Important note: Information in this article was accurate in 2008. The state of the art may have changed since the publication date.
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New York Times (12.04.08) - Wednesday, December 10, 2008
Roni Caryn Rabin
"To the extent there are still patients out there who are on this form of maintenance therapy, there is a real take-home message: It should be stopped," said lead author Dr. Adrian M. Di Bisceglie, professor of internal medicine and co-director of the liver center at St. Louis University School of Medicine.
The findings were based on a randomized, controlled trial involving 1,050 chronic hepatitis C patients who had not responded to previous treatment with peginterferon and ribavirin. Patients were randomly assigned to receive peginterferon (517 patients) or no therapy (533 patients) for 3.5 years. They were assessed at three-month intervals and underwent liver biopsy at 1.5 years and at 3.5 years.
Despite significantly lowering hepatitis C levels in patients' blood and reducing conventional signs of liver damage, maintenance therapy failed, Di Bisceglie said. Patients on peginterferon did just as poorly as those who did not receive maintenance therapy. About a third of patients in both groups developed serious complications of hepatitis C, including liver cancer and liver failure. Eight patients taking peginterferon died compared with two patients not on the maintenance regimen, a statistically significant difference.
There may still be a "glimmer of hope" for extended maintenance therapy in non-responders, though very little evidence suggests this, said Dr. David Bernstein, chief of gastroenterology and hepatology at North Shore Hospital on Long Island, who was not involved in the study. For now, he said, "there's no reason to make someone feel sicker than they generally feel."
The full report, "Prolonged Therapy of Advanced Chronic Hepatitis C with Low-Dose Peginterferon," was published in the New England Journal of Medicine (2008;359:2429-2441).
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