B/F/TAF Oral Therapy for HIV

No longer recruiting at 20 trial locations

Overseen By Gilead Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Gilead Sciences

Must be taking: CAB+RPV

Must not be taking: Immunosuppressants, Chemotherapeutics

Disqualifiers: B/F/TAF intolerance, INSTI failure, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the safety and effectiveness of switching to a daily oral HIV treatment called Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) for individuals currently managing HIV with monthly injections of CAB+RPV. It targets those whose HIV is under control (not detectable in blood tests) and who either cannot or prefer not to continue with injections. Participants should have received the injection treatment without any missed doses and should not have resistance to the oral treatment components. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications that are not allowed with B/F/TAF, starting 30 days before the trial and continuing until 30 days after the last dose. If you're on any medications that are not compatible with B/F/TAF, you will need to stop them.

What is the safety track record for Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)?

Research has shown that the oral treatment Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) is safe for people living with HIV. Studies have found that B/F/TAF is highly effective, with many participants achieving undetectable virus levels after treatment. Over 48 weeks, participants tolerated the treatment well, and no major drug resistance was reported. Some side effects related to the drug were noted, but they were uncommon.

One study found that 92% of people using B/F/TAF maintained low virus levels after 12 months. This finding indicates that the treatment is safe and effective for long-term use. There were no major changes in the virus that could reduce the treatment's effectiveness.

Overall, B/F/TAF has a strong safety record and has been successfully used by many people with HIV. This makes it a promising option for those considering switching from other treatments. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

B/F/TAF is unique because it combines three powerful drugs—Bictegravir, Emtricitabine, and Tenofovir—into a single daily pill. This triple combination targets HIV in a new way by integrating an integrase inhibitor (Bictegravir) with two nucleoside reverse transcriptase inhibitors, which is different from many current treatments that might use separate pills or different combinations. Researchers are excited about B/F/TAF because it simplifies the treatment regimen for people with HIV, potentially improving adherence and overall effectiveness in managing the virus compared to traditional multi-pill therapies.

What is the effectiveness track record for B/F/TAF as an oral therapy for HIV?

Research has shown that the medication Bictegravir/Emtricitabine/Tenofovir (B/F/TAF), which participants in this trial will receive, works very well for people with HIV. Studies have found that it keeps the virus under control in 98% of participants over 96 weeks. Another study showed it was 92% effective after one year. B/F/TAF is also known to be safe and generally does not cause harmful changes in the body's metabolism. This treatment is already approved for HIV and has proven effective in managing the virus. ^{1 2 4 6 7}

Who Is on the Research Team?

Gilead Study Director

Principal Investigator

Gilead Sciences

Are You a Good Fit for This Trial?

This trial is for people with HIV-1 who have undetectable viral levels and are currently on CAB+RPV injections but want to switch to or need an oral medication due to side effects, inconvenience, or other reasons. Participants should be virologically suppressed for at least 6 months and have no resistance to the study drugs.

Inclusion Criteria

My HIV is under control with CAB+RPV injections every 2 months.

I am on a 2-month CAB+RPV injection schedule and haven't missed any doses.

I can start B/F/TAF treatment up to 7 days before my next CAB+RPV dose.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants switch to an oral therapy of B/F/TAF from CAB+RPV and receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bictegravir/Emtricitabine/Tenofovir (B/F/TAF)

Trial Overview The EMPOWER study is testing the safety and effectiveness of switching from injectable Cabotegravir + Rilpivirine (CAB+RPV) treatment to an oral regimen of Bictegravir/Emtricitabine/Tenofovir (B/F/TAF) in individuals whose HIV-1 virus is already well-controlled.

How Is the Trial Designed?

Group I: B/F/TAF Experimental Treatment 1 Intervention

Participants will receive a fixed dose combination of B/F/TAF 50/200/25 mg once daily for 24 weeks

Who Is Running the Clinical Trial?

Gilead Sciences

Lead Sponsor

Trials

1,150

Recruited

878,000+

Daniel O'Day

Gilead Sciences

Chief Executive Officer since 2019

MBA from Columbia University

Dietmar Berger

Gilead Sciences

Chief Medical Officer

MD and PhD from Albert-Ludwigs University School of Medicine

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39564653/

Effectiveness, safety, and patient-reported outcomes of ... BIC/FTC/TAF demonstrated high persistence, safety, virological efficacy, and favorable metabolic profile over 48 weeks.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2772707625001201

Real-world effectiveness, safety, and health-related quality ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) confirmed a high effectiveness of 92% in persons with HIV after 12 months. •. No major mutations ...

3. academic.oup.com academic.oup.com/jac/article/80/1/281/7903192

Efficacy of bictegravir/emtricitabine/tenofovir alafenamide ... In studies of intermittent ARV treatment, B/F/TAF maintained viral suppression in 98% of participants through Week 96 when administered 4 or 5 ...

4. tandfonline.com tandfonline.com/doi/abs/10.1080/25787489.2025.2456890

final 24-month effectiveness and safety outcomes in key ... Outcomes at 24 months included virologic suppression (HIV-1 RNA <50 copies/mL), immunologic effectiveness (change in CD4 cell count and CD4/CD8 ratio), ...

5. link.springer.com link.springer.com/article/10.1007/s40121-025-01153-y

A Pooled Analysis of Studies in People with HIV Outcomes after viremic events were categorized as: virologic resuppression (≥ 1 subsequent VL < 50 copies/mL); continued viremia (all subsequent ...

6. academic.oup.com academic.oup.com/ofid/article/11/11/ofae630/7826499

Effectiveness and Safety of Bictegravir/Emtricitabine/Tenofovir ... The BIC/FTC/TAF regimen showed a high virologic suppression rate, with HIV-1 RNA <50 copies/mL at an estimated rate of 93.8% at 48 weeks, similar to results of ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT02607930?tab=results

NCT02607930 | Study to Evaluate the Safety and Efficacy ... Bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF) shows high efficacy in clinical study participants infected with HIV-1 subtype F. [Poster P124]. HIV ...