Reuters Health Information (2008-12-04): Prolonged peginterferon therapy for hepatitis C not useful after initial failure
Prolonged peginterferon therapy for hepatitis C not useful after initial failure
Last Updated: 2008-12-04 10:24:19 -0400 (Reuters Health)
NEW YORK (Reuters Health) - In patients with advanced chronic hepatitis C who have not responded to prior therapy with peginterferon and ribavirin, prolonged low-dose therapy does not reduce the rate of disease progression, new research shows.
Patients who do not respond to initial antiviral therapy are at risk for progression to cirrhosis, liver failure, hepatocellular carcinoma, and ultimately, death, Dr. Adrian M. Di Bisceglie, from Saint Louis University School of Medicine, and colleagues note. Whether extended peginterferon treatment might prevent disease progression was unclear.
The Hepatitis C Antiviral Long-Term Treatment against Cirrhosis (HALT-C) trial included 1050 patients who were randomized to receive low-dose peginterferon alfa-2a (90 micrograms/week) or no treatment for 3.5 years after previous non-response to standard peginterferon and ribavirin therapy.
The patients were clinically evaluated at 3-month intervals and liver biopsies were performed at 1.5 and 3.5 years. The results are reported in The New England Journal of Medicine for December 4.
Although serum aminotransferase levels, hepatitis C virus RNA levels, and histologic necroinflammatory scores fell significantly with peginterferon therapy, disease progression occurred in 34.1% of the treatment group and in 33.8% of the control group (p = 0.90).
The rate of serious adverse events was higher, but not significantly different in the peginterferon group than in the no-treatment group: 38.6% vs. 31.8% (p = 0.07).
The authors conclude "that long-term maintenance therapy with half-dose peginterferon is ineffective in preventing clinical and histologic disease progression and is not indicated in patients with hepatitis C-associated advanced fibrosis, with or without cirrhosis, who have not had a response to a standard course of peginterferon and ribavirin therapy."
N Engl J Med 2008;359:2429-2441.