Trial Outcomes & Findings for Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) (NCT NCT06104306)

NCT ID: NCT06104306

Last Updated: 2026-02-11

Results Overview

Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale. The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines: * Grade 1 indicates a mild event * Grade 2 indicates a moderate event * Grade 3 indicates a severe event * Grade 4 indicates a potentially life-threatening event * Grade 5 indicates death

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 33 participants
• Primary outcome timeframe: Week 12
• Results posted on: 2026-02-11

Participant Flow

Participants were enrolled at study sites in the United States, France, and Canada.

36 participants were screened.

Participant milestones

Measure	Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on cabotegravir + rilpivirine (CAB + RPV) intramuscular (IM) injections or were wishing to switch to oral therapy, received a fixed dose combination of bictegravir/emtricitabine/tenofovir (B/F/TAF) 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Overall Study STARTED	33
Overall Study COMPLETED	29
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Measure	Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on cabotegravir + rilpivirine (CAB + RPV) intramuscular (IM) injections or were wishing to switch to oral therapy, received a fixed dose combination of bictegravir/emtricitabine/tenofovir (B/F/TAF) 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Overall Study Lost to Follow-up	2
Overall Study Death	1
Overall Study Withdrew Consent	1

Baseline Characteristics

Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)

Baseline characteristics by cohort

Measure	B/F/TAF n=33 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on cabotegravir + rilpivirine (CAB + RPV) intramuscular (IM) injections or were wishing to switch to oral therapy, received a fixed dose combination of bictegravir/emtricitabine/tenofovir (B/F/TAF) 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Age, Categorical <=18 years	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	28 Participants n=4 Participants
Age, Categorical >=65 years	5 Participants n=4 Participants
Age, Continuous	47 years STANDARD_DEVIATION 14.7 • n=4 Participants
Sex: Female, Male Female	9 Participants n=4 Participants
Sex: Female, Male Male	24 Participants n=4 Participants
Race/Ethnicity, Customized Race · White	18 Participants n=4 Participants
Race/Ethnicity, Customized Race · Black or African American	6 Participants n=4 Participants
Race/Ethnicity, Customized Race · Not Collected	4 Participants n=4 Participants
Race/Ethnicity, Customized Race · Other or More Than One Race	2 Participants n=4 Participants
Race/Ethnicity, Customized Race · American Indian or Alaska Native	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Asian	1 Participants n=4 Participants
Race/Ethnicity, Customized Race · Native Hawaiian or Other Pacific Islander	1 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Hispanic or Latino	20 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Hispanic or Latino	11 Participants n=4 Participants
Race/Ethnicity, Customized Ethnicity · Not Collected	2 Participants n=4 Participants
Region of Enrollment United States	27 Participants n=4 Participants
Region of Enrollment France	4 Participants n=4 Participants
Region of Enrollment Canada	2 Participants n=4 Participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants in the Safety Analysis Set were analyzed.

Treatment emergent adverse events (TEAEs) were defined as any AE that began on or after the date of first dose of study drug up to the date of last dose of study drug plus 30 days or any AE leading to study drug discontinuation. The severity of AEs were be graded using the Division of AIDS (DAIDS) Toxicity Grading Scale.

The DAIDS grading table provide an adverse events (AE) severity grading scale ranging from grades 1 to 5 with descriptions for each AE based on the following general guidelines:

• Grade 1 indicates a mild event
• Grade 2 indicates a moderate event
• Grade 3 indicates a severe event
• Grade 4 indicates a potentially life-threatening event
• Grade 5 indicates death

Outcome measures

Measure	B/F/TAF n=33 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint)	0 percentage of participants

PRIMARY outcome

Timeframe: Week 12

Population: Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation, were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.

The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.

Outcome measures

Measure	B/F/TAF n=32 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint)	3.1 percentage of participants

SECONDARY outcome

Timeframe: Day 1 (Predose)

Population: CAB Pharmacokinetics (PK) Analysis Set and RPV PK Analysis Set included all enrolled participants who received at least 1 dose of study drug and CAB and RPV prior to joining the study, and had at least 1 nonmissing CAB and RPV concentration values reported by the PK laboratory tests. Participants in the CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed.

Outcome measures

Measure	B/F/TAF n=29 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose) CAB	1650 ng/mL Standard Deviation 1010
Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose) RPV	68.3 ng/mL Standard Deviation 26.1

SECONDARY outcome

Timeframe: Week 4 (at trough and 2 hours postdose)

Population: BIC PK Analysis Set included all enrolled participants who received at least 1 dose of study drug and CAB and RPV prior to joining the study, and had at least 1 nonmissing BIC concentration value reported by the PK laboratory test. Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed.

Outcome measures

Measure	B/F/TAF n=25 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 BIC, Trough	3590 ng/mL Standard Deviation 2030
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 BIC, 2 Hours Postdose	6350 ng/mL Standard Deviation 2210
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 CAB, Trough	929 ng/mL Standard Deviation 739
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 CAB, 2 Hours Postdose	975 ng/mL Standard Deviation 761
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 RPV, Trough	57.8 ng/mL Standard Deviation 20.8
Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 RPV, 2 Hours Postdose	55.7 ng/mL Standard Deviation 21.1

SECONDARY outcome

Timeframe: Week 12 (at trough and 2 hours postdose)

Population: Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed.

Outcome measures

Measure	B/F/TAF n=24 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Plasma Concentration of BIC, CAB, and RPV at Week 12 BIC, Trough	3850 ng/mL Standard Deviation 2550
Plasma Concentration of BIC, CAB, and RPV at Week 12 BIC, 2 Hours Postdose	6550 ng/mL Standard Deviation 2100
Plasma Concentration of BIC, CAB, and RPV at Week 12 CAB, Trough	667 ng/mL Standard Deviation 982
Plasma Concentration of BIC, CAB, and RPV at Week 12 CAB, 2 Hours Postdose	647 ng/mL Standard Deviation 873
Plasma Concentration of BIC, CAB, and RPV at Week 12 RPV, Trough	47.2 ng/mL Standard Deviation 22.4
Plasma Concentration of BIC, CAB, and RPV at Week 12 RPV, 2 Hours Postdose	45.4 ng/mL Standard Deviation 22.4

SECONDARY outcome

Timeframe: Week 24 (at trough and 2 hours postdose)

Population: Participants in the BIC PK, CAB PK and RPV PK Analysis Sets with available data (samples collected as per the protocol) were analyzed.

Outcome measures

Measure	B/F/TAF n=20 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Plasma Concentration of BIC, CAB, and RPV at Week 24 BIC, Trough	2820 ng/mL Standard Deviation 1530
Plasma Concentration of BIC, CAB, and RPV at Week 24 BIC, 2 Hours Postdose	6410 ng/mL Standard Deviation 1340
Plasma Concentration of BIC, CAB, and RPV at Week 24 CAB, Trough	NA ng/mL Standard Deviation NA Data not available, as per the pre-specified analysis in the SAP, that data cannot be calculated where 1/3 participants had below the level of quantification (BLQ) concentrations.
Plasma Concentration of BIC, CAB, and RPV at Week 24 CAB, 2 Hours Postdose	NA ng/mL Standard Deviation NA Data not available, as per the pre-specified analysis in the SAP, that data cannot be calculated where 1/3 participants had below the level of quantification (BLQ) concentrations.
Plasma Concentration of BIC, CAB, and RPV at Week 24 RPV, Trough	37.1 ng/mL Standard Deviation 22.3
Plasma Concentration of BIC, CAB, and RPV at Week 24 RPV, 2 Hours Postdose	33.1 ng/mL Standard Deviation 17.4

SECONDARY outcome

Timeframe: Week 12

Population: The Full Analysis Set included all enrolled participants who received at least 1 dose of the study drug (B/F/TAF). Participants in the Full Analysis Set with available data were analyzed.

This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.

Outcome measures

Measure	B/F/TAF n=30 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach	0.0 percentage of participants Interval 0.0 to 11.6

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

This outcome measure analyzed using the Missing = Excluded (M = E) method. In this approach, all missing data were excluded in the analysis.

Outcome measures

Measure	B/F/TAF n=29 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach	0.0 percentage of participants Interval 0.0 to 11.9

SECONDARY outcome

Timeframe: Week 12

Population: Participants in the Full Analysis Set with available data were analyzed.

This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.

