Last reviewed 2026-04-23 · How we verify

darunavir; ritonavir; emtricitabine/tenofovir

darunavir; ritonavir; emtricitabine/tenofovir is a Antiretroviral combination therapy (protease inhibitor + reverse transcriptase inhibitors) Small molecule drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 infection in resource-limited settings (ANRS focus).

This combination inhibits HIV protease and reverse transcriptase to suppress viral replication.

This combination inhibits HIV protease and reverse transcriptase to suppress viral replication. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 infection in resource-limited settings (ANRS focus).

At a glance

Mechanism of action

Darunavir is a protease inhibitor that blocks HIV protease, preventing the maturation of viral particles. Ritonavir is a pharmacokinetic booster that inhibits cytochrome P450 metabolism, increasing darunavir levels. Emtricitabine and tenofovir are nucleoside/nucleotide reverse transcriptase inhibitors that block HIV reverse transcriptase, preventing viral DNA synthesis. Together, these agents target multiple steps of the HIV replication cycle.

Approved indications

• HIV-1 infection in treatment-naïve and treatment-experienced patients
• HIV-1 infection in resource-limited settings (ANRS focus)

Common side effects

• Diarrhea
• Nausea
• Headache
• Rash
• Lipid elevation
• Renal impairment (tenofovir-related)

Key clinical trials

• 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 Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
• Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
• Pharmacokinetic Study of Antiretroviral Drugs and Related Drugs During and After Pregnancy
• Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (PHASE4)
• Study Evaluating the Safety, in Terms of HBV Virological Control At 96 Weeks, of 2 Antiviral Treatment Relief Strategies, in Patients Co-infected with the HIV-1 and HBV Viruses (PHASE2)
• Body Composition Sub-study of the D2EFT Trial (PHASE4)
• B-free Multistage Trial (PHASE4)

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

• darunavir; ritonavir; emtricitabine/tenofovir CI brief — competitive landscape report
• darunavir; ritonavir; emtricitabine/tenofovir updates RSS · CI watch RSS
• ANRS, Emerging Infectious Diseases portfolio CI

Frequently asked questions about darunavir; ritonavir; emtricitabine/tenofovir

Related

• Drug class: All Antiretroviral combination therapy (protease inhibitor + reverse transcriptase inhibitors) drugs
• Target: All drugs targeting HIV protease, HIV reverse transcriptase, CYP3A4
• Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline
• Therapeutic area: All drugs in Infectious Disease
• Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced patients
• Indication: Drugs for HIV-1 infection in resource-limited settings (ANRS focus)
• Compare: darunavir; ritonavir; emtricitabine/tenofovir vs similar drugs
• Pricing: darunavir; ritonavir; emtricitabine/tenofovir cost, discount & access