Bristol-Myers’ all-oral daclatasvir and asunaprevir combo shines in Ph III

10 April 2014
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US pharma major Bristol-Myers Squibb (NYSE: BMY) has presented new Phase III trial data of its combination therapy showing cure rates of up to 90% in certain groups of hepatitis C patients.

The Phase III global HALLMARK-Dual study investigated the all-oral, interferon- and ribavirin-free regimen of daclatasvir (DCV), a NS5A inhibitor, and asunaprevir (ASV), a NS3 inhibitor, among genotype 1b hepatitis C virus (HCV) infected patients.

Results showed that the 24-week regimen achieved an overall sustained virologic response (a functional cure) 12 weeks after the end of treatment (SVR12) among treatment-naive (90%), peginterferon/ribavirin non-responder (82%), and peginterferon/ribavirin ineligible/intolerant (82%) patients, including cirrhotic and non-cirrhotic patients (84% and 85%). In the study the DCV+ASV regimen was generally well tolerated. These data will be presented this week at the 49th annual meeting of the European Association for the Study of the Liver (EASL) in London, April 9-13.

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