Final Results of Ideal Study Presented at Annual Meeting of the European Association for the Study of the Li...(rm vs. Pegasysarm]. -- Safety and tol...),Health

-- Safety and tolerability were similar among the three treatment groups, with no new peginterferon or ribavirin related adverse events identified in this large study. Overall adverse events reported for the three treatment regimens were similar. As seen in other studies with these treatments, a range of "flu-like symptoms" were the most commonly reported adverse events for all three treatment regimens. Overall, the proportion of patients reporting serious adverse events was similar (9 vs. 9 vs. 12 percent, respectively). Discontinuation rates due to adverse events were similar across the three treatment arms (13 vs. 10 vs. 13 percent, respectively) as were discontinuations due to psychiatric adverse events (3 vs. 2 vs. 2 percent, respectively).

The complete results of the IDEAL study will be submitted for peer-reviewed publication, 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 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-approval commitment to the U.S. Food and Drug Administration (FDA). The comparison of the PEGINTRON and Pegasys combination therapy regimens was added to the study because no randomized, controlled head-to-head study
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