Clinical data on simeprevir for treatment of hepatitis C patients to be presented at EASL meeting

Medivir AB (STO:MVIR-B) today announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of genotype 1 hepatitis C patients.

These primary efficacy and safety results from two global phase III studies demonstrate that use of the investigational protease inhibitor simeprevir led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 80 and 81 percent, respectively, of treatment-naïve genotype 1 chronic hepatitis C adult patients with compensated liver disease, when administered once daily with pegylated interferon and ribavirin. In both studies, 50 percent of patients receiving pegylated interferon and ribavirin alone achieved SVR12.

The data will be presented this week at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL) in Amsterdam, The Netherlands. The QUEST-1 and QUEST-2 data will also be discussed in an official EASL press conference on April 24 at 11:00 a.m. CEST.

"We are very happy about the robust high cure rates and the very good safety profile of simeprevir as demonstrated in the QUEST 1 and 2 studies both also including patients with severe liver disease and other characteristics that are predictors of more difficult to cure patients", said Charlotte Edenius, EVP Development, Medivir AB. " These data together with the data from a third phase III study in relapser patients (PROMISE study) form the basis for the regulatory filings which were recently submitted in both Japan and US while the EU submission is expected in the near future."

In QUEST-1 and QUEST-2, patients were randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 36 weeks. In findings related to a secondary endpoint, 85 (QUEST-1) and 91 percent (QUEST-2) of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks due to meeting response-guided therapy (RGT) criteria. Of those patients meeting RGT criteria to stop treatment at 24 weeks, 91 percent (QUEST-1) and 86 percent of patients (QUEST-2) achieved SVR12.

"These data represent new and important improvements infor the future treatment of genotype 1 hepatitis C patients", said Maris Hartmanis, Medivir's CEO.

Patients enrolled in QUEST-1 and QUEST-2 were stratified by HCV genotype 1 subtype and IL28B genotype. In QUEST-1, among patients treated with simeprevir, SVR12 rates according to IL28B genotype were 94 percent (CC), 76 percent (CT), and 65 percent (TT). In QUEST-2, in the simeprevir arm, SVR12 rates according to IL28B genotype were 96 percent (CC), 80 percent (CT), and 58 percent (TT). Among patients with METAVIR scores F3 and F4, 70 percent of patients treated with simeprevir in QUEST-1 and 66 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. Among patients with METAVIR scores F0 to F2, 83 percent of patients treated with simeprevir in QUEST-1 and 85 percent of patients treated with simeprevir in QUEST-2 achieved SVR12. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a four-point scale.

The most common adverse events seen in patients receiving simeprevir in QUEST-1 were fatigue (42 percent versus 41 percent for placebo), itch (26 percent versus 16 percent for placebo), and headache (33 percent versus 39 percent for placebo). The most common adverse events seen in patients receiving simeprevir in QUEST-2 were fatigue (37 percent versus 42 percent for placebo), itch (25 percent versus 25 percent for placebo), headache (39 percent versus 37 percent for placebo), fever (31 percent versus 40 percent for placebo), and influenza-like illness (26 percent versus 26 percent for placebo). In QUEST-1, in both the simeprevir and placebo arms, 3 percent of patients discontinued treatment due to an adverse event. In QUEST-2, 2 percent of patients in the simeprevir arm and 1 percent of patients in the placebo arm discontinued treatment due to an adverse event.