Treatment of chronic hepatitis C with recombinant human interferon-α2a: Results of a randomized controlled clinical trial

✍ Scribed by Giulio Diodati; Paola Bonetti; Franco Noventa; Carla Casarin; Massimo Rugge; Sergio Scaccabarozzi; Alessandro Tagger; Lucio Pollice; Federico Tremolada; Cristina Davite; Giuseppe Realdi; Arturo Ruol

• Publisher: John Wiley and Sons
• Year: 1994
• Tongue: English
• Weight: 506 KB
• Volume: 19
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.1840190102

✦ Synopsis

Sixty consecutive patients with chronic hepatitis C were included in a randomized controlled trial of recombinant human interferon-%, vs. no treatment. Treated patients received tapering doses of interferon thrice weekly for 1 yr. Twenty treated cases (66.7%) normalized serum aminotransferase levels within the first 4 m o of treatment, but reactivation or breakthrough frequently occurred afterward (20% in both cases). Only one of the untreated patients showed spontaneous normalization of serum amhotransferase 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 reactivating patients. Lack of response does not appear to be related to serum interferon antibodies, although their early appearance is more frequent in patients who showed reactivation later on.

No biochemical parameter was found to be predictive for positive response to treatment. Antibody to c l O O became negative in 62.5% of long-term responders, whereas no change was recorded in other treated patients or controls. Reactivation and breakthrough often occur during treatment, and further studies are needed to determine the most effective schedule (dose and time) of interferon treatment. Lose of clOO antibody during therapy may be a marker of long-term maintenance of response to interferon therapy. (HEPA-TOLOGY 1994;lSl-5.)

The recent discovery of hepatitis C virus ( H C V ) (1) and the availability of a test for the corresponding serum antibody (2) allowed us to demonstrate that chronic liver disease of unknown origin is often related to this viral