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

NCT ID: NCT06868264

Last Updated: 2025-12-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

880 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-07

Study Completion Date

2026-12-31

Brief Summary

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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

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Conditions

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HEPATITIS C VIRUS CHRONIC INFECTION

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Bemnifosbuvir-Ruzasvir (BEM/RZR)

Group Type EXPERIMENTAL

Bemnifosbuvir-Ruzasvir (BEM/RZR)

Intervention Type 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)

Group Type ACTIVE_COMPARATOR

Sofosbuvir-Velpatasvir (SOF/VEL)

Intervention Type DRUG

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

Interventions

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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)

Intervention Type DRUG

Sofosbuvir-Velpatasvir (SOF/VEL)

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

Intervention Type DRUG

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Atea Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Atea Study Site

Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Chandler, Arizona, United States

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Flagstaff, Arizona, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tucson, Arizona, United States

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Little Rock, Arkansas, United States

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Bakersfield, California, United States

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Coronado, California, United States

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Escondido, California, United States

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Fresno, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Orange, California, United States

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Pasadena, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Valencia, California, United States

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Colorado Springs, Colorado, United States

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Washington D.C., District of Columbia, United States

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Washington D.C., District of Columbia, United States

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Coral Gables, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Ft. Pierce, Florida, United States

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Gainesville, Florida, United States

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Inverness, Florida, United States

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Jupiter, Florida, United States

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Lauderdale Lakes, Florida, United States

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Maitland, Florida, United States

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Miami, Florida, United States

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Miami Lakes, Florida, United States

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Orlando, Florida, United States

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Pembroke Pines, Florida, United States

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Sarasota, Florida, United States

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West Palm Beach, Florida, United States

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Macon, Georgia, United States

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Marietta, Georgia, United States

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Chicago, Illinois, United States

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New Albany, Indiana, United States

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Fairway, Kansas, United States

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Topeka, Kansas, United States

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Louisville, Kentucky, United States

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New Iberia, Louisiana, United States

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New Orleans, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Boston, Massachusetts, United States

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Boston, Massachusetts, United States

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Springfield, Massachusetts, United States

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Worcester, Massachusetts, United States

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Detroit, Michigan, United States

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Grosse Pointe Woods, Michigan, United States

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Novi, Michigan, United States

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Wyoming, Michigan, United States

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Tupelo, Mississippi, United States

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Camden, New Jersey, United States

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Hackensack, New Jersey, United States

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Hillsborough, New Jersey, United States

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Newark, New Jersey, United States

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Newark, New Jersey, United States

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Brooklyn, New York, United States

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New York, New York, United States

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Yonkers, New York, United States

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Asheville, North Carolina, United States

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Charlotte, North Carolina, United States

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Fayetteville, North Carolina, United States

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Beavercreek, Ohio, United States

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Cincinnati, Ohio, United States

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Tulsa, Oklahoma, United States

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Allentown, Pennsylvania, United States

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DuBois, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Charleston, South Carolina, United States

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Chattanooga, Tennessee, United States

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Cordova, Tennessee, United States

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Jackson, Tennessee, United States

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Arlington, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Denison, Texas, United States

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Houston, Texas, United States

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Plano, Texas, United States

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San Antonio, Texas, United States

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Temple, Texas, United States

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Waco, Texas, United States

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Ogden, Utah, United States

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Chesapeake, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Seattle, Washington, United States

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Vancouver, British Columbia, Canada

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Moncton, New Brunswick, Canada

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St. John's, Newfoundland and Labrador, Canada

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Brampton, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Québec, Quebec, Canada

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Countries

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United States Canada

Other Identifiers

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AT-01B-007

Identifier Type: -

Identifier Source: org_study_id

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