Trial Outcomes & Findings for (mo)BETTA Trial in Transwomen for Optimization of ART (NCT NCT03348163)

Results Overview

Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

26 participants

Primary outcome timeframe

48 weeks

Results posted on

2022-10-03

Participant Flow

Of 26 enrolled participants, 21 met inclusion criteria and were randomized.

Participant milestones

Participant milestones
Measure	Switch ART Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.	Continue Current ART Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.
Overall Study STARTED	12	9
Overall Study COMPLETED	10	9
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Switch ART Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.	Continue Current ART Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.
Overall Study Withdrawal by Subject	2	0

Baseline Characteristics

(mo)BETTA Trial in Transwomen for Optimization of ART

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Total n=21 Participants Total of all reporting groups
Age, Continuous	45 years STANDARD_DEVIATION 10 • n=5 Participants	47 years STANDARD_DEVIATION 3 • n=7 Participants	45.85 years STANDARD_DEVIATION 7.85 • n=5 Participants
Sex/Gender, Customized Self-identified transgender women (TW)	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latina	7 Participants n=5 Participants	4 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized White	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Alaskan Native/American Indian	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race/Ethnicity, Customized Native Hawaiian/ Pacific/Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	12 participants n=5 Participants	9 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Number of participants who maintain \<50 copies/mL HIV-1 RNA for 48 weeks

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Frequency of Maintaining Undetectable HIV-1 RNA	8 Participants	10 Participants

PRIMARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Number of participants who discontinue study drug due to study-drug related adverse events (AEs, includes \>/= Grade 3 lab or clinical events)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Frequency of Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Baseline

Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Total	55.41 pounds (lbs) Interval 52.83 to 72.79	53.49 pounds (lbs) Interval 49.16 to 59.08

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Fat mass, total, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Total	71.57 pounds (lbs) Interval 47.22 to 77.42	62.07 pounds (lbs) Interval 53.12 to 71.29

SECONDARY outcome

Timeframe: Baseline

Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Trunk	42.21 pounds (lbs) Interval 22.34 to 46.9	30.80 pounds (lbs) Interval 27.82 to 38.14

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Fat mass, trunk, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Trunk	44.81 pounds (lbs) Interval 28.99 to 53.84	34.77 pounds (lbs) Interval 31.4 to 44.02

SECONDARY outcome

Timeframe: baseline

Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Limbs	19.60 pounds (lbs) Interval 12.3 to 20.77	21.09 pounds (lbs) Interval 16.19 to 23.5

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Fat mass, limbs, as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fat Mass, Limbs	22.50 pounds (lbs) Interval 16.33 to 35.39	23.59 pounds (lbs) Interval 17.92 to 25.48

SECONDARY outcome

Timeframe: Baseline

Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Total)	32.00 percentage of fat mass Interval 30.8 to 38.2	33.70 percentage of fat mass Interval 31.47 to 36.8

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Percentage of Fat mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Total)	34.00 percentage of fat mass Interval 29.6 to 44.1	35.70 percentage of fat mass Interval 33.0 to 40.0

SECONDARY outcome

Timeframe: Baseline

Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Trunk)	38.20 percentage of fat mass Interval 30.35 to 41.7	40.15 percentage of fat mass Interval 34.2 to 42.25

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Percentage of Fat mass (trunk) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Trunk)	43.30 percentage of fat mass Interval 31.2 to 45.9	41.90 percentage of fat mass Interval 37.7 to 44.15

SECONDARY outcome

Timeframe: Baseline

Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Limbs)	47.80 percentage of fat mass Interval 39.85 to 58.55	57.80 percentage of fat mass Interval 49.3 to 61.88

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Percentage of Fat mass (limbs) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Percentage of Fat Mass (Limbs)	62.60 percentage of fat mass Interval 47.2 to 71.7	59.50 percentage of fat mass Interval 56.85 to 65.35

SECONDARY outcome

Timeframe: Baseline

lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Lean Mass (Total)	124.38 pounds (lbs) Interval 112.11 to 146.06	108.74 pounds (lbs) Interval 99.65 to 121.56

