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Epclusa (SOF/VEL)
Epclusa combines a nucleotide polymerase inhibitor (sofosbuvir) and a non-nucleoside polymerase inhibitor (velpatasvir) to block hepatitis C virus replication.
Epclusa combines a nucleotide polymerase inhibitor (sofosbuvir) and a non-nucleoside polymerase inhibitor (velpatasvir) to block hepatitis C virus replication. Used for Chronic hepatitis C virus infection (genotypes 1-6), treatment-naïve and treatment-experienced patients, Hepatitis C virus infection in patients with compensated cirrhosis.
At a glance
| Generic name | Epclusa (SOF/VEL) |
|---|---|
| Sponsor | University of California, San Francisco |
| Drug class | Direct-acting antiviral combination (nucleotide + non-nucleoside polymerase inhibitor) |
| Target | HCV NS5B RNA-dependent RNA polymerase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | FDA-approved |
Mechanism of action
Sofosbuvir inhibits the HCV NS5B RNA-dependent RNA polymerase, preventing viral RNA synthesis. Velpatasvir inhibits the NS5B polymerase through a non-nucleoside mechanism at a different binding site. Together, these complementary inhibitors provide potent and broad-spectrum activity against multiple HCV genotypes.
Approved indications
- Chronic hepatitis C virus infection (genotypes 1-6), treatment-naïve and treatment-experienced patients
- Hepatitis C virus infection in patients with compensated cirrhosis
Common side effects
- Headache
- Fatigue
- Diarrhea
- Nausea
- Insomnia
Key clinical trials
- Prophylaxis With Direct-acting Antivirals for Kidney Transplantation From HCV-Infected Donors to Uninfected Recipients (NA)
- C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV (PHASE3)
- C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV (PHASE3)
- Simplifying Hepatitis C Pathways for People Who Inject Drugs in Armenia, Georgia, and Tanzania (EARLY_PHASE1)
- The No One Waits Study: Acceptability and Feasibility of Community-based Point-of-diagnosis HCV Treatment Study (PHASE4)
- Transmission of Chronic Hepatitis C in Pregnancy
- 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
- Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection (PHASE4)
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 |