All-Oral Hepatitis C Virus Treatment with Bristol-Myers Squibb’s Investigational Compounds Daclatasvir And Asunaprevir Achieved Sustained Virologic Response In 77% of Difficult-to-Treat Patients

Bristol-Myers Squibb Company 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 47th annual meeting of the European Association for the Study of the Liver (EASL) in Barcelona, Spain, confirmed the previously announced sentinel cohort data.