Last reviewed · How we verify
Emtricitabine/tenofovir disoproxil fumarate
Emtricitabine/tenofovir disoproxil fumarate is a Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI/NtRTI) combination Small molecule drug developed by Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections. It is currently FDA-approved for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals. Also known as: Truvada, Isentress, Kaletra, FTC/TDF.
Emtricitabine and tenofovir are nucleoside/nucleotide reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA.
Emtricitabine and tenofovir are nucleoside/nucleotide reverse transcriptase inhibitors that block HIV replication by inhibiting the enzyme responsible for converting viral RNA into DNA. Used for HIV-1 infection treatment (as part of combination antiretroviral therapy), HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals.
At a glance
| Generic name | Emtricitabine/tenofovir disoproxil fumarate |
|---|---|
| Also known as | Truvada, Isentress, Kaletra, FTC/TDF, Truvada, FTC/TDF |
| Sponsor | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections |
| Drug class | Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI/NtRTI) combination |
| Target | HIV-1 reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Emtricitabine and tenofovir disoproxil fumarate (TDF) are antiretroviral agents that work synergistically to suppress HIV-1 replication. Both drugs inhibit reverse transcriptase, the viral enzyme essential for HIV to integrate into host cell DNA. This combination is commonly used as part of highly active antiretroviral therapy (HAART) regimens and is also approved for HIV pre-exposure prophylaxis (PrEP).
Approved indications
- HIV-1 infection treatment (as part of combination antiretroviral therapy)
- HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
Common side effects
- Nausea
- Diarrhea
- Headache
- Fatigue
- Rash
- Renal impairment (with tenofovir)
- Bone density loss (with tenofovir)
Key clinical trials
- ImPrEP LEN Brasil: Twice-Yearly Lenacapavir for HIV Prevention (NA)
- A Study of MK-8527 to Prevent Human Immunodeficiency Virus Type 1 (HIV-1) (MK-8527-010) (PHASE3)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, 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)
- Implementation Study of Lenacapavir Pre-exposure Prophylaxis for HIV Prevention
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Antiviral Clinical Trial for Long Covid-19 (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:
- Emtricitabine/tenofovir disoproxil fumarate CI brief — competitive landscape report
- Emtricitabine/tenofovir disoproxil fumarate updates RSS · CI watch RSS
- Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections portfolio CI
Frequently asked questions about Emtricitabine/tenofovir disoproxil fumarate
What is Emtricitabine/tenofovir disoproxil fumarate?
How does Emtricitabine/tenofovir disoproxil fumarate work?
What is Emtricitabine/tenofovir disoproxil fumarate used for?
Who makes Emtricitabine/tenofovir disoproxil fumarate?
Is Emtricitabine/tenofovir disoproxil fumarate also known as anything else?
What drug class is Emtricitabine/tenofovir disoproxil fumarate in?
What development phase is Emtricitabine/tenofovir disoproxil fumarate in?
What are the side effects of Emtricitabine/tenofovir disoproxil fumarate?
What does Emtricitabine/tenofovir disoproxil fumarate target?
Related
- Drug class: All Nucleoside/nucleotide reverse transcriptase inhibitor (NRTI/NtRTI) combination drugs
- Target: All drugs targeting HIV-1 reverse transcriptase
- Manufacturer: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection treatment (as part of combination antiretroviral therapy)
- Indication: Drugs for HIV-1 pre-exposure prophylaxis (PrEP) in at-risk individuals
- Also known as: Truvada, Isentress, Kaletra, FTC/TDF, Truvada, FTC/TDF
- Compare: Emtricitabine/tenofovir disoproxil fumarate vs similar drugs
- Pricing: Emtricitabine/tenofovir disoproxil fumarate cost, discount & access