direct bilirubin, Grade 3	13 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Direct bilirubin, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from creatinine adjusted using CKD EPI,Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from creatinine adjusted using CKD EPI,Grade 2	165 Participants	101 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from creatinine adjusted using CKD EPI,Grade 3	38 Participants	24 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from creatinine adjusted using CKD EPI,Grade 4	0 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from cystatin C adjusted using CKD-EPI,Grade 1	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from cystatin C adjusted using CKD-EPI,Grade 2	169 Participants	183 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from cystatin C adjusted using CKD-EPI,Grade 3	46 Participants	58 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 GFR from cystatin C adjusted using CKD-EPI,Grade 4	1 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypercalcemia, Grade 1	8 Participants	9 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypercalcemia, Grade 2	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypercalcemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypercalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperglycemia, Grade 1	73 Participants	77 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperglycemia, Grade 2	40 Participants	31 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperglycemia, Grade 3	4 Participants	4 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperglycemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperkalemia, Grade 1	3 Participants	2 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperkalemia, Grade 2	2 Participants	1 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypocalcemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypoglycemia, Grade 1	9 Participants	10 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperkalemia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypernatremia, Grade 3	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypernatremia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hyperkalemia, Grade 4	0 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypernatremia, Grade 1	4 Participants	3 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypernatremia, Grade 2	1 Participants	0 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypocalcemia, Grade 1	14 Participants	5 Participants
Number of Participants With Maximum Post-Baseline Emergent Clinical Chemistry Toxicities: Up to Week 144 Hypocalcemia, Grade 2	1 Participants	2 Participants

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Population: Safety Population. Total of 741 participants were analyzed but 740 participants are presented in this Outcome Measure and 1 participant is presented separately in next Outcome Measure. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles).

Urine samples were collected at Baseline, Week 24 and Week 48. Baseline is defined as Day 1. Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. Change from Baseline in UP/C and UA/C was calculated as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio calculated at Baseline, respectively. Estimated geometric mean adjusted ratio (each visit over Baseline) and 95% CI have been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 UA/C, Week 24, n=235, 230	1.080 Ratio Interval 1.007 to 1.158	1.022 Ratio Interval 0.956 to 1.091
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 UA/C, Week 48, n=230, 224	1.125 Ratio Interval 1.036 to 1.222	1.059 Ratio Interval 0.963 to 1.165
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 UP/C, Week 24, n=267, 261	0.955 Ratio Interval 0.917 to 0.995	0.976 Ratio Interval 0.937 to 1.016
Change From Baseline in Renal Biomarkers- Urine Albumin/Creatinine (UA/C) Ratio and Urine Protein/Creatinine (UP/C) Ratio at Weeks 24 and 48 UP/C, Week 48, n=261, 257	0.971 Ratio Interval 0.926 to 1.018	1.016 Ratio Interval 0.964 to 1.07

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Population: Safety Population. Only those participants with data available at the specified data points were analyzed (represented by n= X in the category titles). Data not collected post week 48 as the participant withdrew from the study.

Urine samples were collected at Baseline, Week 24 and Week 48 to assess renal biomarkers - urine albumin/creatinine ratio and urine protein/creatinine ratio. Baseline was defined as the latest pre-dose assessment value with a non-missing value. (Day 1). Change from Baseline in UA/C was calculated as UA/C ratio at post-Baseline visit minus UA/C ratio calculated at Baseline. Change from Baseline in UP/C was calculated as UP/C ratio at post-Baseline visit minus UP/C ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen UA/C, Week 24, n=1	0 Ratio	—
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 24 and 48 in Participants Randomized to TBR Receiving TDF-based Regimen UP/C, Week 24, n=1	0.3 Ratio	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Urine samples were collected at Baseline, Weeks 96 and 144. Baseline is defined as Day 1. Change from Baseline in UA/C is defined as UA/C ratio at post-Baseline visit minus UA/C ratio at Baseline. Change from Baseline in UP/C and UA/C is defined as UP/C and UA/C ratio at post-Baseline visit minus UP/C and UA/C ratio at Baseline, respectively. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 UA/C, Week 96, n=208, 175	1.058 Ratio Interval 0.974 to 1.149	1.075 Ratio Interval 0.968 to 1.195
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 UA/C, Week 144, n=202, 179	1.203 Ratio Interval 1.093 to 1.324	1.200 Ratio Interval 1.051 to 1.371
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 UP/C, Week 96, n=245, 206	1.048 Ratio Interval 0.997 to 1.102	1.105 Ratio Interval 1.044 to 1.169
Change From Baseline in Renal Biomarkers- UA/C Ratio and UP/C Ratio at Weeks 96 and 144 UP/C, Week 144, n=237, 220	1.182 Ratio Interval 1.121 to 1.247	1.188 Ratio Interval 1.104 to 1.278

