Phase 3, Randomized, Controlled, Open-Label, Study To Compare The Efficacy And Safety Of Bemnifosbuvir-Ruzasvir Fixed-Dose Combination (Bem/Rzr Fdc) For 8 Weeks Versus Sofosbuvir-Velpatasvir (Sof/Vel) For 12 Weeks In Subjects With Hepatitis C Virus (Hc
Posted Date: Sep 9, 2025
- Investigator: Khurram Bari
- Specialties:
- Type of Study: Drug
Protocol Title: Phase 3, Randomized, Controlled, Open-label, Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination (BEM/RZR FDC) for 8 Weeks Versus Sofosbuvir-Velpatasvir (SOF/VEL) for 12 Weeks in Subjects with Hepatitis C Virus (HCV) Infection Study Rationale: A combination of BEM and RZR has the potential to provide a convenient, protease-sparing, pan-genotypic treatment regimen for HCV-infected patients with or without cirrhosis. This Phase 3 study is designed to compare the efficacy and safety of this combination therapy after 8 weeks of treatment. Target Population: HCV RNA positive, GTs 1 7, either non-cirrhotic or have compensated cirrhosis, no prior use of a DAA for current HCV infection (prior treatment with pegylated interferon with or without ribavirin is acceptable), inclusive of subjects with HCV/HIV co-infection.
Criteria:
Al Adults Ages 85 Or Less With Chronic Hepatitis C, Genotype 1-7, Naive To Prior Direct Acting Antiviral Drugs Without Decompensated Cirrhosis
Keywords:
Hepatitis C
For More Information:
Adrienne Crusey
(513)-584-2363
cruseyla@ucmail.uc.edu