Background/aims: We evaluated the effect of immunomodulatory treatment with levamisole in HBeAg positive or anti-HBe positive patients with chronic HBV infection and ongoing viral replication. The majority of patients had an expected poor response to IFN-alpha.
Methodology: Twenty-five viremic patients (15 males and 10 females) with chronic HBV infection were treated with Levamisole for 12 months or until negative serum HBV DNA occurred for at least 3 months. Viral replication and aminotransferase activity were controlled at the end of 3, 6, 9 and 12 months during the treatment.
Results: A decrease of serum HBV DNA was noted when serum HBV DNA levels before and after treatment with levamisole were compared, by t-test for dependent samples (p < 0.05). There was a significant reduction of ALT activity, too. HBV DNA fell below the detection limit of our assay at the end of 3, 6, 9 and 12 months in 7, 7, 8 and 10 of the patients, respectively. In 3 of 16 initially HBeAg positive patients, seroconversion to anti-HBe antibody occurred. At the end of 12 months 10 patients were with negative serum HBV DNA and normal ALT activity. Two of them lost HBsAg during the treatment. Ten patients were without any effect from the therapy. The potential responder initially is anti-HBe positive, with low serum HBV DNA < 500 pg/ml and low ALT activity (< 3 times the upper limit of normal).
Conclusions: Immunomodulation with levamisole may benefit some patients with chronic ongoing viral replication including patients with expected poor response to IFN-alpha. This treatment could be used as an alternative therapeutic schedule in patients contraindicated for IFN-alpha, and also because it lowers treatment costs.