Medivir releases phase IIb results of TMC435
Medivir, a pharmaceutical company focused on infectious diseases, announced positive results from the phase IIb PILLAR (C205) study of TMC435 in treatment-naive patients with hepatitis C virus (HCV) genotype-1.
In the study, 75mg or 150mg TMC435 was given for either 12 or 24 weeks in combination with 24 weeks of ribavirin and pegIFNalpha-2A, the current standard of care (SoC). Patients in the TMC435 arms stopped all treatment at week 24 if certain criteria were met. In the TMC435 treatment groups 83% of patients were able to stop all therapy at week 24. Patients who did not meet the criteria continued with SoC until week 48 as did the placebo group.
At week four after cessation of treatment 87.2%, 86.5%, 84.9% and 88.5% of patients taking TMC435 and Peg-IFN/RBV (SoC) achieved undetectable HCV RNA levels. At week 24 after cessation of treatment 83.6%, 76.1%, 83.1% and 84.4% of patients taking TMC435 and Peg-IFN/RBV(SoC) achieved undetectable HCV RNA levels, i.e. SVR24. At week four after cessation of treatment 71.2% in the placebo SoC group had achieved undetectable HCV RNA levels.