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine beta-2 microglobulin/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 Week 24, n=136, 141	0.991 Ratio Interval 0.899 to 1.093	1.034 Ratio Interval 0.931 to 1.149
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 24 and 48 Week 48, n=126, 141	0.973 Ratio Interval 0.87 to 1.088	0.922 Ratio Interval 0.832 to 1.022

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Population: Safety Population. Data was not collected for this arm. Data not collected post week 48 as the participant withdrew from the study.

Urine biomarker samples were collected to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine was calculated as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine beta-2 microglobulin/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine beta-2-microglobulin/urine creatinine is defined as urine beta-2-microglobulin/urine creatinine ratio at post-Baseline visit minus urine beta-2-microglobulin/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 Week 96, n=109, 107	1.080 Ratio Interval 0.931 to 1.253	0.986 Ratio Interval 0.844 to 1.152
Change From Baseline in Renal Biomarkers- Urine Beta-2 Microglobulin/Urine Creatinine Ratio at Weeks 96 and 144 Week 144, n=101, 97	0.904 Ratio Interval 0.768 to 1.065	0.958 Ratio Interval 0.808 to 1.136

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Urine biomarker samples were collected at Baseline and at Weeks 24 and 48 to assess urine phosphate. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 Week 24, n=348, 352	0.955 Ratio Interval 0.888 to 1.028	0.940 Ratio Interval 0.871 to 1.014
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 Week 48, n=342, 340	0.969 Ratio Interval 0.892 to 1.052	0.970 Ratio Interval 0.9 to 1.044

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Urine biomarker samples were collected to assess urine phosphate. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate was calculated as urine phosphate at post-Baseline visit minus urine phosphate calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Week 24, n=1	2.9 Ratio	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine phosphate. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine phosphate is defined as urine phosphate at post-Baseline visit minus urine phosphate at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 Week 96, n=312, 286	0.960 Ratio Interval 0.871 to 1.057	0.978 Ratio Interval 0.882 to 1.085
Change From Baseline in Renal Biomarkers- Urine Phosphate at Weeks 96 and 144 Week 144, n=313, 298	0.890 Ratio Interval 0.805 to 0.985	0.912 Ratio Interval 0.825 to 1.007

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Urine biomarker samples were collected at Baseline, Weeks 24 and 48 to assess urine retinol binding protein 4/urine creatinine. Geometric mean ratio (visit divided by Baseline) and 95% CI of geometric mean ratio has been presented. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio was calculated as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 Week 24, n=344, 343	0.860 Ratio Interval 0.79 to 0.936	0.920 Ratio Interval 0.847 to 0.999
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 Week 48, n=340, 335	1.063 Ratio Interval 0.992 to 1.139	1.068 Ratio Interval 0.996 to 1.144

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Urine biomarker samples were collected to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value was the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in urine retinol binding protein 4/urine creatinine was calculated as urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus urine retinol binding protein 4/urine creatinine ratio calculated at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Week 24, n=1	1.04 Ratio	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Urine biomarker samples were collected at Baseline, Weeks 96 and 144 to assess urine retinol binding protein 4/urine creatinine. Baseline (Day 1) value is the value from the latest pre-dose assessment with a non-missing value, including those from unscheduled visits. Change from Baseline in Urine retinol binding protein 4/urine creatinine ratio is defined as Urine retinol binding protein 4/urine creatinine ratio at post-Baseline visit minus Urine retinol binding protein 4/urine creatinine ratio at Baseline. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 Week 96, n=310, 282	0.926 Ratio Interval 0.845 to 1.014	0.851 Ratio Interval 0.775 to 0.933
Change From Baseline in Renal Biomarkers- Urine Retinol Binding Protein 4/Urine Creatinine at Weeks 96 and 144 Week 144, n=304, 288	1.188 Ratio Interval 1.086 to 1.298	1.227 Ratio Interval 1.109 to 1.359

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Blood samples were collected at Baseline (Day 1), Week 24 and Week 48 to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma high density lipoprotein (HDL) cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma cholesterol, Week 24, n=282, 264	-0.325 Millimoles per liter Interval -0.75 to 0.15	0.000 Millimoles per liter Interval -0.4 to 0.4
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma cholesterol, Week 48, n=275, 263	-0.200 Millimoles per liter Interval -0.75 to 0.15	0.100 Millimoles per liter Interval -0.35 to 0.5
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma LDL Cholesterol, Week 24, n=282, 264	-0.210 Millimoles per liter Interval -0.57 to 0.13	-0.060 Millimoles per liter Interval -0.34 to 0.41
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma LDL Cholesterol, Week 48, n=275, 263	-0.170 Millimoles per liter Interval -0.56 to 0.21	0.070 Millimoles per liter Interval -0.32 to 0.43
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma Triglycerides, Week 24, n=282, 264	-0.100 Millimoles per liter Interval -0.46 to 0.16	0.060 Millimoles per liter Interval -0.2 to 0.35
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma Triglycerides, Week 48, n=275, 263	-0.100 Millimoles per liter Interval -0.44 to 0.16	0.100 Millimoles per liter Interval -0.28 to 0.38
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma HDL Cholesterol, Week 24, n=282, 264	-0.050 Millimoles per liter Interval -0.15 to 0.1	0.050 Millimoles per liter Interval -0.15 to 0.15
Change From Baseline in Fasting Lipids at Weeks 24 and 48 Plasma HDL Cholesterol, Week 48, n=275, 263	0.000 Millimoles per liter Interval -0.2 to 0.15	0.050 Millimoles per liter Interval -0.15 to 0.15

SECONDARY outcome

Timeframe: Baseline (Day 1) and at weeks 24 and 48

Blood samples were collected at Baseline (Day 1), weeks 24 and 48 visit (participant withdrew from the study at Week 36) to assess fasting lipids which included plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value was the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for fasting lipids in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Plasma cholesterol, Week 24, n=1	0 Millimoles per liter	—
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Plasma LDL Cholesterol, Week 24, n=1	-0.67 Millimoles per liter	—
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Plasma Triglycerides, Week 24, n=1	1.36 Millimoles per liter	—
Change From Baseline in Fasting Lipids at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Plasma HDL Cholesterol, Week 24, n=1	0.05 Millimoles per liter	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Blood samples were collected at Baseline (Day 1), Weeks 96 and 144 to assess fasting lipids which includes plasma cholesterol, plasma LDL cholesterol, plasma HDL cholesterol and plasma triglycerides. Baseline value is the value from the latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma cholesterol, Week 96, n=238, 213	-3.7 Millimoles per liter Interval -12.4 to 5.6	1.2 Millimoles per liter Interval -6.0 to 10.6
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma cholesterol, Week 144, n=243, 230	-4.0 Millimoles per liter Interval -13.0 to 6.4	3.8 Millimoles per liter Interval -5.0 to 14.5
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma LDL Cholesterol, Week 96, n=238, 213	-5.6 Millimoles per liter Interval -17.3 to 10.8	1.7 Millimoles per liter Interval -8.9 to 15.8
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma LDL Cholesterol, Week 144, n=243, 230	-5.0 Millimoles per liter Interval -16.2 to 10.7	4.2 Millimoles per liter Interval -9.0 to 20.9
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma Triglycerides, Week 96, n=238, 213	-2.1 Millimoles per liter Interval -25.8 to 22.2	4.9 Millimoles per liter Interval -20.0 to 38.9
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma Triglycerides, Week 144, n=243, 230	-9.4 Millimoles per liter Interval -32.8 to 21.2	2.2 Millimoles per liter Interval -23.0 to 30.3
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma HDL Cholesterol, Week 96, n=238, 213	-3.8 Millimoles per liter Interval -13.8 to 8.5	0.0 Millimoles per liter Interval -10.8 to 13.0
Change From Baseline in Fasting Lipids at Weeks 96 and 144 Plasma HDL Cholesterol, Week 144, n=243, 230	-3.8 Millimoles per liter Interval -14.3 to 12.0	3.8 Millimoles per liter Interval -8.0 to 17.4

