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

Phase 3

Recruiting

• Conditions: HEPATITIS C VIRUS CHRONIC INFECTION; Hepatitis C, Chronic; Hepatitis C Virus Infection; Hepatitis C
• Interventions: Drug: Bemnifosbuvir-Ruzasvir; Drug: Sofosbuvir-Velpatasvir

• Registration Number: NCT07037277
• 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 Start: 2025-06-02
• Study First Submitted: 2025-06-10
• Study First Submitted QC: 2025-06-23
• Study First Posted: 2025-06-25
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-26
• Last Update Posted: 2025-09-30
• Primary Completion: 2026-12
• Study Completion: 2027-03-01

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
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at 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 as measured by HCV RNA RT-qPCR	Day 1 through Week 24

Trial Locations

Locations (2)

Atea Clinical Study Site; 🇲🇩 Chisinau, Moldova

Atea Study Site; 🇰🇷 Busan, South Korea