Clinical trial NCT06868264: C-BEYOND: Efficacy and Safety of BEM/RZR vs. SOF/VEL in Subjects With Chronic HCV
Official title: Phase 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 type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: HEPATITIS C VIRUS CHRONIC INFECTION
Lead sponsor: Atea Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2025-03-10
Enrollment: 880
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Key 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

Primary outcomes:
measure: Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.
timeFrame: Day 1 through Week 24
Secondary outcomes:
measure: Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs.
timeFrame: Day 1 through 12 weeks after the end of treatment
measure: Proportion of subjects experiencing virologic failure.
timeFrame: Day 1 through Week 24
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Atea Study Site
state: Alabama
city: Dothan
country: United States
facility: Atea Study Site
state: Alabama
city: Mesa
country: United States
facility: Atea Study Site
state: Arizona
city: Phoenix
country: United States
facility: Atea Study Site
state: Arizona
city: Tucson
country: United States
facility: Atea Study Site
state: Arizona
city: Little Rock
country: United States
facility: Atea Study Site
state: Arkansas
city: Bakersfield
country: United States
facility: Atea Study Site
state: California
city: Escondido
country: United States
facility: Atea Study Site
state: California
city: Fresno
country: United States
facility: Atea Study Site
state: California
city: Los Angeles
country: United States
facility: Atea Study Site
state: California
city: Colorado Springs
country: United States
facility: Atea Study Site
state: Colorado
city: Washington
country: United States
facility: Atea Study Site
state: District of Columbia
city: Washington
country: United States
facility: Atea Study Site
state: District of Columbia
city: Coral Gables
country: United States
facility: Atea Study Site
state: Florida
city: DeLand
country: United States
facility: Atea Study Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Atea Study Site
state: Florida
city: Fort Pierce
country: United States
facility: Atea Study Site
state: Florida
city: Inverness
country: United States
facility: Atea Study Site
state: Florida
city: Jupiter
country: United States
facility: Atea Study Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Atea Study Site
state: Florida
city: Miami Lakes
country: United States
facility: Atea Study Site
state: Florida
city: Miami
country: United States
facility: Atea Study Site
state: Florida
city: Pembroke Pines
country: United States
facility: Atea Study Site
state: Florida
city: West Palm Beach
country: United States
facility: Atea Study Site
state: Florida
city: Macon
country: United States
facility: Atea Study Site
state: Georgia
city: Marietta
country: United States
facility: Atea Study Site
state: Georgia
city: New Albany
country: United States
facility: Atea Study Site
state: Indiana
city: Fairway
country: United States
facility: Atea Study Site
state: Kansas
city: Topeka
country: United States
facility: Atea Study Site
state: Kansas
city: Louisville
country: United States
facility: Atea Study Site
state: Kentucky
city: Lake Charles
country: United States
facility: Atea Study Site
state: Louisiana
city: New Iberia
country: United States
facility: Atea Study Site
state: Louisiana
city: Baltimore
country: United States
facility: Atea Study Site
state: Maryland
city: Springfield
country: United States
facility: Atea Study Site
state: Massachusetts
city: Wyoming
country: United States
facility: Atea Study Site
state: Michigan
city: Hillsborough
country: United States
facility: Atea Study Site
state: New Jersey
city: Newark
country: United States
facility: Atea Study Site
state: New Jersey
city: Yonkers
country: United States
facility: Atea Study Site
state: New York
city: Asheville
country: United States
facility: Atea Study Site
state: North Carolina
city: Fayetteville
country: United States
facility: Atea Study Site
state: North Carolina
city: Tulsa
country: United States
facility: Atea Study Site
state: Oklahoma
city: DuBois
country: United States
facility: Atea Study Site
state: Pennsylvania
city: Chattanooga
country: United States
facility: Atea Study Site
state: Tennessee
city: Cordova
country: United States
facility: Atea Study Site
state: Tennessee
city: Jackson
country: United States
facility: Atea Study Site
state: Tennessee
city: Arlington
country: United States
facility: Atea Study Site
state: Texas
city: Denison
country: United States
facility: Atea Study Site
state: Texas
city: Plano
country: United States
facility: Atea Study Site
state: Texas
city: San Antonio
country: United States
facility: Atea Study Site
state: Texas
city: Waco
country: United States
facility: Atea Study Site
state: Texas
city: Ogden
country: United States
facility: Atea Study Site
state: Utah
city: Chesapeake
country: United States
facility: Atea Study Site
state: Virginia
city: Norfolk
country: United States
facility: Atea Study Site
state: Virginia
city: Seattle
country: United States
facility: Atea Study Site
state: Washington
Study officials:
References: