Bristol-Myers Squibb Company (NYSE: BMY) today announced new Phase II data demonstrating that an investigational quad therapy regimen combining the NS5A replication complex inhibitor daclatasvir (DCV), the NS3 protease inhibitor asunaprevir (ASV), and a backbone of alfa interferon and ribavirin (alfa/RBV) achieved sustained virologic response rates 12- and 24-weeks post-treatment (SVR 12 and SVR 24) of 95% (39/41) and 93% (38/41), respectively, in patients with genotype 1 (GT1) hepatitis C virus (HCV) who were prior null responders to alfa/RBV. The DCV ASV Quad treatment groups included predominantly GT1a patients (36/41), a patient population with limited effective treatment options.
These data were presented today at the American Association for the Study of Liver Diseases congress in Boston, along with safety and efficacy data on DCV/ASV Dual therapy in GT1b prior null responders enrolled in this same study.
There were no serious adverse events related to study drug or discontinuations due to adverse events in the DCV ASV Quad therapy treatment groups of this study. Overall, headache was the most common adverse event in the DCV ASV Quad treatment groups (60%, 43%).
“In this study, we are encouraged to see that patients who are among the most difficult to treat – those with genotype 1a who did not respond to previous treatment with alfa interferon and ribavirin – demonstrated high SVR rates of 93 percent,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The results seen with this daclatasvir-based quadruple regimen are important as we continue to evaluate treatment approaches that improve response rates in this challenging 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.