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Simeprevir Administered Once Daily as Part of Combination Therapy Demonstrates Sustained Virologic Response in Treatment-Naive and Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:11/2/2013

                           
In a pooled analysis of the Phase 3 QUEST-1 and QUEST-2 studies, 80 percent of treatment-naive patients treated with simeprevir in combination with pegylated interferon and ribavirin achieved the primary endpoint of sustained virologic response 12 weeks after the end of treatment (SVR12) compared to 50 percent of patients treated with placebo plus pegylated interferon and ribavirin. The pooled analysis found that 61 percent of patients with the IL28B TT genotype, 60 percent of patients with a METAVIR score of F4 and 75 percent of patients with genotype 1a HCV treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 21 percent, 34 percent and 47 percent of patients taking placebo plus pegylated interferon and ribavirin, respectively. Among patients with the genotype 1a Q80K polymorphism at baseline, 58 percent of patients treated with simeprevir combined with pegylated interferon and ribavirin achieved SVR12 compared to 52 percent of patients treated with placebo in combination with pegylated interferon and ribavirin, but the difference was not statistically significant.

Eight percent and 10 percent of patients treated with simeprevir combined with pegylated interferon and ribavirin experienced on-treatment failure and relapse, respectively, compared to 33 percent and 15 percent of patients taking placebo plus pegylated interferon and ribavirin, respectively. Three percent of patients treated with simeprevir discontinued treatment early due to an adverse event compared to two percent of patients treated with placebo.

Analysis from PROMISE Reinforces Efficacy of Simeprevir in Sub-Populations of Patients (Abstract 1092)                    
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SOURCE Janssen R&D Ireland
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Related medicine technology :

1. Simeprevir Data in Hepatitis C Patients to be Presented at the Annual Meeting of the American Association for the Study of Liver Diseases (AASLD)
2. 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
3. U.S. FDA Grants Priority Review to Simeprevir (TMC435) for Combination Treatment of Genotype 1 Chronic Hepatitis C
4. Janssen and Johnson & Johnson to Provide Webcast Presentation of Simeprevir Phase 3 Clinical Data Presented at The International Liver Congress of the European Association for the Study of the Liver (EASL)
5. Findings from Two Phase 3 Studies of Janssens Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Genotype 1 Chronic Hepatitis C Patients
6. Janssen Submits New Drug Application to U.S. FDA for Simeprevir (TMC435) for Combination Treatment of Adult Patients with Genotype 1 Chronic Hepatitis C
7. 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
8. 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
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