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news.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.
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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.