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

Sponsor

Atea Pharmaceuticals, Inc. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05904470

Collaborator

(none)

280

Enrollment

Location

Arm

15.1

Anticipated Duration (Months)

18.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Hepatitis C Virus Hepatitis C, Chronic Hepatitis C Hepatic Cirrhosis HCV	Drug: Bemnifosbuvir Drug: Ruzasvir	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

280 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 30, 2023

Anticipated Primary Completion Date :

Jun 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Bemnifosbuvir and Ruzasvir Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules	Drug: Bemnifosbuvir 550 mg administered orally once a day (QD) for 8 weeks Other Names: AT-527 Drug: Ruzasvir 180 mg administered orally once a day (QD) for 8 weeks Other Names: AT-038

Arm

Intervention/Treatment

Experimental: Bemnifosbuvir and Ruzasvir

Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules

Drug: Bemnifosbuvir

550 mg administered orally once a day (QD) for 8 weeks

Other Names:

AT-527

Drug: Ruzasvir

180 mg administered orally once a day (QD) for 8 weeks

Other Names:

AT-038

Outcome Measures

Primary Outcome Measures

Proportion of subjects experiencing treatment-emergent adverse events [Day 1 through 4 weeks after end of treatment]
Proportion of subjects achieving sustained virologic response at 12 weeks post-treatment (SVR12) [Day 1 through12 weeks after end of treatment ] SVR defined as the HCV RNA < lower limit of quantitation (LLOQ) at 12 weeks after end of treatment]

Secondary Outcome Measures

Proportion of subjects experiencing virologic failure [Day 1 thru 12 weeks after end of treatment]
Proportion of subjects achieving sustained virologic response at 24 weeks post-treatment (SVR24) [Day 1 thru 24 weeks after end of treatment]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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