A randomized controlled trial of a 12-month course of recombinant human interferon-α in chronic delta (type D) hepatitis: A multicenter Italian study

✍ Scribed by Floriano Rosina; Cristina Pintus; Carlton Meschievitz; Mario Rizzetto

• Publisher: John Wiley and Sons
• Year: 1991
• Tongue: English
• Weight: 547 KB
• Volume: 13
• Category: Article
• ISSN: 0270-9139
• DOI: 10.1002/hep.1840130608

✦ Synopsis

To determine whether long-term therapy with recombinant interferon-a can improve the course of chronic delta hepatitis, 61 Italian patients with this disease were randomly assigned to receive either interferon-a-2b three times a week (5 MU/m2 for 4 mo and then 3 MU/m2 for another 8 mo) or no treatment. At the end of the 12-mo study, all patients were followed-up for 12 additional months. Normalization or decrease of more than 50% from baseline of serum ALT levels occurred in 42% of treated patients the fourth month of therapy, 26% the twelfth month and 3% the twenty-fourth month vs. 7%, 7% and 0%, respectively, in the control group. However, relapses occurred in 7 of 8 (87.5%) responders 1 to 10 mo (mean = 3.5 mo) after cessation of therapy.

Liver biopsies were carried out at baseline and during the twelfth month of treatment. Histological improvement, mostly caused by decrease of portal inflammation, was observed in 57% of treated and 36% of untreated patients. Measures of antiviral activity (serum hepatitis delta virus RNA and intrahepatic hepatitis delta antigen) showed similar levels in treated and control patients. In treated patients the percentage of patients who were negative for HDV RNA never exceeded that of baseline.