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

Results Overview

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

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=99 Participants	47 years STANDARD_DEVIATION 3 • n=107 Participants	45.85 years STANDARD_DEVIATION 7.85 • n=206 Participants
Sex/Gender, Customized Self-identified transgender women (TW)	12 Participants n=99 Participants	9 Participants n=107 Participants	21 Participants n=206 Participants
Sex: Female, Male Female	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Sex: Female, Male Male	12 Participants n=99 Participants	9 Participants n=107 Participants	21 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic/Latina	7 Participants n=99 Participants	4 Participants n=107 Participants	11 Participants n=206 Participants
Race/Ethnicity, Customized White	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Race/Ethnicity, Customized Black/African American	3 Participants n=99 Participants	2 Participants n=107 Participants	5 Participants n=206 Participants
Race/Ethnicity, Customized Asian	2 Participants n=99 Participants	0 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Alaskan Native/American Indian	0 Participants n=99 Participants	2 Participants n=107 Participants	2 Participants n=206 Participants
Race/Ethnicity, Customized Native Hawaiian/ Pacific/Islander	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Region of Enrollment United States	12 participants n=99 Participants	9 participants n=107 Participants	21 participants n=206 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	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.	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.
Frequency of Maintaining Undetectable HIV-1 RNA	10 Participants	8 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	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.	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.
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	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.
Fat Mass, Total	53.49 pounds (lbs) Interval 49.16 to 59.08	55.41 pounds (lbs) Interval 52.83 to 72.79

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	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.	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.
Fat Mass, Total	62.07 pounds (lbs) Interval 53.12 to 71.29	71.57 pounds (lbs) Interval 47.22 to 77.42

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Fat Mass, Trunk	30.80 pounds (lbs) Interval 27.82 to 38.14	42.21 pounds (lbs) Interval 22.34 to 46.9

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	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.	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.
Fat Mass, Trunk	34.77 pounds (lbs) Interval 31.4 to 44.02	44.81 pounds (lbs) Interval 28.99 to 53.84

SECONDARY outcome

Timeframe: baseline

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

Outcome measures

Outcome measures
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.
Fat Mass, Limbs	21.09 pounds (lbs) Interval 16.19 to 23.5	19.60 pounds (lbs) Interval 12.3 to 20.77

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	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.	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.
Fat Mass, Limbs	23.59 pounds (lbs) Interval 17.92 to 25.48	22.50 pounds (lbs) Interval 16.33 to 35.39

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Percentage of Fat Mass (Total)	33.70 percentage of fat mass Interval 31.47 to 36.8	32.00 percentage of fat mass Interval 30.8 to 38.2

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	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.	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.
Percentage of Fat Mass (Total)	35.70 percentage of fat mass Interval 33.0 to 40.0	34.00 percentage of fat mass Interval 29.6 to 44.1

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Percentage of Fat Mass (Trunk)	40.15 percentage of fat mass Interval 34.2 to 42.25	38.20 percentage of fat mass Interval 30.35 to 41.7

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	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.	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.
Percentage of Fat Mass (Trunk)	41.90 percentage of fat mass Interval 37.7 to 44.15	43.30 percentage of fat mass Interval 31.2 to 45.9

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Percentage of Fat Mass (Limbs)	57.80 percentage of fat mass Interval 49.3 to 61.88	47.80 percentage of fat mass Interval 39.85 to 58.55

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	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.	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.
Percentage of Fat Mass (Limbs)	59.50 percentage of fat mass Interval 56.85 to 65.35	62.60 percentage of fat mass Interval 47.2 to 71.7

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Lean Mass (Total)	108.74 pounds (lbs) Interval 99.65 to 121.56	124.38 pounds (lbs) Interval 112.11 to 146.06

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Lean Mass (Limb)	49.79 pounds (lbs) Interval 43.43 to 54.23	50.14 pounds (lbs) Interval 47.28 to 59.86

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	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.	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.
Lean Mass (Total)	110.20 pounds (lbs) Interval 101.34 to 116.69	137.37 pounds (lbs) Interval 111.4 to 150.36

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	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.	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.
Lean Mass (Limb)	48.59 pounds (lbs) Interval 43.53 to 55.1	56.34 pounds (lbs) Interval 47.7 to 66.7

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	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.
Hepatic Fat Content	254 decibel per meter (dB/m) Interval 234.5 to 297.5	301 decibel per meter (dB/m) Interval 271.0 to 318.0

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.

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	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.	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.
Hepatic Fat Content	253 decibel per meter (dB/m) Interval 236.5 to 309.5	256 decibel per meter (dB/m) Interval 235.0 to 294.0

SECONDARY outcome

Timeframe: Baseline

Total cholesterol level

Outcome measures

Outcome measures
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 Cholesterol	173 milligrams per deciliter (mg/dL) Interval 168.0 to 191.0	162 milligrams per deciliter (mg/dL) Interval 148.0 to 180.0

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	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.	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 Cholesterol	167 milligrams per deciliter (mg/dL) Interval 158.0 to 185.0	162 milligrams per deciliter (mg/dL) Interval 156.0 to 171.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
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.
High-density Lipoprotein (HDL) Cholesterol Level	42 milligrams per deciliter (mg/dL) Interval 38.0 to 50.0	44 milligrams per deciliter (mg/dL) Interval 37.0 to 58.0

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	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.	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.
High-density Lipoprotein (HDL) Cholesterol Level	54 milligrams per deciliter (mg/dL) Interval 45.0 to 59.0	45 milligrams per deciliter (mg/dL) Interval 39.0 to 52.0

SECONDARY outcome

Timeframe: Baseline

Triglyceride level

Outcome measures

Outcome measures
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.
Triglycerides	167 milligrams per deciliter (mg/dL) Interval 96.0 to 335.0	90 milligrams per deciliter (mg/dL) Interval 87.0 to 131.0

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	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.	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.
Triglycerides	112 milligrams per deciliter (mg/dL) Interval 93.0 to 129.0	81 milligrams per deciliter (mg/dL) Interval 74.0 to 145.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
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.
Low-density Lipoprotein (LDL) Cholesterol Level	98 milligrams per deciliter (mg/dL) Interval 91.0 to 112.0	93 milligrams per deciliter (mg/dL) Interval 79.0 to 104.0

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	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.	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.
Low-density Lipoprotein (LDL) Cholesterol Level	96 milligrams per deciliter (mg/dL) Interval 81.0 to 118.0	92 milligrams per deciliter (mg/dL) Interval 92.0 to 95.0

SECONDARY outcome

Timeframe: Baseline

Fasting Glucose level

Outcome measures

Outcome measures
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.
Fasting Glucose Level	90 milligrams per deciliter (mg/dL) Interval 86.0 to 99.0	92 milligrams per deciliter (mg/dL) Interval 87.0 to 100.0

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	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.	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.
Fasting Glucose Level	86 milligrams per deciliter (mg/dL) Interval 83.0 to 91.0	95 milligrams per deciliter (mg/dL) Interval 87.0 to 108.0

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	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.
Insulin Resistance	2.6 index Interval 1.8 to 3.6	3.5 index Interval 1.3 to 9.9

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	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.	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.
Insulin Resistance	1.8 index Interval 1.1 to 3.1	3.9 index Interval 2.0 to 7.5

SECONDARY outcome

Timeframe: Baseline

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

Outcome measures

Outcome measures
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.
Oxidized Low-density Lipoprotein (LDL) Level	39859.07 Units per milliliter (U/mL) Interval 27316.6 to 53677.53	46282.62 Units per milliliter (U/mL) Interval 29348.98 to 51762.23

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.

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

Outcome measures

Outcome measures
Measure	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.	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.
Oxidized Low-density Lipoprotein (LDL) Level	44375.63 units per milliliter Interval 27151.89 to 46665.4	35476.24 units per milliliter Interval 31894.04 to 45307.38

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	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.
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	4.35 kilopascal (kPa) Interval 4.15 to 4.45	4.40 kilopascal (kPa) Interval 4.1 to 4.6

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.

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	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.	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.
Hepatic Fibrosis as Indicated by Liver Stiffness Measurement	4.30 kilopascal (kPa) Interval 3.8 to 5.15	3.90 kilopascal (kPa) Interval 3.8 to 5.1

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
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.
Aspartate Aminotransferase (AST) Level	20.50 international units per liter (IU/L) Interval 17.75 to 24.75	19.00 international units per liter (IU/L) Interval 13.0 to 26.0

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	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.	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.
Aspartate Aminotransferase (AST) Level	19.00 international units per liter (IU/L) Interval 14.5 to 23.0	20.00 international units per liter (IU/L) Interval 14.0 to 23.0

SECONDARY outcome

Timeframe: Baseline

Outcome measures

Outcome measures
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.
Alanine Transaminase (ALT) Level	18.50 international units per liter (IU/L) Interval 15.0 to 22.25	18.00 international units per liter (IU/L) Interval 14.0 to 28.0

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	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.	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.
Alanine Transaminase (ALT) Level	17.00 international units per liter (IU/L) Interval 11.0 to 21.0	16.00 international units per liter (IU/L) Interval 13.0 to 29.0

SECONDARY outcome

Timeframe: Baseline

glomerular filtration rate (GFR) level

Outcome measures

Outcome measures
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.
Estimated Glomerular Filtration Rate (CKD- Epi Equations)	110.65 mL/min/1.73m^2 Interval 97.08 to 121.93	105.00 mL/min/1.73m^2 Interval 95.1 to 114.3

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