Phase 4
N=33
Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER)
HIV-1-infection
Bottom Line
View on ClinicalTrials.gov: NCT06104306 ↗Enrolled (actual)
33
Serious AEs
6.1%
Results posted
Feb 2026
Primary outcome: Primary: Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) — 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- B/F/TAF (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Gilead Sciences
- Primary completion
- Jan 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Experiencing Treatment Emergent Grade 3 or 4 Drug-related Adverse Events Through Week 12 (Co-Primary Endpoint) |
— | — |
| PRIMARY Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 12 (Co-Primary Endpoint) |
3.1 | — |
| SECONDARY Plasma Concentrations of Cabotegravir (CAB), and Rilpivirine (RPV) at Day 1 (Predose) |
1650; 68.3 | — |
| SECONDARY Plasma Concentration of Bictegravir (BIC), CAB, and RPV at Week 4 |
3590; 6350; 929; 975; 57.8; 55.7 | — |
| SECONDARY Plasma Concentration of BIC, CAB, and RPV at Week 12 |
3850; 6550; 667; 647; 47.2; 45.4 | — |
| SECONDARY Plasma Concentration of BIC, CAB, and RPV at Week 24 |
2820; 6410; NA; NA; 37.1; 33.1 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Missing = Excluded Approach |
0.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Missing = Excluded Approach |
0.0 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 12 as Determined by Discontinuation = Failure Approach |
3.2 | — |
| SECONDARY Percentage of Participants With HIV-1 RNA ≥ 50 Copies/mL at Week 24 as Determined by Discontinuation = Failure Approach |
9.4 | — |
| SECONDARY Percentage of Participants With Discontinuation of B/F/TAF by Week 12 |
3.0 | — |
| SECONDARY Percentage of Participants With Discontinuation of B/F/TAF by Week 24 |
9.1 | — |
| SECONDARY Percentage of Participants Experiencing Treatment-emergent Grade 3 or 4 Laboratory Abnormalities Through Week 24 |
6.3 | — |
| SECONDARY HIV Treatment Satisfaction (HIVTSQc) Score at Week 4 |
27 | — |
Summary
The goal of this clinical study is to learn how safe it is to switch to an oral therapy of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) from Cabotegravir + Rilpivirine (CAB+RPV) in participants living with virologically suppressed human immunodeficiency virus type 1 (HIV-1), meaning participants with HIV RNA levels below detectable levels.
The primary objective of this study is to assess the safety of switching to B/F/TAF in virologically suppressed participants unable/unwilling to continue on CAB+RPV intramuscular (IM) injections or wishing to switch to oral therapy through Week 12.
Eligibility Criteria
Key Inclusion Criteria
- People with human immunodeficiency virus type 1 (HIV-1) (PWH) or provider decision to switch off cabotegravir + rilpivirine (CAB+RPV) intramuscular (IM) injections due to intolerance, inconvenience, adverse events (AEs), or willing to switch to (and intention to remain on) daily bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF).
- Currently virologically suppressed (HIV-1 ribonucleic acid (RNA) < 50 copies/mL) on CAB+RPV IM injections every 2 months.
- Currently on CAB+RPV IM injections every 2 months and received at least one dose of CAB+RPV IM injection; no missed CAB+RPV injections.
- Ability to receive B/F/TAF up to 7 days prior to the next scheduled dose of CAB+RPV.
- Documented plasma HIV-1 RNA < 50 copies/mL during treatment for ≥ 6 months preceding the screening visit.
- No documented or suspected resistance to bictegravir, emtricitabine, or tenofovir.
Key Exclusion Criteria
- History of B/F/TAF intolerance.
- History of previous integrase strand-transfer inhibitor (INSTI) virologic failure including CAB+RPV.
- Requirement for ongoing therapy with any prohibited medications listed in local prescribing information for B/F/TAF starting within 30 days prior to screening until 30 days following the last dose of study drug.
- Have been treated within 3 months of study screening or expected to receive during the study immunosuppressant therapies or chemotherapeutic agents (eg, chronic (at least 4 weeks) systemic steroids, immunoglobulins, and other immune- or cytokine-based therapies)
- Need for oral antiretroviral therapy (ART) bridge or use of other antiretroviral (ARV) agents prior to starting B/F/TAF on Day 1
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Data sourced from ClinicalTrials.gov (NCT06104306). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.