Medivir and Tibotec provide proof-of-concept for TMC435
Swedish Medivir AB (Huddinge) and Belgian Tibotec BVBA (Beerse) have reported positive data from an ongoing Phase IIb study (48 weeks) with Tibotec’s hepatitis C virus protease blocker TMC435 in patients that responded poorly to prior treatment with ribavirine or PEG-interferon. The companies say that addition of TMC 435 to either of the antiviral therapies “substantially” improved the so-called SV4 rates, making the virus “undetectable…four weeks after the end of treatment.” At that point, the EoT (92%, 83% and 71% of relapser patients, partial responder patients and null responder patients respectively) taking 150 mg of TMC435 once daily and placebo, achieved undetectable HCV RNA levels compared to 70%, 17% and 25% in the placebo, PegIFN/RBV groups. Four weeks after cessation of treatment (SVR4), 88%, 77% and 57% of prior relapser patients, partial responder patients and null responder patients taking 150 mg of TMC435 once daily and placebo (respectively), achieved undetectable HCV RNA levels. That compared to 50%, 11% and 23% in the placebo groups. According to the companies, TMC435 was also safe and well-tolerated at all doses.