Medivir AB announced that new Phase 3 data for the once-daily protease inhibitor simeprevir have been presented at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia.The Phase 3 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.
Pooled analysis of data from the Phase 3 QUEST-1 and QUEST-2 studies confirmed efficacy in treatment-naïve genotype 1b HCV patients, with 85 percent (ITT analysis) of treatment-naïve patients achieving SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 53% when treated with placebo in combination with PegIFN/RBV.
In the PROMISE Phase 3 trial of prior relapse patients, a subgroup analysis of genotype 1b patients demonstrated that 86% (ITT analysis) of these patients achieved SVR12 when treated with simeprevir in combination with PegIFN/RBV, compared to 43% when treated with placebo in combination with PegIFN/RBV.
“We are very pleased to report on the successfully completed phase III ATTAIN study demonstrating non-inferiority of simeprevir compared with telaprevir, and a superior safety profile in this difficult to treat patient group. Moreover, the further analysis of the genotype 1b HCV patients of the phase III studies QUEST-1, QUEST-2 and PROMISE demonstrated very high SVR12 rates supporting the strength of simeprevir as a treatment option for this large patient population,” said Charlotte Edenius, EVP Development, Medivir AB.
Date: March 17, 2014
Source: Medivir
