C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
Trial Parameters
Brief Summary
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
Eligibility Criteria
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 di