Atea Pharmaceuticals reported topline Phase III results from its C-BEYOND trial showing the BEM/RZR combination met primary and key secondary endpoints and was statistically non-inferior to SOF/VEL. In the mITT cohort of 905 participants in the US and Canada, BEM/RZR achieved 93.9% SVR12 versus 94.8% for SOF/VEL, with the difference within a 5% non-inferiority margin. The regimen was generally well tolerated with no drug-related serious adverse events or early discontinuations. Results from the parallel C-FORWARD study outside North America are expected in early 2027.
Atea’s Phase III C-BEYOND: BEM/RZR Achieves 93.9% SVR12, Non-Inferior to SOF/VEL in 905-Patient mITT
BEM/RZR achieved a 93.9% SVR rate
Atea Pharmaceuticals today announced topline results from its Phase III C-BEYOND trial in North America showing that the once-daily fixed-dose combination bemnifosbuvir/ruzasvir (BEM/RZR) met primary and key secondary endpoints and was statistically non-inferior to the established regimen sofosbuvir/velpatasvir (SOF/VEL).
Topline Results
In the modified intent-to-treat (mITT) population of 905 participants enrolled across the United States and Canada, BEM/RZR produced a 93.9% sustained virologic response (SVR) rate versus 94.8% for SOF/VEL when assessed at 12 weeks post-treatment (SVR12). The difference in SVR rates remained within the trial's pre-specified 5% non-inferiority margin, with the confidence interval contained inside that boundary.
Outcomes by Cirrhosis Status
Participants without cirrhosis — treated for 8 weeks with BEM/RZR compared with 12 weeks of SOF/VEL — achieved SVR rates of 93.5% and 94.6%, respectively. Among participants with cirrhosis, both regimens administered for 12 weeks produced identical SVR rates of 95.4%.
Safety And Secondary Analyses
BEM/RZR was generally well tolerated. There were no drug-related serious adverse events reported and no early treatment discontinuations attributed to the regimen. Investigators noted low and comparable rates of virologic failure across both arms, and non-inferiority was preserved in secondary and per-protocol analyses.
Jean-Pierre Sommadossi, Atea's founder and CEO, 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."
The C-BEYOND trial enrolled a contemporary HCV population across approximately 120 sites in North America. A parallel Phase III study, C-FORWARD, has completed enrollment outside North America with topline results expected in early 2027.
Note: These are topline data released by Atea Pharmaceuticals. Full trial data, including genotype- and subgroup-specific analyses, will be published when available.
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