Atea Pharmaceuticals has reported top line results from its Phase III C-BEYOND trial in North America, assessing the once-daily fixed-dose bemnifosbuvir and ruzasvir (BEM/RZR) combination for chronic hepatitis C virus (HCV) infection.
The study met both its primary and secondary endpoints, with BEM/RZR showing statistical non-inferiority to sofosbuvir and velpatasvir (SOF/VEL).
The modified intent-to-treat (mITT) analysis included 905 patients with and without cirrhosis from the US and Canada.
In this group, BEM/RZR achieved a 93.9% sustained virologic response (SVR) rate, compared to 94.8% for SOF/VEL at week 24, encompassing SVR at 12 weeks following treatment, which is the generally accepted definition of cure in HCV.
The confidence interval for the difference in SVR rates remained within the pre-established 5% margin.
Among patients without cirrhosis, who received eight weeks of BEM/RZR treatment versus 12 weeks of SOF/VEL, SVR rates were 93.5% and 94.6%, respectively.
For those with cirrhosis, 12 weeks of both treatments resulted in matching SVR rates of 95.4%. The rates of virologic failure were described as low and similar in both arms, and non-inferiority was maintained in secondary endpoints, including per-protocol analysis.
Atea Pharmaceuticals founder and CEO Jean-Pierre Sommadossi said: “We are pleased to announce these positive results from C-BEYOND showing our regimen of BEM/RZR achieved high cure rates across all populations and genotypes. As today is World Hepatitis Day, it underscores that HCV presents complex public health challenges.
“We believe the profile of our regimen will substantially contribute to the World Health Organization’s goal of HCV eradication. We look forward to sharing results from C-FORWARD, Atea’s second Phase III trial of BEM/RZR outside North America, in early 2027, and to bringing BEM/RZR to patients as soon as possible.”
BEM/RZR was reported as generally safe and well tolerated, with no drug-related serious adverse events and no early discontinuations due to treatment.
The trial enrolled participants reflective of the current HCV population in North America.
C-BEYOND took place at around 120 sites, and a parallel Phase III study, C-FORWARD, has completed enrolment outside North America.
