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Findings from Two Phase 3 Studies of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
Date:4/23/2013

ek 4 and <25 IU/mL undetectable at week 12. In patients meeting RGT criteria, HCV therapy was stopped at week 24. All other patients continued treatment until week 48.

About Simeprevir

Simeprevir (TMC435) is an investigational NS3/4A protease inhibitor jointly developed by Janssen and Medivir AB for the treatment of genotype 1 chronic hepatitis C in adult patients with compensated liver disease, including all stages of liver fibrosis. Simeprevir is believed to work by blocking the protease enzyme that enables the hepatitis C virus to survive and replicate in host cells. Janssen recently announced the submission of new drug applications for simeprevir in Japan and the United States for the treatment of genotype 1 hepatitis C, and anticipates submitting simeprevir for regulatory authorization in the EU in the first half of 2013.

Global Phase 3 studies of simeprevir include QUEST-1 and QUEST-2 in treatment-naive adult patients, PROMISE in patients who have relapsed after prior interferon-based treatment and ATTAIN in null-responder adult patients. In parallel to these trials, Phase 3 studies for simeprevir are ongoing in treatment-naive and treatment-experienced HIV-HCV co-infected patients and HCV genotype 4 patients. To date, 1,846 patients have been treated with simeprevir in clinical trials.

Simeprevir is also being studied in Phase 2 interferon-free trials with and without ribavirin in combination with:

  • Janssen's non-nucleoside inhibitor TMC647055 and ritonavir in treatment-naive genotype 1a and 1b HCV patients;
  • Gilead Sciences, Inc.'s nucleotide inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 HCV patients; and
  • Bristol- Myers Squibb 's NS5A replication complex inhibitor daclatasvir (BMS-790052) in treatment-naive and previous null-resp
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SOURCE Janssen R&D Ireland
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