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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 acco…