Simeprevir: Phase III data

The double-blind, international Phase III PROMISE trial in 393 patients with HCV genotype 1 infection who relapsed after previous interferon-based therapy showed that a significantly greater proportion of patients who received once-daily 150 mg oral simeprevir for 12 weeks plus Pegasys peginterferon alfa-2a and Copegus ribavirin for 24 or 48 weeks (n=260) met the primary endpoint of a greater proportion of patients achieving an SVR defined as undetectable HCV RNA levels (<25 IU/mL) 12 weeks after the end of treatment vs. placebo plus Pegasys and Copegus (n=133) (79% vs. 37%, p<0.001). Additionally, 93% of patients in the simeprevir arm met the response-guided criteria for stopping all treatment at week 24. 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 Pegasys and Copegus for 48 weeks. Simeprevir was generally well tolerated. Mild and reversible increases in bilirubin were observed in the simeprevir arm. SVR24 data are expected in 1H13. ...