A Phase 2, Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic HCV

A Phase 2, Open-label Study to Assess the Safety and Efficacy of Bemnifosbuvir (BEM) and Ruzasvir (RZR) in Subjects With Chronic Hepatitis C Virus (HCV) Infection

This is an open-label trial to evaluate safety and efficacy of treatment with BEM + RZR in subjects with chronic HCV infection.

Inclusion Criteria:

• Willing and able to provide written informed consent

• Male or female subjects between ≥ 18 years of age (or the legal age of consent per local regulations) and ≤ 85 years of age

• Female subjects of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or to the use of an acceptable effective contraception

• Females must have a negative pregnancy test at Screening and at Day 1 prior to dosing

• Subjects must be direct-acting antiviral (DAA)-treatment-naïve, defined as never exposed to an approved or experimental DAA for HCV

• Documented medical history compatible with chronic HCV

• Liver disease staging assessment as follows:

  • Absence of cirrhosis (F0 to F3)
  • Compensated cirrhosis (F4)

Exclusion Criteria:

• Female subject is pregnant or breastfeeding
• Co-infected with hepatitis B virus (HBV; positive for hepatitis B surface antigen [HBsAg]) and/or human immunodeficiency virus (HIV)
• 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
• Use of other investigational drugs within 30 days of dosing or plans to enroll in another clinical trial of an investigational agent while participating in the present study
• Subject with known allergy to the study medications or any of their components
• History or signs of decompensated liver disease: ascites, variceal bleeding, hepatic encephalopathy, spontaneous bacterial peritonitis, or other clinical signs of portal hypertension or hepatic insufficiency
• Cirrhotic and has a Child-Pugh score >6, corresponding to a Child-Pugh Class B or C
• History of hepatocellular carcinoma (HCC) or findings suggestive of possible 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