Last reviewed · How we verify
Sofosbuvir / Velpatasvir
Sofosbuvir inhibits hepatitis C virus NS5B polymerase while velpatasvir inhibits NS5A protein, together blocking viral replication.
Sofosbuvir inhibits hepatitis C virus NS5B polymerase while velpatasvir inhibits NS5A protein, together blocking viral replication. Used for Chronic hepatitis C virus (HCV) infection, all genotypes, HCV in treatment-naïve and treatment-experienced patients.
At a glance
| Generic name | Sofosbuvir / Velpatasvir |
|---|---|
| Also known as | Epclusa |
| Sponsor | Peking University First Hospital |
| Drug class | Direct-acting antiviral (DAA) combination |
| Target | HCV NS5B polymerase and NS5A protein |
| Modality | Small molecule |
| Therapeutic area | Virology / Hepatology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir is a nucleotide analog that acts as a chain terminator of the HCV RNA-dependent RNA polymerase (NS5B), preventing viral RNA synthesis. Velpatasvir is a non-structural protein 5A (NS5A) inhibitor that disrupts viral replication and assembly. Together, this fixed-dose combination provides direct-acting antiviral activity against multiple HCV genotypes.
Approved indications
- Chronic hepatitis C virus (HCV) infection, all genotypes
- HCV in treatment-naïve and treatment-experienced patients
Common side effects
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- People With CHC Who Achieved a Sustained Virological Response Following Therapy With Direct Acting Antiviral Agents (PHASE4)
- A Trial of Transplanting Hepatitis C Kidneys Into Hepatitis C-Negative Kidney Recipients (PHASE2)
- Implementing Low-Barrier HCV Treatment in a Jail Setting (PHASE4)
- Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients (NA)
- Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy (PHASE4)
- Transplant of Redeemed Organs by Judicious Administration of New Direct-Acting Antivirals for Hepatitis-C Heart Recipients (PHASE2)
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Expanding the Pool in Orthotopic Heart Transplantation (PHASE2)
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 / Velpatasvir CI brief — competitive landscape report
- Sofosbuvir / Velpatasvir updates RSS · CI watch RSS
- Peking University First Hospital portfolio CI