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EFV/TDF/FTC
This is a fixed-dose combination of three antiretroviral agents that work together to inhibit HIV replication through different mechanisms: efavirenz blocks reverse transcriptase, while tenofovir and emtricitabine are nucleotide/nucleoside reverse transcriptase inhibitors.
This is a fixed-dose combination of three antiretroviral agents that work together to inhibit HIV replication through different mechanisms: efavirenz blocks reverse transcriptase, while tenofovir and emtricitabine are nucleotide/nucleoside reverse transcriptase inhibitors. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients.
At a glance
| Generic name | EFV/TDF/FTC |
|---|---|
| Also known as | NNRTI-Based Regimen |
| Sponsor | Juan A. Arnaiz |
| Drug class | Antiretroviral combination therapy (NNRTI + NtRTI + NRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
EFV/TDF/FTC combines efavirenz (a non-nucleoside reverse transcriptase inhibitor), tenofovir disoproxil fumarate (a nucleotide reverse transcriptase inhibitor), and emtricitabine (a nucleoside reverse transcriptase inhibitor). Together, these three agents target HIV reverse transcriptase through complementary mechanisms, reducing viral replication and allowing immune reconstitution in HIV-infected patients.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients
Common side effects
- Neuropsychiatric effects (dizziness, impaired concentration, abnormal dreams)
- Rash
- Nausea
- Diarrhea
- Headache
- Renal dysfunction (tenofovir-related)
- Bone density loss (tenofovir-related)
Key clinical trials
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
- Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
- Study To Evaluate Emtricitabine/Tenofovir Alafenamide (F/TAF) in Human Immunodeficiency Virus 1 (HIV-1) Infected Children and Adolescents Virologically Suppressed on a 2-Nucleoside/Nucleotide Reverse Transcriptase Inhibitor (2-NRTI)-Containing Regimen (PHASE2, PHASE3)
- Effects of Switching From ATRIPLA™ (Efavirenz, Tenofovir, Emtricitabine) to MK-1439A (Doravirine, Tenofovir, Lamivudine) in Virologically-Suppressed Participants (MK-1439A-028) (PHASE2)
- REMEMBER: Reducing Early Mortality & Morbidity by Empiric Tuberculosis (TB) Treatment (PHASE4)
- Pharmacologic Strategies to Use the Levonorgestrel Implant in HIV-infected Women (PHASE2)
- Good-first: B/F/TAF As First-line ART
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:
- EFV/TDF/FTC CI brief — competitive landscape report
- EFV/TDF/FTC updates RSS · CI watch RSS
- Juan A. Arnaiz portfolio CI