BOSTON, December 22, 2025 — Leads & Copy — Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) announced the completion of enrollment of over 880 treatment-naïve patients in the C-BEYOND Phase 3 trial.
The trial is evaluating the fixed-dose combination (FDC) regimen of bemnifosbuvir and ruzasvir compared to the FDC regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV). The C-BEYOND trial is being conducted at approximately 120 clinical trial sites in the US and Canada. Phase 3 topline results are expected mid-year 2026.
Atea is also advancing enrollment of treatment-naïve patients in C-FORWARD, a Phase 3 trial evaluating the same FDC regimen in 880 patients at approximately 120 clinical trial sites in up to 17 countries outside of North America. Completion of enrollment in C-FORWARD is expected mid-year 2026, with Phase 3 topline results anticipated year-end 2026.
In both studies, the FDC regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for 8 weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis). The comparator FDC regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks.
According to Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea, completing enrollment in C-BEYOND marks a critical inflection point in Atea’s Phase 3 HCV program, and the company is on track to deliver topline results from this trial mid-2026. Sommadossi added that Atea’s goal is to develop a best-in-class HCV treatment that advances the standard of care, and they believe that the target profile of their regimen will uniquely position them to address the evolving needs of patients and bring them closer to the ultimate goal of HCV eradication.
HCV continues to be a significant global health burden despite the availability of direct-acting antivirals (DAAs). Up to 4 million people in the US are living with chronic HCV, and an estimated 50 million people are infected worldwide with approximately one million new infections occurring each year. In the US, HCV diagnoses continue to outpace annual cure rates.
Atea’s HCV development program includes two open-label Phase 3 trials, C-BEYOND conducted in the US and Canada, and C-FORWARD conducted outside of North America. Each trial is enrolling approximately 880 treatment-naïve patients, including those with or without compensated cirrhosis.
The trials compare the FDC regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir an NS5A inhibitor, to the FDC regimen of sofosbuvir and velpatasvir. The regimen of bemnifosbuvir and ruzasvir is administered orally once-daily for eight weeks (in patients without cirrhosis) or 12 weeks (in patients with compensated cirrhosis) while the regimen of sofosbuvir and velpatasvir is administered orally once-daily for 12 weeks to all patients, with or without compensated cirrhosis.
The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint occurs at the same relative timepoint from the start of treatment in all patients.
HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue.
An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, up to 4 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.
Atea Pharmaceuticals is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. For more information, please visit www.ateapharma.com.
Contacts:
Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
Barnes.jonae@ateapharma.com
Joyce Allaire
LifeSci Advisors
jallaire@lifesciadvisors.com
Source: Atea Pharmaceuticals
