Last reviewed 2026-04-22 · How we verify

Rilpivirine + darunavir/cobicistat

Rilpivirine + darunavir/cobicistat is a Antiretroviral combination (NNRTI + protease inhibitor + pharmacokinetic booster) Small molecule drug developed by A.O. Ospedale Papa Giovanni XXIII. It is currently FDA-approved for HIV-1 infection in treatment-experienced adults.

This combination inhibits HIV reverse transcriptase and protease to block viral replication, with cobicistat enhancing darunavir levels.

This combination inhibits HIV reverse transcriptase and protease to block viral replication, with cobicistat enhancing darunavir levels. Used for HIV-1 infection in treatment-experienced adults.

At a glance

Mechanism of action

Rilpivirine is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase. Darunavir is a protease inhibitor that prevents HIV protease from cleaving viral polyproteins. Cobicistat is a cytochrome P450 inhibitor that boosts darunavir plasma concentrations, allowing for lower dosing and improved tolerability.

Approved indications

• HIV-1 infection in treatment-experienced adults

Common side effects

• Nausea
• Diarrhea
• Headache
• Rash
• Elevated transaminases

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)
• 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
• Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
• Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive (PHASE4)
• A Study of Teropavimab and Zinlirvimab in Combination With Capsid Inhibitor Lenacapavir in Virologically Suppressed Adults With HIV-1 Infection (PHASE2)
• 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)
• Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (PHASE3)

Primary sources

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Competitive intelligence

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

• Rilpivirine + darunavir/cobicistat CI brief — competitive landscape report
• Rilpivirine + darunavir/cobicistat updates RSS · CI watch RSS
• A.O. Ospedale Papa Giovanni XXIII portfolio CI

Frequently asked questions about Rilpivirine + darunavir/cobicistat

Related

• Drug class: All Antiretroviral combination (NNRTI + protease inhibitor + pharmacokinetic booster) drugs
• Target: All drugs targeting HIV reverse transcriptase, HIV protease
• Manufacturer: A.O. Ospedale Papa Giovanni XXIII — full pipeline
• Therapeutic area: All drugs in Infectious Disease (HIV/AIDS)
• Indication: Drugs for HIV-1 infection in treatment-experienced adults
• Compare: Rilpivirine + darunavir/cobicistat vs similar drugs
• Pricing: Rilpivirine + darunavir/cobicistat cost, discount & access