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Final Results of Ideal Study Presented at Annual Meeting of the European Association for the Study of the Liver (EASL)
Date:4/26/2008

redictive value, PPV) than patients in the Pegasys combination arm (92 vs. 87 vs. 80 percent, and 81 vs. 83 vs. 74 percent, respectively).(5)

-- Relapse after the end of treatment was lower for patients in the PEGINTRON combination therapy arms compared to patients receiving Pegasys and Copegus (24 vs. 20 vs. 32 percent, respectively). In a multivariate logistic regression analysis, among the factors significantly affecting relapse were: baseline viral load greater than 600,000 IU/mL vs. less than or equal to 600,000 IU/mL (p-value less than 0.001); age greater than 40 vs. less than or equal to 40 (p-value less than 0.001); fibrosis F3/4 vs. F0/1/2 (p-value equal to 0.001); Pegasys regimen vs. PEGINTRON 1.0 mcg regimen (p-value less than 0.001); glucose fasting greater than or equal to 5.6 vs. less than 5.6 (p-value equal to 0.002); steatosis 0 percent vs. greater than 0 percent (p-value equal to 0.002); ALT normal vs. elevated (p-value equal to 0.008); and Pegasys regimen vs. PEGINTRON 1.5 mcg regimen (p-value equal to 0.012).

-- End of treatment response was higher in the Pegasys combination arm (53 vs. 49 vs. 64 percent, respectively).

-- Ribavirin dose: One of the key questions of the study has been whether the protocol-assigned ribavirin dose regimen or the protocol-specified dose reduction schedule disadvantaged patients in any of the treatment arms, particularly in the Pegasys combination arm. However, the final results of IDEAL showed that the majority of patients in the Pegasys therapy arm received a higher ribavirin dose over the duration of the study, including patients with ribavirin dose reductions or discontinuations, based on the actual median ribavirin dose received (mg/kg/day), regardless of treatment outcome (SVR, relapsers and nonresponders) [p-value less than 0.001 for ribavirin dose received in the PEGINTRON 1.5 mcg arm vs. Pegasys arm and p-value less than or equal to 0.001 for ribavirin dose received in the PEGINTRON 1.0 a
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SOURCE Schering-Plough Corporation
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