Study to Evaluate the Safety and Efficacy of Daclatasvir/Sofosbuvir/Ribavirin for 16 Versus 24 Weeks for HCV Genotype 3 Cirrhotics

Inclusion Criteria

• Signed, written, informed consent must be available from the subject before any study-specific procedures are performed;
• Male or female 18-75 years of age;
• All of the following at least 6 months prior to screening visit:
• Documented HCV infection based on history of a positive serum anti-HCV antibody test and/or detectable levels of HCV RNA >= 10,000 IU/mL, and
• Documented HCV genotype 3.
• Subjects with evidence of cirrhosis defined by either a liver biopsy 12.5 kPa. If a subject is evaluated by more than one testing method, then the liver biopsy results take precedence;
• Women of childbearing potential (WOCBP) must:
• have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.
• WOCBP must agree to follow instructions for method(s) of contraception for 7 months post-treatment completion.
• Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the following duration for 7 months post-treatment completion.
• Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of 40 at the Screening visit;
• Any of the following within one month of screening:
• Uncontrolled diabetes;
• Unstable or uncontrolled thyroid disease (subjects requiring medication to control their thyroid disease are eligible if all other inclusion/exclusion criteria are met).
• Any of the following within 6 months of screening visit, any of the following:
• Decompensated liver disease, esophageal variceal bleeding, or a hepatic mass lesion suspicious for hepatocellular carcinoma (HCC);
• Subjects who have been treated for HCV infection;
• History of unstable or deteriorating cardiovascular or cerebrovascular disease;
• Alcohol and/or drug.
• QTcF ≥ 500 ms at the baseline visit.
• Any of the following laboratory abnormalities within 8 weeks of the baseline visit:
• Hemoglobin =3 mg/dL or >=34 mol/L (with the exception of subjects with Gilbert's syndrome);
• Albumin =10 × ULN;
• Alpha-fetoprotein >200ng/mL.
• Prior exposure to NS5A inhibitors is prohibited but other classes and pegIFN/RBV are acceptable for treatment-experienced subjects;
• Use of any prohibited or restricted treatment at least is five half-lives or 14 days (whichever is longer) of the first dose of study drug (refer to section 4.5);
• History of cancer within 1 year of the screening visit with the exception of localized basal or squamous cell carcinoma;
• Any gastrointestinal disease or surgical procedure that may impact the absorption of study drug. (Subjects who have had cholecystectomy are permitted to enter the study);
• Known HIV infection;
• Confirmed, uncontrolled hypertension (any screening systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg should be excluded);
• Presence or history of non-HCV chronic liver disease, including autoimmune hepatitis, alpha-1-antitrypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis and sclerosing cholangitis. Subjects with fatty liver and/or chronic hepatitis B virus in addition to HCV may be considered in the study;
• Uncontrolled seizures disorder;
• History of hemoglobinopathies, (e.g., thalassemia, sickle cell anemia, spherocytosis) or other cause of hemolytic anemia, including autoimmune causes;
• Active disease at screening visit known to cause significant alteration in immunologic function including hematologic malignancy, sarcoidosis or autoimmune disorder (e.g., rheumatoid arthritis, systemic lupus erythemato