Digestive and Liver Disease
Volume 42, Issue 7 , Pages 509-514 , July 2010

Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe®, for the prophylaxis of viral B hepatitis after liver transplantation

  • Franco Filipponi

      Affiliations

    • U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy
    • ,
  • Alessandro Franchello

      Affiliations

    • Centro Trapianti di Fegato, Azienda Ospedaliera S. Giovanni Battista, Torino, Italy
    • ,
  • Paola Carrai

      Affiliations

    • U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy
    • ,
  • Renato Romagnoli

      Affiliations

    • Centro Trapianti di Fegato, Azienda Ospedaliera S. Giovanni Battista, Torino, Italy
    • Corresponding Author InformationCorresponding author at: Centro Trapianti di Fegato, Azienda Ospedaliera S. Giovanni Battista di Torino, Corso Bramante 88/90, Torino 10126, Italy. Tel.: +39 011 6336553; fax: +39 011 6336770/6965923.
    • ,
  • Paolo De Simone

      Affiliations

    • U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy
    • ,
  • Michael K. Woodward

      Affiliations

    • Instituto Grifols S.A., Department of Clinical Trials and Pharmacovigilance, Parets del Vallès, Barcelona, Spain
    • ,
  • Antonio Paez

      Affiliations

    • Instituto Grifols S.A., Department of Clinical Trials and Pharmacovigilance, Parets del Vallès, Barcelona, Spain
    • ,
  • Mauro Salizzoni

      Affiliations

    • Centro Trapianti di Fegato, Azienda Ospedaliera S. Giovanni Battista, Torino, Italy

Received 12 May 2009 ,Accepted 11 September 2009.

