A clinical research team led by Timothy Hatlen, MD, investigator in the Infectious Diseases and Immunology Innovation Hub at The Lundquist Institute, contributed to a major Phase 3 hepatitis C study that reported positive topline results for a potential shorter treatment regimen for chronic hepatitis C virus (HCV) infection. The North American C-BEYOND trial, sponsored by Atea Pharmaceuticals, Inc., met its primary endpoint of statistical non-inferiority compared with a current standard-of-care regimen.
C-BEYOND enrolled treatment-naïve participants in the United States and Canada, reflecting the real-world population living with HCV. The study evaluated the once-daily fixed-dose combination of bemnifosbuvir and ruzasvir (BEM/RZR) and compared it with sofosbuvir and velpatasvir (SOF/VEL), a widely used standard-of-care therapy. Dr. Hatlen’s team was one of approximately 120 clinical trial sites participating in the study.
In the modified intent-to-treat analysis, BEM/RZR achieved sustained virologic response rates comparable to SOF/VEL. Sustained virologic response is commonly used as a marker that treatment has cleared the virus. Among participants without cirrhosis, BEM/RZR given for eight weeks achieved a 93.5% sustained virologic response rate, compared with 94.6% for 12 weeks of SOF/VEL. Among participants with cirrhosis, both treatment arms achieved a 95.4% sustained virologic response rate with 12 weeks of therapy.
Why This Research Matters
HCV continues to be a significant public health challenge. If left untreated, hepatitis C can lead to cirrhosis, end-stage liver disease and liver cancer, and it remains a major contributor to chronic liver disease and liver transplantation worldwide. Approximately 50 million people globally are living with HCV, including up to 4 million people in the United States.
A shorter, once-daily regimen could help simplify treatment decisions for clinicians and patients, particularly for individuals managing other chronic health conditions and taking multiple medications. Streamlined treatment options may also support broader test-and-treat strategies aimed at advancing HCV elimination.
The study reflects The Lundquist Institute’s ongoing commitment to advancing clinical research that addresses significant infectious disease and public health challenges. Through participation in C-BEYOND, Dr. Hatlen and his team helped evaluate a potential treatment option designed to simplify care and support improved access for people living with hepatitis C.