Last reviewed · How we verify
Epclusa
At a glance
| Generic name | Epclusa |
|---|---|
| Also known as | Procedure, Sofosbuvir/velpatasvir, Sofosbuvir and Velpatasvir, Sofosbuvir/Velpatasvir |
| Sponsor | Duke University |
| Modality | Small molecule |
| Therapeutic area | Other |
| Phase | FDA-approved |
Approved indications
Boxed warnings
- WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with EPCLUSA. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV
Common side effects
- Fatigue
- Anemia
- Headache
- Nausea
- Insomnia
- Headache
- Diarrhea
- Fatigue
- Asthenia
- Irritability
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 |