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Roche responds to announcement of 'IDEAL' hepatitis C trial results
Date:1/14/2008

NUTLEY, N.J., Jan. 14 /PRNewswire/ -- Following an announcement from Schering-Plough, Roche today affirmed the value of PEGASYS(R) (peginterferon alfa-2a) in combination with ribavirin as the market-leading treatment for patients with hepatitis C, in the United States and globally. Despite clear biases in the design of the "IDEAL" study that potentially favored patients taking Peg-Intron(TM) (peginterferon alfa-2b) regimens - particularly the ribavirin dose reduction protocol - the study results have shown that patients treated with a PEGASYS regimen had a similar chance of being successfully treated for hepatitis C.

"I do not expect that the results of the IDEAL study will meaningfully impact clinical practice, except to inform physicians on the appropriate dosing of Peg-Intron and to reinforce the already widely-accepted view that optimizing ribavirin dosing throughout treatment is critical to achieving success and preventing treatment relapse in hepatitis C," said Douglas Dieterich, M.D., Professor of Medicine in the Division of Hepatology at Mt. Sinai School of Medicine in New York, New York.

In 2001, the U.S. Food and Drug Administration (FDA) required Schering- Plough to conduct a post approval commitment trial to determine if a lower dose of Peg-Intron (1.0 mcg/kg) was as effective as the approved dose of 1.5 mcg/kg, both in combination with identical ribavirin regimens. A third arm was added to the study in which patients received PEGASYS 180 mcg with a different ribavirin dosing schedule. This mismatch of ribavirin dosing introduces several potential biases into the study because experts agree that an optimized dose of ribavirin, with either pegylated interferon, is critical to achieving success in hepatitis C treatment. In particular, maintaining a full dose of ribavirin has shown an important ability to reduce relapse following the end of treatment.

"PEGASYS quickly became the market leader after its launch, based on robust cli
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