Conditions: Hepatitis C Cirrhosis Portal Hypertension With or Without Liver Decompensation
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 50
Healthy volunteers: no

Brief summary:
This study will evaluate the antiviral efficacy of combination therapy with sofosbuvir (SOF) plus ribavirin (RBV) for 48 weeks in adults with compensated and decompensated chronic hepatitis C virus (HCV) infection. Approximately 50 adults will be randomized (1:1) to receive study drug for 48 weeks or take part in an untreated observational arm for the first 24 weeks followed by study drug for another 48 weeks.

Detailed description:

Arms:
arm 1: Participants will receive SOF+RBV for 48 weeks. arm 2: Participants will undergo 24 weeks of observation and then receive SOF+RBV for 48 additional weeks.

Interventions: intervention 1: SOF intervention 2: RBV
Intervention descriptions: intervention 1: SOF 400 mg tablet administered orally once daily intervention 2: RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Protocol document: