NCT06868264

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 880 (estimated)
• Sponsor: Atea Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• HEPATITIS C VIRUS CHRONIC INFECTION

Interventions

Type	Name	Description
DRUG	Bemnifosbuvir-Ruzasvir (BEM/RZR)	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)
DRUG	Sofosbuvir-Velpatasvir (SOF/VEL)	SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Timeline

• Start date: 2025-04-07
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2025-03-10
• Last updated: 2025-12-05

Locations

105 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study