Bristol-Myers Squibb Company (NYSE: BMY) today announced for the first time Phase II data demonstrating that the 12-week Triple DAA treatment regimen of daclatasvir (DCV), asunaprevir (ASV), and BMS-791325 achieved sustained virologic response 12 weeks post-treatment (SVR 12) in 94% (15/16) of treatment-naïve, genotype 1 chronic hepatitis C patients. The remaining one patient had undetectable viral load at the end of treatment and was lost to follow-up until approximately 24 weeks post-treatment; in preliminary data, this patient has achieved SVR 24. The Phase II results from this interferon-, ribavirin- and ritonavir-free investigational regimen combining three different classes of direct-acting antivirals (DAAs) – an NS5A replication complex inhibitor (DCV), an NS3 protease inhibitor (ASV) and an NS5B non-nucleoside polymerase inhibitor (BMS-791325) – were presented today at the American Association for the Study of Liver Diseases congress in Boston.
One serious adverse event was reported in this study and was determined by the investigator to be unrelated to study drug. There were no discontinuations due to adverse events. Headache was the most common adverse event in the study (31%, 10/32).
“We are encouraged that this 12-week daclatasvir-based regimen with compounds in different classes of DAAs achieved SVR 12 in a majority of patients without the use of interferon, ribavirin or ritonavir,” said Brian Daniels, MD, senior vice president, Global Development and Medical Affairs, Research and Development, Bristol-Myers Squibb. “The development of regimens for hepatitis C with the potential to avoid the use of ribavirin and ritonavir is an important approach in this therapeutic area, and we look forward to studying it further.”
Phase II studies of this investigational Triple DAA regimen are ongoing. Phase III development is anticipated to begin in 2014.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. BMS-791325 is a non-nucleoside inhibitor of the NS5B polymerase, currently in Phase II development for hepatitis C as a component of daclatasvir-based treatment regimens.