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

Recruitment Status
ACTIVE, NOT RECRUITING
(See Contacts and Locations)Verified October 2025 by Atea Pharmaceuticals, Inc.
Sponsor
Atea Pharmaceuticals, Inc.
Information Provided by (Responsible Party)
Atea Pharmaceuticals, Inc.
Clinicaltrials.gov Identifier
NCT06868264
Other Study ID Numbers:
AT-01B-007
First Submitted
March 6, 2025
First Posted
March 9, 2025
Last Update Posted
December 4, 2025
Last Verified
October 2025

ClinicalTrials.gov processed this data on December 2025. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
HEPATITIS C VIRUS CHRONIC INFECTION
Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR)Drug: Sofosbuvir-Velpatasvir (SOF/VEL)

Study Design

Study TypeInterventional
Actual Enrollment880 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitlePhase 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
Study Start DateApril 6, 2025
Actual Primary Completion Date3mos 1w from now
Actual Study Completion Date6mos 1w from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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)
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

Outcome Measures

Primary Outcome Measures
  1. Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
Secondary Outcome Measures
  1. Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.
  2. Proportion of subjects experiencing virologic failure.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsAtea Pharmaceuticals, Inc.
Locations
Atea Study Site | Birmingham Alabama, United States, 35215Atea Study Site | Dothan Alabama, United States, 36301Atea Study Site | Chandler Arizona, United States, 85225Atea Study Site | Flagstaff Arizona, United States, 86001Atea Study Site | Mesa Arizona, United States, 85210Atea Study Site | Phoenix Arizona, United States, 85006Atea Study Site | Phoenix Arizona, United States, 85015Atea Study Site | Tucson Arizona, United States, 85745Atea Study Site | Little Rock Arkansas, United States, 72204Atea Study Site | Bakersfield California, United States, 93301Atea Study Site | Coronado California, United States, 92118Atea Study Site | Escondido California, United States, 92025Atea Study Site | Fresno California, United States, 93711Atea Study Site | Long Beach California, United States, 98015Atea Study Site | Los Angeles California, United States, 90048Atea Study Site | Los Angeles California, United States, 90067Atea Study Site | Orange California, United States, 92868Atea Study Site | Pasadena California, United States, 91105Atea Study Site | Sacramento California, United States, 95817Atea Study Site | Torrance California, United States, 90502Atea Study Site | Valencia California, United States, 91355Atea Study Site | Colorado Springs Colorado, United States, 80907Atea Study Site | Washington D.C. District of Columbia, United States, 20017Atea Study Site | Washington D.C. District of Columbia, United States, 20037Atea Study Site | Coral Gables Florida, United States, 33134Atea Study Site | DeLand Florida, United States, 32720Atea Study Site | Fort Lauderdale Florida, United States, 33308Atea Study Site | Ft. Pierce Florida, United States, 34982Atea Study Site | Gainesville Florida, United States, 32610Atea Study Site | Inverness Florida, United States, 34452Atea Study Site | Jupiter Florida, United States, 33458Atea Study Site | Lauderdale Lakes Florida, United States, 33313Atea Study Site | Maitland Florida, United States, 32751Atea Study Site | Miami Florida, United States, 33125Atea Study Site | Miami Lakes Florida, United States, 33014Atea Study Site | Orlando Florida, United States, 32803Atea Study Site | Pembroke Pines Florida, United States, 33024Atea Study Site | Sarasota Florida, United States, 34237Atea Study Site | West Palm Beach Florida, United States, 33407Atea Study Site | Macon Georgia, United States, 31201Atea Study Site | Marietta Georgia, United States, 30060Atea Study Site | Chicago Illinois, United States, 60613Atea Study Site | New Albany Indiana, United States, 47150Atea Study Site | Fairway Kansas, United States, 66205Atea Study Site | Topeka Kansas, United States, 66606Atea Study Site | Louisville Kentucky, United States, 40218Atea Study Site | New Iberia Louisiana, United States, 70560Atea Study Site | New Orleans Louisiana, United States, 70112Atea Study Site | Baltimore Maryland, United States, 21201Atea Study Site | Baltimore Maryland, United States, 21287Atea Study Site | Boston Massachusetts, United States, 02114Atea Study Site | Boston Massachusetts, United States, 02118Atea Study Site | Springfield Massachusetts, United States, 01105Atea Study Site | Worcester Massachusetts, United States, 01655Atea Study Site | Detroit Michigan, United States, 48201Atea Study Site | Grosse Pointe Woods Michigan, United States, 48236Atea Study Site | Novi Michigan, United States, 48377Atea Study Site | Wyoming Michigan, United States, 49519Atea Study Site | Tupelo Mississippi, United States, 38801Atea Study Site | Camden New Jersey, United States, 08103Atea Study Site | Hackensack New Jersey, United States, 07601Atea Study Site | Hillsborough New Jersey, United States, 08844Atea Study Site | Newark New Jersey, United States, 07102Atea Study Site | Newark New Jersey, United States, 07103Atea Study Site | Brooklyn New York, United States, 11215Atea Study Site | New York New York, United States, 10016Atea Study Site | Yonkers New York, United States, 10701Atea Study Site | Asheville North Carolina, United States, 28801Atea Study Site | Charlotte North Carolina, United States, 28204Atea Study Site | Fayetteville North Carolina, United States, 28304Atea Study Site | Beavercreek Ohio, United States, 45440Atea Study Site | Cincinnati Ohio, United States, 45267Atea Study Site | Tulsa Oklahoma, United States, 74104Atea Study Site | Allentown Pennsylvania, United States, 18103Atea Study Site | DuBois Pennsylvania, United States, 15801Atea Study Site | Philadelphia Pennsylvania, United States, 19104Atea Study Site | Philadelphia Pennsylvania, United States, 19107Atea Study Site | Charleston South Carolina, United States, 29425Atea Study Site | Chattanooga Tennessee, United States, 37421Atea Study Site | Cordova Tennessee, United States, 38018Atea Study Site | Jackson Tennessee, United States, 38301Atea Study Site | Arlington Texas, United States, 76012Atea Study Site | Dallas Texas, United States, 75203Atea Study Site | Dallas Texas, United States, 75242Atea Study Site | Denison Texas, United States, 75020Atea Study Site | Houston Texas, United States, 77030Atea Study Site | Plano Texas, United States, 75093Atea Study Site | San Antonio Texas, United States, 78215Atea Study Site | Temple Texas, United States, 76508Atea Study Site | Waco Texas, United States, 76710Atea Study Site | Ogden Utah, United States, 84405Atea Study Site | Chesapeake Virginia, United States, 23320Atea Study Site | Norfolk Virginia, United States, 23502Atea Study Site | Richmond Virginia, United States, 23226Atea Study Site | Richmond Virginia, United States, 23298Atea Study Site | Seattle Washington, United States, 98101Atea Study Site | Vancouver British Columbia, Canada, V6Z 2C7Atea Study Site | Moncton New Brunswick, Canada, E1C6Z8Atea Study Site | St. John's Newfoundland and Labrador, Canada, A1B3V6Atea Study Site | Brampton Ontario, Canada, L6R 3J7Atea Study Site | Ottawa Ontario, Canada, K1H8L6Atea Study Site | Toronto Ontario, Canada, M5G2C4Atea Study Site | Montreal Quebec, Canada, H4A3J1Atea Study Site | Québec Quebec, Canada, G1V 4T3Atea Study Site | Québec Quebec, Canada, G1V4G2