C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

Key Inclusion Criteria:

• Use of adequate contraception for females of childbearing potential

• Must be direct-acting antiviral (DAA)-treatment-naïve (never exposed to an approvedor 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 CD4T-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 tostudy requirements as judged by the investigator

• 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 theinvestigator, would jeopardize the safety of the subject or impact the validity ofthe study results