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ritonavir-boosted fosamprenavir
Fosamprenavir is a protease inhibitor that blocks HIV protease, preventing viral replication, and is boosted by ritonavir which inhibits its metabolism to increase drug levels.
Fosamprenavir is a protease inhibitor that blocks HIV protease, preventing viral replication, and is boosted by ritonavir which inhibits its metabolism to increase drug levels. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients.
At a glance
| Generic name | ritonavir-boosted fosamprenavir |
|---|---|
| Also known as | Lexiva plus Norvir |
| Sponsor | The University of Texas Health Science Center, Houston |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | FDA-approved |
Mechanism of action
Fosamprenavir is a prodrug that is converted to amprenavir, which binds to and inhibits HIV protease, an enzyme essential for processing viral polyproteins and producing mature, infectious viral particles. Ritonavir acts as a pharmacokinetic booster by inhibiting cytochrome P450 3A4, dramatically increasing fosamprenavir plasma concentrations and allowing for lower, more convenient dosing while maintaining therapeutic efficacy.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients
Common side effects
- Diarrhea
- Nausea
- Rash
- Headache
- Vomiting
- Hyperglycemia
- Lipid abnormalities
Key clinical trials
- Trial to Evaluate the Interest of a Reductive Anti Retroviral Strategy Using Dual Therapy Inspite of Triple Therapy (PHASE3)
- Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir (PHASE1)
- Two Part Study to Evaluate Pharmacokinetics, Safety, and Antiviral Activity of Elvitegravir Administered With a PI/r Background Regimen for ARV Treatment-Experienced Pediatric Participants (PHASE2, PHASE3)
- HIV Reservoir Dynamics After Switching to Dolutegravir in Patients on a PI and 2 NRTI Based Regimen (PHASE4)
- Immuno-stimulation With Maraviroc Combined to Antiretroviral Therapy in Advanced Late Diagnosed HIV-1 Infected Patients (PHASE3)
- Study to Evaluate Switching From Regimens Consisting of a Ritonavir-boosted Protease Inhibitor Plus Emtricitabine/Tenofovir Fixed-Dose Combination to the Elvitegravir/Cobicistat/Emtricitabine/Tenofovir DF Single-Tablet Regimen in Virologically Suppressed, HIV-1 Infected Patients (PHASE3)
- Multicenter, Randomized, Double-Blind, Double-Dummy, Phase 3 Study of the Safety and Efficacy of Elvitegravir Versus Raltegravir (PHASE3)
- MARCH Central Nervous System Substudy
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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