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BIC/FTC/TAF
BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that work together to suppress HIV replication by inhibiting reverse transcriptase and integrase enzymes.
BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that work together to suppress HIV replication by inhibiting reverse transcriptase and integrase enzymes. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection as a complete regimen for antiretroviral therapy.
At a glance
| Generic name | BIC/FTC/TAF |
|---|---|
| Also known as | Biktarvy, Bictegravir/emtricitabine/tenofovir alafenamide, BIKTARVY®, Bictegravir/Emtricitabine/Tenofovir Alafenamide, bictegravir/emtricitabine/tenofovir alafenamide |
| Sponsor | Prism Health North Texas |
| Drug class | Antiretroviral combination therapy (integrase inhibitor + nucleoside reverse transcriptase inhibitors) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Bictegravir (BIC) is an integrase strand transfer inhibitor that prevents HIV from integrating into host cell DNA. Emtricitabine (FTC) and tenofovir alafenamide (TAF) are nucleoside/nucleotide reverse transcriptase inhibitors that block the reverse transcriptase enzyme needed for HIV replication. Together, these three agents provide complementary mechanisms to achieve potent viral suppression.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 infection as a complete regimen for antiretroviral therapy
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Abnormal liver function tests
Key clinical trials
- A Clinical Study of Islatravir and Ulonivirine for People With HIV-1 Who Have Not Been Treated Before (MK-8591B-062) (PHASE2, PHASE3)
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide Fixed Dose Combination in Adolescents and Children With Human Immunodeficiency Virus-1 (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)
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (PHASE3)
- Dose Ranging, Switch Study of Islatravir (MK-8591) and Ulonivirine (MK-8507) Once-Weekly in Virologically-Suppressed Adults With Human Immunodeficiency Virus Type 1 (HIV-1) [MK-8591-013] (PHASE2)
- A Study to Evaluate the Efficacy, Safety, and Tolerability of Using an Oral Once-daily 2 Drug Regimen Compared to an Oral Once-daily 3 Drug Regimen for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Adults Who Have Not Previously Taken Antiretroviral Therapy (PHASE3)
- A Study to Evaluate Efficacy, Safety and Tolerability in Antiretroviral Therapy (ART)-Experienced Participants of at Least 50 Years of Age Living With Human Immunodeficiency Virus (HIV) With Virologic Suppression Who Switch to DTG/3TC FDC From BIC/FTC/TAF (PHASE3)
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:
- BIC/FTC/TAF CI brief — competitive landscape report
- BIC/FTC/TAF updates RSS · CI watch RSS
- Prism Health North Texas portfolio CI