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

December 3, 2025 updated by: Atea Pharmaceuticals, Inc.

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

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

880

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2C7
        • Atea Study Site
    • New Brunswick
      • Moncton, New Brunswick, Canada, E1C6Z8
        • Atea Study Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada, A1B3V6
        • Atea Study Site
    • Ontario
      • Brampton, Ontario, Canada, L6R 3J7
        • Atea Study Site
      • Ottawa, Ontario, Canada, K1H8L6
        • Atea Study Site
      • Toronto, Ontario, Canada, M5G2C4
        • Atea Study Site
    • Quebec
      • Montreal, Quebec, Canada, H4A3J1
        • Atea Study Site
      • Québec, Quebec, Canada, G1V 4T3
        • Atea Study Site
      • Québec, Quebec, Canada, G1V4G2
        • Atea Study Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Atea Study Site
      • Dothan, Alabama, United States, 36301
        • Atea Study Site
    • Arizona
      • Chandler, Arizona, United States, 85225
        • Atea Study Site
      • Flagstaff, Arizona, United States, 86001
        • Atea Study Site
      • Mesa, Arizona, United States, 85210
        • Atea Study Site
      • Phoenix, Arizona, United States, 85006
        • Atea Study Site
      • Phoenix, Arizona, United States, 85015
        • Atea Study Site
      • Tucson, Arizona, United States, 85745
        • Atea Study Site
    • Arkansas
      • Little Rock, Arkansas, United States, 72204
        • Atea Study Site
    • California
      • Bakersfield, California, United States, 93301
        • Atea Study Site
      • Coronado, California, United States, 92118
        • Atea Study Site
      • Escondido, California, United States, 92025
        • Atea Study Site
      • Fresno, California, United States, 93711
        • Atea Study Site
      • Long Beach, California, United States, 98015
        • Atea Study Site
      • Los Angeles, California, United States, 90048
        • Atea Study Site
      • Los Angeles, California, United States, 90067
        • Atea Study Site
      • Orange, California, United States, 92868
        • Atea Study Site
      • Pasadena, California, United States, 91105
        • Atea Study Site
      • Sacramento, California, United States, 95817
        • Atea Study Site
      • Torrance, California, United States, 90502
        • Atea Study Site
      • Valencia, California, United States, 91355
        • Atea Study Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Atea Study Site
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20017
        • Atea Study Site
      • Washington D.C., District of Columbia, United States, 20037
        • Atea Study Site
    • Florida
      • Coral Gables, Florida, United States, 33134
        • Atea Study Site
      • DeLand, Florida, United States, 32720
        • Atea Study Site
      • Fort Lauderdale, Florida, United States, 33308
        • Atea Study Site
      • Ft. Pierce, Florida, United States, 34982
        • Atea Study Site
      • Gainesville, Florida, United States, 32610
        • Atea Study Site
      • Inverness, Florida, United States, 34452
        • Atea Study Site
      • Jupiter, Florida, United States, 33458
        • Atea Study Site
      • Lauderdale Lakes, Florida, United States, 33313
        • Atea Study Site
      • Maitland, Florida, United States, 32751
        • Atea Study Site
      • Miami, Florida, United States, 33125
        • Atea Study Site
      • Miami Lakes, Florida, United States, 33014
        • Atea Study Site
      • Orlando, Florida, United States, 32803
        • Atea Study Site
      • Pembroke Pines, Florida, United States, 33024
        • Atea Study Site
      • Sarasota, Florida, United States, 34237
        • Atea Study Site
      • West Palm Beach, Florida, United States, 33407
        • Atea Study Site
    • Georgia
      • Macon, Georgia, United States, 31201
        • Atea Study Site
      • Marietta, Georgia, United States, 30060
        • Atea Study Site
    • Illinois
      • Chicago, Illinois, United States, 60613
        • Atea Study Site
    • Indiana
      • New Albany, Indiana, United States, 47150
        • Atea Study Site
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Atea Study Site
      • Topeka, Kansas, United States, 66606
        • Atea Study Site
    • Kentucky
      • Louisville, Kentucky, United States, 40218
        • Atea Study Site
    • Louisiana
      • New Iberia, Louisiana, United States, 70560
        • Atea Study Site
      • New Orleans, Louisiana, United States, 70112
        • Atea Study Site
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Atea Study Site
      • Baltimore, Maryland, United States, 21287
        • Atea Study Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Atea Study Site
      • Boston, Massachusetts, United States, 02118
        • Atea Study Site
      • Springfield, Massachusetts, United States, 01105
        • Atea Study Site
      • Worcester, Massachusetts, United States, 01655
        • Atea Study Site
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Atea Study Site
      • Grosse Pointe Woods, Michigan, United States, 48236
        • Atea Study Site
      • Novi, Michigan, United States, 48377
        • Atea Study Site
      • Wyoming, Michigan, United States, 49519
        • Atea Study Site
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Atea Study Site
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Atea Study Site
      • Hackensack, New Jersey, United States, 07601
        • Atea Study Site
      • Hillsborough, New Jersey, United States, 08844
        • Atea Study Site
      • Newark, New Jersey, United States, 07102
        • Atea Study Site
      • Newark, New Jersey, United States, 07103
        • Atea Study Site
    • New York
      • Brooklyn, New York, United States, 11215
        • Atea Study Site
      • New York, New York, United States, 10016
        • Atea Study Site
      • Yonkers, New York, United States, 10701
        • Atea Study Site
    • North Carolina
      • Asheville, North Carolina, United States, 28801
        • Atea Study Site
      • Charlotte, North Carolina, United States, 28204
        • Atea Study Site
      • Fayetteville, North Carolina, United States, 28304
        • Atea Study Site
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Atea Study Site
      • Cincinnati, Ohio, United States, 45267
        • Atea Study Site
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Atea Study Site
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18103
        • Atea Study Site
      • DuBois, Pennsylvania, United States, 15801
        • Atea Study Site
      • Philadelphia, Pennsylvania, United States, 19104
        • Atea Study Site
      • Philadelphia, Pennsylvania, United States, 19107
        • Atea Study Site
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Atea Study Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Atea Study Site
      • Cordova, Tennessee, United States, 38018
        • Atea Study Site
      • Jackson, Tennessee, United States, 38301
        • Atea Study Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Atea Study Site
      • Dallas, Texas, United States, 75203
        • Atea Study Site
      • Dallas, Texas, United States, 75242
        • Atea Study Site
      • Denison, Texas, United States, 75020
        • Atea Study Site
      • Houston, Texas, United States, 77030
        • Atea Study Site
      • Plano, Texas, United States, 75093
        • Atea Study Site
      • San Antonio, Texas, United States, 78215
        • Atea Study Site
      • Temple, Texas, United States, 76508
        • Atea Study Site
      • Waco, Texas, United States, 76710
        • Atea Study Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Atea Study Site
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Atea Study Site
      • Norfolk, Virginia, United States, 23502
        • Atea Study Site
      • Richmond, Virginia, United States, 23226
        • Atea Study Site
      • Richmond, Virginia, United States, 23298
        • Atea Study Site
    • Washington
      • Seattle, Washington, United States, 98101
        • Atea Study Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Bemnifosbuvir-Ruzasvir (BEM/RZR)
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)
Active Comparator: Sofosbuvir-Velpatasvir (SOF/VEL)
Drug: Sofosbuvir-Velpatasvir (SOF/VEL)
SOF/VEL Fixed-dose Combination (FDC) tablets administered orally once daily for a total of 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 through Week 24

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Day 1 through 12 weeks after the end of treatment
Proportion of subjects experiencing virologic failure.
Time Frame: Day 1 through Week 24
Day 1 through Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Atea Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 7, 2025

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 7, 2025

First Submitted That Met QC Criteria

March 7, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

December 5, 2025

Last Update Submitted That Met QC Criteria

December 3, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AT-01B-007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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