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Darunavir (DRV/r)
Darunavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and maturation of infectious HIV particles.
Darunavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and maturation of infectious HIV particles. Used for HIV-1 infection in treatment-experienced patients, HIV-1 infection in treatment-naïve patients (in combination antiretroviral therapy).
At a glance
| Generic name | Darunavir (DRV/r) |
|---|---|
| Sponsor | Community Research Initiative of New England |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Darunavir binds to the active site of HIV protease with high affinity, inhibiting the enzyme's ability to process viral precursor proteins into functional structural and enzymatic proteins. This prevents the formation of mature, infectious viral particles. It is typically administered with ritonavir (a CYP3A4 inhibitor) to boost plasma concentrations and improve efficacy.
Approved indications
- HIV-1 infection in treatment-experienced patients
- HIV-1 infection in treatment-naïve patients (in combination antiretroviral therapy)
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Elevated liver enzymes
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)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (PHASE3)
- Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen (PHASE2)
- Patients' Experiences and Perceptions of 3TC/DTG Dual Therapy (the PEDAL Study)
- Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors (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:
- Darunavir (DRV/r) CI brief — competitive landscape report
- Darunavir (DRV/r) updates RSS · CI watch RSS
- Community Research Initiative of New England portfolio CI