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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

mmon form of the virus worldwide and most difficult to treat, were randomized and treated with one of three treatment regimens:

(1) PEGINTRON 1.5 mcg/kg/week and REBETOL 800-1,400 mg/day;

(2) PEGINTRON 1.0 mcg/kg/week and REBETOL 800-1,400 mg/day; and

(3) Pegasys 180 mcg/week and Copegus 1,000-1,200 mg/day

Patients received up to 48 weeks of combination therapy with 24 weeks of follow-up.

In IDEAL, the combination regimen of Pegasys and Copegus used the recommended doses in accordance with their approved U.S. labeling, which includes a flat dose of Pegasys (180 mcg/week) for all patients regardless of body weight, and 1,000 or 1,200 mg/day of Copegus, adjusted for two weight categories. PEGINTRON was dosed either at 1.5 mcg/kg/week or an investigational combination dose of 1.0 mcg/kg/week with REBETOL at a dose of 800-1,400 mg/day, adjusted by four weight categories.

As a result, 51 percent of patients in the study were assigned the same dose of ribavirin (either REBETOL or Copegus) based on their weight groups, 39 percent of patients in the Pegasys arm were assigned a higher dose of ribavirin and 10 percent of patients in the PEGINTRON arms were assigned a higher dose of ribavirin.

Key Findings from IDEAL

(For the PEGINTRON 1.5 mcg, PEGINTRON 1.0 mcg, and Pegasys combination arms, respectively.)

-- SVR, the primary endpoint of the study, was similar for the three treatment regimens (40 vs. 38 vs. 41 percent, respectively) overall, and among those patients who were assigned equivalent doses of ribavirin based on their weight group (40 vs. 38 vs. 38 percent, respectively) (ITT).(3,4)

-- Predictability of response at early treatment milestones was confirmed in a secondary analysis as an important assessment tool for physicians. More patients in the PEGINTRON combination arms who had undetectable virus (HCV-RNA) in plasma at treatment week 4 or treatment week 12 went on to achieve SVR (positive p
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SOURCE Schering-Plough Corporation
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