BioCentury
ARTICLE | Clinical News

Simeprevir: Additional Phase III data

May 6, 2013 7:00 AM UTC

Medivir reported subgroup data from the double-blind, placebo-controlled, international Phase III QUEST-2 trial in 391 treatment-naive patients with HCV genotype 1 infection evaluating once-daily 150 mg oral simeprevir for 12 weeks plus Pegasys peginterferon alfa-2a and Copegus ribavirin or PegIntron peginterferon alfa-2b and Rebetol ribavirin for 24 or 48 weeks. In patients treated with simeprevir, rates of SVR 12 weeks after the end of treatment were 96% in patients with the CC genotype of the interleukin-28B (IL-28B; IFNL3) gene, 80% in patients with the CT genotype and 58% in patients with the TT genotype. In patients with METAVIR scores of F3 and F4, simeprevir led to an SVR12 rate of 66%. In patients with METAVIR scores of F0-F2, simeprevir led to an SVR12 rate of 85%. Data were presented at the European Association for the Study of the Liver meeting in Amsterdam.

Last December, the partners reported that simeprevir plus peginterferon and ribavirin met the primary endpoint of a greater proportion of patients achieving an SVR12 vs. placebo plus peginterferon and ribavirin (81% vs. 50%, p<0.001) (see BioCentury, Dec. 24, 2012). According to the trial design, patients in the simeprevir arm who achieved HCV RNA levels of <25 IU/mL at week 4 and HCV RNA levels of <15 IU/mL at treatment week 12 were eligible to stop all treatment at week 24. Patients in the control arm received peginterferon and ribavirin for 48 weeks. ...