SECONDARY outcome

Timeframe: Baseline

lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Lean Mass (Limb)	50.14 pounds (lbs) Interval 47.28 to 59.86	49.79 pounds (lbs) Interval 43.43 to 54.23

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

lean mass (total) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Lean Mass (Total)	137.37 pounds (lbs) Interval 111.4 to 150.36	110.20 pounds (lbs) Interval 101.34 to 116.69

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

lean mass (limb) as measured by Dual-energy X-ray absorptiometry (DXA)

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Lean Mass (Limb)	56.34 pounds (lbs) Interval 47.7 to 66.7	48.59 pounds (lbs) Interval 43.53 to 55.1

SECONDARY outcome

Timeframe: Baseline

The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Hepatic Fat Content	301 decibel per meter (dB/m) Interval 271.0 to 318.0	254 decibel per meter (dB/m) Interval 234.5 to 297.5

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

The controlled attenuation parameter (CAP) indicates quantity of fat in the liver (that is, hepatic fat content). CAP is assessed by performing transient elastography (TE) using a FibroScan device, which uses ultrasound. The CAP score is measured in decibels per meter (dB/m). CAP score ranges from 100 dB/m to 400 dB/m, and a higher score indicates greater hepatic fat content.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Hepatic Fat Content	256 decibel per meter (dB/m) Interval 235.0 to 294.0	253 decibel per meter (dB/m) Interval 236.5 to 309.5

SECONDARY outcome

Timeframe: Baseline

Total cholesterol level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Total Cholesterol	162 milligrams per deciliter (mg/dL) Interval 148.0 to 180.0	173 milligrams per deciliter (mg/dL) Interval 168.0 to 191.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Total cholesterol level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Total Cholesterol	162 milligrams per deciliter (mg/dL) Interval 156.0 to 171.0	167 milligrams per deciliter (mg/dL) Interval 158.0 to 185.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
High-density Lipoprotein (HDL) Cholesterol Level	44 milligrams per deciliter (mg/dL) Interval 37.0 to 58.0	42 milligrams per deciliter (mg/dL) Interval 38.0 to 50.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
High-density Lipoprotein (HDL) Cholesterol Level	45 milligrams per deciliter (mg/dL) Interval 39.0 to 52.0	54 milligrams per deciliter (mg/dL) Interval 45.0 to 59.0

SECONDARY outcome

Timeframe: Baseline

Triglyceride level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Triglycerides	90 milligrams per deciliter (mg/dL) Interval 87.0 to 131.0	167 milligrams per deciliter (mg/dL) Interval 96.0 to 335.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Triglyceride level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Triglycerides	81 milligrams per deciliter (mg/dL) Interval 74.0 to 145.0	112 milligrams per deciliter (mg/dL) Interval 93.0 to 129.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Low-density Lipoprotein (LDL) Cholesterol Level	93 milligrams per deciliter (mg/dL) Interval 79.0 to 104.0	98 milligrams per deciliter (mg/dL) Interval 91.0 to 112.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Low-density Lipoprotein (LDL) Cholesterol Level	92 milligrams per deciliter (mg/dL) Interval 92.0 to 95.0	96 milligrams per deciliter (mg/dL) Interval 81.0 to 118.0

SECONDARY outcome

Timeframe: Baseline

Fasting Glucose level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fasting Glucose Level	92 milligrams per deciliter (mg/dL) Interval 87.0 to 100.0	90 milligrams per deciliter (mg/dL) Interval 86.0 to 99.0

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Fasting Glucose level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Fasting Glucose Level	95 milligrams per deciliter (mg/dL) Interval 87.0 to 108.0	86 milligrams per deciliter (mg/dL) Interval 83.0 to 91.0

SECONDARY outcome

Timeframe: Baseline

The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as (\[(fasting insulin in mU/L) x (glucose in mmol/L)\]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Insulin Resistance	3.5 index Interval 1.3 to 9.9	2.6 index Interval 1.8 to 3.6

