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

Phase 2

Completed

• Conditions: Chronic Hepatitis C Virus; Hepatitis C; Hepatitis C, Chronic; Hepatic Cirrhosis; HCV
• Interventions: Drug: Bemnifosbuvir; Drug: Ruzasvir

• Registration Number: NCT05904470
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2023-05-30
• Study First Submitted: 2023-06-06
• Study First Submitted QC: 2023-06-06
• Study First Posted: 2023-06-15
• Primary Completion: 2024-12-09
• Study Completion: 2025-01-28
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-05
• Last Update Posted: 2025-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 275

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Bemnifosbuvir and Ruzasvir	Ruzasvir	Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules
Bemnifosbuvir and Ruzasvir	Bemnifosbuvir	Bemnifosbuvir (BEM; AT-527) Tablets Ruzasvir (RZR; AT-038) Capsules

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Atea Study Site; 🇹🇷 Kayseri, Turkey