Last reviewed · How we verify
Bictegravir, emtricitabine, and tenofovir alafenamide
Bictegravir, emtricitabine, and tenofovir alafenamide is a Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) Small molecule drug developed by CAN Community Health. It is currently FDA-approved for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 infection as a complete regimen for antiretroviral therapy. Also known as: B/F/TAF, BIKTARVY®.
This combination inhibits HIV reverse transcriptase and integrase to block viral replication and prevent the integration of viral DNA into the host genome.
This combination inhibits HIV reverse transcriptase and integrase to block viral replication and prevent the integration of viral DNA into the host genome. 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 | Bictegravir, emtricitabine, and tenofovir alafenamide |
|---|---|
| Also known as | B/F/TAF, BIKTARVY® |
| Sponsor | CAN Community Health |
| Drug class | Antiretroviral combination (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 is an integrase strand transfer inhibitor (INSTI) that prevents HIV from integrating into host cell DNA. Emtricitabine and tenofovir alafenamide are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs) that block the enzyme responsible for converting viral RNA into DNA. Together, these three agents target multiple steps of the HIV replication cycle to suppress viral load.
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
- Renal impairment (with tenofovir component)
Key clinical trials
- Spotting Syphilis: A Dual Point-of-Care Syphilis Screening Initiative in a Low-Resource Healthcare Setting (NA)
- 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)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study of Bictegravir/Emtricitabine/Tenofovir Alafenamide in Newborns Exposed to HIV (PHASE1)
- Study of GS-3242 in Participants With HIV-1; Substudy-05 (PHASE1)
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:
- Bictegravir, emtricitabine, and tenofovir alafenamide CI brief — competitive landscape report
- Bictegravir, emtricitabine, and tenofovir alafenamide updates RSS · CI watch RSS
- CAN Community Health portfolio CI
Frequently asked questions about Bictegravir, emtricitabine, and tenofovir alafenamide
What is Bictegravir, emtricitabine, and tenofovir alafenamide?
How does Bictegravir, emtricitabine, and tenofovir alafenamide work?
What is Bictegravir, emtricitabine, and tenofovir alafenamide used for?
Who makes Bictegravir, emtricitabine, and tenofovir alafenamide?
Is Bictegravir, emtricitabine, and tenofovir alafenamide also known as anything else?
What drug class is Bictegravir, emtricitabine, and tenofovir alafenamide in?
What development phase is Bictegravir, emtricitabine, and tenofovir alafenamide in?
What are the side effects of Bictegravir, emtricitabine, and tenofovir alafenamide?
What does Bictegravir, emtricitabine, and tenofovir alafenamide target?
Related
- Drug class: All Antiretroviral combination (integrase inhibitor + nucleoside reverse transcriptase inhibitors) drugs
- Target: All drugs targeting HIV integrase, HIV reverse transcriptase
- Manufacturer: CAN Community Health — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced adults
- Indication: Drugs for HIV-1 infection as a complete regimen for antiretroviral therapy
- Also known as: B/F/TAF, BIKTARVY®
- Compare: Bictegravir, emtricitabine, and tenofovir alafenamide vs similar drugs
- Pricing: Bictegravir, emtricitabine, and tenofovir alafenamide cost, discount & access