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Darunavir/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-naive patients (in combination with ritonavir and other antiretrovirals), HIV-1 infection in treatment-experienced patients (in combination with ritonavir and other antiretrovirals).
At a glance
| Generic name | Darunavir/r |
|---|---|
| Also known as | Ritonavir-boosted Darunavir |
| Sponsor | Juan A. Arnaiz |
| 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. When boosted with ritonavir (a CYP3A4 inhibitor that increases darunavir plasma concentrations), it effectively suppresses viral replication. This combination is used to treat HIV-1 infection in both treatment-naive and treatment-experienced patients.
Approved indications
- HIV-1 infection in treatment-naive patients (in combination with ritonavir and other antiretrovirals)
- HIV-1 infection in treatment-experienced patients (in combination with ritonavir and other antiretrovirals)
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)
- 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)
- Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen (PHASE2)
- Impact of Raltegravir Intensification on HIV-1-infected Subjects With Complete Viral Suppression Under Monotherapy With Protease Inhibitors (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 |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Darunavir/r CI brief — competitive landscape report
- Darunavir/r updates RSS · CI watch RSS
- Juan A. Arnaiz portfolio CI