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Darunavir/Ritonavir (DRV/r)
Darunavir/Ritonavir (DRV/r) is a Protease inhibitor (PI) Small molecule drug developed by Janssen-Cilag S.p.A.. It is currently in Phase 3 development for HIV-1 infection in treatment-experienced patients, HIV-1 infection in treatment-naïve patients.
Darunavir is a protease inhibitor that blocks HIV protease, preventing viral polyprotein cleavage and maturation, while ritonavir acts as a pharmacokinetic booster to increase darunavir levels.
Darunavir is a protease inhibitor that blocks HIV protease, preventing viral polyprotein cleavage and maturation, while ritonavir acts as a pharmacokinetic booster to increase darunavir levels. Used for HIV-1 infection in treatment-experienced patients, HIV-1 infection in treatment-naïve patients.
At a glance
| Generic name | Darunavir/Ritonavir (DRV/r) |
|---|---|
| Sponsor | Janssen-Cilag S.p.A. |
| Drug class | Protease inhibitor (PI) |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Darunavir binds to HIV protease and inhibits its enzymatic activity, preventing the cleavage of viral polyproteins into functional proteins required for viral replication and assembly. Ritonavir is a potent CYP3A4 inhibitor that dramatically increases darunavir plasma concentrations by reducing hepatic metabolism, allowing for lower and less frequent darunavir dosing while maintaining therapeutic efficacy.
Approved indications
- HIV-1 infection in treatment-experienced patients
- HIV-1 infection in treatment-naïve patients
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Lipid elevation
- Hepatotoxicity
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)
- Prevention of Perinatal Transmission of HIV-1 Without Nucleoside Reverse Transcriptase Inhibitors (PHASE2)
- Strategy for Maintenance of HIV Suppression With Once Daily Integrate Inhibitor+Darunavir/Ritonavir in Children (PHASE2, 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/Ritonavir (DRV/r) CI brief — competitive landscape report
- Darunavir/Ritonavir (DRV/r) updates RSS · CI watch RSS
- Janssen-Cilag S.p.A. portfolio CI
Frequently asked questions about Darunavir/Ritonavir (DRV/r)
What is Darunavir/Ritonavir (DRV/r)?
How does Darunavir/Ritonavir (DRV/r) work?
What is Darunavir/Ritonavir (DRV/r) used for?
Who makes Darunavir/Ritonavir (DRV/r)?
What drug class is Darunavir/Ritonavir (DRV/r) in?
What development phase is Darunavir/Ritonavir (DRV/r) in?
What are the side effects of Darunavir/Ritonavir (DRV/r)?
What does Darunavir/Ritonavir (DRV/r) target?
Related
- Drug class: All Protease inhibitor (PI) drugs
- Target: All drugs targeting HIV protease
- Manufacturer: Janssen-Cilag S.p.A. — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection in treatment-experienced patients
- Indication: Drugs for HIV-1 infection in treatment-naïve patients
- Compare: Darunavir/Ritonavir (DRV/r) vs similar drugs
- Pricing: Darunavir/Ritonavir (DRV/r) cost, discount & access