Schering-Plough to Initiate First Head-to-Head Study of Leading Hepatitis C Therapies

KENILWORTH, N.J. -- Schering-Plough Corporation today announced plans to initiate a major clinical study involving 2,880 patients that for the first time will directly compare the two approved forms of pegylated interferon therapy(1) for chronic hepatitis C virus (HCV) infection: PEG-INTRON (peginterferon alfa-2b/Schering Corporation) vs. PEGASYS (peginterferon alfa-2a/Hoffmann-La Roche, Inc.), both used in combination with ribavirin.

Schering-Plough Research Institute (SPRI), in collaboration with leading medical centers, will conduct the comparative study in response to requests by the hepatitis C medical and patient communities, and to clear up misperceptions in the marketplace about these two treatments.

The IDEAL trial (Individualized Dosing Efficacy vs. flat dosing to Assess optimaL pegylated interferon therapy) will compare the efficacy and safety of individualized weight-based dosing with PEG-INTRON and REBETOL (ribavirin, USP) vs. PEGASYS, which is administered as a flat dose to all patients regardless of individual body weight, and COPEGUS (ribavirin, USP) dosed either at 1,000 mg or 1,200 mg, in U.S. patients with chronic hepatitis C, genotype 1.

Genotype 1 virus is the most common worldwide, the most difficult to treat successfully and accounts for about 70 percent of HCV infection among Americans. PEG-INTRON is a form of interferon alfa-2b that has been chemically "pegylated" so it is retained in the body longer than standard interferon, thereby providing for once weekly administration. PEGASYS is a pegylated form of interferon alfa-2a.

PEG-INTRON and REBETOL combination therapy is the most-prescribed treatment for chronic hepatitis C worldwide, with more than 300,000 patients having received this treatment since its introduction in 2001.

"This is a very important study because these two treatment regimens have never before been directly compared," said John McHutchison, MD, medical director of liver research, at Duke University Medical Center, and co-principal investigator of the trial. "Findings from previous studies of PEG-INTRON and PEGASYS cannot be compared because of differences in study design, patient populations and other variables," he said.

"The IDEAL trial will include a large number of patients, providing a high degree of 'statistical power' to determine for the first time differences in the efficacy and safety of these two therapies," said Mark Sulkowski, MD, assistant professor of medicine and medical director of the Viral Hepatitis Center, Division of Infectious Diseases, Johns Hopkins University School of Medicine, and co-principal investigator of the trial. "Patients infected with the hepatitis C virus and their healthcare providers want answers to these important questions as they seek the best available treatment options for the patient's individual circumstances," he said.

"As the leading innovator of interferon-based treatments for hepatitis C, we are very excited about scientifically addressing this medical issue in a robust and highly powered clinical trial. We are confident that this large head-to-head study between PEG-INTRON and PEGASYS will provide valuable information that will help physicians make informed choices and provide hepatitis C patients with the best chance for achieving a sustained viral response," said Robert J. Spiegel, MD, senior vice president of medical affairs and chief medical officer, Schering-Plough Research Institute.

Source: Schering-Plough Corporation