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

NCT06868264 | Active Not Recruiting Phase 3 FDA Drug

• 1 other identifier: AT-01B-007
• Study Type: interventional
• Target: 880
• Locations: 2 countries
• Sites: 105

Brief Summary

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

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

Outcome Measures

Primary Outcomes (1)

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

  Day 1 through Week 24

Secondary Outcomes (2)

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

  Day 1 through 12 weeks after the end of treatment

• Proportion of subjects experiencing virologic failure.

  Day 1 through Week 24

Study Arms (2)

Bemnifosbuvir-Ruzasvir (BEM/RZR)

EXPERIMENTAL

Drug: Bemnifosbuvir-Ruzasvir (BEM/RZR)

Sofosbuvir-Velpatasvir (SOF/VEL)

ACTIVE COMPARATOR

Drug: Sofosbuvir-Velpatasvir (SOF/VEL)

Interventions

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)

Bemnifosbuvir-Ruzasvir (BEM/RZR)

Sofosbuvir-Velpatasvir (SOF/VEL) DRUG

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

Sofosbuvir-Velpatasvir (SOF/VEL)

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Atea Pharmaceuticals, Inc.: lead

Study Sites (105)

Atea Study Site

Birmingham, Alabama, 35215, United States

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Dothan, Alabama, 36301, United States

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Chandler, Arizona, 85225, United States

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Flagstaff, Arizona, 86001, United States

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Mesa, Arizona, 85210, United States

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Phoenix, Arizona, 85006, United States

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Phoenix, Arizona, 85015, United States

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Tucson, Arizona, 85745, United States

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Little Rock, Arkansas, 72204, United States

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Bakersfield, California, 93301, United States

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Coronado, California, 92118, United States

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Escondido, California, 92025, United States

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Fresno, California, 93711, United States

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Long Beach, California, 98015, United States

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Los Angeles, California, 90048, United States

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Los Angeles, California, 90067, United States

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Orange, California, 92868, United States

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Pasadena, California, 91105, United States

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Sacramento, California, 95817, United States

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Torrance, California, 90502, United States

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Valencia, California, 91355, United States

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Colorado Springs, Colorado, 80907, United States

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Washington D.C., District of Columbia, 20017, United States

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Washington D.C., District of Columbia, 20037, United States

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Coral Gables, Florida, 33134, United States

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DeLand, Florida, 32720, United States

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Fort Lauderdale, Florida, 33308, United States

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Ft. Pierce, Florida, 34982, United States

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Gainesville, Florida, 32610, United States

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Inverness, Florida, 34452, United States

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Jupiter, Florida, 33458, United States

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Lauderdale Lakes, Florida, 33313, United States

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Maitland, Florida, 32751, United States

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Miami, Florida, 33125, United States

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Miami Lakes, Florida, 33014, United States

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Orlando, Florida, 32803, United States

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Pembroke Pines, Florida, 33024, United States

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Sarasota, Florida, 34237, United States

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West Palm Beach, Florida, 33407, United States

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Macon, Georgia, 31201, United States

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Marietta, Georgia, 30060, United States

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Chicago, Illinois, 60613, United States

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New Albany, Indiana, 47150, United States

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Fairway, Kansas, 66205, United States

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Topeka, Kansas, 66606, United States

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Louisville, Kentucky, 40218, United States

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New Iberia, Louisiana, 70560, United States

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New Orleans, Louisiana, 70112, United States

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Baltimore, Maryland, 21201, United States

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Baltimore, Maryland, 21287, United States

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Boston, Massachusetts, 02114, United States

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Boston, Massachusetts, 02118, United States

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Springfield, Massachusetts, 01105, United States

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Worcester, Massachusetts, 01655, United States

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Detroit, Michigan, 48201, United States

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Grosse Pointe Woods, Michigan, 48236, United States

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Novi, Michigan, 48377, United States

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Wyoming, Michigan, 49519, United States

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Tupelo, Mississippi, 38801, United States

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Camden, New Jersey, 08103, United States

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Hackensack, New Jersey, 07601, United States

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Hillsborough, New Jersey, 08844, United States

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Newark, New Jersey, 07102, United States

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Newark, New Jersey, 07103, United States

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Brooklyn, New York, 11215, United States

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New York, New York, 10016, United States

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Yonkers, New York, 10701, United States

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Asheville, North Carolina, 28801, United States

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Charlotte, North Carolina, 28204, United States

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Fayetteville, North Carolina, 28304, United States

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Beavercreek, Ohio, 45440, United States

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Cincinnati, Ohio, 45267, United States

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Tulsa, Oklahoma, 74104, United States

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Allentown, Pennsylvania, 18103, United States

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DuBois, Pennsylvania, 15801, United States

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Philadelphia, Pennsylvania, 19104, United States

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Philadelphia, Pennsylvania, 19107, United States

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Charleston, South Carolina, 29425, United States

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Chattanooga, Tennessee, 37421, United States

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Cordova, Tennessee, 38018, United States

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Jackson, Tennessee, 38301, United States

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Arlington, Texas, 76012, United States

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Dallas, Texas, 75203, United States

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Dallas, Texas, 75242, United States

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Denison, Texas, 75020, United States

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Houston, Texas, 77030, United States

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Plano, Texas, 75093, United States

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San Antonio, Texas, 78215, United States

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Temple, Texas, 76508, United States

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Waco, Texas, 76710, United States

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Ogden, Utah, 84405, United States

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Chesapeake, Virginia, 23320, United States

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Norfolk, Virginia, 23502, United States

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Richmond, Virginia, 23226, United States

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Richmond, Virginia, 23298, United States

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Seattle, Washington, 98101, United States

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Vancouver, British Columbia, V6Z 2C7, Canada

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Moncton, New Brunswick, E1C6Z8, Canada

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St. John's, Newfoundland and Labrador, A1B3V6, Canada

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Brampton, Ontario, L6R 3J7, Canada

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Ottawa, Ontario, K1H8L6, Canada

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Toronto, Ontario, M5G2C4, Canada

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Montreal, Quebec, H4A3J1, Canada

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Québec, Quebec, G1V 4T3, Canada

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Québec, Quebec, G1V4G2, Canada

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MeSH Terms

Interventions

sofosbuvir-velpatasvir drug combination

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 10, 2025
• Study Start: April 7, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 5, 2025

Record last verified: 2025-11

Locations

US (96); CA (9)