Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics

• Status: Completed
• Trial end date: 2016-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The investigators will treat 100 patients with cirrhosis due to hepatitis C with sofosbuvir 400 mg daily, daclatasvir 60 mg daily and weight-based ribavirin (1000 mg/d if <75 kg, 1200 mg/d if >75 kg, divided in two daily doses) for 12 weeks and calculate the sustained viral response rate at 12 weeks.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tehran University of Medical Sciences
• Treatments: Ribavirin; Sofosbuvir

Criteria

Inclusion Criteria:

• Positive qualitative HCV RNA test on two occasions at least 6 months apart

• Cirrhosis proven by either of: 1. Liver biopsy, 2. Liver elasticity > 12 kilopascal (KPa), 3. Clinical certainty (ascites, splenomegaly, small liver, low albumin, low platelet)

Exclusion Criteria:

• Renal failure (eGFR < 30 cc/min),

• MELD score > 20,

• Child's C (CTP score > 12),

• Heart rate < 50/min,

• Taking amiodarone