Sofosbuvir and Ribavirin in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 2 or 3 HCV Infection

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the safety, tolerability, and antiviral efficacy of GS-7977 with ribavirin (RBV) in participants with genotype 2 or 3 hepatitis C virus (HCV) infection.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Age > 18 with chronic genotype 2 or 3 HCV infection

• HCV RNA > 10,000 IU/mL at screening

• Subjects must be treatment naive or treatment experienced

• Presence or absence of cirrhosis; a liver biopsy may be required

• Healthy according to medical history and physical examination with the exception of HCV diagnosis

• Agree to use two forms of highly effective contraception for the duration of the study and 6 months after the last dose of study medication

Exclusion Criteria:

• Prior use of any other inhibitor of the HCV NS5B Polymerase

• History of any other clinically significant chronic liver disease

• Evidence of or history of decompensated liver disease

• HIV or chronic hepatitis B virus (HBV) infection

• Hepatocellular carcinoma (HCC) or other malignancy (with exception of certain resolved skin cancers)

• Chronic use of immunosuppressive agents or immunomodulatory agents

• 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 subject's participation for the full duration of the study or not be in the best interest of the subject in the opinion of the investigator