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

Phase 3

Recruiting

• Conditions: HEPATITIS C VIRUS CHRONIC INFECTION
• Interventions: Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR); Drug: Sofosbuvir-Velpatasvir (SOF/VEL)

• Registration Number: NCT06868264
• Lead Sponsor: Atea Pharmaceuticals, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-07
• Study First Submitted QC: 2025-03-07
• Study First Posted: 2025-03-10
• Study Start: 2025-04-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-15
• Primary Completion: 2026-09
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 880

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bemnifosbuvir-Ruzasvir (BEM/RZR)	Bemnifosbuvir-Ruzasvir (BEM/RZR)	-
Sofosbuvir-Velpatasvir (SOF/VEL)	Sofosbuvir-Velpatasvir (SOF/VEL)	-

Primary Outcome Measures

Name	Time	Method
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.	Day 1 through Week 24

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.	Day 1 through 12 weeks after the end of treatment
Proportion of subjects experiencing virologic failure.	Day 1 through Week 24

Trial Locations

Locations (1)

Atea Study Site; 🇺🇸 Seattle, Washington, United States