Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis

Exclusion Criteria

• •Current participation in an interventional clinical trial.
• •Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
• •History of any other clinically significant chronic liver disease (e.g., hemochromatosis; Wilson's disease; α1-antitrypsin deficiency), except nonalcoholic steatohepatitis (NASH).
• •Decompensated liver
• •History of hemoglobinopathies
• •Contraindication or hypersensitivity to RBV
• •History or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might confound the results of the study, or interfere with the participation for the full duration of the study, such that it is not in the best interest of the individual to participate.
• •Clinically significant ECG abnormality at screening.
• •History of solid organ transplantation.
• •Prior treatment with an NS5B polymerase inhibitor.
• •Chronic use of systemic immunosuppressive agents or immunomodulatory agents (e.g., prednisone equivalent \> 10 mg/day).
• •Concomitant disallowed as per the Sovaldi Packet Insert.
• •Known hypersensitivity to the study drug, the metabolites, or formulation excipient.
• •History of difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
• •Use of any prohibited concomitant medications as described in the study protocol
• •Gastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug.
• •Male with pregnant female partner.
• •In the judgment of the investigator any clinically-relevant drug or alcohol abuse within 12 months of screening that may interfere with treatment, assessment or compliance with the protocol.