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B/FTC/TAF
B/FTC/TAF is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase to prevent viral replication.
B/FTC/TAF is a fixed-dose combination antiretroviral that inhibits HIV reverse transcriptase and integrase to prevent viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults.
At a glance
| Generic name | B/FTC/TAF |
|---|---|
| Sponsor | The University of Texas Health Science Center, Houston |
| Drug class | Antiretroviral combination (integrase inhibitor + nucleoside/nucleotide reverse transcriptase inhibitors) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Bictegravir (B) is an integrase strand transfer inhibitor that blocks HIV integration into host DNA. Emtricitabine (FTC) and tenofovir alafenamide (TAF) are nucleoside/nucleotide reverse transcriptase inhibitors that prevent reverse transcription of viral RNA. Together, these three agents target multiple steps of the HIV replication cycle.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
Key clinical trials
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (PHASE2, PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- REINItiation of Antiretroviral Therapy Using Oral bicTegravir, emtrIcitAbine and Tenofovir alafenamidE: A Multi-Center, Single-Arm, Open-Label, Phase 4 Study Assessing the Safety and Efficacy of B/F/TAF in HIV-Positive Adults Returning to Care After Experiencing a Treatment Interruption of ≥12 Weeks (PHASE4)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- A Phase 2b Study Evaluating Oral VH4524184 Regimens in Treatment Naïve Persons With HIV-1 (INNOVATE Study) (PHASE2)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV (PHASE1)
- Study of B/F/TAF in Participants Switching From CAB + RPV to B/F/TAF for HIV-1 Infection (EMPOWER) (PHASE4)
- Study Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- B/FTC/TAF CI brief — competitive landscape report
- B/FTC/TAF updates RSS · CI watch RSS
- The University of Texas Health Science Center, Houston portfolio CI