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Simeprevir with Peginterferon and Ribavirin in GT-4 RESTORE

Phase 3. Treatment Naïve and Treatment Experienced. Simeprevir with Peginterferon and Ribavirin in GT-4 RESTORE. Moreno C, et al. 49 th EASL. April 2014: Abstract P1319. Simeprevir + Peginterferon + Ribavirin in Genotype 4 RESTORE: Study Features.

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Simeprevir with Peginterferon and Ribavirin in GT-4 RESTORE

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  1. Phase 3 Treatment Naïve and Treatment Experienced Simeprevir with Peginterferon and Ribavirin in GT-4RESTORE Moreno C, et al. 49th EASL. April 2014: Abstract P1319.

  2. Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Study Features Source: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.

  3. Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Study Design Week 0 12 24 48 Simeprevir Treatment-NaïveorPrior Relapse RGTdetermines if PEG + RBV x 24 or 48 wks Peginterferon+ Ribavirin Simeprevir Peginterferon+ Ribavirin Simeprevir Partial ResponseorNull Response Peginterferon+ Ribavirin Response Guided Therapy (RGT) Criteria: Week 4 HCV RNA < 25 IU/mL (detectable or undetectable) and Week 12 HCV RNA < 25 IU/mL (undetectable) Drug DosingSimeprevir: 150 mg once dailyPeginterferon alfa-2a (PEG): 180 mcg/week Ribavirin (RBV) weight-based (in 2 divided doses): 1000 mg if < 75kg or 1200 mg/day if ≥ 75kg Source: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.

  4. Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Results RESTORE: SVR12 by Prior Treatment Status 70/107 29/35 19/22 6/10 16/40 Treatment-Naïve &Experienced Relapsers Treatment-Experienced Nonresponders Source: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.

  5. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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