A Phase 3 Trial Comparing Whether BEM/RZR is Similar to SOF/VEL in Patients with Hepatitis C Virus Infection

Ki vehet részt

• 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-1RNA level < LLOQ 2. Suitable ARV treatment and not taking any contraindicated medications

Ki nem vehet részt

• Abuse of alcohol and/or illicit drug use that could interfere with adherence to study requirements as judged by the investigator
• Requirement of any prohibited medications
• Use of other investigational drugs within 30 days of dosing
• Co-infected with hepatitis B virus
• 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
• Pregnant or breastfeeding