C-BEYOND, A Phase 3 trial for the treatment of chronic hepatitis C virus (HCV) infection conducted in North America met its Primary Endpoint of Statistical Non-inferiority according to a press release by the sponsor, Atea Pharmaceuticals, Inc.  Dr Timothy Hatlen, who is also the Harbor-UCLA Hepatitis C Clinic Director,  and his team were one of approximately 120 sites in the US and Canada conducting the trial. C-BEYOND enrolled patients reflective of the current real-world population to evaluate the once-daily fixed-dose combination of bemnifosbuvir and ruzasvir (BEM/RZR) compared to the fixed-dose standard-of-care combination of sofosbuvir and velpatasvir (SOF/VEL) in the modified intent-to-treat (mITT) population.  The mITT analysis in patients without cirrhosis (n=721) showed BEM/RZR (8 weeks of treatment) achieved a 93.5% SVR rate vs. 94.6% for SOF/VEL (12 weeks of treatment). In patients with cirrhosis (12 weeks treatment in both arms) (n=184), BEM/RZR achieved a 95.4% SVR rate vs. 95.4% for SOF/VEL. In CBEYOND, rates of virologic failure across all populations were low and comparable between treatment arms

Impact of the Research

Chronic HCV infection remains an ongoing public health crisis. If left untreated, HCV can progress to cirrhosis, end-stage liver disease and liver cancer, and it remains one of the leading cause of chronic liver disease and liver transplants and can be spread through blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Approximately 50 million people worldwide are living with HCV, including up to 4 million people in the US, while new diagnoses continue to outpace annual cures. Additionally, many people living with HCV are also managing other chronic conditions, and roughly 80% take multiple concomitant medications for common comorbidities such as heartburn, heart arrhythmia, high blood pressure and gastroesophageal reflux disease (GERD), which may increase the potential for drug-drug interactions with currently approved therapies. A shorter, simpler regimen has the potential to streamline prescribing decisions and accelerate the test-and-treat strategies that are essential to HCV elimination

For more information on Dr. Hatlen’s research or about the Division of HIV Medicine at The Lundquist Institute, please visit : Lundquist.org/Timothy-Hatlen-MD.