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C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE3

C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV

Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) Versus Sofosbuvir-Velpatasvir Fixed-dose Combination (SOF/VEL FDC) in Subjects With Chronic Hepatitis C Virus (HCV) Infection

NCT06868264•Atea Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

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

Exclusion Criteria

•Pregnant or breastfeeding
•Co-infected with hepatitis B virus
•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
•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

Locations (105)

Atea Study Site

Birmingham, Alabama, United States

Atea Study Site

Dothan, Alabama, United States

Atea Study Site

Chandler, Arizona, United States

Atea Study Site

Flagstaff, Arizona, United States

Atea Study Site

Mesa, Arizona, United States

Atea Study Site

Phoenix, Arizona, United States

Atea Study Site

Phoenix, Arizona, United States

Atea Study Site

Tucson, Arizona, United States

Atea Study Site

Little Rock, Arkansas, United States

Atea Study Site

Bakersfield, California, United States

Key Dates

Start Date

April 7, 2025

Primary Completion Date

September 1, 2026

Completion Date

December 1, 2026

Last Updated

December 5, 2025

Enrollment

880

ESTIMATED participants

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

Interventions

Bemnifosbuvir-Ruzasvir (BEM/RZR)

DRUG

Sofosbuvir-Velpatasvir (SOF/VEL)

DRUG