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Schering-Plough Reports Top-Line Results of the IDEAL Study
Date:1/14/2008

egus, 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 an investigational dose of 800-1,400 mg/day, adjusted by four weight categories. As a result, the majority of patients (1598/3070, 52 percent) were assigned the same dose of ribavirin (either REBETOL or Copegus) based on their weight groups. In the study, 39 percent of patients in the Pegasys arm were assigned a higher dose of ribavirin, while 9 percent of patients in the PEGINTRON arms were assigned a higher dose of ribavirin. Among those who were assigned equivalent doses of ribavirin based on their weight group, SVR also was similar (40 vs. 38 vs. 38 percent, respectively). Also, fewer of these patients treated with PEGINTRON and REBETOL relapsed after the end of therapy compared with those treated with Pegasys and Copegus (22 vs. 20 vs. 35 percent, respectively).

Complete results of the IDEAL study will be submitted for peer-reviewed publication and for presentation at upcoming medical meetings, as well as to Health Authorities worldwide.

About IDEAL

The IDEAL study was undertaken by Schering-Plough as an important step in meeting the needs of the hepatitis C medical and patient communities to identify improved treatment strategies to optimize outcomes for patients. IDEAL, a Phase IIIb, randomized, parallel-group study, was conducted at 118 academic and community centers across the United States. The study treated 3,070 adult patients with chronic HCV genotype 1. Of these, 82 percent of patients had high viral load (greater than or equal to 600,000 IU/mL),(3) 11 percent had grade F3/4 fibrosis/cirrhosis, and 19 percent were African Americans. There were no significant differences in patient demographics or disease characteristics across the three treatment arms.

The comparison of the two PEGINTRON combination therapy doses (1.5 vs. 1.0 mcg/kg/week) was conducted as a post-app
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