Conditions: Recurrent Chronic Hepatitis C Virus Post Liver Transplant
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 40
Healthy volunteers: no

Brief summary:
This is an open-label, single-arm study of sofosbuvir (GS-7977) and ribavirin (RBV) in adults who have had a liver transplant which has become re-infected with hepatitis C. The treatment period is 24 weeks with up to 48 weeks of follow up. The total time in this study will last up to 72 weeks not including the screening visit.

Detailed description:

Arms:
arm 1: Participants will receive sofosbuvir+RBV for 24 weeks.

Interventions: intervention 1: Sofosbuvir intervention 2: RBV
Intervention descriptions: intervention 1: Sofosbuvir 400 mg tablet administered orally once daily intervention 2: Ribavirin (RBV) 200-mg tablet(s) administered orally in a divided daily dose starting at 400 mg, subsequently adjusted (range: 200 to 1200 mg in a divided daily dose) based upon a number of factors including hemoglobin value, creatinine clearance, and weight.

Protocol document: