PRECLINICAL CHARACTERIZATION OF THE HEPATITIS C VIRUS NS5B POLYMERASE NON-NUCLEOSIDE INHIBITOR BI 207127

pharmacokinetics in a phase 1 study, when compared to the standard 500mg tablet. The aim of the current study was to evaluate the safety and efficacy of two doses of CR NTZ in combination with PegIFN plus RBV for treatment of CHC. Methods: In this phase 2 single-center (University of Tanta), double-blind, controlled study, 41 treatment-naive patients with CHC genotype 4 were randomized to receive placebo (n =8) versus CR NTZ 675 (n =17) or 1350mg (n =16) twice daily for 4 weeks followed by the same regimen plus PegIFN alfa-2a 180mg weekly and RBV 1000 to 1200mg daily for 48 weeks. In the three treatment groups, the mean (± SD) ages were 43±11, 36±9, and 32±11 years, and baseline serum HCVRNA levels 5.6±0.7, 5.3±0.6, and 5.6±0.5 log IU/mL, respectively. Results: Dose-dependent reductions in serum HCVRNA were observed 4 days after starting combination therapy. Median HCVRNA reduction of −4.74, −5.11 and −5.57 for the placebo, lowdose and high-dose groups, respectively, were observed at week 16. Virologic response rates are shown: