Last reviewed · How we verify
Placebo to FTC/TDF
FTC/TDF is a combination of two nucleoside reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.
FTC/TDF is a combination of two nucleoside reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA. Used for HIV-1 infection treatment, HIV-1 pre-exposure prophylaxis (PrEP).
At a glance
| Generic name | Placebo to FTC/TDF |
|---|---|
| Sponsor | Merck Sharp & Dohme LLC |
| 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 (NRTIs/NtRTIs) that work by being incorporated into the growing HIV DNA chain, causing chain termination and preventing viral replication. This combination is commonly used as part of antiretroviral therapy regimens for HIV treatment and prevention.
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
- 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)
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- A Clinical Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-011) (PHASE3)
- Injectable Cabotegravir Compared to TDF/FTC For PrEP in HIV-Uninfected Men and Transgender Women Who Have Sex With Men (PHASE2, PHASE3)
- Oral ISL QM as PrEP in Cisgender Women at High Risk for HIV-1 Infection (MK-8591-022) (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)
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 FTC/TDF CI brief — competitive landscape report
- Placebo to FTC/TDF updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI