TMC 435 (Medivir) begins two new Phase III trials for Hepatitis C

Patient dosing and screening has begun in two new Phase III clinical trials testing TMC 435, from Medivir/Tibotec, in Hepatitis C infected patients. Trial HPC3001 is an efficacy, safety and tolerability study comparing TMC 435 against telaprevir, each in combination with Pegylated Interferon alpha-2a (PegINF) and ribavirin (RBV), in 744 Hepatitis C genotype-1 infected patients. Patients will receive TMC 435 150 mg once daily or telaprevir 750 mg administered every eight hours (q8h) in combination with PegINF/RBV for 12 weeks followed by 36 weeks of PegIFN/RBV alone. The other trial, HPC3011, will explore the efficacy, safety and tolerability of TMC 435 150 mg once daily, in combination with PegIFN/RBV in 100 treatment naive or treatment experienced, Hepatitis C genotype-4 infected patients. All subjects will receive 12 weeks triple therapy of TMC 435 150 mg once daily and PegIFN/RBV, followed by PegIFN/RBV alone.