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

Atea Pharmaceuticals

Status and phase

Completed

Phase 2

Conditions

Hepatic Cirrhosis

Chronic Hepatitis C Virus

Hepatitis C, Chronic

Hepatitis C

HCV

Treatments

Drug: Bemnifosbuvir

Drug: Ruzasvir

Study type

Interventional

Funder types

Industry

Identifiers

AT-01B-004

Details and patient eligibility

About

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

Enrollment

275 patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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