C – Beyond AT-01B-007

Hepatitis C virus (HCV) is a blood-borne single stranded RNA virus which primarily infects cells of the liver. Approximately 50 million people globally are chronically infected with HCV, with about 1.0 million new infections occurring per year. While Oral Direct Acting Antivirals have drastically improved efficacy and safety profiles compared to the interferon - containing regimens of the past, currently approved DAAs have important limitations that impact treatment effectiveness and usability.  A key determinant of treatment success is adherence to an HCV treatment regimen. Noncompliance with treatment contributes to poor disease control, and increased risk for disease transmission. Shorter-course treatments impose less drug burden on patients. There are presently no short-course (i.e., 8 week) nucleoside inhibitor-based, pan-genotypic HCV treatment regimens.

The C-Beyond AT-01B-007 study is a Phase 3, randomized, open-label study comparing the efficacy of a novel 8-12 week oral treatment for HCV (combination of bemnifosbuvir and ruzasvir) with standard of care HCV treatment (sofosbuvir/velpatasvir). Participants will have a 50/50 chance of being randomized to the novel treatment versus the standard treatment. All participants will attend the same number of study visits through Week 36. Participants with HCV/HIV-1 co-infection will also be eligible.