A RANDOMIZED, CONTROLLED TRIAL OF INTERFERON ALFA-2B ALONE AND WITH SIMULTANEOUS PREDNISONE FOR THE TREATMENT OF CHRONIC HEPATITIS-B

The aim of the study was to evaluate the safety and effectiveness of i nterferon alpha-2b with or without concomitant corticosteroid treatmen t in patients with chronic hepatitis B. Fifty-six patients were random ly allocated to two treatment groups. Group I (n=25) received interfer on alpha-2b (INTRON A, Schering-Plough Corporation) 5 million units su bcutaneously, three times a week for 24 weeks. Group II (n=31) receive d interferon according to the same protocol and prednisolone in decrea sing doses of 60, 40, 20 mg for 6 weeks. The two groups were well matc hed for demographic, biochemical, virological and histologic features. Both groups were followed up for 24 weeks after treatment. No statist ical difference was observed between the two groups at the end of the follow-up in alanine aminotransferase values, HBV DNA negativation, HB eAg loss, anti-HBe seroconversion and the Knodell score. The greater p roportion of HBsAg clearance in the combination group, particularly in patients with low alanine aminotransferase values, was, however, not significant. In patients with low alanine aminotransferase values, onl y the Knodell score was significantly decreased in patients treated wi th interferon and prednisolone. The only factor which was found to be a predictor of response was the assumed duration of hepatitis. These f indings showed that a concomitant short administration of corticostero ids during the first weeks of interferon therapy did not improve resul ts with interferon alone. (C) Journal of Hepatology.