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Active, Not Recruiting

NCT Number: NCT06868264

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Atea Study Site, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

Bemnifosbuvir-Ruzasvir (BEM/RZR)

Drug

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)

Sofosbuvir-Velpatasvir (SOF/VEL)

Drug

SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

Primary outcomes

  1. Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.

    Time frame: Day 1 through Week 24

Secondary outcomes

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

    Time frame: Day 1 through 12 weeks after the end of treatment

  2. Proportion of subjects experiencing virologic failure.

    Time frame: Day 1 through Week 24

Sponsors and collaborators

Lead sponsor

Atea Pharmaceuticals, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2025
Registry last updated
Dec 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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