Medivir AB Announces Phase III Data for Simeprevir Demonstrating Efficacy and Safety in Genotype 1 Hepatitis C Patients

Medivir AB announced the results from three pivotal phase III trials examining the one pill, once-daily, investigational protease inhibitor, simeprevir (TMC435), administered with pegylated interferon and ribavirin. Results from the QUEST-1 (one) and QUEST-2 (two) trials found that 80% and 81% of treatment-naive patients with chronic genotype one hepatitis C infection who were treated with simeprevir achieved sustained virologic response 12 weeks after the planned end of treatment (SVR12). Results from the PROMISE trial found that 79% of prior relapsed patients treated with simeprevir achieved SVR12. All three studies utilized response-guided treatment (RGT) criteria and 85%, 91% and 93 % of the patients, respectively, were eligible to stop all treatments after 24 weeks. The overall safety, tolerability and efficacy results from these studies were consistent with those previously obtained in phase II studies. Final analysis of the phase III trials is ongoing and the full data set from these studies will be submitted for presentation at future scientific conferences. Simeprevir was generally safe and well tolerated and overall incidence of adverse events (AEs), including rash and anemia was similar to the placebo control and consistent with prior simeprevir phase II studies. In all three phase III studies, AEs leading to permanent discontinuation were lower in the simeprevir treated subjects compared to the placebo control (pegylated interferon and ribavirin).