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).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
400 mg, included in a combination pill (Sovodak) with 60 mg daclatasvir
60 mg, included in a combination pill (Sovodak) with 400 mg sofosbuvir
1000 mg/day if \<75 kg, 1200 mg/day for \>75 kg. Divided into two daily doses
Shariati Hospital
Tehran, Iran
The sustained viral response rate
Qualitative HCV RNA polymerase chain reaction (PCR)
Time frame: week 24 (12 weeks after end of treatment)
Adverse drug events
Questionnaire
Time frame: week 2, 4, 8, 12, 24
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