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

The Homeostatic Assessment Model of Insulin Resistance (HOMA-IR) is an index used to determine if insulin resistance is present. HOMA-IR is calculated as (\[(fasting insulin in mU/L) x (glucose in mmol/L)\]/22.5). Higher HOMA-IR values indicate greater insulin resistance. The threshold HOMA-IR value that indicates insulin resistance differs among different populations, but a common clinical cutoff is 2.6 (in other words, a HOMA-IR value of 2.6 or above is commonly interpreted to indicate insulin resistance).

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Insulin Resistance	3.9 index Interval 2.0 to 7.5	1.8 index Interval 1.1 to 3.1

SECONDARY outcome

Timeframe: Baseline

Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Oxidized Low-density Lipoprotein (LDL) Level	46282.62 Units per milliliter (U/mL) Interval 29348.98 to 51762.23	39859.07 Units per milliliter (U/mL) Interval 27316.6 to 53677.53

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Oxidized Low-density Lipoprotein (LDL) levels are assessed by testing blood

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Oxidized Low-density Lipoprotein (LDL) Level	35476.24 units per milliliter Interval 31894.04 to 45307.38	44375.63 units per milliliter Interval 27151.89 to 46665.4

SECONDARY outcome

Timeframe: Baseline

Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	4.40 kilopascal (kPa) Interval 4.1 to 4.6	4.35 kilopascal (kPa) Interval 4.15 to 4.45

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Fibrosis (that is, scarring of the liver) results in liver stiffness, and liver stiffness can be measured by liver elastography using a FibroScan device, which uses ultrasound. The liver stiffness measurement ranges from 2 kPa to 75 kPa, with a higher score indicating greater liver scarring and stiffness

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	3.90 kilopascal (kPa) Interval 3.8 to 5.1	4.30 kilopascal (kPa) Interval 3.8 to 5.15

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Aspartate Aminotransferase (AST) Level	19.00 international units per liter (IU/L) Interval 13.0 to 26.0	20.50 international units per liter (IU/L) Interval 17.75 to 24.75

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Aspartate Aminotransferase (AST) Level	20.00 international units per liter (IU/L) Interval 14.0 to 23.0	19.00 international units per liter (IU/L) Interval 14.5 to 23.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Alanine Transaminase (ALT) Level	18.00 international units per liter (IU/L) Interval 14.0 to 28.0	18.50 international units per liter (IU/L) Interval 15.0 to 22.25

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=11 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Alanine Transaminase (ALT) Level	16.00 international units per liter (IU/L) Interval 13.0 to 29.0	17.00 international units per liter (IU/L) Interval 11.0 to 21.0

SECONDARY outcome

Timeframe: Baseline

glomerular filtration rate (GFR) level

Outcome measures

Outcome measures
Measure	Continue Current ART n=9 Participants Continue current (ART) therapy (emtricitabine plus tenofovir disoproxil fumarate or tenofovir alafenamide plus 3rd agent) for 48 weeks Current ART: Comparator arm. Participant continues open label entry ART.	Switch ART n=12 Participants Switch from current antiretroviral therapy (ART) to B/FTC/TAF for 48 weeks B/FTC/TAF: B/FTC/TAF in one pill (single tablet regimen) for administration to participants in Arm A.
Estimated Glomerular Filtration Rate (CKD- Epi Equations)	105.00 mL/min/1.73m^2 Interval 95.1 to 114.3	110.65 mL/min/1.73m^2 Interval 97.08 to 121.93

SECONDARY outcome

Timeframe: 48 weeks

Population: Per the protocol, participants who have to discontinue study drug early but have been on study drug for at least 12 weeks will undergo a final evaluation at the time they discontinue. One participant in the Switch ART arm discontinued the study early at 36 weeks, and data was collected for this participant at 36 weeks--this 36-week data is included in the analysis of the 48 week timepoint.

glomerular filtration rate (GFR) level