Successful Phase III trial of Daklinza (daclatasvir) + sofosbuvir in treatment of Hepatitis C patients with fibrosis or cirrhosis.- BMS
BMS announced late-breaking data from the Phase III ALLY-3 trial investigating a regimen of Daklinza (daclatasvir, DCV) in combination with sofosbuvir (SOF) and ribavirin (RBV) in genotype 3 hepatitis C (HCV) patients with advanced fibrosis or cirrhosis, for treatment durations of 12 and 16 weeks. This patient population is one of the most difficult to treat, among whom sustained virologic response (SVR) rates, or cure, have proved harder to achieve.
The results show that 100% of patients in the advanced fibrosis (F3) cohort achieved SVR12 in both the 12- and 16-week arms of the study. SVR12 rates were 83% and 89% in patients with cirrhosis in the 12- and 16-week arms, respectively. Results weree presented The Liver Meeting 2015, the annual meeting of The American Association for the Study of Liver Diseases (AASLD), in San Francisco, CA, November 13 – 17.
Comment: Daklinza is contraindicated in combination with medicinal products that strongly induce CYP3A and P-glycoprotein transporter, as this may lead to lower exposure and loss of efficacy of Daklinza. Daklinza must not be administered as a monotherapy.
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