Medivir Announces Positive Phase 2b 48-week (SVR24) Interim Results of TMC435 in Treatment-Naïve Patients Chronically Infected with Genotype-1 Hepatitis C Virus

23-Feb-2011 - Sweden

Medivir AB announced further positive results from the phase 2b PILLAR (C205) study of TMC435 in treatment-naïve patients with hepatitis C virus (HCV) genotype-1:

  • TMC435 was safe and well tolerated with no clinically relevant differences in adverse events between treatment groups and standard of care (SoC).
  • In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24
  • Potent and consistent antiviral efficacy was demonstrated with SVR24 rates of up to 84%

"We are very pleased by both the efficacy and safety shown by TMC435 in this 48-Week interim analysis. With the additional features of once daily dosing, TMC435 also has a more convenient and competitive dosing regimen” stated Bertil Samuelsson, CSO of Medivir. "The recently published start of three global phase 3 clinical trials is an important milestone in the continued development of TMC435. We are now looking forward to the 48-week interim data from the phase 2b trial C206 (ASPIRE) in treatment-experienced patients during Q2 2011.”

The 48-week interim results from the 5-arm phase 2b response guided PILLAR study in 386 treatment-naïve patients showed further consistent high antiviral activity, and the good safety and tolerability previously demonstrated was confirmed. The 24-week (EOT) interim results were presented at the AASLD conference in Boston, MA, in November 2010.

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