Trial Outcomes & Findings for Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen (NCT NCT02478632)

Last Updated: 2020-10-19

Results Overview

Percent change in BMD (expressed as areal density in grams per centimeter square \[g/cm\^2\]) as specified by dual energy X-ray absorptiometry (DEXA) scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at Baseline and Week 48. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An analysis of covariance (ANCOVA) model was used to compare the difference. The analysis was performed on Intent-to-Treat exposed DEXA (ITT-ED) Population which comprised of all participants in the ITT-E Population who received at least one dose of study treatment, and who were registered for the 202094 study.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

102 participants

Primary outcome timeframe

Baseline (Day 1) and Week 48

Results posted on

2020-10-19

Participant Flow

Participants from early switch dolutegravir (DTG) plus rilpivirine (RPV) treatment groups and from late switch group who continue their current antiretroviral regimen (CAR) through Week 52 across both NCT02429791 and NCT02422797 were included in this sub-study 202094.

Total 146 participants were screened, of which, 44 were screen failures and 102 were registered to study 202094. The study included an early switch phase and a late switch phase.

Participant milestones

Participant milestones
Measure	DTG + RPV Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Early Switch Phase (Up to Week 52) STARTED	53	49
Early Switch Phase (Up to Week 52) COMPLETED	49	44
Early Switch Phase (Up to Week 52) NOT COMPLETED	4	5
Late Switch Phase (Week 52 to Week 148) STARTED	49	44
Late Switch Phase (Week 52 to Week 148) COMPLETED	42	40
Late Switch Phase (Week 52 to Week 148) NOT COMPLETED	7	4

Reasons for withdrawal

Reasons for withdrawal
Measure	DTG + RPV Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Early Switch Phase (Up to Week 52) Withdrawal from parent study	4	5
Late Switch Phase (Week 52 to Week 148) Withdrawal from parent study	2	3
Late Switch Phase (Week 52 to Week 148) Prohibited medication use	5	1

Baseline Characteristics

Bone Mineral Density in Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Adult Subjects Switching From a Tenofovir Regimen to a Dolutegravir Plus Rilpivirine Regimen

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	DTG + RPV n=53 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=49 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).	Total n=102 Participants Total of all reporting groups
Age, Continuous	42.6 Years STANDARD_DEVIATION 10.80 • n=5 Participants	44.8 Years STANDARD_DEVIATION 10.66 • n=7 Participants	43.7 Years STANDARD_DEVIATION 10.73 • n=5 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	26 Participants n=7 Participants	53 Participants n=5 Participants
Sex: Female, Male Male	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race/Ethnicity, Customized American Indian/ Alaska native Heritage	4 Participants n=5 Participants	1 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian- Central/South Asian Heritage	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Asian- Japanese/East Asian (EA)/ South EA heritage	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Black / African American	3 Participants n=5 Participants	7 Participants n=7 Participants	10 Participants n=5 Participants
Race/Ethnicity, Customized White	44 Participants n=5 Participants	40 Participants n=7 Participants	84 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.

Outcome measures

Outcome measures
Measure	DTG + RPV n=46 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=35 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Baseline in Total Hip Bone Mineral Density (BMD) at Week 48	1.34 Percent change Interval 0.68 to 2.01	0.05 Percent change Interval -0.71 to 0.82

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.

Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at Baseline and Week 48. The difference is adjusted percent change from Baseline to Week 48 between treatment groups. The estimated value in the statistical analysis is this difference and the upper and lower limit values shown are the 95% confidence intervals. Baseline was considered as Day 1 value and percent change from Baseline was calculated as Value at Week 48 minus Baseline value divided by Baseline value multiplied by 100. An ANCOVA model was used to compare the difference in percentage change from Baseline at week 48 in lumbar spine BMD between the DTG+RPV and CAR arms.

Outcome measures

Outcome measures
Measure	DTG + RPV n=46 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=35 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Baseline in Lumbar Spine BMD at Week 48	1.46 Percent change Interval 0.65 to 2.28	0.15 Percent change Interval -0.79 to 1.09

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 48, Week 100 and Week 148

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

Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of left 'total hip' which included femoral neck, trochanter and inter-trochanter areas and 'lumbar spine' which included L1 to L4 was assessed by areal density. Percent change from Baseline is post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of multiple DEXA scanner instruments in this study. Data presented through Week 48 only represent results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.

Outcome measures

Outcome measures
Measure	DTG + RPV n=53 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Week 48; n=46	1.492 Percent change Interval 0.74 to 2.24	—
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Week 100; n=41	1.081 Percent change Interval 0.06 to 2.1	—
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Week 148; n=40	0.978 Percent change Interval -0.23 to 2.18	—
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Week 48; n=46	1.648 Percent change Interval 0.83 to 2.46	—
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Week 100; n=43	0.810 Percent change Interval -0.39 to 2.01	—
Percent Change From Baseline in Total Hip and Lumbar Spine BMD-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Week 148; n=42	0.526 Percent change Interval -0.93 to 1.98	—

SECONDARY outcome

Timeframe: LS Baseline (Week 48), Week 100 and Week 148

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

Percent change in BMD (expressed as areal density in g/cm\^2) as specified by DEXA scans of the left 'total hip' which included the femoral neck, trochanter and inter-trochanter areas was assessed by areal density at indicated time points. Percent change in BMD as specified by DEXA scans of the 'lumbar spine' which included the first lumbar vertebra (L1) to the fourth lumbar vertebra (L4) was assessed by areal density at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose visit value minus LS Baseline value divided by LS Baseline value multiplied by 100. The analysis was based on Late-Switch Intent-to-Treat Exposed DEXA (LS-ITT-ED) Population which comprised of all participants in the LS-ITT-E Population, and who were registered for the DEXA study.

Outcome measures

Outcome measures
Measure	DTG + RPV n=44 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase Total hip; Week 100; n=41	1.107 Percent change Interval 0.25 to 1.96	—
Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase Total hip; Week 148; n=40	1.275 Percent change Interval 0.39 to 2.16	—
Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase Lumbar spine; Week 100; n=41	1.135 Percent change Interval 0.11 to 2.16	—
Percent Change From Late Switch (LS) Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD-CAR Late Switch Group Through Late Switch Phase Lumbar spine; Week 148; n=40	0.436 Percent change Interval -0.64 to 1.51	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

Population: ITT-ED Population. Only those participants with data available at specified time point were analyzed.

Total hip and lumbar spine BMD was assessed by T-scores and Z-scores. Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.

Outcome measures

Outcome measures
Measure	DTG + RPV n=46 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=35 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score Total hip; T-score	0.09 Scores on a scale Interval 0.05 to 0.14	0.01 Scores on a scale Interval -0.05 to 0.06
Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score Total hip; Z-score	0.11 Scores on a scale Interval 0.06 to 0.15	0.02 Scores on a scale Interval -0.03 to 0.08
Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score Lumbar spine; T-score	0.13 Scores on a scale Interval 0.05 to 0.2	0.01 Scores on a scale Interval -0.08 to 0.1
Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 Assessed by T-score and Z-score Lumbar spine; Z-score	0.17 Scores on a scale Interval 0.09 to 0.25	0.02 Scores on a scale Interval -0.07 to 0.11

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 48, Week 100 and Week 148

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

T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z- scores. T-score values: \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is post-dose visit value minus Baseline value. Data for Week 48 only represent final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.

Outcome measures

Outcome measures
Measure	DTG + RPV n=53 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; T-score; Week 48; n=46	0.101 Scores on a scale Standard Deviation 0.1681	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; T-score; Week 100; n=41	0.066 Scores on a scale Standard Deviation 0.2248	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; T-score; Week 148; n=40	0.062 Scores on a scale Standard Deviation 0.2600	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Z-score; Week 48; n=46	0.115 Scores on a scale Standard Deviation 0.1742	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Z-score; Week 100; n=41	0.107 Scores on a scale Standard Deviation 0.2222	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; Z-score; Week 148; n=40	0.117 Scores on a scale Standard Deviation 0.2757	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; T-score; Week 48; n=46	0.139 Scores on a scale Standard Deviation 0.2511	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; T-score; Week 100; n=43	0.059 Scores on a scale Standard Deviation 0.3510	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; T-score; Week 148; n=42	0.034 Scores on a scale Standard Deviation 0.4183	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Z-score; Week 48; n=46	0.182 Scores on a scale Standard Deviation 0.2563	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Z-score; Week 100; n=43	0.142 Scores on a scale Standard Deviation 0.3868	—
Change From Baseline in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores - DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; Z-score; Week 148; n=42	0.139 Scores on a scale Standard Deviation 0.4507	—

SECONDARY outcome

Timeframe: LS Baseline (Week 48), Week 100, Week 148

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

The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose visit value minus LS Baseline value. DEXA scans of the left 'total hip' (femoral neck, hip, inter-trochanter areas, trochanter) and 'lumbar spine' (lumbar vertebral column) were performed. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.

Outcome measures

Outcome measures
Measure	DTG + RPV n=44 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Total hip; T-score; Week 100; n=41	0.080 Scores on a scale Standard Deviation 0.1957	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Total hip; T-score; Week 148; n=40	0.091 Scores on a scale Standard Deviation 0.1995	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Total hip; Z-score; Week 100; n=41	0.107 Scores on a scale Standard Deviation 0.2055	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Total hip; Z-score; Week 148; n=40	0.125 Scores on a scale Standard Deviation 0.2117	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Lumbar spine; T-score; Week 100; n=41	0.111 Scores on a scale Standard Deviation 0.2914	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Lumbar spine; T-score; Week 148; n=40	0.049 Scores on a scale Standard Deviation 0.3204	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Lumbar spine; Z-score; Week 100; n=41	0.176 Scores on a scale Standard Deviation 0.2598	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD as Assessed by T-scores and Z-scores-CAR Late Switch Group Through Late Switch Phase Lumbar spine; Z-score; Week 148; n=40	0.127 Scores on a scale Standard Deviation 0.3392	—

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

Outcome measures

Outcome measures
Measure	DTG + RPV n=46 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=35 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Total hip; INSTI; n=7, 4	2.03 Percent change Interval -0.47 to 4.53	1.38 Percent change Interval -1.93 to 4.69
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Total hip; NNRTI; n=28, 24	1.33 Percent change Interval 0.51 to 2.16	-0.27 Percent change Interval -1.16 to 0.62
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Total hip; PI; n=11, 7	1.11 Percent change Interval -0.34 to 2.56	0.12 Percent change Interval -1.72 to 1.95
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Lumbar spine; INSTI; n=7, 3	1.43 Percent change Interval -0.31 to 3.17	-2.42 Percent change Interval -5.08 to 0.24
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Lumbar spine; NNRTI; n=28, 26	1.38 Percent change Interval 0.34 to 2.42	0.12 Percent change Interval -0.96 to 1.2
Percent Change From Baseline in Total Hip and Lumbar Spine BMD at Week 48 by Baseline Third Agent Lumbar spine; PI; n=11, 6	1.78 Percent change Interval -0.22 to 3.78	1.40 Percent change Interval -1.32 to 4.11

SECONDARY outcome

Timeframe: Baseline (Day 1) and Week 48

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

Total hip and lumbar spine BMD was assessed by Baseline third agent class (INSTI, NNRTI, PI) using T-scores and Z-scores at Baseline and Week 48. DEXA scans of hip and spine were performed. Value at Day 1 was considered as Baseline. Change from Baseline was calculated as the value at Week 48 minus Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.

Outcome measures

Outcome measures
Measure	DTG + RPV n=46 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen n=35 Participants Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; T-score; INSTI; n=7, 4	0.13 Scores on a scale Interval -0.04 to 0.29	0.11 Scores on a scale Interval -0.11 to 0.33
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; T-score; NNRTI; n=28, 24	0.09 Scores on a scale Interval 0.04 to 0.15	-0.02 Scores on a scale Interval -0.08 to 0.04
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; T-score; PI; n=11, 7	0.08 Scores on a scale Interval -0.02 to 0.18	0.01 Scores on a scale Interval -0.12 to 0.13
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; Z-score; INSTI; n=7, 4	0.18 Scores on a scale Interval 0.0 to 0.36	0.12 Scores on a scale Interval -0.13 to 0.36
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; Z-score; NNRTI; n=28, 24	0.10 Scores on a scale Interval 0.04 to 0.16	0.00 Scores on a scale Interval -0.06 to 0.06
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Total hip; Z-score; PI; n=11, 7	0.08 Scores on a scale Interval -0.02 to 0.19	0.05 Scores on a scale Interval -0.08 to 0.18
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; T-score; INSTI; n=7, 3	0.14 Scores on a scale Interval -0.04 to 0.33	-0.22 Scores on a scale Interval -0.51 to 0.07
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; T-score; NNRTI; n=28, 26	0.11 Scores on a scale Interval 0.02 to 0.21	0.00 Scores on a scale Interval -0.1 to 0.1
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; T-score; PI; n=11, 6	0.15 Scores on a scale Interval -0.03 to 0.34	0.14 Scores on a scale Interval -0.11 to 0.39
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; Z-score; INSTI; n=7, 3	0.19 Scores on a scale Interval 0.01 to 0.38	-0.19 Scores on a scale Interval -0.48 to 0.1
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; Z-score; NNRTI; n=28, 26	0.13 Scores on a scale Interval 0.04 to 0.23	0.01 Scores on a scale Interval -0.09 to 0.11
Change From Baseline in Total Hip and Lumbar Spine BMD T-scores and Z-scores at Week 48 by Baseline Third Agent Lumbar spine; Z-score; PI; n=11,6	0.24 Scores on a scale Interval 0.06 to 0.41	0.19 Scores on a scale Interval -0.05 to 0.43

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 48, Week 100 and Week 148

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

Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. Percent change from Baseline was calculated as post-dose value minus Baseline value divided by Baseline value multiplied by 100. BMD parameters expressed as areal density (g/cm\^2) at Weeks 48, 100 and 148 reflect data adjusted following the ongoing longitudinal and cross-calibration of the multiple DEXA scanner instruments in this study. Data and analyses presented through Week 48 only represent the final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations though Week 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, the actual values of Week 48 DEXA data may vary slightly between the Week 48 and Week 148 analyses.

Outcome measures

Outcome measures
Measure	DTG + RPV n=53 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; INSTI; Week 48; n=7	1.918 Percent change Standard Deviation 3.3468	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; INSTI; Week 100; n=6	1.165 Percent change Standard Deviation 4.5857	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; INSTI; Week 148; n=6	1.738 Percent change Standard Deviation 3.1881	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; NNRTI; Week 48; n=28	1.422 Percent change Standard Deviation 2.4137	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; NNRTI; Week 100; n=25	0.722 Percent change Standard Deviation 2.6977	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; NNRTI; Week 148; n=24	0.524 Percent change Standard Deviation 4.0553	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; PI; Week 48; n=11	1.401 Percent change Standard Deviation 2.4406	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; PI; Week 100; n=10	1.927 Percent change Standard Deviation 3.7412	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Total hip; PI; Week 148; n=10	1.610 Percent change Standard Deviation 3.5534	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; INSTI; Week 48; n=7	1.439 Percent change Standard Deviation 2.2786	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; INSTI; Week 100; n=6	0.779 Percent change Standard Deviation 2.6627	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; INSTI; Week 148; n=6	-0.306 Percent change Standard Deviation 0.8815	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; NNRTI; Week 48; n=28	1.570 Percent change Standard Deviation 2.9752	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; NNRTI; Week 100; n=26	-0.025 Percent change Standard Deviation 3.9606	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; NNRTI; Week 148; n=25	0.067 Percent change Standard Deviation 5.4222	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; PI; Week 48; n=11	1.977 Percent change Standard Deviation 2.5587	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; PI; Week 100; n=11	2.801 Percent change Standard Deviation 3.8743	—
Percent Change From Baseline (Day 1) in Total Hip and Lumbar BMD by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase Lumbar spine; PI; Week 148; n=11	2.026 Percent change Standard Deviation 3.8869	—

SECONDARY outcome

Timeframe: Baseline (Day 1), Week 48, Week 100 and Week 148

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

T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of same sex. Caucasian reference values were used to calculate T- and Z-scores. T-score values \> -1.0 is normal; \<= -1.0 to \> -2.5 indicate osteopenia; \<= -2.5 to \<-3.5 indicate osteoporosis; \<= -3.5 indicate severe osteoporosis. Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex in this study. Change from Baseline is the post-dose value minus Baseline value. Data for Week 48 only represents final results of Week 48 Primary Endpoint analysis which applied DEXA scanner calibrations through 48, with no subsequent calibration applied. In the final analysis conducted at Week 148, DEXA scanner calibration data acquired from Day 1 to Week 148 was applied to all raw DEXA BMD data at Weeks 48, 100 and 148. Hence, actual values of Week 48 DEXA data may vary slightly between Weeks 48 and 148 analyses.

Outcome measures

Outcome measures
Measure	DTG + RPV n=53 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; T-score; Week 48; n=7	0.119 Scores on a scale Standard Deviation 0.2171	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; T-score; Week 100; n=6	0.069 Scores on a scale Standard Deviation 0.2854	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; T-score; Week 148; n=6	0.116 Scores on a scale Standard Deviation 0.2057	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; Z-score; Week 48; n=7	0.162 Scores on a scale Standard Deviation 0.2402	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; Z-score; Week 100; n=6	0.161 Scores on a scale Standard Deviation 0.2912	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Total hip; Z-score; Week 148; n=6	0.219 Scores on a scale Standard Deviation 0.2360	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; T-score; Week 48; n=7	0.141 Scores on a scale Standard Deviation 0.2212	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; T-score; Week 100; n=6	0.087 Scores on a scale Standard Deviation 0.2611	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; T-score; Week 148; n=6	-0.026 Scores on a scale Standard Deviation 0.0826	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; Z-score; Week 48; n=7	0.196 Scores on a scale Standard Deviation 0.2100	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; Z-score; Week 100; n=6	0.267 Scores on a scale Standard Deviation 0.3905	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase INSTI; Lumbar spine; Z-score; Week 148; n=6	0.191 Scores on a scale Standard Deviation 0.2644	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; T-score; Week 48; n=28	0.098 Scores on a scale Standard Deviation 0.1593	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; T-score; Week 100; n=25	0.045 Scores on a scale Standard Deviation 0.1938	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; T-score; Week 148; n=24	0.028 Scores on a scale Standard Deviation 0.2786	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; Z-score; Week 48; n=28	0.107 Scores on a scale Standard Deviation 0.1574	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; Z-score; Week 100; n=25	0.077 Scores on a scale Standard Deviation 0.1856	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Total hip; Z-score; Week 148; n=24	0.071 Scores on a scale Standard Deviation 0.2958	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; T-score; Week 48; n=28	0.126 Scores on a scale Standard Deviation 0.2687	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; T-score; Week 100; n=26	-0.022 Scores on a scale Standard Deviation 0.3558	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; T-score; Week 148; n=25	-0.015 Scores on a scale Standard Deviation 0.4802	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; Z-score; Week 48; n=28	0.150 Scores on a scale Standard Deviation 0.2669	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; Z-score; Week 100; n=26	0.021 Scores on a scale Standard Deviation 0.3539	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase NNRTI; Lumbar spine; Z-score; Week 148; n=25	0.049 Scores on a scale Standard Deviation 0.5248	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; T-Score; Week 48; n=11	0.097 Scores on a scale Standard Deviation 0.1731	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; T-Score; Week 100; n=10	0.118 Scores on a scale Standard Deviation 0.2740	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; T-Score; Week 148; n=10	0.110 Scores on a scale Standard Deviation 0.2521	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; Z-Score; Week 48; n=11	0.106 Scores on a scale Standard Deviation 0.1823	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; Z-Score; Week 100; n=10	0.150 Scores on a scale Standard Deviation 0.2722	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Total hip; Z-Score; Week 148 ;n=10	0.166 Scores on a scale Standard Deviation 0.2441	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; T-Score; Week 48 ;n=11	0.172 Scores on a scale Standard Deviation 0.2406	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; T-Score; Week 100 ;n=11	0.235 Scores on a scale Standard Deviation 0.3396	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; T-Score; Week 148 ;n=11	0.179 Scores on a scale Standard Deviation 0.3599	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; Z-Score; Week 48 ;n=11	0.257 Scores on a scale Standard Deviation 0.2601	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; Z-Score; Week 100 ;n=11	0.360 Scores on a scale Standard Deviation 0.3732	—
Change From Baseline (Day 1) in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-DTG+RPV Early Switch Group Through Early and Late Switch Phase PI; Lumbar spine; Z-Score; Week 148 ;n=11	0.317 Scores on a scale Standard Deviation 0.2828	—

SECONDARY outcome

Timeframe: LS Baseline (Week 48), Week 100 and Week 148

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

Total hip and lumbar spine BMD (expressed as areal density in g/cm\^2) assessed by third agent class (INSTI, NNRTI, PI) at indicated time points. The last pre-switch value (Week 48) was considered as LS Baseline and percent change from LS Baseline was calculated as post-dose value minus LS Baseline value divided by LS Baseline value multiplied by 100.

Outcome measures

Outcome measures
Measure	DTG + RPV n=44 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; NNRTI; Week 148; n=29	0.335 Percent change Standard Deviation 3.5996	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; INSTI; Week 100; n=3	2.298 Percent change Standard Deviation 2.7510	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; INSTI; Week 148; n=3	2.405 Percent change Standard Deviation 1.8787	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; NNRTI; Week 100; n=29	1.049 Percent change Standard Deviation 2.9845	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; NNRTI; Week 148; n=29	1.498 Percent change Standard Deviation 2.8487	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; PI; Week 100; n=9	0.898 Percent change Standard Deviation 1.7838	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Total hip; PI; Week 148; n=8	0.042 Percent change Standard Deviation 2.5640	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; INSTI; Week 100; n=3	2.195 Percent change Standard Deviation 1.1188	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; INSTI; Week 148; n=3	1.121 Percent change Standard Deviation 1.3711	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; NNRTI; Week 100; n=29	1.017 Percent change Standard Deviation 2.7142	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; PI; Week 100; n=9	1.160 Percent change Standard Deviation 5.1050	—
Percent Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase Lumbar Spine; PI; Week 148; n=8	0.546 Percent change Standard Deviation 3.1654	—

SECONDARY outcome

Timeframe: LS Baseline (Week 48), Week 100 and Week 148

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

Total hip and lumbar spine BMD was assessed by Baseline third agent (INSTI, NNRTI, PI) using T-scores and Z-scores at indicated time points. DEXA scans of hip and spine were performed. The last pre-switch value (Week 48) was considered as LS Baseline and change from LS Baseline was calculated as the post-dose value minus LS Baseline value. T-score is the number of standard deviations above or below the mean BMD of a 30-year-old participant of the same sex. Caucasian reference values were used for all participants to calculate T-scores. T-score values \> -1.0 are considered normal, T-score values \<= -1.0 to \> -2.5 indicate osteopenia, T-score values \<= -2.5 to \<-3.5 indicate osteoporosis and T-score values \<= -3.5 indicate severe osteoporosis. The Z-score is the number of standard deviations above or below the mean BMD for a reference population of same age and sex and in this study. Caucasian reference values were used in calculation of Z-scores.

Outcome measures

Outcome measures
Measure	DTG + RPV n=44 Participants Participants received randomized DTG together with RPV once daily in an open-label fashion up to Week 52 during early switch phase in the parent study and continued to receive DTG + RPV up to Week 148 during the late switch phase in the parent study (study medication was administered in the parent study and not in study 202094).	Current Antiretroviral Regimen Participants continued to receive their current antiretroviral regimen (CAR) (two nucleoside reverse transcriptase inhibitors \[NRTIs\] + a third agent). A third agent included either an: integrase strand transfer inhibitor (INSTI), a non-nucleoside reverse transcriptase inhibitor (NNRTI) or a protease inhibitor (PI). CAR was administered according to the approved labeling in an open-label fashion up to Week 52 during early switch phase in the parent study. At Week 52, participants with human immunodeficiency virus-1 (HIV-1) ribonucleic acid (RNA) \<50 copies per milliliter (c/mL), switched to DTG + RPV once daily and were followed until Week 148 in the parent study (study medication was administered in the parent study and not in study 202094).
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Hip; T-score; Week 100; n=3	0.166 Scores on a scale Standard Deviation 0.1971	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Hip; T-score; Week 148; n=3	0.173 Scores on a scale Standard Deviation 0.1333	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Hip; Z-score; Week 100; n=3	0.167 Scores on a scale Standard Deviation 0.1623	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Hip; Z-score; Week 148; n=3	0.197 Scores on a scale Standard Deviation 0.0800	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Spine; T-score; Week 100; n=3	0.201 Scores on a scale Standard Deviation 0.1102	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Spine; T-score; Week 148; n=3	0.099 Scores on a scale Standard Deviation 0.1164	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Spine; Z-score; Week 100; n=3	0.247 Scores on a scale Standard Deviation 0.0376	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase INSTI; Spine; Z-score; Week 148; n=3	0.145 Scores on a scale Standard Deviation 0.1888	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Hip; T-score; Week 100; n=29	0.075 Scores on a scale Standard Deviation 0.2149	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Hip; T-score; Week 148; n=29	0.106 Scores on a scale Standard Deviation 0.2064	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Hip; Z-score; Week 100; n=29	0.101 Scores on a scale Standard Deviation 0.2261	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Hip; Z-score; Week 148; n=29	0.136 Scores on a scale Standard Deviation 0.2213	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Spine; T-score; Week 100; n=29	0.103 Scores on a scale Standard Deviation 0.2630	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Spine; T-score; Week 148; n=29	0.045 Scores on a scale Standard Deviation 0.3441	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Spine; Z-score; Week 100; n=29	0.164 Scores on a scale Standard Deviation 0.2711	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase NNRTI; Spine; Z-score; Week 148; n=29	0.124 Scores on a scale Standard Deviation 0.3482	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Hip; T-Score; Week 100; n=9	0.069 Scores on a scale Standard Deviation 0.1309	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Hip; T-Score; Week 148; n=8	0.007 Scores on a scale Standard Deviation 0.1856	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Hip; Z-Score; Week 100; n=9	0.107 Scores on a scale Standard Deviation 0.1558	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Hip; Z-Score; Week 148 ;n=8	0.061 Scores on a scale Standard Deviation 0.2111	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Spine; T-Score; Week 100 ;n=9	0.105 Scores on a scale Standard Deviation 0.4198	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Spine; T-Score; Week 148 ;n=8	0.044 Scores on a scale Standard Deviation 0.3052	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Spine; Z-Score; Week 100 ;n=9	0.191 Scores on a scale Standard Deviation 0.2776	—
Change From LS Baseline (Week 48) Through Week 148 in Total Hip and Lumbar Spine BMD T-scores and Z-scores by Baseline Third Agent-CAR Late Switch Group Through Late Switch Phase PI; Spine; Z-Score; Week 148 ;n=8	0.133 Scores on a scale Standard Deviation 0.3817	—

Adverse Events

DTG + RPV (Early Switch)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CAR (Early Switch)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

DTG + RPV (Early + Late Switch)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

CAR (Late Switch)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

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