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Simeprevir Data in Hepatitis C Patients to be Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
Date:10/1/2013

meprevir
Simeprevir is an investigational NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland 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 works by blocking the protease enzyme that enables the hepatitis C virus to replicate in host cells.

Janssen is responsible for the global clinical development of simeprevir and has acquired exclusive, worldwide marketing rights, except for in the Nordic countries. Medivir will retain marketing rights for simeprevir in these countries. A Marketing Authorisation Application was submitted to the European Medicines Agency (EMA) in April seeking approval of simeprevir for the treatment of genotype 1 or genotype 4 chronic hepatitis C. To date, more than 3,700 patients have been treated with simeprevir in clinical trials.

Additionally, simeprevir is being studied in combination with several direct-acting antiviral agents (DAAs) with different mechanisms of action, with and without ribavirin, as part of interferon-free regimens. These include:

  • The Phase 2 COSMOS study of simeprevir and Gilead's nucleotide polymerase inhibitor sofosbuvir (GS-7977) in treatment-naive and previous null-responder genotype 1 HCV patients, including patients with cirrhosis; 
  • A Phase 2 study of simeprevir and Bristol-Myers Squibb's NS5A replication complex inhibitor daclatasvir in treatment-naive and previous null-responder genotype 1 HCV patients; 
  • The Phase 2 HELIX-1 study of simeprevir and Idenix's once-daily pan-genotypic NS5A inhibitor samatasvir (IDX719) in treatment-naive genotype 1b and genotype 4 HCV patients.

For additional information about simeprevir, please visit www.clinicaltrials.gov.

About Hepatitis C
Hepatitis C, a blood-borne in
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1. Janssen Announces Collaboration with Vertex on Phase 2 Study to Investigate an All-Oral Regimen of Simeprevir (TMC435) and VX-135 for Treatment of Hepatitis C
2. Efficacy and Safety Data from Phase 2B Trials of Janssens Simeprevir in Hepatitis C Patients with Advanced Fibrosis of the Liver Presented at Annual Meeting of the American Association for the Study of Liver Diseases
3. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
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7. Primary Efficacy and Safety Findings from Phase 3 Study of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
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