C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study
Atea Pharmaceuticals, Inc.
880 participants
Jun 2, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria7
- 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:
- Antiretroviral (ARV) regimen for \>8 weeks prior to screening visit, with CD4 T-cell count \>200 cells/mm3 and plasma HIV-1 RNA \<LLOQ
- Suitable ARV treatment and not taking any contraindicated medications
Exclusion Criteria9
- 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
Interventions
BEM/RZR Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 8 weeks (in those without cirrhosis) or 12 weeks (in those with compensated cirrhosis)
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks
Locations(89)
View Full Details on ClinicalTrials.gov
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NCT07037277