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Maintenance Peginterferon Therapy Not Helpful in Advanced Chronic Hepatitis C
Patients without initial responses to peginterferon and ribavirin did not benefit from long-term low-dose peginterferon therapy in the HALT-C trial.
About half of all patients with chronic hepatitis C fail to respond to initial therapy with peginterferon and ribavirin. Long-term maintenance peginterferon therapy is often then initiated, but until now, the safety and efficacy of this practice had not been evaluated in a randomized trial.
In this multicenter, U.S.-based study, 1050 patients with chronic hepatitis C and advanced fibrosis who had not responded to previous treatment were randomized to receive maintenance therapy (90 µg of peginterferon alfa-2a weekly) or no therapy for 3.5 years. Patients were seen every 3 months and underwent liver biopsies at baseline and 1.5 and 3.5 years after randomization. The criteria for the primary outcome — progression of liver disease — varied according to whether patients had cirrhosis or noncirrhotic fibrosis at baseline.
Maintenance therapy was associated with significant decreases in aminotransferase and hepatitis C virus RNA levels, but it did not influence the likelihood of disease progression, which was about 34% in each group (hazard ratio, 1.01). Serious adverse events occurred in 39% of peginterferon recipients versus 32% of untreated patients (P=0.07).
Comment: Long-term low-dose peginterferon does not reduce the rate of disease progression and may increase the risk for serious adverse events in patients with failure on initial regimens. Based on these data, the continued use of peginterferon in this setting cannot be recommended.
Published in Journal Watch Infectious Diseases December 10, 2008
Citation(s):
Di Bisceglie AM et al. Prolonged therapy of advanced chronic hepatitis C with low-dose peginterferon. N Engl J Med 2008 Dec 4; 359:2429.
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