Cingles Info

Schering-Plough's Intron A gets EU label change
27th April 2006
By Helen Marshall
The European Commission has adopted changes to the EU label for
Schering-Plough's Intron A based on long-term efficacy data from a follow-up
study to evaluate the durability of sustained virological response in chronic
hepatitis C patients.
The large five-year study confirms that sustained loss of serum hepatitis C
virus (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 chronic HCV. However, long-term
clearance of the virus does not preclude the occurrence of hepatic events in
patients with cirrhosis, including hepatocarcinoma.
In the study, 1,071 patients were enrolled after completing prior treatment with
nonpegylated interferon alfa-2b (with or without ribavirin). Of these, 492
patients achieved a sustained virological response (SVR) and only 12 relapsed
during the follow-up period.
"This large study involving more than 1,000 hepatitis C patients demonstrates
that, even with close follow-up over a five-year period, patients who have
achieved an SVR have essentially no evidence of clinical or virological
disease," said Dr John McHutchison, lead investigator of the study. "Recognition
of this durability of response underscores the efficacy of interferon-based
antiviral therapy. Furthermore, it may help motivate hepatitis C patients to
seek treatment and provides physicians confidence that they are giving their
patients a meaningful chance for a cure."
A similar long-term follow-up study with pegylated interferon alfa-2b
(PEG-Intron) is ongoing.
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