Bristol-Myers Squibb announces results from daclatasvir plus asunaprevir Phase II HCV study

Bristol-Myers Squibb .Apr 20 2012

Bristol-Myers Squibb Company (NYSE: BMY) today announced results from a Phase II study in which treatment with an all-oral, dual direct-acting antiviral (DAA) regimen of daclatasvir, an investigational NS5A replication complex inhibitor, and asunaprevir, an investigational NS3 protease inhibitor, achieved undetectable viral load 24 weeks post-treatment (SVR₂₄) in 77% (33/43) of difficult-to-treat genotype 1b hepatitis C (HCV) patients. Difficult-to-treat patients in this study included null responders, or patients who had previously not responded to treatment with peginterferon alfa and ribavirin (alfa/RBV), and patients who were medically ineligible or intolerant to previous treatment with alfa/RBV. In this study, serious adverse events (SAE) included three patients with fever (pyrexia), one with hypochondriasis, and one with hyperbilirubinemia which led to treatment discontinuation. The study findings, presented in an oral session at the International Liver Congress (ILC), the 47^th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, confirmed the previously announced sentinel cohort data.    

"Currently there are no treatments available for hepatitis C genotype 1 that can be administered without the concurrent use of alfa and ribavirin, which gives rise to a serious unmet need for patients who are ineligible or intolerant to alfa/ribavirin," said principal investigator Fumitaka Suzuki, Toranomon Hospital, Tokyo, Japan. "The results of this Phase II study with Bristol-Myers Squibb's daclatasvir and asunaprevir are encouraging as we study potential hepatitis C therapies for this difficult-to-treat patient population."