Bristol-Myers Squibb Company (NYSE: BMY) today announced new Phase II data demonstrating that the dual regimen of the investigational NS5A replication complex inhibitor daclatasvir (DCV) and the investigational NS3 protease inhibitor asunaprevir (ASV), without interferon or ribavirin, achieved high rates of sustained virologic response 12 weeks post-treatment (SVR 12) in patients with genotype 1b (GT1b) hepatitis C virus (HCV) who were prior null responders to alfa interferon and ribavirin (alfa/RBV). In this study, the DCV/ASV Dual regimen achieved SVR 12 in 78% (14/18) and 65% (13/20) of GT1b patients when asunaprevir was dosed twice daily (Group A1) or once daily (Group A2), respectively.
These results were presented today at the American Association for the Study of Liver Diseases congress in Boston, along with data from this same study on the safety and efficacy of quadruple therapy with DCV/ASV/alfa/RBV in predominantly GT1a prior null responders.
In the patients treated with the DCV/ASV Dual regimen therapy, there were no serious adverse events related to study drug or discontinuations due to adverse events. Overall, headache was the most common adverse event in the DCV/ASV Dual regimen groups (Group A1: 44%, Group A2: 40%).
“We continue to see a significant unmet need for treatment approaches that improve response rates in patients with hepatitis C genotype1b who have not responded to prior therapy, with currently available treatment regimens achieving low cure rates of 30 to 40%,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The high response rates seen in this study with daclatasvir and asunaprevir are encouraging as we seek interferon- and ribavirin-free hepatitis C regimens for this difficult-to-treat patient population.”Daclatasvir is the first NS5A replication complex inhibitor to be investigated in HCV clinical trials and is currently in Phase III development. Asunaprevir is an oral, NS3 protease inhibitor in Phase III development with daclatasvir. The DCV/ASV Dual regimen is part of a global registrational program and a registrational program specific to Japan, where the majority of HCV patients have GT1b.