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SCHERING-PLOUGH REPORTS TOP-LINE RESULTS OF THE IDEAL STUDY
First Large Study Comparing Leading Hepatitis C Therapies Shows Similar Sustained Response Rates;
Fewer Patients Relapsed Following PEGINTRON Combination Therapy
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KENILWORTH, N.J., Jan. 14, 2008 - Schering-Plough Corporation (NYSE: SGP), a leader in hepatitis research, today reported top-line results of the IDEAL study, the first large, randomized, clinical study comparing the leading therapies for chronic hepatitis C: PEGINTRONTM (peginterferon alfa-2b) and REBETOL (ribavirin, USP) combination therapy vs. Pegasys (peginterferon alfa-2a) and Copegus (ribavirin, USP) combination therapy,1 as well as a lower dose of PEGINTRON in an investigational combination regimen. The results showed that sustained virologic response (SVR),2 the primary endpoint of the study, was similar for the two leading combination therapies for hepatitis C; and that using a lower dose of PEGINTRON with REBETOL also resulted in a similar SVR. The study also showed that fewer patients treated with both PEGINTRON regimens relapsed after the end of treatment compared to those receiving Pegasys and Copegus.
In the IDEAL (Individualized Dosing Efficacy vs. Flat Dosing to Assess optimaL pegylated interferon therapy) study, both PEGINTRON regimens utilized investigational weight-based ribavirin dosing. The three treatment regimens studied were:
(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
In the study, 3,070 previously untreated U.S. patients with HCV genotype 1, the most common form of the virus worldwide and most difficult to treat, were randomized to one of the three treatment regimens and received up to 48 weeks of combination therapy with 24 weeks of follow-up. SVR, the primary endpoint of the study, was similar for the three treatment regimens (40 vs. 38 vs. 41 percent, respectively). Importantly, while end of treatment response was higher in the Pegasys combination therapy arm, IDEAL showed that fewer patients receiving PEGINTRON combination therapy relapsed after the end of treatment (24 vs. 20 vs. 32 percent, respectively).
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