SECONDARY outcome

Timeframe: Up to Week 48

Population: CVW Population comprised of all participants in the ITT-E Population who had met the derived CVW criteria. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Plasma samples were collected for drug resistance testing. Number of participants, who met confirmed virologic withdrawal (CVW) criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, nucleoside reverse transcriptase inhibitor (NRTI), NNRTI and PI was summarized.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Genotypic Resistance: Up to Week 48 INSTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 48 NRTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 48 NNRTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 48 PI	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Population: CVW Population comprises all participants in the ITT-E Population who had met the derived CVW criteria and who had resistance data. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Plasma samples were collected for drug resistance testing. Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with genotypic resistance to INSTI, NRTI, NNRTI and PI are summarized.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=2 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Genotypic Resistance: Up to Week 144 INSTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 144 NRTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 144 NNRTI	—	0 Participants
Number of Participants With Genotypic Resistance: Up to Week 144 PI	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 48

Population: CVW Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable.

Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI, NNRTI,NRTI and PI were summarized. Assessment of antiviral activity of ART using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, DTG, Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, DTG, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, Bictegravir (BIC), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, BIC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, Elvitegravir (EVG), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, EVG, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, Raltegravir (RAL), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 INSTI, RAL, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, Delavirdine (DLV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, DLV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, Efavirenz (EFV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, EFV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, Etravirine (ETR), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, ETR, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, Nevirapine (NVP), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, NVP, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, Rilpivirine (RPV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NNRTI, RPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, 3TC, Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, 3TC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Abacavir (ABC), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, ABC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Zidovudine (AZT), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, AZT, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Stavudine (D4T), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, D4T, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Didanosine (DDI), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, DDI, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Emtricitabine (FTC), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, FTC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, Tenofovir (TDF), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 NRTI, TDF, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Atazanavir (ATV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, ATV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Darunavir (DRV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, DRV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Fosamprenavir (FPV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, FPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Indinavir (IDV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, IDV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Lopinavir (LPV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, LPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Nelfinavir (NFV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, NFV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Ritonavir (RTV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, RTV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Saquinavir (SQV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, SQV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, Tipranavir (TPV), Sensitive	—	1 Participants
Number of Participants With Phenotypic Resistance: Up to Week 48 PI, TPV, Resistant	—	0 Participants

