Efficacy and Safety Study of Simeprevir in Combination With Sofosbuvir in Participants With Chronic Hepatitis C Virus Infection Without Cirrhosis

• Status: Completed
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the efficacy and safety of a treatment regimen of 12 weeks or 8 weeks of simeprevir in combination with sofosbuvir in chronic hepatitis C virus (HCV) genotype 1 infected men and women without cirrhosis who are HCV treatment-naïve or treatment-experienced.

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

Details

• Lead Sponsor: Janssen Infectious Diseases BVBA
• Treatments: Simeprevir; Sofosbuvir

Criteria

Inclusion Criteria:

• Hepatitis C virus (HCV) genotype 1a or 1b infection confirmed before randomization

• Documentation of the presence or absence of a NS3 Q80K polymorphism in HCV genotype 1a infected participants before randomization

• Documentation of the IL28B genotype before randomization

• HCV ribonucleic acid level greater than 10,000 IU/mL at screening

• Treatment-experienced participants must have at least 1 documented previous course of interferon-based regimen with or without ribavirin

• Absence of cirrhosis in participants

Exclusion Criteria:

• Evidence of clinical hepatic decompensation (history or current evidence of ascites, bleeding varices or hepatic encephalopathy)

• Infection/co-infection with HCV non-genotype 1a or 1b

• Co-infection with human immunodeficiency virus (HIV) type 1 or type 2 (HIV-1 or HIV-2) (positive HIV-1 or HIV-2 antibodies test at screening)

• Co-infection with hepatitis-B virus (hepatitis-B-surface-antigen positive)

• Previously been treated with any direct acting anti-HCV agent (approved or investigational) for chronic HCV infection