The trial demonstrate the potent and consistent antiviral efficacy of TMC435 in patients who had failed earlier treatment with peg-IFN and ribavarin (standard of care), as well as an safety and adverse event profile for TMC435 that is consistent with what the company reported in the Phase 2b Pillar C205 study.
TMC435, a hepatitis C protease inhibitor, dosed once daily (q.d.) is being developed jointly by Tibotec Pharmaceuticals and Medivir.
The ASPIRE study evaluates the effect of TMC435 in combination with standard of care in 462 patients infected with the difficult to treat genotype-1 hepatitis C virus who had undergone and failed prior treatment with standard of care.
The study includes patients that have relapsed, achieved partial response, or achieved no response (null responders) to treatment with standard of care.
In the trial, TMC435 was administered once daily at a dose of either 100 mg or 150mg given for either 12, 24, or 48 weeks in combination with standard of care.