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FTC/TDF FDC
FTC/TDF is a fixed-dose combination of two nucleoside reverse transcriptase inhibitors that block HIV reverse transcriptase to prevent viral replication.
FTC/TDF 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 (treatment), HIV-1 pre-exposure prophylaxis (PrEP).
At a glance
| Generic name | FTC/TDF FDC |
|---|---|
| Sponsor | Janssen Sciences Ireland UC |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor combination |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Emtricitabine (FTC) and tenofovir disoproxil fumarate (TDF) are both nucleoside/nucleotide reverse transcriptase inhibitors that work by incorporating into the growing HIV DNA chain and causing chain termination. Together in this fixed-dose combination, they provide complementary antiretroviral activity against HIV-1 and HIV-2, reducing viral load and slowing disease progression.
Approved indications
- HIV-1 infection (treatment)
- HIV-1 pre-exposure prophylaxis (PrEP)
Common side effects
- Nausea
- Diarrhea
- Headache
- Renal impairment
- Bone density loss
- Lactic acidosis
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 of Lenacapavir and Emtricitabine/Tenofovir Disoproxil Fumarate (F/TDF) for Prevention of HIV in People Who Inject Drugs (HPTN 103) (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)
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:
- FTC/TDF FDC CI brief — competitive landscape report
- FTC/TDF FDC updates RSS · CI watch RSS
- Janssen Sciences Ireland UC portfolio CI