SECONDARY outcome

Timeframe: Up to Week 144

Number of participants, who meet CVW criteria (one plasma HIV-1 RNA \>=200 c/mL after Day 1 with immediate prior HIV RNA \>=50 c/mL), with phenotypic resistance to INSTI,NNRT,NRTI and PI were summarized. Assessment of antiviral activity of anti-retroviral therapy (ART) using phenotypic test results was interpreted through a proprietary algorithm (from Monogram Biosciences), which provided the overall susceptibility of the drug. Partially sensitive and resistant calls were considered resistant in this analysis. The phenotypic resistance was calculated using binary scoring system, where 0 was considered as sensitive and 1 as resistance. Phenotypic Resistance data for the following INSTI, NNRTI, NRTI and PI drugs in participants Meeting CVW Criteria has been presented.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=2 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, NFV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, BIC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, Elvitegravir (EVG), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, DTG, Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, DTG, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, Bictegravir (BIC), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, EVG, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, Raltegravir (RAL), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 INSTI, RAL, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, Delavirdine (DLV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, DLV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, Efavirenz (EFV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, EFV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, Etravirine (ETR), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, ETR, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, Nevirapine (NVP), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, NVP, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, Rilpivirine (RPV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NNRTI, RPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, 3TC, Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, 3TC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Abacavir (ABC), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, ABC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Zidovudine (AZT), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, AZT, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Stavudine (D4T), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, D4T, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Didanosine (DDI), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, DDI, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Emtricitabine (FTC), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, FTC, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, Tenofovir (TDF), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 NRTI, TDF, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Atazanavir (ATV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, ATV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Darunavir (DRV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, DRV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Fosamprenavir (FPV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, FPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Indinavir (IDV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, IDV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Lopinavir (LPV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, LPV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Nelfinavir (NFV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Ritonavir (RTV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, RTV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Saquinavir (SQV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, SQV, Resistant	—	0 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, Tipranavir (TPV), Sensitive	—	2 Participants
Number of Participants With Phenotypic Resistance: Up to Week 144 PI, TPV, Resistant	—	0 Participants

SECONDARY outcome

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

Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was the estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, body mass index (BMI) (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 Bone-ALP, Week 24, n=350, 354	-0.77 Micrograms per liter Standard Error 0.112	-1.05 Micrograms per liter Standard Error 0.089
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 Bone-ALP, Week 48, n=343, 342	-0.03 Micrograms per liter Standard Error 0.145	-0.34 Micrograms per liter Standard Error 0.117
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 Osteocalcin, Week 24, n=350 ,353	-1.08 Micrograms per liter Standard Error 0.248	0.26 Micrograms per liter Standard Error 0.229
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 Osteocalcin, Week 48, n=343, 342	-1.15 Micrograms per liter Standard Error 0.260	0.69 Micrograms per liter Standard Error 0.279
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 P1NP, Week24, n=349 ,356	7.0 Micrograms per liter Standard Error 0.87	5.0 Micrograms per liter Standard Error 0.72
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 P1NP, Week48, n=342, 343	9.3 Micrograms per liter Standard Error 1.06	6.4 Micrograms per liter Standard Error 1.00
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 CTX-1, Week 24,n=350,356	0.0350 Micrograms per liter Standard Error 0.01057	-0.0031 Micrograms per liter Standard Error 0.00833
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum Procollagen 1 N-Terminal Propeptide (P1NP) and Serum Type 1 Collagen C-telopeptides (CTX-1) at Weeks 24 and 48 CTX-1, Week 48, n=343, 343	0.0602 Micrograms per liter Standard Error 0.01024	0.0310 Micrograms per liter Standard Error 0.00889

SECONDARY outcome

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

Serum samples were collected for analysis of bone biomarkers. Baseline was latest pre-dose assessment with a non-missing value (Day 1) . Change from Baseline is post-dose visit value minus Baseline value. Change from Baseline in bone biomarkers-serum bone-specific ALP (Bone-ALP), osteocalcin, serum P1NP and serum CTX-1 in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 Bone-ALP, Week 24, n=1	0.3 Micrograms per liter	—
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 Osteocalcin, Week 24, n=1	13.4 Micrograms per liter	—
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 P1NP, Week24, n=1	11 Micrograms per liter	—
Change From Baseline in Bone Biomarkers-serum Bone-specific ALP (Bone-ALP), Osteocalcin, Serum P1NP and Serum CTX-1 in Participants Randomized to TBR Arm Receiving TDF-based Regimen at Weeks 24 and 48 CTX-1, Week 24,n=1	0.045 Micrograms per liter	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Serum samples were collected for analysis of bone biomarkers. Baseline is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 Bone-ALP, Week 96, n=316, 289	-0.62 Micrograms per liter Standard Error 0.145	-0.79 Micrograms per liter Standard Error 0.137
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 Bone-ALP, Week 144, n=314, 301	-0.27 Micrograms per liter Standard Error 0.163	-0.40 Micrograms per liter Standard Error 0.177
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 Osteocalcin, Week 96, n=315 , 288	-1.97 Micrograms per liter Standard Error 0.288	-0.10 Micrograms per liter Standard Error 0.306
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 Osteocalcin, Week 144, n=315, 301	-0.74 Micrograms per liter Standard Error 0.266	1.21 Micrograms per liter Standard Error 0.320
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 P1NP, Week 96, n=316 ,290	6.7 Micrograms per liter Standard Error 0.87	4.7 Micrograms per liter Standard Error 0.80
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 P1NP, Week 144, n=315, 302	3.9 Micrograms per liter Standard Error 0.94	3.5 Micrograms per liter Standard Error 1.04
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 CTX-1, Week 96 ,n=315, 289	0.0201 Micrograms per liter Standard Error 0.01123	0.0050 Micrograms per liter Standard Error 0.00929
Change From Baseline in Bone Biomarkers-serum Bone-ALP, Osteocalcin, Serum P1NP and Serum Type 1 CTX-1 at Weeks 96 and 144 CTX-1, Week 48, n=315, 300	0.0022 Micrograms per liter Standard Error 0.00947	-0.0104 Micrograms per liter Standard Error 0.00907

