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 Sex
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

More Details

NCT ID
NCT06868264
Status
Active, not recruiting
Sponsor
Atea Pharmaceuticals, Inc.

For help using this page: trialstoday@researchmatch.org or call 855-514-7001

ResearchMatch is funded in part by the National Institutes of Health (NIH) Clinical and Translational Science Award (CTSA) program, led by the NIH’s National Center for Advancing Translational Sciences (NCATS), grants UL1TR000445 and 1U54RR032646-01, and grant U24TR001579 from NCATS and the National Library of Medicine. The content of this website is solely the responsibility of ResearchMatch and Vanderbilt University and does not necessarily represent the official views of the NIH, NCATS, or NLM.

Vanderbilt University Medical Center