BioCentury
ARTICLE | Clinical News

Incivek telaprevir: Interim Phase IIIb data

April 29, 2013 7:00 AM UTC

Interim data from 85 evaluable patients in the 12-week treatment arm of the open-label, placebo-controlled, international Phase IIIb CONCISE trial showed that twice-daily 1,125 mg Incivek plus peginterferon and ribavirin for 12 weeks led to an SVR 12 weeks after end of treatment in 87% of patients. In 30 evaluable patients in the 24-week treatment arm of the trial, twice-daily 1,125 mg Incivek plus peginterferon and ribavirin for 12 weeks followed by peginterferon and ribavirin alone for 12 weeks led to an SVR12 rate of 97%. The trial enrolled 239 patients with chronic HCV genotype 1 infection carrying the CC genotype of the interleukin-28B (IL-28B; IFNL3) gene. Patients were either treatment-naïve or had relapsed after >=1 course of prior treatment with peginterferon and ribavirin alone. Of the 239 patients, 159 completed 12 weeks of Incivek plus peginterferon and ribavirin and achieved a rapid virologic response (RVR), defined as undetectable HCV RNA levels at week 4. Of the 159 patients, 107 were randomized to receive no further treatment and 52 patients were randomized to receive an additional 12 weeks of peginterferon and ribavirin alone. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam. ...