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Placebo to BIC/FTC/TAF
BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication.
BIC/FTC/TAF is a fixed-dose combination of three antiretroviral agents that inhibit HIV reverse transcriptase and integrase to suppress viral replication. Used for HIV-1 infection in treatment-naïve adults, HIV-1 infection in treatment-experienced adults (as part of combination antiretroviral therapy).
At a glance
| Generic name | Placebo to BIC/FTC/TAF |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Antiretroviral combination (INSTI + NRTI + NtRTI) |
| Target | HIV integrase, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Bictegravir (BIC) is an integrase strand transfer inhibitor (INSTI) that blocks HIV integrase, preventing viral DNA integration into the host genome. Emtricitabine (FTC) and tenofovir alafenamide (TAF) are nucleoside/nucleotide reverse transcriptase inhibitors (NRTIs/NtRTIs) that inhibit reverse transcriptase, blocking conversion of viral RNA to DNA. Together, these three agents provide complementary mechanisms to suppress HIV replication.
Approved indications
- HIV-1 infection in treatment-naïve adults
- HIV-1 infection in treatment-experienced adults (as part of combination 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 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 Switch to Doravirine/Islatravir (DOR/ISL) in Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Who Are Virologically Suppressed on Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-052) (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With Biktarvy (PHASE3)
- DOR/ISL in HIV-1 Antiretroviral Treatment-naïve Participants (MK-8591A-053) (PHASE3)
- Phase IV, a Clinical Trial to Assess Safety and Convenience of the Change From DTG/3TC to BIC/FTC/TAF in People With HIV, Good Virological Control and Neuropsychiatric Vulnerabilities (PHASE4)
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:
- Placebo to BIC/FTC/TAF CI brief — competitive landscape report
- Placebo to BIC/FTC/TAF updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI