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Darunavir ritonavir
Darunavir is a protease inhibitor that blocks HIV protease, preventing viral replication, while ritonavir acts as a pharmacokinetic booster to increase darunavir levels.
Darunavir is a protease inhibitor that blocks HIV protease, preventing viral replication, while ritonavir acts as a pharmacokinetic booster to increase darunavir levels. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients, HIV-1 infection in combination antiretroviral therapy.
At a glance
| Generic name | Darunavir ritonavir |
|---|---|
| Sponsor | St Stephens Aids Trust |
| Drug class | HIV protease inhibitor (boosted) |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Darunavir inhibits HIV protease, an enzyme essential for processing viral polyproteins into functional components needed for infectious particle assembly. Ritonavir is a potent CYP3A4 inhibitor that dramatically increases darunavir plasma concentrations by reducing hepatic metabolism, allowing lower darunavir doses while maintaining therapeutic efficacy. Together, they suppress HIV replication and reduce viral load in infected individuals.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients
- HIV-1 infection in combination antiretroviral therapy
Common side effects
- Diarrhea
- Nausea
- Headache
- Rash
- Abdominal pain
- Elevated liver enzymes
- Lipid abnormalities
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)
- 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
- Pharmacokinetic Properties of Antiretroviral and Anti-Tuberculosis Drugs During Pregnancy and Postpartum
- Population Pharmacokinetics of Antiretroviral in Children
- Ndovu RCT: Investing the Optimal Management of Dolutegravir Resistance (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 CI brief — competitive landscape report
- Darunavir ritonavir updates RSS · CI watch RSS
- St Stephens Aids Trust portfolio CI