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Simeprevir + Sofosbuvir
Simeprevir and sofosbuvir work together to inhibit hepatitis C virus (HCV) replication by blocking the NS3/4A protease and NS5B polymerase, respectively.
Simeprevir and sofosbuvir work together to inhibit hepatitis C virus (HCV) replication by blocking the NS3/4A protease and NS5B polymerase, respectively. Used for Chronic hepatitis C virus infection (genotypes 1-6).
At a glance
| Generic name | Simeprevir + Sofosbuvir |
|---|---|
| Also known as | Sovaldi, Olysio |
| Sponsor | Federal University of São Paulo |
| Drug class | Antiviral combination (protease inhibitor + nucleotide polymerase inhibitor) |
| Target | HCV NS3/4A protease and HCV NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Virology/Hepatology |
| Phase | FDA-approved |
Mechanism of action
Simeprevir is a protease inhibitor that blocks HCV NS3/4A protease, preventing viral polyprotein processing. Sofosbuvir is a nucleotide analog inhibitor of the NS5B RNA-dependent RNA polymerase, directly inhibiting viral RNA synthesis. Together, they provide dual-mechanism suppression of HCV replication across multiple viral genotypes.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1-6)
Common side effects
- Fatigue
- Headache
- Nausea
- Diarrhea
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 |