Efficacy and Safety of Sofosbuvir+Ribavirin in Genotype 2 HCV-infected U.S. Veterans With Cirrhosis
Condition: Hepatitis C Virus Infection
MeSH terms: Hepatitis C
Intervention: Sofosbuvir; RBV
Intervention description: Sofosbuvir 400 mg tablet administered orally once daily; Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
Intervention MeSH terms: Sofosbuvir
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 66.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Veterans HCV

Summary:

      This study will examine the safety, tolerability, and antiviral efficacy of sofosbuvir
      (SOF)+ribavirin (RBV) in treatment-naive and treatment-experienced United States Veterans
      with compensated cirrhosis and genotype 2 HCV infection.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Willing and able to provide written informed consent.

          -  Treatment-naive or treatment-experienced adult, U.S. Veteran

          -  Chronic genotype 2 (GT2) HCV infection Classified as:

               -  Eligible for treatment with interferon (IFN)-based therapy

               -  Ineligible for IFN treatment

               -  Intolerant to IFN.

          -  Cirrhosis determination

          -  Laboratory parameters within prespecified ranges at screening:

          -  A negative serum pregnancy test is required for females of childbearing potential

          -  Males and females of childbearing potential who engage in heterosexual intercourse
             must agree to use protocol specified method(s) of contraception

          -  Lactating females must agree to discontinue nursing before study drug is administered.

          -  Males must agree to refrain from sperm donation from the date of screening until at
             least 7 months after the last dose of RBV, or 90 days after their last dose of study
             drug if not taking RBV.

          -  Must be able to comply with the dosing instructions for study drug administration and
             able to complete the study schedule of assessments.

          -  Must be of generally good health as determined by the Investigator.

        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.

          -  Presence of hepatocellular carcinoma (HCC) Malignancy within 5 years prior to
             screening, with the exception of specific cancers that are entirely cured by surgical
             resection (basal cell skin cancer and prostate cancer in remission). Individuals under
             evaluation for possible malignancy are not eligible.

          -  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.