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TAF/FTC FDC
TAF/FTC is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors that block HIV reverse transcriptase to prevent viral replication.
TAF/FTC is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors that block HIV reverse transcriptase to prevent viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced adults, HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals.
At a glance
| Generic name | TAF/FTC FDC |
|---|---|
| Sponsor | Janssen Scientific Affairs, LLC |
| Drug class | Nucleoside reverse transcriptase inhibitor (NRTI) combination |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Tenofovir alafenamide (TAF) and emtricitabine (FTC) are both nucleoside reverse transcriptase inhibitors (NRTIs) that work synergistically to inhibit HIV reverse transcriptase, an enzyme essential for viral replication. TAF is a prodrug that delivers tenofovir to target cells with improved intracellular activation and reduced systemic exposure compared to tenofovir disoproxil fumarate (TDF). When combined as an FDC, they provide complementary antiviral activity with a favorable tolerability profile.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced adults
- HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Abnormal liver function tests
- Renal function changes
Key clinical trials
- 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)
- 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 Evaluating the Safety and Efficacy of Islatravir in Combination With Lenacapavir in Virologically Suppressed People With HIV (PHASE2)
- 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)
- Study to Evaluate the Pharmacokinetics, Safety, and Antiviral Activity of the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) Single Tablet Regimen (STR) in HIV-1 Infected Antiretroviral Treatment-Naive Adolescents and Virologically Suppressed Children (PHASE2, PHASE3)
- 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)
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:
- TAF/FTC FDC CI brief — competitive landscape report
- TAF/FTC FDC updates RSS · CI watch RSS
- Janssen Scientific Affairs, LLC portfolio CI