Atea Completes Enrollment in Phase 3 Hepatitis C Trial Evaluating Bemnifosbuvir and Ruzasvir

Atea Pharmaceuticals has completed enrollment in its phase 3 C-FORWARD clinical trial, marking a significant milestone in the company's global hepatitis C virus (HCV) development program and advancing efforts to evaluate a potential new treatment option designed to simplify care and improve access.

The C-FORWARD study is one of 2 pivotal phase 3 trials evaluating the investigational oral combination of bemnifosbuvir and ruzasvir in adults with chronic HCV infection. Together with the companion C-BEYOND study, the program is the first global head-to-head phase 3 comparison of direct-acting antiviral (DAA) regimens in HCV, comparing the investigational therapy with the current standard of care.

According to the company, the clinical program is designed to support the growing emphasis on a "test-and-treat" model, which aims to rapidly diagnose patients and initiate treatment, an approach considered essential to achieving the World Health Organization's goal of eliminating hepatitis C as a public health threat.

"Completing enrollment in C-FORWARD is a meaningful milestone for our global phase 3 HCV program, bringing us one step closer to a regimen designed around the unique needs of people living with HCV and the test-and-treat model that is critical to advancing HCV elimination efforts,”Arantxa Horga, MD, Chief Medical Officer at Atea Pharmaceuticals, told Infection Control Today^®. “Together, C-FORWARD and C-BEYOND represent the first global head-to-head phase 3 program of direct-acting antivirals in HCV. We believe bemnifosbuvir and ruzasvir's potential best-in-class profile with a short treatment duration, low risk of drug-drug interactions with common medications, and ability to be taken with or without food substantially differentiates it from the current standard of care and could make it easier for patients to access and adhere to treatment. That is significant in a disease that, if left untreated, can progress to cirrhosis, end-stage liver disease, and liver cancer. HCV is a leading cause of liver cancer in the US."

Hepatitis C remains a major global public health challenge despite the availability of highly effective antiviral therapies. Although direct-acting antivirals have transformed HCV treatment by achieving sustained virologic response rates exceeding 95% in many patient populations, barriers to diagnosis, treatment initiation, medication access, and adherence continue to prevent many individuals from receiving curative therapy.

Investigational regimens that shorten treatment duration and reduce medication restrictions may help support broader treatment uptake, particularly in populations with limited access to specialty care or those taking multiple medications for other chronic conditions.

Atea's investigational combination pairs bemnifosbuvir, a nucleotide polymerase inhibitor, with ruzasvir, an NS5A inhibitor. The company believes the regimen's potential to be administered with or without food and its low potential for clinically significant drug-drug interactions could simplify treatment for patients with complex medical needs.

The completion of enrollment in C-FORWARD follows continued progress across Atea's global Phase 3 program. Data from both C-FORWARD and C-BEYOND will help determine whether the investigational regimen can demonstrate noninferior or superior efficacy compared with currently available DAA therapies while maintaining a favorable safety profile.

If successful, the program could provide clinicians with an additional treatment option that supports simplified HCV management strategies, particularly as health systems increasingly adopt decentralized screening and treatment models designed to reach underserved populations.

With hepatitis C remaining a leading cause of cirrhosis, liver failure, and hepatocellular carcinoma worldwide, expanding the availability of effective, easy-to-administer antiviral therapies remains an important component of global elimination efforts. The results of Atea's Phase 3 program are expected to further clarify whether bemnifosbuvir and ruzasvir can help address remaining gaps in HCV treatment and improve access to curative therapy for patients around the world.