Treatment of chronic hepatitis B with recombinant interferon alpha versus recombinant interferon alpha plus levamisole.

To compare the efficacy and tolerance of the simultaneous administration of levamisole plus IFN versus treatment with IFN alone in chronic hepatitis B, 39 patients were randomly assigned into two groups. Nineteen patients received 15 million units of recombinant alpha interferon 2b (rIFN-alpha 2b) 3 times a week for 4 months. The other 20 patients were treated with the same dose and schedule of rIFN-alpha 2b and 150 mg of levamisole simultaneously given during the first 6 weeks of treatment. At the end of the study (thirteenth month), serum HBV-DNA was negative in 59% of patients treated with interferon alone and in 37% of those treated with interferon and levamisole. HBeAg was negative in a similar percentage in the two groups (41% vs. 37%). Serum alanine aminotransferase levels decreased in patients who lost viral DNA. These data demonstrate that the combination of alpha interferon and levamisole, at the doses and under the schedule used in this study, does not achieve better results than the treatment with alpha interferon alone. Although tolerance to the simultaneous administration of alpha interferon and levamisole is good, secondary effects may be hazardous.