SECONDARY outcome

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

Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value was latest pre-dose assessment (Day 1) with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count (continuous), age (continuous), sex, race, BMI (continuous), smoking status, vitamin D use, Baseline biomarker (continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor.One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 Week 24, n=351, 355	0.0 Nanomoles per liter Standard Error 1.10	2.1 Nanomoles per liter Standard Error 1.15
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 Week 48, n=344, 343	-5.8 Nanomoles per liter Standard Error 1.21	-3.5 Nanomoles per liter Standard Error 1.13

SECONDARY outcome

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

Serum samples were collected for the analysis of 25-hydroxyvitamin D. Baseline value was the value from latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum 25-hydroxyvitamin D in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Week 24, n=1	2 Nanomoles per liter	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Serum samples were collected for analysis of 25-hydroxyvitamin D. Baseline value is latest pre-dose assessment with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 Week 96, n=315, 291	-11.5 Nanomoles per liter Standard Error 1.17	-2.2 Nanomoles per liter Standard Error 2.06
Change From Baseline in Bone Biomarker: Serum 25-hydroxyvitamin D at Weeks 96 and 144 Week 144, n=315, 303	-7.5 Nanomoles per liter Standard Error 1.28	-1.9 Nanomoles per liter Standard Error 1.50

SECONDARY outcome

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

Serum samples were collected to assess renal biomarker. Baseline was latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from a repeated measures model adjusting for following:treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 Week 24, n=351, 357	-0.03 Milligrams per liter Standard Error 0.005	-0.02 Milligrams per liter Standard Error 0.004
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 Week 48, n=344, 343	0.00 Milligrams per liter Standard Error 0.006	0.01 Milligrams per liter Standard Error 0.005

SECONDARY outcome

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

Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - cystatin C. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline values for serum cystatin -C biomarker in TDF based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Week 24, n=1	0 Milligrams per liter	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Serum samples were collected to assess renal biomarker. Baseline is latest pre-dose assessment value with non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 Week 144, n=315, 302	0.13 Milligrams per liter Standard Error 0.006	0.14 Milligrams per liter Standard Error 0.006
Change From Baseline in Renal Biomarker- Serum Cystatin C at Weeks 96 and 144 Week 96, n=316, 290	0.07 Milligrams per liter Standard Error 0.008	0.10 Milligrams per liter Standard Error 0.009

SECONDARY outcome

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

Serum samples assessed:serum GFR from cystatin C and from creatinine adjusted using CKD-EPI Baseline(Day 1) was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value.Adjusted mean and standard error is presented.Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class,CD4+ cell count(continuous),age(continuous), sex, race, BMI(continuous),presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, and Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 GFR from cystatin C CKD-EPI, Week 24, n=351, 357	3.2 Milliliters/minute/1.73*meter square Standard Error 0.52	1.5 Milliliters/minute/1.73*meter square Standard Error 0.46
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 GFR from cystatin C CKD-EPI, Week 48, n=344, 343	0.1 Milliliters/minute/1.73*meter square Standard Error 0.61	-1.6 Milliliters/minute/1.73*meter square Standard Error 0.59
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 GFR from creatinine CKD-EPI, Week 24, n=351, 359	-8.8 Milliliters/minute/1.73*meter square Standard Error 0.48	-3.8 Milliliters/minute/1.73*meter square Standard Error 0.47
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 GFR from creatinine CKD-EPI, Week 48, n=344, 345	-7.7 Milliliters/minute/1.73*meter square Standard Error 0.48	-2.9 Milliliters/minute/1.73*meter square Standard Error 0.48

