1. Atea completed enrollment for C-BEYOND trial with over 880 patients. 2. Phase 3 trial topline results expected mid-2026 for C-BEYOND. 3. C-FORWARD trial also underway, results anticipated year-end 2026. 4. New treatment aims for high efficacy and low drug interactions. 5. HCV remains a significant health burden despite current therapies.
FAQ
Why Bullish?
Positive advancements in Phase 3 trials can attract investors, similar to other biopharma successes.
How important is it?
Successful trial results could significantly improve AVIR's market position in HCV treatment.
Why Long Term?
With results expected in 2026, investor sentiment will build as trials progress.
Atea Pharmaceuticals Completes Patient Enrollment in North American Phase 3 Trial Evaluating Regimen of Bemnifosbuvir and Ruzasvir for Treatment of Hepatitis C Virus
BOSTON, Dec. 22, 2025 (GLOBE NEWSWIRE) - Atea Pharmaceuticals, Inc. (Nasdaq: AVIR), a clinical-stage biopharmaceutical company, has announced the completion of enrollment for over 880 treatment-naïve patients in its C-BEYOND Phase 3 trial. This study evaluates the fixed-dose combination (FDC) regimen of bemnifosbuvir and ruzasvir against the FDC regimen of sofosbuvir and velpatasvir for the treatment of hepatitis C virus (HCV).
C-BEYOND Phase 3 Trial Overview
The C-BEYOND trial is being conducted at approximately 120 clinical sites across the US and Canada. The topline results from this Phase 3 trial are expected in mid-2026. This trial represents a significant advancement in Atea’s strategy to develop effective therapies for HCV, especially given the ongoing struggles in managing this disease.
C-FORWARD Phase 3 Trial Details
In addition to C-BEYOND, Atea is simultaneously working on the C-FORWARD Phase 3 trial, which aims to enroll 880 treatment-naïve patients in 17 countries outside of North America. Enrollment for C-FORWARD is also expected to complete by mid-2026, with topline results anticipated by the end of 2026.
Combination Treatment Protocol
In both trials, the FDC regimen of bemnifosbuvir and ruzasvir is administered orally once daily for:
- 8 weeks for patients without cirrhosis
- 12 weeks for patients with compensated cirrhosis
In comparison, the standard FDC regimen of sofosbuvir and velpatasvir is administered once daily for 12 weeks for all participants, regardless of cirrhosis status.
Key Insights from Atea’s CEO
Jean-Pierre Sommadossi, PhD, CEO and Founder of Atea, stated, “Completing enrollment in C-BEYOND marks a critical inflection point in our Phase 3 HCV program, and we are on track to deliver topline results from this trial mid-2026. Our goal is to develop a best-in-class HCV treatment that advances the standard of care.”
The Growing Appeal for New HCV Treatments
Despite the availability of direct-acting antivirals (DAAs), HCV remains a major public health challenge globally. Approximately 4 million individuals in the US are living with chronic HCV, and around 50 million are infected worldwide. The annual new infections approach one million, and treatment rates lag behind diagnoses.
A new treatment option that combines high efficacy, shorter treatment duration, and a low risk of drug-drug interactions could significantly benefit patients and help to achieve the ultimate goal of HCV eradication.
Understanding HCV
HCV, a blood-borne RNA virus, is a leading cause of chronic liver disease worldwide. It primarily spreads through blood transfusion, hemodialysis, and needle sticks. Annually, approximately 240,000 deaths occur due to HCV complications. Chronic infection with HCV is responsible for a substantial percentage of liver cancer cases in the US, Europe, and Japan.
About Atea Pharmaceuticals
Atea Pharmaceuticals is focused on developing and commercializing innovative oral antiviral therapies addressing serious viral infections. Atea has established a proprietary nucleos(t)ide prodrug platform to create new candidates targeting single-stranded RNA viruses. The bemnifosbuvir and ruzasvir regimen, a crucial component of their pipeline, aims to improve the therapeutic landscape for HCV.
Forward-Looking Statements
This press release contains “forward-looking statements” regarding various aspects of Atea’s business, including the potential profile of the bemnifosbuvir and ruzasvir regimen. These statements encompass future operations, business strategies, and anticipated clinical trial results.