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Minerva Medica 2010 December;101(6):373-83


language: English

Pharmacokinetics and efficacy of intravenous or intramuscular hepatitis B immunoglobulins in prophylaxis of hepatitis B after liver transplantation

Marzano A. 1, Marengo A. 1, Andreone P. 2, Volpes R. 3, Canova D. 4, Cursaro C. 2, Riili A. 2, Fiorentino B. 5, Bacci M. 5, Guazzini S. 5, Burra P. 4

1 Unit of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy; 2 Medical Semeiotics, Orsola Malpighi Hospital Bologna, Italy; 3 ISMETT, Palermo, Italy; 4 Unit of Gastroenterology, Padua Hospital Padua, Italy; 5 Kedrion S.p.A, Castelvecchio Pascoli, Lucca, Italy


Aim. The use of hepatitis B immunoglobulin (HBIg) combined with nucleos(t)ide analogues (NUCs) has improved outcomes in post-hepatitis B (PHB) liver transplant (LT), reducing the 1-year recurrence rate below 10%. The aim of this study was to evaluate efficacy and pharmacokinetics of prophylaxis with NUC(s) and intravenous (iv-) or intramuscular (im-) HBIg in 33 PHBLTs, transplanted for more than 1 year.
Methods. During the first six months of the study, 18 subjects received 5 000 IU of iv-HBIg every four weeks and 15 patients 2 160 IU/12 mL of im-HBIg every two weeks. In the following six months, 31 subjects were switched to two different concentrations of im-HBIg, 2 160/12 mL (16 patients) or 2 000 IU/6 mL every two weeks (15 patients).
Results. All patients remained HBsAg-negative and 30/31 maintained anti-HBs >100 IU/L. Overall mean anti-HBs titer during treatment was 363 IU/mL. Mean HBIg half-life was 21.4, 27.3 and 26 days with intravenous, diluted or concentrated im-preparations, respectively.
Conclusion. These results confirm an analogue efficacy and tolerance of iv- and im-HBIg combined with antivirals in prophylaxis of hepatitis B after LT. Anti-HBs titers three times higher than aimed and four weeks mean half-life could suggest the reduction of doses and the elongation of the interval of administration of im-HBIg.

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