SECONDARY outcome

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

Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarkers - serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum GFR from cystatin C adjusted using CKD-EPI and serum GFR from creatinine adjusted using CKD-EPI in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen GFR from cystatin C CKD-EPI, Week 24, n=1	0 Milliliters/minute/1.73*meter square	—
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen GFR from creatinine CKD-EPI, Week 24, n=1	4 Milliliters/minute/1.73*meter square	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Serum samples were collected to assess serum GFR from cystatin C and from creatinine adjusted for BSA. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 GFR from cystatin C CKD-EPI, Week 96, n=316, 290	-7.6 Milliliters/minute/1.73*meter square Standard Error 0.89	-11.7 Milliliters/minute/1.73*meter square Standard Error 0.99
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 GFR from cystatin C CKD-EPI, Week 144, n=315, 302	-13.9 Milliliters/minute/1.73*meter square Standard Error 0.71	-15.8 Milliliters/minute/1.73*meter square Standard Error 0.70
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 GFR from creatinine adjusted for BSA, Week 96, n=315, 294	-7.2 Milliliters/minute/1.73*meter square Standard Error 0.55	-1.9 Milliliters/minute/1.73*meter square Standard Error 0.52
Change From Baseline in Renal Biomarker- Serum GFR From Cystatin C Adjusted Using CKD-EPI and Serum GFR From Creatinine Adjusted Using CKD-EPI at Weeks 96 and 144 GFR from creatinine adjusted for BSA, Week 144, n=311, 300	-11.5 Milliliters/minute/1.73*meter square Standard Error 0.62	-7.0 Milliliters/minute/1.73*meter square Standard Error 0.60

SECONDARY outcome

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

Serum samples assessed: renal inflammation biomarker serum creatinine.Baseline(Day 1)was value from latest pre-dose assessment with non-missing value. Change from Baseline is post-dose visit value minus Baseline value. Adjusted mean and its corresponding standard error has been presented. Adjusted mean was estimated mean change from Baseline at each visit in each arm calculated from repeated measures model adjusting for treatment, visit, Baseline third agent class, CD4+ cell count(continuous), age(continuous), sex, race, BMI(continuous), presence of diabetes mellitus, presence of hypertension, Baseline biomarker(continuous), treatment by visit interaction, Baseline value by visit interaction, with visit as repeated factor. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 Week 24, n=351, 359	7.47 Micromoles per liter Standard Error 0.466	3.11 Micromoles per liter Standard Error 0.495
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 Week 48, n=344, 345	6.67 Micromoles per liter Standard Error 0.493	2.18 Micromoles per liter Standard Error 0.450

SECONDARY outcome

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

Serum samples were collected at Baseline, Week 24 and Week 48 to assess renal inflammation biomarker - serum creatinine. Baseline was defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value. Change from Baseline in serum creatinine in TDF-based regimen participants has been presented. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen."

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=1 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 24 and 48 in Participants Randomized to TBR Arm Receiving TDF-based Regimen Week 24, n=1	-8 Micromoles per liter	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

Serum samples were collected to assess renal inflammation biomarker - serum creatinine. Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is post-dose visit value minus Baseline value. One participant randomized to TBR but received TDF-based regimen and because the safety profiles of TDF and TAF differ, this participant was removed from the overall safety population and is presented in separate arm "Randomized to TBR but received TDF-based regimen"

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=371 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 Week 96, n=316, 294	5.53 Micromoles per liter Standard Error 0.553	0.58 Micromoles per liter Standard Error 0.515
Change From Baseline in Renal Biomarker- Serum Creatinine at Weeks 96 and 144 Week 144, n=311, 302	9.25 Micromoles per liter Standard Error 0.637	5.17 Micromoles per liter Standard Error 0.633

SECONDARY outcome

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

Population: ITT-E Population. One participant randomized to TBR but received TDF-based regimen and was presented within the "TBR (TAF-based regimen) arm" as efficacy of TAF and TDF are comparable. Only those participants with data available at the specified data points were analyzed.

