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Primary Efficacy and Safety Findings from Phase 3 Study of Janssen's Simeprevir Administered Once Daily Demonstrate Sustained Virologic Response in Treatment-Experienced Genotype 1 Chronic Hepatitis C Adult Patients
Date:5/21/2013

re randomized to receive simeprevir or placebo for 12 weeks plus pegylated interferon and ribavirin for 24 or 48 weeks. In findings related to a secondary endpoint, 93 percent of patients receiving simeprevir were able to shorten therapy with pegylated interferon and ribavirin to 24 weeks as a result of meeting response-guided therapy criteria. Eighty-three percent of those patients meeting response-guided therapy criteria to stop treatment at 24 weeks achieved SVR12.

Patients enrolled in PROMISE were stratified by hepatitis C virus (HCV) genotype 1 subtype and IL28B genotype. SVR12 rates among patients treated with simeprevir according to IL28B genotype were 89 percent for the CC allele, 78 percent for the CT allele, and 65 percent for the TT allele, compared to 53 percent for the CC allele, 34 percent for the CT allele and 19 percent for the TT allele in the placebo arm. Among patients with METAVIR scores F0 to F2, 82 percent of patients treated with simeprevir and 41 percent with placebo achieved SVR12. Among patients with METAVIR scores F3 and F4, 73 percent and 74 percent of patients treated with simeprevir and 20 percent and 26 percent treated with placebo achieved SVR12, respectively. The METAVIR score is used to quantify the degree of inflammation and fibrosis of the liver and patients are scored on a five-point scale. 

"Janssen is pleased to share the primary endpoint results from PROMISE with the scientific community alongside primary data from our Phase 3 QUEST-1 and QUEST-2 studies of simeprevir, which are also being presented at DDW," said Maria Beumont , M.D., medical leader for simeprevir, Janssen. "We now have robust data for simeprevir in both treatment-experienced and treatment-naïve patients that demonstrate primary efficacy and safety in patients with genotype 1 chronic hepatitis C."

The most common adverse events seen in patients receiving simeprevir versus placebo in
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SOURCE Janssen R&D Ireland
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