Realize, a randomised, double-blind, placebo-controlled Phase 3 trial compared the efficacy, safety and tolerability of telaprevir in 662 patients with chronic genotype-1 HCV who failed prior treatment with peginterferon alfa and ribavirin (PR).
Patients received 48 weeks total treatment with PR alone or one of two telaprevir-based regimens (T/PR): 12 weeks T/PR plus 36 weeks PR alone, or 4 weeks PR alone followed by 12 weeks T/PR and 32 weeks PR alone.
The data demonstrated that telaprevir, in combination with peginterferon alfa and ribavirin (PR), was associated with cure rates higher than PR alone in patients with genotype-1 chronic HCV and cirrhosis.