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

Purpose

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

Condition

  • HEPATITIS C VIRUS CHRONIC INFECTION

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Atea Study Site
Birmingham, Alabama 35215

Atea Study Site
Dothan, Alabama 36301

Atea Study Site
Mesa, Arizona 85210

Atea Study Site
Phoenix, Arizona 85006

Atea Study Site
Tucson, Arizona 85745

Atea Study Site
Little Rock, Arkansas 72204

Atea Study Site
Bakersfield, California 93301

Atea Study Site
Escondido, California 92025

Atea Study Site
Fresno, California 93711

Atea Study Site
Los Angeles, California 90067

Atea Study Site
Colorado Springs, Colorado 80907

Atea Study Site
Washington, District of Columbia 20017

Atea Study Site
Washington, District of Columbia 20037

Atea Study Site
Coral Gables, Florida 33134

Atea Study Site
DeLand, Florida 32720

Atea Study Site
Fort Lauderdale, Florida 33308

Atea Study Site
Fort Pierce, Florida 34982

Atea Study Site
Inverness, Florida 34452

Atea Study Site
Jupiter, Florida 33458

Atea Study Site
Lauderdale Lakes, Florida 33313

Atea Study Site
Miami Lakes, Florida 33014

Atea Study Site
Miami, Florida 33125

Atea Study Site
Pembroke Pines, Florida 33024

Atea Study Site
West Palm Beach, Florida 33407

Atea Study Site
Macon, Georgia 31201

Atea Study Site
Marietta, Georgia 30060

Atea Study Site
New Albany, Indiana 47150

Atea Study Site
Fairway, Kansas 66205

Atea Study Site
Topeka, Kansas 66606

Atea Study Site
Louisville, Kentucky 40218

Atea Study Site
Lake Charles, Louisiana 70601

Atea Study Site
New Iberia, Louisiana 70560

Atea Study Site
Baltimore, Maryland 21287

Atea Study Site
Springfield, Massachusetts 01105

Atea Study Site
Wyoming, Michigan 49519

Atea Study Site
Hillsborough, New Jersey 08844

Atea Study Site
Newark, New Jersey 07102

Atea Study Site
Yonkers, New York 10701

Atea Study Site
Asheville, North Carolina 28801

Atea Study Site
Fayetteville, North Carolina 28304

Atea Study Site
Tulsa, Oklahoma 74104

Atea Study Site
DuBois, Pennsylvania 15801

Atea Study Site
Chattanooga, Tennessee 37421

Atea Study Site
Cordova, Tennessee 38018

Atea Study Site
Jackson, Tennessee 38301

Atea Study Site
Arlington, Texas 76012

Atea Study Site
Denison, Texas 75020

Atea Study Site
Plano, Texas 75093

Atea Study Site
San Antonio, Texas 78215

Atea Study Site
Waco, Texas 76710

Atea Study Site
Ogden, Utah 84405

Atea Study Site
Chesapeake, Virginia 23320

Atea Study Site
Norfolk, Virginia 23502

Atea Study Site
Seattle, Washington 98101

More Details

NCT ID
NCT06868264
Status
Recruiting
Sponsor
Atea Pharmaceuticals, Inc.

Study Contact

Clinical Trials Administrator
1-(857) 284-8891
ateaclinicaltrials@ateapharma.com

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Vanderbilt University Medical Center