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

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ribavirin; Sofosbuvir

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.