Drug Development

E.U. label change for INTRON A incorporates long-term efficacy data in chronic hepatitis C

Published in Hepatitis Weekly, May 22nd, 2006

Schering-Plough Corporation (SGP) reported that the European Commission has adopted changes to the European Union (E.U.) label for INTRON A (interferon alfa-2b) based on long-term efficacy data from a large, five-year follow-up study to evaluate the durability of sustained virological response (SVR) in patients treated for chronic hepatitis C virus infection (HCV).

This large study confirms that sustained loss of serum HCV RNA six months following the completion of treatment with nonpegylated interferon alfa-2b (with or without ribavirin) is a strong predictor of long-term clearance of the virus, providing resolution of the hepatic infection and clinical "cure" from...

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Source: Hepatitis Weekly (2006-05-22)

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