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Final Results of the Phase IIIb IDEAL Study (Individualized Dosing Efficacy
vs. Flat Dosing to Assess OptimaL PegInterferon Therapy)
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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
![Regie-1.gif](../images/042808/Regie-1.gif)
![demo-2.gif](../images/042808/demo-2.gif)
![ITT-3.gif](../images/042808/ITT-3.gif)
![Based-4.gif](../images/042808/Based-4.gif)
![Riba-5.gif](../images/042808/Riba-5.gif)
![common-6.gif](../images/042808/common-6.gif)
![SVR-7.gif](../images/042808/SVR-7.gif)
![stepwise-8.gif](../images/042808/stepwise-8.gif)
![method-9.gif](../images/042808/method-9.gif)
![mark-10.gif](../images/042808/mark-10.gif)
![Ass-11.gif](../images/042808/Ass-11.gif)
![dsoe-12.gif](../images/042808/dsoe-12.gif)
![Reduction-13.gif](../images/042808/Reduction-13.gif)
![Relapse-14.gif](../images/042808/Relapse-14.gif)
![not-15.gif](../images/042808/not-15.gif)
![ideal-16.gif](../images/042808/ideal-16.gif)
![sign-17.gif](../images/042808/sign-17.gif)
![pracCon-18.gif](../images/042808/pracCon-18.gif)
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