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

NCT07037277
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Phase
Phase 3
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Recruitment status
Active, not recruiting
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Participants
880
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Lead sponsor
Atea Pharmaceuticals, Inc.
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Start date
2025-06-02
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Number of sites
107
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Summary
The purpose of this study is to compare the efficacy and safety of BEM/RZR to SOF/VEL in adults with chronic HCV.
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Short title
C-Forward: Efficacy and Safety of BEM/RZR vs SOF/VEL in Subjects With Chronic HCV
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Official title
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
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Active, not recruiting
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Phase
Phase 3
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Study type
Interventional
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Completion date
2027-03-01
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First posted
2025-06-25
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Registry last updated
2026-06-29
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Primary completion date
2026-12-01
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Start date
2025-06-02
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Participants
880
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Participant count basis
Estimated
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Planned participants
880
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Protocol amendments
0
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Number of sites
107
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Data monitoring committee
Yes
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Registry sponsor category
Industry
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Lead sponsor
Atea Pharmaceuticals, Inc.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT07037277
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ClinicalTrials.gov ID
NCT07037277
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Single masking
Masked roles
Outcome assessors
Sources for study design
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  1. Portion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at week 24

    Timeframe: Day 1 through Week 24

  1. Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs

    Timeframe: Day 1 through 12 weeks after the end of treatment

  2. Proportion of subjects experiencing virologic failure as measured by HCV RNA RT-qPCR

    Timeframe: Day 1 through Week 24

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Maximum age
85 Years
Healthy volunteers
No

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
Sources for eligibility
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  • Atea Study SiteCairo, Egypt
  • Atea Study SiteNice, France
  • Atea Study SiteStrasbourg, France
  • Atea Study SiteClichy, France
  • Atea Study SiteMontpellier, France
  • Atea Study SiteClermont-Ferrand, France
  • Atea Study SiteCréteil, France
  • Atea Study SiteFrankfurt am Main, Germany
  • Atea Study SiteLeipzig, Germany
  • Atea Study SiteHamburg, Germany
  • Atea Study SiteAlexandroupoli, Greece
  • Atea Study SiteAthens, Greece
  • Atea Study SiteAthens, Greece
  • Atea Study SiteHeraklion, Greece
  • Atea Study SiteRhodes, Greece
  • Atea Study SiteHyderabad, India
  • Atea Study SitePatna, India
  • Atea Study SiteRajkot, India
  • Atea Study SiteSurat, India
  • Atea Study SiteShimla, India
  • Atea Study SiteBelagavi, India
  • Atea Study SiteKochi, India
  • Atea Study SiteMumbai, India
  • Atea Study SiteMumbai, India
  • Atea Study SiteNagpur, India

And 82 more, listed on the interactive page.

Sources for sites
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Related records

Drugs (4)

Lead sponsors (1)

Conditions (2)