Outcome measures

Measure	B/F/TAF n=31 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach	3.2 percentage of participants Interval 0.1 to 16.7

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Full Analysis Set with available data were analyzed.

This outcome measure was analyzed using the Discontinuation = Failure (D = F) method. In this approach, all discontinuation were treated as HIV-1 RNA >= 50 copies/mL (failure) in the analysis.

Outcome measures

Measure	B/F/TAF n=32 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach	9.4 percentage of participants Interval 2.0 to 25.0

SECONDARY outcome

Timeframe: Up to 12 Weeks

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	B/F/TAF n=33 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With Discontinuation of B/F/TAF by Week 12	3.0 percentage of participants Interval 0.1 to 15.8

SECONDARY outcome

Timeframe: Up to 24 Weeks

Population: Participants in the Full Analysis Set were analyzed.

Outcome measures

Measure	B/F/TAF n=33 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants With Discontinuation of B/F/TAF by Week 24	9.1 percentage of participants Interval 1.9 to 24.3

SECONDARY outcome

Timeframe: Week 24

Population: Participants in the Safety Analysis Set with at least 1 postbaseline value for the test under evaluation value were analyzed.

Treatment-emergent laboratory abnormalities were defined as values that increased at least 1 toxicity grade from baseline at any time after baseline up to and including the date of last dose of study drug plus 30 days.

The DAIDS Toxicity Grading Scale, Version 2.1 was used to assign toxicity grades (0 to 4) to laboratory results for analysis. Grade 0 included all values that did not meet the criteria for an abnormality of at least Grade 1. Grade 1 mild, Grade 2 moderate, Grade 3 severe, and Grade 4 potentially life-threatening.

Outcome measures

Measure	B/F/TAF n=32 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24	6.3 percentage of participants

SECONDARY outcome

Timeframe: Week 4

Population: Participants in the Full Analysis Set with available data were analyzed.

The HIVTSQc was a 1-12 items questionnaire. Each item was scored -3 to 3. The total score ranged from -33 to +33, based on 11 items. Higher the score, greater the improvement in satisfaction with treatment; the lower the score, the greater the deterioration in satisfaction with treatment. A score of 0 represented no change.

Outcome measures

Measure	B/F/TAF n=32 Participants Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
HIV Treatment Satisfaction (HIVTSQc) Score at Week 4	27 score on scale Standard Deviation 9.0

Adverse Events

B/F/TAF

Serious events: 2 serious events

Other events: 10 other events

Deaths: 1 deaths

Serious adverse events

Measure	B/F/TAF n=33 participants at risk Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Gastrointestinal disorders Abdominal pain upper	3.0% 1/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Gastrointestinal disorders Diverticulum intestinal	3.0% 1/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Gastrointestinal disorders Gastrointestinal haemorrhage	3.0% 1/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Injury, poisoning and procedural complications Road traffic accident	3.0% 1/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).

Other adverse events

Measure	B/F/TAF n=33 participants at risk Participants living with virologically suppressed HIV-1 infection who were unable/unwilling to continue on CAB + RPV IM injections or were wishing to switch to oral therapy, received a fixed dose combination of B/F/TAF 50/200/25 mg tablets orally, once daily for up to 24 weeks.
Gastrointestinal disorders Diarrhoea	12.1% 4/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Gastrointestinal disorders Nausea	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Gastrointestinal disorders Vomiting	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Infections and infestations Upper respiratory tract infection	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Musculoskeletal and connective tissue disorders Back pain	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Musculoskeletal and connective tissue disorders Neck pain	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Nervous system disorders Dizziness	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).
Nervous system disorders Headache	6.1% 2/33 • All-cause mortality: Up to 25 weeks; Adverse events: Up to 24 weeks plus 30 days All-cause mortality: The All Enrolled Analysis Set included all participants enrolled into the study after screening. Adverse events: The Safety Analysis Set included all enrolled participants who have received at least 1 dose of the study drug (B/F/TAF).

Additional Information

Gilead Clinical Study Information Center

Gilead Sciences

Phone: 1-833-445-3230 (GILEAD-0)

Email: GileadClinicalTrials@gilead.com

Results disclosure agreements

• Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
• Publication restrictions are in place

Restriction type: OTHER