The purpose of this study is to compare the safety and effectiveness of an experimental drug called bemnifosbuvir-ruzasvir (BEM/RZR) to another drug, sofosbuvir/velpatasvir (SOF/VEL), in treating chronic hepatitis C virus (HCV) infection. The study focuses on adults who have a chronic HCV infection and have not been treated with any direct-acting antiviral (DAA) medications for HCV infection. (DAAs are medications that target the virus directly and prevent it from making copies of itself and spreading throughout the body.) Researchers will examine how BEM/RZR moves through the body (pharmacokinetics), whether it works to remove HCV from the body, and how the level of HCV in the blood changes over time. BEM/RZR is a combination of 2 investigational drugs: bemnifosbuvir (BEM) and ruzasvir (RZR). BEM is designed to block a specific enzyme; by blocking this enzyme, the virus is not able to make copies of itself and spread throughout the body. RZR is a direct-acting antiviral drug designed to stop the virus’s copying “machine” so that it cannot spread throughout the body. Researchers hope that this combination can eradicate the virus in a similar or shorter treatment duration, with potentially fewer side effects and greater tolerability compared to the current standard-of-care regimen. SOF/VEL is a standard-of-care treatment (approved by the U.S. Food and Drug Administration) for people with HCV infection; it is a combination of 2 medications: sofosbuvir (SOF) and velpatasvir (VEL). Participants will be randomly assigned to 1 of 2 groups. Group 1 will receive BEM/RZR, and Group 2 will receive SOF/VEL.
What is the full name of this clinical trial?
Phase 3, Randomized, Controlled, Open-label Study to Compare the Efficacy and Safety of Bemnifosbuvir-Ruzasvir Fixed-dose Combination Versus Sofosbuvir-Velpatasvir Fixed-dose Combination in Subjects with Chronic Hepatitis C Virus Infection