Sofosbuvir, Daclatasvir, Ribavirin for Hepatitis C Virus (HCV) Cirrhotics (SD100)

Sustained Viral Response Rate in 100 Subjects With Cirrhosis Due to Hepatitis C Treated With 12 Weeks of Sofosbuvir, Daclatasvir and Ribavirin

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.

Cirrhosis due to Hepatitis C presents a rather difficult treatment problem as many cannot tolerate interferon, the previous standard of treatment. The new direct acting antivirals have provided these patients with a new hope. One such combination is sofosbuvir (SOF) 400 mg and daclatasvir (DCV) 60 mg given once daily with or without weight-based ribavirin (RBV) for 12 or 24 weeks. The current recommendation for cirrhotics is SOF/DCV/RBV for 24 weeks but that recommendation is based on the lack of data for shorter periods. In order to evaluate the response rate to the combination of SOF/DCV/RBV the investigators decided to treat 100 HCV cirrhotics with this combination for 12 weeks. Subjects include genotype 1 and 3 patients, the prevalent genotypes in Iran. Patients with Model for End stage Liver Disease (MELD) > 20 are excluded. The investigators will calculate the sustained viral response rate at 12 weeks (SVR12).

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