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Sofosbuvir + Simeprevir
Sofosbuvir and simeprevir work together to inhibit hepatitis C virus replication by blocking the NS5B polymerase and NS3 protease, respectively.
Sofosbuvir and simeprevir work together to inhibit hepatitis C virus replication by blocking the NS5B polymerase and NS3 protease, respectively. Used for Chronic hepatitis C virus infection (genotype 1-6).
At a glance
| Generic name | Sofosbuvir + Simeprevir |
|---|---|
| Also known as | Sovaldi, Olysio, TMC435 |
| Sponsor | University of California, San Francisco |
| Drug class | Antiviral combination (nucleotide polymerase inhibitor + protease inhibitor) |
| Target | HCV NS5B polymerase and NS3/4A protease |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a nucleotide analog that inhibits the NS5B RNA-dependent RNA polymerase, preventing viral RNA synthesis. Simeprevir is a protease inhibitor that blocks the NS3/4A serine protease, which is essential for viral polyprotein processing. Together, they provide dual inhibition of critical viral enzymes needed for HCV replication.
Approved indications
- Chronic hepatitis C virus infection (genotype 1-6)
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
- Anemia
- Rash
Key clinical trials
- Switching Regimen in Treating Cirrhotic HCV GT1b Subjects (PHASE2)
- An Efficacy, Safety and Pharmacokinetics Study of Simeprevir, Daclatasvir and Sofosbuvir in Participants With Chronic Hepatitis C Virus Genotype 1 or 4 Infection and Decompensated Liver Disease (PHASE2)
- A Registry for Participants With Cirrhosis Who Achieve a Sustained Virologic Response Following Treatment With a Sofosbuvir-Based Regimen Without Interferon for Chronic Hepatitis C Infection
- Safety and Efficacy of Sofosbuvir-Based Regimens in the Treatment of Egyptian Patients With Hepatitis C Infection (PHASE4)
- Effect of New Oral Treatment for Hepatitis C Virus on Seminal Parameters (PHASE2, PHASE3)
- Levels of Interleukin-6 andTransforming Growth Factor Beta in HCV Patients Sera (EARLY_PHASE1)
- Efficacy and Safety of Therapy Against HCV Based on Direct-acting Antivirals in Real-life Conditions
- Reversal of Hepatic Impairment in Patients With Hepatitis C Virus (HCV) and Early Decompensation of Cirrhosis (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:
- Sofosbuvir + Simeprevir CI brief — competitive landscape report
- Sofosbuvir + Simeprevir updates RSS · CI watch RSS
- University of California, San Francisco portfolio CI