Daclatasvir plus asunaprevir(BMS) in Phase II Hepatitis C trial

cThe full results were published in the New England Journal of Medicine, from a Phase II clinical trial in patients with Hepatitis C virus (HCV) genotype 1 who had not responded to prior therapy with PEG-interferon alfa and ribavirin (�null responders�1). The study demonstrated that its primary endpoint of the achievement of sustained virologic response 12-weeks post-treatment (SVR12) is possible with a direct-acting antiviral (DAA)-only combination containing daclatasvir the first NS5A replication complex inhibitor from BMS and asunaprevir an oral, selective NS3 protease inhibitor (4/11 patients, including two of two patients infected with HCV genotype 1b). This study was the first study to demonstrate the possibility that Hepatitis C can be cured (defined as sustained virologic response 48 weeks post-treatment or SVR48) without the use of interferon. The study also demonstrated that 100 percent (10/10) of these difficult-to-treat patients dosed with quadruple therapy containing daclatasvir and asunaprevir in combination with PEG-Interferon alfa and ribavirin achieved SVR12.