Atea Pharmaceuticals Completes Enrollment in North American Phase 3 Hepatitis C Trial

Atea Pharmaceuticals (NASDAQ: AVIR) has completed patient enrollment in its C-BEYOND Phase 3 clinical trial, a pivotal study evaluating an oral, fixed-dose combination of bemnifosbuvir and ruzasvir for the treatment of chronic hepatitis C virus infection. The trial enrolled more than 880 treatment-naïve adults across approximately 120 clinical sites in the United States and Canada, marking a key milestone in Atea’s late-stage development program.

Trial Design and Treatment Approach

C-BEYOND is a randomized, active-controlled study designed to compare Atea’s investigational regimen directly against the current standard-of-care combination of sofosbuvir and velpatasvir. Participants receive once-daily oral therapy, with an eight-week treatment duration for patients without cirrhosis and a 12-week course for those with compensated cirrhosis.

The study’s primary endpoint is sustained virologic response at 12 weeks after treatment completion (SVR12), a widely accepted measure of virologic cure in hepatitis C. Secondary endpoints include safety, tolerability, and efficacy across different viral genotypes.

Significance of Enrollment Completion

Completing enrollment allows the trial to move fully into treatment completion and follow-up, keeping the program on track for topline results expected in mid-2026. The North American study is part of a broader global Phase 3 development effort, which also includes the C-FORWARD trial, currently enrolling patients outside North America and expected to report results in late 2026.

Together, the two studies represent the first global head-to-head Phase 3 program comparing novel direct-acting antiviral regimens in hepatitis C, providing a robust dataset across geographies and patient populations.

Broader Context in Hepatitis C Treatment

While highly effective therapies for hepatitis C already exist, ongoing development efforts focus on simplifying treatment, shortening therapy duration, and maintaining high cure rates across all viral genotypes. Atea’s regimen is designed as a single-tablet, once-daily option, which could help streamline care and support broader treatment access if clinical outcomes are favorable.

Hepatitis C remains a significant global health challenge, with millions of people living with chronic infection and many still undiagnosed or untreated.

What Comes Next

With enrollment complete, attention now shifts to data collection and analysis as patients finish treatment and follow-up. Results from the C-BEYOND trial will be an important determinant of the program’s future direction and potential regulatory discussions.