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

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

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06868264

Enrollment

880

Registered

2025-03-10

Start date

2025-04-07

Completion date

2026-12-31

Last updated

2025-12-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HEPATITIS C VIRUS CHRONIC INFECTION

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.

Interventions

DRUGBemnifosbuvir-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)

DRUGSofosbuvir-Velpatasvir (SOF/VEL)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

Inclusion 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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects achieving HCV RNA less than the lower limit of quantitation (LLOQ) at study week 24.	Day 1 through Week 24

Secondary

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026