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

Launched by ATEA PHARMACEUTICALS, INC. · Mar 7, 2025

Keywords

ClinConnect Summary

The C-BEYOND clinical trial is studying two different treatment options for adults with chronic Hepatitis C virus (HCV) infection: BEM/RZR and SOF/VEL. The main goal is to find out which treatment works better and is safer for patients. This trial is currently looking for participants aged 18 to 75 who have never received direct-acting antiviral (DAA) treatments for HCV before. Eligible participants should have a documented history of chronic HCV and either no liver cirrhosis or compensated liver cirrhosis—a condition where the liver is damaged but still functions well.

If you or a loved one is considering joining this trial, you'll need to meet certain criteria, like using effective birth control if you are a woman of childbearing age and being free of significant health issues that could affect the study. Participants can expect to receive either of the two treatments and will be closely monitored for their health and safety throughout the study. This trial is an important opportunity to contribute to research that could improve treatment options for people living with chronic HCV.

Gender

ALL

Eligibility criteria

• Key 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
• Key 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