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

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=364 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=370 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 Week 24	0.0029 Scores on a scale Standard Error 0.00383	0.0046 Scores on a scale Standard Error 0.00352
Change From Baseline in European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Utility Score at Week 24 and 48 Week 48	0.0037 Scores on a scale Standard Error 0.00407	0.0023 Scores on a scale Standard Error 0.00373

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

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

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 Week 96, n=364, 370	-0.0036 Scores on a scale Standard Error 0.00442	-0.0038 Scores on a scale Standard Error 0.00446
Change From Baseline in EQ-5D-5L Utility Score at Weeks 96 and 144 Week 144, n=364, 369	-0.0151 Scores on a scale Standard Error 0.00502	-0.0042 Scores on a scale Standard Error 0.00492

SECONDARY outcome

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

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

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=364 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 Week 24	1.2 Scores on a scale Standard Error 0.49	1.3 Scores on a scale Standard Error 0.44
Change From Baseline in EQ-5D-5L Thermometer Scores at Week 24 and 48 Week 48	1.1 Scores on a scale Standard Error 0.52	1.7 Scores on a scale Standard Error 0.43

SECONDARY outcome

Timeframe: Baseline (Day 1) and at Weeks 96 and 144

EQ-5D-5L questionnaire provides a profile of participant function and a global health state rating. The five-item measure has one question assessing each of five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression and 5 levels for each dimension including 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L included EQ visual Analogue scale (EQ VAS) 'Thermometer' which provided Self-rated current health status. Score ranges from 0 (worst imaginable health state) to 100 (best imaginable health state). Baseline is defined as the latest pre-dose assessment value with a non-missing value (Day 1). Change from Baseline is defined as post-dose visit value minus Baseline value.

Outcome measures

Outcome measures
Measure	DTG+3TC FDC (Early Switch) n=369 Participants Participants who were on a stable TBR and who had an HIV-1 ribonucleic acid (RNA) \<50 copies per millilter (c/mL) at the time of screening, received fixed dose combination of DTG 50 milligrams (mg) + 3TC 300 mg once daily up to 148 weeks during early switch phase.	TAF Based Regimen (Early Switch) n=372 Participants Participants who were on a stable TBR and who had an HIV-1 RNA\<50 c/mL at the time of screening, received TBR up to 148 weeks during early switch phase. One participant randomized to the TAF-based regimen arm received TDF rather than TAF-and was presented within the "TAF-based regimen" arm for efficacy because the efficacy of TAF and TDF are comparable. However, the participant was presented separately under "TDF-based regimen" for Safety because the safety profiles of TDF and TAF differ.
Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 Week 96, n=364, 369	0.7 Scores on a scale Standard Error 0.52	1.9 Scores on a scale Standard Error 0.48
Change From Baseline in EQ-5D-5L Thermometer Scores at Weeks 96 and 144 Week 144, n=364, 368	0.2 Scores on a scale Standard Error 0.58	1.4 Scores on a scale Standard Error 0.50

Adverse Events

DTG + 3TC FDC (Early Switch + Late Switch)-Overall

Serious events: 65 serious events

Other events: 327 other events

Deaths: 4 deaths

TAF Based Regimen (Early Switch)

Serious events: 44 serious events

Other events: 304 other events

Deaths: 0 deaths

Randomized to TBR But Received TDF-based Regimen (Early Switch)

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

TAF Based Regimen (Early Switch) Followed by DTG + 3TC FDC (Late Switch)

Serious events: 15 serious events

Other events: 187 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Additional Information

GSK Response Center

ViiV Healthcare

Phone: 866-435-7343

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER