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Switch to DRV/cobicistat + 3TC
This combination inhibits HIV protease and integrase while providing nucleoside reverse transcriptase inhibition to suppress viral replication.
This combination inhibits HIV protease and integrase while providing nucleoside reverse transcriptase inhibition to suppress viral replication. Used for HIV-1 infection in treatment-experienced or treatment-naive adults.
At a glance
| Generic name | Switch to DRV/cobicistat + 3TC |
|---|---|
| Sponsor | Hospitales Universitarios Virgen del Rocío |
| Drug class | Antiretroviral combination therapy (protease inhibitor + pharmacokinetic booster + nucleoside reverse transcriptase inhibitor) |
| Target | HIV protease, CYP3A4, HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Darunavir (DRV) is a protease inhibitor that blocks HIV protease, preventing the maturation of infectious viral particles. Cobicistat is a pharmacokinetic booster that inhibits CYP3A4, increasing darunavir levels. Lamivudine (3TC) is a nucleoside reverse transcriptase inhibitor that blocks reverse transcription of viral RNA. Together, these three agents target multiple steps of the HIV replication cycle.
Approved indications
- HIV-1 infection in treatment-experienced or treatment-naive adults
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Elevated transaminases
- Lipid abnormalities
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)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- A Clinical Trial to Evaluate the Reversibility of Abacavir/Lamivudine/Dolutegravir CNS-Related Neurotoxicity After Switching to Tenofovir/Alafenamide/Emtricitabine/Darunavir/Cobicistat (TAF/FTC/DRV/c) (PHASE4)
- Study to Evaluate Switching From a Regimen of Two Nucleos(t)Ide Reverse Transcriptase Inhibitors (NRTI) Plus a Third Agent to a Fixed Dose Combination (FDC) of Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/F/TAF), in Virologically-Suppressed, HIV-1 Infected African American Participants (PHASE3)
- Tripe Versus Dual Antiretroviral Therapy in HIV-infected Patients With Virological Suppression (Tridual) (PHASE4)
- Switching From a Tenofovir Disoproxil Fumarate (TDF) Containing Regimen to Elvitegravir/Cobicistat/Emtricitabine/ Tenofovir Alafenamide (E/C/F/TAF) Fixed-Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Infected Adults Aged ≥ 60 Years (PHASE3)
- Switch Study to Evaluate F/TAF in HIV-1 Infected Adults Who Are Virologically Suppressed on Regimens Containing ABC/3TC (PHASE3)
- Safety and Efficacy of Switching From Regimens of ABC/3TC + a 3rd Agent to E/C/F/TAF Fixed-Dose Combination (FDC) in Virologically-Suppressed HIV 1 Infected Adults (PHASE3)
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 |
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