Janssen R&D Ireland (Janssen) announces that data will be presented on the investigational protease inhibitor simeprevir (TMC435) for the treatment of hepatitis C at The International Liver Congress 2013 of the European Association for the Study of the Liver (EASL), which will take place April 24 to 28 in Amsterdam, The Netherlands. These data presentations will include primary efficacy and safety results from the Phase 3 QUEST-1 study of simeprevir administered once daily in combination with pegylated interferon and ribavirin in treatment-naive genotype 1 chronic hepatitis C patients.
"The presentation of this primary efficacy Phase 3 data in a peer-reviewed setting such as The International Liver Congress represents a significant milestone for simeprevir," said Maria Beumont , M.D., medical leader for simeprevir, Janssen. "These data show the potential utility of simeprevir for people living with hepatitis C."
Janssen recently announced the submission of new drug applications in Japan and the United States for simeprevir administered once daily in combination with pegylated interferon and ribavirin for the treatment of genotype 1 chronic hepatitis C in adult patients and anticipates submitting simeprevir for regulatory authorization in the EU in the first half of 2013. Simeprevir is also being studied in combination with pegylated interferon and ribavirin for the treatment of genotype 4 HCV infection and in several interferon-free regimens using selected combinations of direct-acting antiviral agents with different mechanisms of action.
Additional simeprevir data from the QUEST-2 study have been accepted by The International Liver Congress, but are subject to EASL's embargo policy until April 23. The data to be presented at The International Liver Congress 2013 include: