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Data Suggest that PEGASYS May be an Option in Hepatitis C Patients Unable to Tolerate Peg-Intron

http://biz.yahoo.com/bw/070521/20070521005687.html?.v=1

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Monday May 21, 8:10 am ET

WASHINGTON--(BUSINESS WIRE)--Roche today announced results of a small study demonstrating that all patients who discontinued treatment with Peg-Intron® (peginterferon alfa-2b) and ribavirin due to adverse events within the first 12 weeks, were able to complete 12 weeks of treatment with PEGASYS® (peginterferon alfa-2a) and ribavirin. Furthermore, 92 percent of these patients were able to go on and complete a full course of treatment with PEGASYS. The data, which were presented at the 38th annual Digestive Disease Week (DDW) conference, suggest that PEGASYS may be an option for patients who prematurely discontinue treatment with Peg-Intron for tolerability reasons.

"Tolerability, particularly early on in therapy, is so important to consider because a patient who is unable to complete a full course of therapy cannot achieve a successful outcome. This study was designed to explore an important question: whether patients who are intolerant to one form of pegylated interferon may be more tolerant to another form," said Vinod K. Rustgi, M.D., Clinical Professor of Medicine and Surgery at Georgetown University Medical Center, Washington, D.C. "These results indicate patients who have discontinued treatment with Peg-Intron due to symptoms such as depression, fatigue and flu-like symptoms, may be able to complete 12 weeks of PEGASYS, and potentially go on to complete a full course of therapy."

About the Study (Abstract ID# M1872)

The data presented today are from an open-label, multicenter trial that enrolled 57 HCV genotype 1 patients who could not tolerate (n=25) or did not respond (n=32) to 12 weeks of treatment with Peg-Intron and ribavirin. Overall, 88 percent of the total study population (100 percent of Peg-Intron non-tolerators and 81 percent of Peg-Intron non-responders) were able to complete 12 weeks of therapy with PEGASYS. Twenty-three of the 25 Peg-Intron non-tolerator patients completed a full course of treatment with PEGASYS (one patient was withdrawn for insufficient response at 12 weeks and one patient withdrew consent).
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