Pharmaceutical Business review

Tibotec to announce positive TMC435 data in HCV infected patients

The PILLAR study [Protease Inhibitor TMC435 trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen] was a five-arm, global phase 2b randomized, double-blind, placebo controlled study involving 386 treatment-naive patients.

The data demonstrated that TMC435 administered in combination with peginterferon a-2a and ribavirin (PR) resulted in higher sustained virologic response (SVR) rates compared to placebo plus PR.

TMC435 was administered in doses of 75mg or 150mg q.d. for either 12 weeks or 24 weeks in combination with 24 or 48 weeks of peg-interferon and ribavirin (PR).

In the two TMC435 treatment groups who received TMC435 75mg, between 75 and 82% of patients achieved SVR24, and in the two TMC435 treatment groups who received TMC435 150mg, between 81 and 86% of patients achieved SVR24.