Overview

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Eligibility

Key Inclusion Criteria:

• Use of adequate contraception for females of childbearing potential
• Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approved or experimental DAA for HCV)
• Documented medical history compatible with chronic HCV
• Either no liver cirrhosis or with compensated liver cirrhosis
• If HIV-1-positive, must meet the following 2 criteria:
  1. Antiretroviral (ARV) regimen for >8 weeks prior to screening visit, with CD4 T-cell count >200 cells/mm3 and plasma HIV-1 RNA <LLOQ
  2. Suitable ARV treatment and not taking any contraindicated medications

Key Exclusion Criteria:

• Pregnant or breastfeeding
• Co-infected with hepatitis B virus
• Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
• Prior exposure to any HCV DAA
• Requirement of any prohibited medications
• Use of other investigational drugs within 30 days of dosing
• History or signs of decompensated liver disease (decompensated cirrhosis)
• History of hepatocellular carcinoma (HCC)
• Any other clinically significant medical condition that, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results