Atea Pharmaceuticals Inc. (NASDAQ:AVIR) announced on Tuesday positive topline findings from its pivotal North American Phase 3 C-BEYOND clinical trial evaluating its oral antiviral therapy for chronic hepatitis C virus infection.
The C-BEYOND study enrolled 905 patients and met its primary endpoint.
The data demonstrated that a once-daily fixed-dose combination of bemnifosbuvir and ruzasvir achieved statistical non-inferiority compared to Gilead Sciences Inc.’s (NASDAQ:GILD) Epclusa (sofosbuvir and velpatasvir) in a modified intent-to-treat population.
Phase 3 Trial Efficacy Outcomes
In the overall modified intent-to-treat analysis encompassing cirrhotic and non-cirrhotic patients, the experimental dual-drug combination achieved a 93.9% sustained virologic response rate at 24 weeks, compared to 94.8% for the control group.
Rates of treatment failure were low and balanced across both study arms.
In non-cirrhotic patients, who represent approximately 80% to 90% of individuals living with chronic hepatitis C in the U.S., an eight-week regimen of bemnifosbuvir and ruzasvir generated a 93.5% cure rate.
The performance was comparable to the 94.6% rate observed with twelve weeks of sofosbuvir and velpatasvir.
Among cirrhotic participants receiving twelve-week regimens, both therapeutic approaches achieved an identical 95.4% cure rate.
Safety Profile And International Expansion
The combination therapy demonstrated strong tolerability, showing no drug-related serious adverse events or treatment discontinuations due to side effects.
Beyond offering a shorter duration for most patients, the regimen provides clinical advantages including no food requirements and a low risk of drug-drug interactions.
Atea is currently conducting its global C-FORWARD trial, which has fully enrolled over 880 participants across 17 nations to evaluate additional viral genotypes.
Topline data from that study are expected in early 2027, with full results planned for medical journals and conferences.
AVIR Price Action: Atea Pharmaceuticals shares were down 2.28% at $4.71 at the time of publication on Tuesday, according to Benzinga Pro data.
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