icon-    folder.gif   Conference Reports for NATAP  
 
  EASL
43rd Annual Meeting of the European Association For The Study Of The Liver
Milan, Italy
April 23-27, 2008
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Final Results of the Phase IIIb IDEAL Study (Individualized Dosing Efficacy vs. Flat Dosing to Assess OptimaL PegInterferon Therapy)
 
 
  Reported by Jules Levin
European Association for the Study of the Liver (43rd EASL Conference)
Milan, Italy
April 26, 2008
 
MS Sulkowski, E Lawitz, ML Shiffman, AJ Muir, G Galler, J McCone, L Nyberg, WM Lee, R Ghalib, E Schiff, J Galati, B Bacon, M Davis, P Mukhopadhyay, Koury K, S Noviello, L Pedicone, J Albrecht, J McHutchison on behalf of the IDEAL Study Team
 
Study Rationale and Aim
 
Two co-primary comparisons
 
1 PEG-IFN _-2b: 1.5 _g/kg vs 1.0 _g/kg
-- Post-approval commitment to FDA
-- 1.0 dose approved as monotherapy, few data with ribavirin
 
2. PEG-IFN _-2b 1.5 _g/kg vs PEG-IFN _-2a 180 _g regimens
-- Cross study comparisons problematic
-- Scientific comparison of approved combination regimens needed to guide treatment
 
Primary endpoint
 
SVR, defined as HCV RNA < 29 IU/mL at the end of follow-up (week 24 or, if missing, week 12)
 
Manns M, et al. Lancet 2001; Fried M, et al. NEJM 2002
 
Study Design
Design: Randomized, open-label, parallel-group study
Population: Treatment-naive, genotype 1
Location: 118 US academic and community centers
Entry criteria:
-- Age 18 - 70 years old
-- Weight 40 - 125 kg
-- Compensated liver disease with liver biopsy with 3 years
Independent Data Analysis Committee:
-- 2 Co-lead principal investigators
-- 2 Independent expert clinicians
-- 1 External statistician who led the analyses

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