TREATMENT OF CHRONIC HEPATITIS-C WITH RECOMBINANT HUMAN INTERFERON-ALPHA-2A - RESULTS OF A RANDOMIZED CONTROLLED CLINICAL-TRIAL

Sixty consecutive patients with chronic hepatitis C were included in a randomized controlled trial of recombinant human interferon-alpha2a v s. no treatment. Treated patients received tapering doses of interfero n thrice weekly for 1 yr. Twenty treated cases (66.7%) normalized seru m aminotransferase levels within the first 4 mo of treatment, but reac tivation or breakthrough frequently occurred afterward (20% in both ca ses). Only one of the untreated patients showed spontaneous normalizat ion of serum aminotransferase levels. Liver histology did not improve in patients without a biochemical response or with breakthrough during therapy, whereas it did not worsen in long-term responders and reacti vating patients. Lack of response does not appear to be related to ser um interferon antibodies, although their early appearance is more freq uent in patients who showed reactivation later on. No biochemical para meter was found to be predictive for positive response to treatment. A ntibody to c100 became negative in 62.5% of long-term responders, wher eas no change was recorded in other treated patients or controls. Reac tivation and breakthrough often occur during treatment, and further st udies are needed to determine the most effective schedule (dose and ti me) of interferon treatment. Loss of c100 antibody during therapy may be a marker of long-term maintenance of response to interferon therapy .