Olysio meets endpoint for HCV in Phase III trials - Medivir

New Phase III data for the once-daily Olysio (simeprevir), from Medivir, for the treatment of patients with Hepatitis C, show the drug has met its primary endpoint. The Phase III ATTAIN study in treatment-experienced adult patients with chronic Hepatitis C virus (HCV) and compensated liver disease achieved its primary efficacy endpoint by demonstrating non-inferiority of simeprevir compared to telaprevir when both are given in combination with PegIFN/RBV. Simeprevir demonstrated superior safety profile including fewer adverse events (AEs), fewer serious adverse events (SAEs) and less anemia versus telaprevir.

In addition, pooled analysis of data from the Phase III QUEST-1 and QUEST-2 studies confirmed efficacy in treatment-na�ve genotype 1b HCV patients, with 85 percent (ITT analysis) of treatment-na�ve patients achieving SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 53 percent when treated with placebo in combination with PegIFN/RBV. Finally in the PROMISE Phase III trial of prior relapse patients, a subgroup analysis of genotype 1b patients demonstrated that 86 percent (ITT analysis) of these patients achieved SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 43 percent when treated with placebo in combination with PegIFN/RBV. Results have been presented at the Conference of the Asian Pacific Association for the Study of the Liver.