title: Therapy for chronic hepatitis B with lymphoblastoid interferon-alpha and levamisole.
abstract: About one third of patients with chronic hepatitis B show a sustained response when treated with interferon-alpha. Combining interferon-alpha with immunomodulators might be a way to increase response rate. The aim of this study was to compare the efficacy of lymphoblastoid interferon-alpha given alone with its efficacy when combined with levamisole in chronic hepatitis B. Forty-five patients with HBeAg-positive chronic hepatitis were randomly selected (with stratification for ALT levels) to receive a 6-mo course of combination therapy with lymphoblastoid interferon-alpha (5 million units/m2 three times per week) and levamisole (150 mg three times per week) or lymphoblastoid interferon at the same dose regimen and a matching placebo. Final evaluation 18 mo after randomization revealed a loss of both HBeAg and hepatitis B virus DNA with ALT normalization in 38% of patients treated with interferon-alpha alone and in 10% of patients receiving combination therapy. The higher response rate observed in patients treated with interferon-alpha alone was maintained after stratification for basal ALT levels (i.e., higher [45% vs. 10%] or lower [31% vs. 9%] than three times the upper normal value). The length of time to sustained HBeAg clearance was significantly (p < 0.05) shorter in patients receiving monotherapy than in patients receiving combination therapy. Blinded histological assessment revealed improvement in 44% of patients treated with interferon-alpha alone compared with improvement in 6% of patients receiving combination therapy. These results indicate that levamisole has no additive effects when combined with interferon-alpha in the treatment of HBeAg-positive chronic hepatitis.
authors.affiliation: Istituto Medicina Clinica, University of Padova, Padua, Italy.
authors.forename: G
authors.initials: G
authors.lastname: Fattovich
authors.forename: G
authors.initials: G
authors.lastname: Giustina
authors.forename: L
authors.initials: L
authors.lastname: Brollo
authors.forename: M
authors.initials: M
authors.lastname: Guido
authors.forename: P
authors.initials: P
authors.lastname: Pontisso
authors.forename: F
authors.initials: F
authors.lastname: Noventa
authors.forename: A
authors.initials: A
authors.lastname: Alberti
mesh_terms: D000328:Adult; D000410:Alanine Transaminase / Q000097:blood; D004279:DNA, Viral / Q000097:blood; D004359:Drug Therapy, Combination; D005260:Female; D006509:Hepatitis B / Q000201:enzymology / Q000382:microbiology / Q000628:therapy*; D006513:Hepatitis B e Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000235:genetics / Q000276:immunology; D006801:Humans; D016898:Interferon-alpha / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007978:Levamisole / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D011897:Random Allocation
chemical_list: D004279:DNA, Viral; D006513:Hepatitis B e Antigens; D016898:Interferon-alpha; D007978:Levamisole; D000410:Alanine Transaminase