Levamisole and interferon in children with chronic hepatitis B

Abstract

To evaluate the possible usefulness of simultaneous administration of levamisole and interferon, we randomly allocated 38 children with chronic hepatitis B to receive either 10 MU/m2 interferon-alpha-2a, three times a week for 6 mo (group 1, n = 20) or 90 mg/m2 of levamisole for 45 days, together with 10 MU/m2 of interferon-alpha-2a, three times a week for 6 mo (group 2, n = 18). At the end of the follow-up period (15 mo), no significant differences were observed between the groups with respect to loss of hepatitis B virus DNA and HBeAg from serum and normalization of serum ALT levels. During therapy, a significant increase in the serum levels of ALT and soluble interleukin-2 receptor was observed in both groups but was higher in patients from group 2. The combination of levamisole with interferon was associated with severe side effects. In summary, the combination of levamisole with interferon in children with chronic hepatitis B does not improve the results obtained with interferon alone.

Treatment of children with HBeAg-positive chronic hepatitis B: A systematic review and meta-analysis

“…The follow-up period in most studies was from 6 months up to 1 year [15,17,24,25,27,30,31], and in one was of 2 years [18]. Treatment was conducted among children with CHB in the immunoactive phase in all studies, except two studies in which it was conducted in the immunotolerant phase [25,30].…”

“…Several studies had an open label design [12][13][14][15][16]25,26], while the others were randomized controlled studies, where the control group could be: no treatment [17][18][19][20][29][30][31], another therapeutic regimen [22,24,27,28], different doses of the same drug [23], or different durations of treatment [21].…”

“…1 highlights the articles' inclusion process. Twenty studies (1112 cases) were eligible; 9 for IFN␣ monotherapy [12][13][14][15][16][17][18][19][20], 6 for combined IFN plus LMV [21][22][23][24][25][26], 2 for IFN␣ plus immune modulators [27,28], 2 for IFN␣ plus prednisone [18,29], 1 for hepatitis B vaccine [30], and 1 for vitamin E [31], (Ref. [18] was used for 2 regimens).…”

Treatment of viral hepatitis B in children

“…Immunomodulation therapy with levamisole and/or vaccination has been reported in children with CHB. The combined intervention of levamisole with IFN-a to treat CHB does not seem to produce synergic effects in children [116].…”

Therapy of Hepadnavirus Infection Using Antisense Oligonucleotides

“…In these patients, primarily immune response-modifying agents were tested. Among them, a-interferon has been shown to be useful with a clinical, biochemical and sero logical remission in 30-40% of highly selected patients [6], Further immunological agents which are being stud ied in clinical trials are P-and y-interferon [7], corticoste roids, levamisole [8], thymosin [9], specific immunother apies (anti-HBs, bone marrow transplantation) [10,11], granulocyte-macrophage colony-stimulating factor [12] and interleukin-2 [13a, b]. Many observations lead to the conclusion that the HBV is not cytopathic to its host cell.…”