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Hepatitisweb study
Hepatitisweb study
Simeprevir with Peginterferon and Ribavirin in GT-4RESTORE
Phase 3
Treatment Naïve and Treatment Experienced
Moreno C, et al. 49th EASL. April 2014: Abstract P1319.
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Hepatitisweb studySource: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.
Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Study Features
RESTORE Trial: Features Design: Open-label, phase 3, study evaluating simeprevir + PEG + RBV for
treatment naïve and experienced patients with genotype 4 chronic HCV
Setting: Multicenter and International
Entry Criteria - Chronic HCV genotype 4 (n = 107)- Treatment naïve (n = 35) or treatment experienced relapsers (n = 22)- Experienced (Nonresponder): partial (n = 10), null (n = 40)
Patient Characteristics- Sex: male 79%- Race: white (72%); black (28%)- Median age: 49- IL genotype: 7.5% CC- METAVIR Fibrosis Stage: F4 = 29%; F3 = 14%
Primary End-Points: Efficacy (SVR12)
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Hepatitisweb studySource: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.
Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Study Design
Simeprevir
Peginterferon + RibavirinTreatment-Naïveor
Prior Relapse
12 24 480Week
Simeprevir
Peginterferon + Ribavirin
Simeprevir
Peginterferon + Ribavirin
Partial Responseor
Null Response
RGTdetermines if PEG + RBV
x 24 or 48 wks
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
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Hepatitisweb study
Simeprevir + Peginterferon + Ribavirin in Genotype 4RESTORE: Results
RESTORE: SVR12 by Prior Treatment Status
Source: Moreno C, et al. 49th EASL. April 2014: Abstract P1319.
All Treatment-Naïve Relapsers Partial Null0
20
40
60
80
100
65
83 86
60
40
Patie
nts
(%) w
ith S
VR12
70/107 29/35 19/22 6/10 16/40
Treatment-Experienced Nonresponders
Treatment-Naïve &Experienced Relapsers
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Hepatitisweb study
Hepatitisweb study
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.