An Evaluation of Bemnifosbuvir-Ruzasvir (BEM/RZR) Versus Sofosbuvir-Velpatasvir (SOF/VEL) for the Treatment of Chronic Hepatitis C Virus (HCV) Infection in a Phase 3 Randomized, Controlled, Open-label Study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-521096-31-00

Acronym

AT-01B-008

Enrollment

275

Registered

2025-09-08

Start date

2025-10-02

Completion date

Unknown

Last updated

2026-01-21

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

Conditions

Chronic Hepatitis C Virus (HCV) Infection

Brief summary

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

Detailed description

Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs., Proportion of subjects experiencing virologic failure.

Interventions

DRUGBemnifosbuvir/Ruzasvir Fixed Dose Combination (FDC)

DRUGSofosbuvir / Velpatasvir

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

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

Secondary

Measure	Time frame
Proportion of subjects achieving HCV RNA < LLOQ 12 weeks after the last dose of study drugs., Proportion of subjects experiencing virologic failure.	—

Countries

France, Germany, Greece, Poland, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026