References 

  1. Lee WM. Hepatitis B virus infection. N Eng J Med. 1997;337:1733–1745
  2. Beasley RP. Hepatitis B virus: the major aetiology of hepatocellular carcinoma. Cancer. 1988;61:1942–1956
  3. McMahon BJ. Hepatocellular carcinoma and viral hepatitis. In:  Wilson RA editors. Viral hepatitis: diagnosis, treatment, prevention. New York, NY: Marcel Deckker; 1997;p. 315–330
  4. Samuel D, Muller R, Alexandre G, et al. Liver transplantation in European patients with the hepatitis B surface antigen. N Engl J Med. 1993;329:1842–1847
  5. McGory R, Ishitani MB, Oliveira WM, et al. Improved outcome of orthotopic liver transplantation for chronic hepatitis B cirrhosis with aggressive passive immunisation. Transplantation. 1996;61:1358–1364
  6. Markowitz JS, Martin P, Conrad AJ, et al. Prophylaxis against hepatitis B recurrence following liver transplantation using combination lamivudine and hepatitis B immune globulin. Hepatology. 1998;28:585–589
  7. Lake JR. Should liver transplantation be performed for patients with chronic hepatitis B? Yes!. Liver Transpl Surg. 1995;1:260–265
  8. Woo HY, Choi JY, Jang JW, et al. Role of long-term lamivudine treatment of hepatitis B virus recurrence after liver transplantation. J Med Virol. 2008;80:1891–1899
  9. Karasu Z, Akyildiz M, Kilic M, et al. Living donor liver transplantation for hepatitis B cirrhosis. J Gastroenterol Hepatol. 2007;22:2124–2129
  10. Karademir S, Astarcioglu H, Akarsu M, et al. Prophylactic use of low-dose, on-demand, intramuscular hepatitis B immunoglobulin and lamivudine after liver transplantation. Transpl Proc. 2006;38:579–583
  11. Han SH, Martin P, Edelstein M, et al. Conversion from intravenous to intramuscular hepatitis B immune globulin in combination with lamivudine is safe and cost-effective in patients receiving long-term prophylaxis to prevent hepatitis B recurrence after liver transplantation. Liver Transpl. 2003;9:182–187
  12. Yoshida EM, Erb SR, Partovi N, et al. Liver transplantation for chronic hepatitis B infection with the use of combination lamivudine and low-dose hepatitis B immune globulin. Liver Transpl Surg. 1999;5:520–525
  13. Mutimer D. Review article: hepatitis B and liver transplantation. Aliment Pharmacol Ther. 2006;23:1031–1041
  14. Shouval D, Samuel D. Hepatitis B immune globulin to prevent hepatitis B virus graft reinfection following liver transplantation: a concise review. Hepatology. 2000;32:1189–1195
  15. Wang ZF, Zhu ZJ, Shen ZY. Advances in prophylaxis and treatment of recurrent hepatitis B after liver transplantation. Hepatobiliary Pancreat Dis Int. 2005;4:509–514
  16. Tung BY, Kowdley KV. Hepatitis B and liver transplantation. Clin Infect Dis. 2005;41:1461–1466
  17. Dickson RC, Terrault NA, Ishitani M, et al. Protective antibody levels and dose requirements for IV 5% Nabi Hepatitis B immune globulin combined with lamivudine in liver transplantation for hepatitis B-induced end stage liver disease. Liver Transpl. 2006;12:124–133
  18. Yan ML, Yan LN, Li B, et al. Intramuscular hepatitis B immune globulin combined with lamivudine in prevention of hepatitis B recurrence after liver transplantation. Hepatobiliary Pancreat Dis Int. 2006;5:360–363
  19. Zheng S, Chen Y, Liang T, et al. Prevention of hepatitis B recurrence after liver transplantation using lamivudine or lamivudine combined with hepatitis B Immunoglobulin prophylaxis. Liver Transpl. 2006;12:253–258
  20. Yao FY, Osorio RW, Roberts JP, et al. Intramuscular hepatitis B immune globulin combined with lamivudine for prophylaxis against hepatitis B recurrence after liver transplantation. Liver Transpl Surg. 1999;5:491–496
  21. Al-Hemsi B, McGory R, Shepard B, et al. Liver transplantation for hepatitis B cirrhosis: clinical sequel of passive immunization. Clin Transpl. 1996;10:668–675
  22. Burbach GJ, Bienzle U, Neuhaus R, et al. Intravenous or intramuscular anti-HBs immunoglobulin for the prevention of hepatitis B reinfection after orthotopic liver transplantation. Transplantation. 1997;63:478–480
  23. Faust D, Rabenau HF, Allwinn R, et al. Cost-effective and safe ambulatory long-term immunoprophylaxis with intramuscular instead of intravenous hepatitis B immunoglobulin to prevent reinfection after orthotopic liver transplantation. Clin Transpl. 2003;17:254–258
  24. Anderson RD, Chinnakotla S, Guo L, et al. Intramuscular hepatitis B immunoglobulin (HBIG) and nucleosides for prevention of recurrent hepatitis B following liver transplantation: comparison with other HBIG regimens. Clin Transpl. 2007;21:510–517
  25. Gane EJ, Angus PW, Strasser S, et al. Lamivudine plus low-dose hepatitis B immunoglobulin to prevent recurrent hepatitis B following liver transplantation. Gastroenterology. 2007;132:931–937
  26. Ferretti G, Merli M, Ginanni CS, et al. Low-dose intramuscular hepatitis B immune globulin and lamivudine for long-term prophylaxis of hepatitis B recurrence after liver transplantation. Transpl Proc. 2004;36:535–538
  27. Caccamo L, Agnelli F, Reggiani P, et al. Role of lamivudine in the posttransplant prophylaxis of chronic hepatitis B virus and hepatitis delta virus coinfection. Transplantation. 2007;83:1341–1344
  28. Cohn EJ, Strong WL, Mulford DJ. Preparation and properties of serum and plasma proteins IV. A system for the separation into fractions of the protein and lipoprotein components of biological tissues and fluids. J Am Chem Soc. 1946;68:459–475
  29. Sawyer RG, Guy McGory RW, Gafey MJ, et al. Improved clinical outcomes with liver transplantation for hepatitis B-induced chronic liver failure using passive immunization. Ann Surg. 1998;227:841–850
  30. The European Agency for the Evaluation of Medicinal Products for Human Use. Note for guidance on the clinical investigation of human normal immunoglobulin for subcutaneous and intramuscular use. EMEA/CPMP/BPWG/283/00 2003.
  31. The European Agency for the Evaluation of Medicinal Products for Human Use. Note for guidance on the clinical investigation of human normal immunoglobulin for intravenous administration. EMEA/CPMP/BPWG/388/95 rev 1 2000.
  32. Anselmo DM, Ghobrial RM, Jung LC, et al. New era of liver transplantation for hepatitis B: a 17-year single-center experience. Ann Surg. 2002;235:611–619
  33. Restrepo JC, Rimola A, Mas A, et al. Prolonged administration of hepatitis B hyperimmune gamma globulin in patients with liver transplantation in liver diseases caused by hepatitis B virus. Gastroenterol Hepatol. 1996;19:491–496
  34. McGory R. Pharmacoeconomic analysis of HBV liver transplant therapies. Clin Transpl. 2000;14(Suppl 2):29–38
  35. Marzano A, Salizzoni M, Debernardi-Venon W, et al. Prevention of hepatitis B virus recurrence after liver transplantation in cirrhotic patients treated with lamivudine and passive immunoprophylaxis. J Hepatol. 2001;34:903–910
  36. Kim WR, Poterucha JJ, Kremers WK, et al. Outcome of liver transplantation for hepatitis B in the United States. Liver Transpl. 2004;10:968–974
  37. Hooman N, Rifai K, Hadem J, et al. Antibody to hepatitis B surface antigen trough levels and half-lives do not differ after intravenous and intramuscular hepatitis B immunoglobulin administration after liver transplantation. Liver Transpl. 2008;14:435–442
  38. Alonso I, Herreros de Tejada A, Moreno JM, et al. Effectiveness of low-dose intramuscular anti-VHB immune globulin in the prophylaxis of viral B hepatitis reinfection after liver transplantation: preliminary report. Transpl Proc. 2003;35:1850–1851
  39. Partovi N, Guy MW, Ensom MHH, et al. A study of the pharmacokinetic profile of low-dose hepatitis B immune globulin in long-term liver transplant recipients for chronic hepatitis B infection. Am J Transpl. 2001;1:51–54

PII: S1590-8658(09)00373-9

doi: 10.1016/j.dld.2009.09.005

Digestive and Liver Disease
Volume 42, Issue 7 , Pages 509-514 , July 2010

Article Tools

* Image Usage & Resolution