In interim findings from the first 28 days of treatment for the first cohort of 50 treatment naive hepatitis C virus plus (HCV+), genotype 1, patients (once daily dose of 25mg or 75mg TMC435 versus placebo), both doses showed dose-dependent antiviral activity.
TMC435 was administered in combination with PegIFNalpha-2a/RBV (triple therapy) for 28 days or as monotherapy for seven days and, thereafter, in combination with PegIFNalpha-2a/RBV (triple therapy) for three weeks. There were neither serious adverse events, nor grade 3 or 4 adverse events, related to TMC435 or any safety-related treatment discontinuations during this 28-day treatment period.
Roger Pomerantz, president of R&D at Tibotec, said: “Tibotec is committed to evaluating the safety and efficacy of TMC435 in clinical studies to determine its potential use in people with HCV. This is an important step in our mission of addressing treatment challenges of infectious diseases, including HCV, HIV and tuberculosis.”