Janssen R&D Ireland announced primary efficacy and safety results from its global Phase 3 PROMISE study. Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis.
PROMISE is a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial assessing the efficacy, safety and tolerability of simeprevir plus pegylated interferon and ribavirin vs. pegylated interferon and ribavirin alone in 393 patients. Patients were randomized to receive one 150mg capsule of simeprevir or placebo once daily plus pegylated interferon and ribavirin for 12 weeks, followed by pegylated interferon and ribavirin alone for either 12 or 36 weeks based on response-guided therapy criteria. Patients in the simeprevir arm were considered to have met response-guided therapy criteria if their HCV RNA levels were <25 IU/mL (detectable or undetectable) at week 4 and <25 IU/mL undetectable at week 12. In patients meeting response-guided therapy criteria, HCV therapy was stopped at week 24. All other patients continued treatment until week 48.
The use of investigational protease inhibitor simeprevir (TMC435) led to sustained virologic response 12 weeks after the end of treatment (SVR12) in 79% of the treatment-experienced genotype 1 chronic hepatitis C adult patients with compensated liver disease, including all stages of liver fibrosis, when administered once daily with pegylated interferon and ribavirin. In the study, 37% of patients receiving placebo plus pegylated interferon and ribavirin achieved SVR12. In the simeprevir arm, on-treatment failure rates were 3% and relapse rates were 19%, compared to 27% and 48% in the placebo arm.
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