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

Launched by ATEA PHARMACEUTICALS, INC. · Jun 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two different treatments for adults with chronic hepatitis C, a long-lasting liver infection caused by the hepatitis C virus. The goal is to see how well and how safely a new medicine called BEM/RZR works compared to an existing treatment called SOF/VEL. Both treatments aim to clear the virus from the body and improve liver health.

Adults who have never been treated before with hepatitis C antiviral medicines may be eligible to join. Participants can have either no liver damage or mild, stable liver scarring (called compensated cirrhosis). People living with well-controlled HIV may also join if they meet certain health requirements. If you join, you’ll be carefully monitored by the study team, and you’ll need to avoid pregnancy during the trial. The study is not open to pregnant or breastfeeding people, those with serious liver problems, or those who have used hepatitis C antiviral drugs before. This trial is currently recruiting participants and offers a chance to receive new treatment options while contributing to important research on hepatitis C.

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
• • Prior exposure to any HCV DAA
• • 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