Medivir Presents HCV Drug Simeprevir Data At APASL Conference

Medivir AB presented new Phase III data for its once-daily protease inhibitor simprevir at the Conference of the Asian Pacific Association for the Study of the Liver (APASL) in Brisbane, Australia. Simeprevir is jointly developed by Janssen R&D Ireland and Medivir AB.

The Phase III ATTAIN study met its primary efficacy endpoint in treatment-experienced adult patients with chronic hepatitis C virus and compensated liver disease by showing on par performance of simeprevir. The drug was compared to telaprevir when both are given in combination with PEglFN/RBV. The drug showed superior safety profile including less adverse events, less serious adverse events, and fewer anemias versus telaprevir.

Combined analysis of data from the Phase III QUEST-1 and QUEST-2 studies affirmed efficacy in treatment-naïve genotype 1b HCV patients. 85 percent of these patients achieved SVR12 when treated with simeprevir in combination with PEglFN/RBV against only 53 percent when treated with placebo with PEglFN/RBV.

Charlotte Edenius, Executive Vice President of Development at Medivir AB, said “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.”

Simeprevir is an NS3/4A protease inhibitor indicated for the treatment of chronic hepatitis C infection. The drug is used in combination with pegylated interferon and ribavirin in HCV genotype 1 infected patients with cirrhosis and other compensated liver disease.

The PROMISE Phase III trial assessed prior relapse patients where a subgroup analysis of genotype 1b patients showed that 86 percent achieved SVR12 when given treatment of simeprevir combined with PegIFN/RBV against only 43 percent when given treatment of placebo combined with PegIFN/RBV.

The drug is currently approved for the treatment of genotype 1 hepatitis C in Japan, Canada, and the U.S. A marketing approval application of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C is presently under review by the EMA.