Tibotec presented results from its Phase 2b study of TMC435 for the treatment of chronic hepatitis C virus (HCV). The study, also known as the PILLAR study (Protease Inhibitor TMC435 trial assessing the optimaL dose and duration as once daiLy Anti-viral Regimen), is an ongoing, five-arm, global, randomized, double-blind, placebo controlled study in 386 treatment-naive patients. TMC435 was administered in doses of 75mg or 150mg daily for either 12 weeks or 24 weeks in combination with 24 weeks of peg-interferon and ribavirin (PR). Patients in the placebo arm receive 24 weeks of placebo plus peg-interferon and ribavirin followed by 24 additional weeks of peg-interferon and ribavirin treatment.
The primary endpoint of the study is sustained virologic response at Week-72. TMC435 demonstrated potent antiviral activity, at week 4 (rapid virologic response) and at week 12 (complete early virologic response) HCV RNA was undetectable (<25 IU/mL) for the majority of patients. The viral breakthrough rate was 4.9% in the TMC435 treatment groups.
TMC435 is a hepatitis C protease inhibitor dosed once daily being jointly developed by Tibotec and Medivir.
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