Hepatitis B immune globulin preparations and use in liver transplantation

Clinics in Liver Disease

Volumn 7, Issue 3, 2003, Pages 537-550

  Terrault, Norah A ^a   Vyas, Girish ^a  

^a UNIVERSITY OF CALIFORNIA   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ADEFOVIR; ANTIHISTAMINIC AGENT; BAYHEP; CORTICOSTEROID; HBIG; HBVAX; HEBAGAM IM; HEPATITIS B ANTIBODY; HEPATITIS B IG; HEPATITIS B VACCINE; LAMIVUDINE; MONOCLONAL ANTIBODY; NARCOTIC AGENT; NUCLEOTIDE DERIVATIVE; OST 577; TRIMERA XTL; UMAN BIG; UNCLASSIFIED DRUG;

ANTIBODY TITER; BACKACHE; CHEMOPROPHYLAXIS; CLINICAL TRIAL; DEVELOPING COUNTRY; DOSE RESPONSE; DRUG COST; DRUG EFFICACY; DRUG FORMULATION; DRUG HALF LIFE; DRUG MEGADOSE; DRUG SAFETY; DRUG TOLERABILITY; EDEMA; FLUSHING; HEADACHE; HEALTH CARE COST; HEPATITIS B; HUMAN; INJECTION PAIN; LIVER TRANSPLANTATION; MONOTHERAPY; NONHUMAN; RECURRENT DISEASE; REVIEW; SIDE EFFECT; TREATMENT FAILURE; TREATMENT OUTCOME; VIRUS REPLICATION;

EID: 0042835575     PISSN: 10893261     EISSN: None     Source Type: Journal    
DOI: 10.1016/S1089-3261(03)00045-X     Document Type: Review

References (44)

1. Belle S, Beringer K, Detre K. Long-term outcome of liver transplant recipients in the US. In: Terasaki CA, editor. Clinical Transplants. Los Angeles: UCLA Tissue Typing Laboratory; 1995. p. 19-31.
2. O'Grady J, Smith H, Davies S, et al. Hepatitis B virus reinfection after orthotopic liver transplantation. J Hepatol 1992;14:104-11.
3. Samuel D, Muller R, Alexander G, et al. Liver transplantation in European patients with the hepatitis B surface antigen. N Engl J Med 1993;329:1842-7.
4. Todo S, Demetris A, Van Thiel D, et al. Orthotopic liver transplantation for patients with hepatitis B virus-related liver disease. Hepatology 1991;13:619-26.
5. Muller R, Gubernatis G, Farle M, et al. Liver transplantation in HBs antigen (HBsAg) carriers: Prevention of hepatitis B virus (HBV) recurrence by passive immunization. J Hepatol 1991;13: 90-6.
6. Samuel D, Bismuth A, Mathieu D, et al. Passive immunoprophylaxis after liver transplantation in HBsAg-positive patients. Lancet 1991;337:813-5.
7. Terrault N, Zhou S, Combs C, et al. Prophylaxis in liver transplant recipients using a fixed dosing schedule of hepatitis B immunoglobulin. Hepatology 1996;24:1327-33
8. Han S, Ofman J, Holt C, et al. An efficacy and cost-effectiveness analysis of combination hepatitis B immune globulin and lamivudine to prevent recurrent hepatitis B after orthotopic liver transplantation compared with hepatitis B immune globulin monotherapy. Liver Transpl 2000;6:741-8.
9. Lok AS. Prevention of recurrent hepatitis B post-liver transplantation. Liver Transpl 2002;8: S67-73.
10. Horowitz B, Bonomo R, Prince A, et al. Solvent/detergent-treated plasma: a virus-inactivated substitute for fresh plasma. Blood 1992;79:826-31.
11. Grady G. Passive immunization against viral hepatitis - Status and prospects. Am J Med Sci 1975; 270:369-74.
12. Groner A. Virus elimination by purification steps during the production of plasma preparations. Biomedical Progress 1998;11:42-6.
13. Barker L, Gerety R, Lorenz D. Biological standardization in viral hepatitis. Philadelphia: Franklin Institute Press; 1978.
14. Saab S, Kim M, Wright TL, et al. Successful orthotopic liver transplantation for lamivudine-associated YMDD mutant hepatitis B virus. Gastroenterology 2000;119:1382-4.
15. Devlin J, Smith H, O'Grady J, et al. Impact of immunoprophylaxis and patient selection on outcome of transplantation for HBsAg-positive liver recipients. J Hepatol 1994;21:204-10.
16. Gugenheim J, Crafa F, Fabiani P, et al. Long-term passive immunoprophylaxis of B virus recurrence after liver transplantation in HBs antigen-positive patients. Transpl Proc 1993;25:1349-50.
17. Konig V, Hopf U, Neuhaus P, et al. Long-term follow-up of hepatitis B virus-infected recipients after orthotopic liver transplantation. Transplantation 1994;58:553-9.
18. McGory R, Ishitani M, Oliveira W, et al. Improved outcome of orthotopic liver transplantation for chronic hepatitis B cirrhosis with aggressive passive immunization. Transplantation 1996;61: 1358-64.
19. Rimoldi P, Belli L, Rondinara G, et al. Recurrent HBV/HDV infections under different immunoprophylaxis protocols. Transplant Proc 1993;25:2675-6.
20. Steinmuller T, Seehofer D, Rayes N, et al. Increasing applicability of liver transplantation for patients with hepatitis B-related liver disease. Hepatology 2002;35:1528-35.
21. Angus P, McCaughan G, Gane E, et al. Combination low-dose hepatitis B immune globulin and lamivudine therapy provides effective prophylaxis against posttransplantation hepatitis B. Liver Transpl 2000;5:429-33.
22. Villamil FG, Vierling JM. Recurrence of viral hepatitis after liver transplantation: insights into management. Liver Transpl Surg 1995;1:89-99.
23. Feray C, Zignego A, Samuel D, et al. Persistent hepatitis B virus infection of mononuclear blood cells without concomitant liver infection. Transplantation 1990;49:1155-8.
24. al-Hemsi B, McGory R, Shepard B, et al. Liver transplantation for hepatitis B cirrhosis: clinical sequela of passive immunization. Clin Transplant 1996;10:668-75.
25. McGory R, Johnson J, Malinowski F, et al. Initial patient experience with an intravenous hepatitis B immune globulin. Hepatology 1998;28:235A.
26. Carman W, Trautwein C, van Deursen F, et al. Hepatitis B virus envelope variation after transplantation with and without hepatitis B immune globulin prophylaxis. Hepatology 1996;24: 489-93.
27. Ghany M, Villamil F, Gish R, et al. Hepatitis B virus S mutants in liver transplant recipients who were reinfected despite hepatitis B immune globulin prophylaxis. Hepatology 1998;27:213-22.
28. Terrault NA, Zhou S, McCory RW, et al. Incidence and clinical consequences of surface and polymerase gene mutations in liver transplant recipients on hepatitis B immunoglobulin. Hepatology 1998;28:555-61.
29. Protzer-Knolle U, Naumann U, Bartenschlager R, et al. Hepatitis B virus with antigenically altered hepatitis B surface antigen is selected by high-dose hepatitis B immune globulin after liver transplantation. Hepatology 1998;27:254-63.
30. Tiollais P, Charnay P, Vyas G. Biology of hepatitis B virus. Science 1981;213:406-11.
31. Kann M, Lu X, Tolle T, et al. Late and early steps in the life cycle of hepatitis B virus. In: Rizzetto M, Purcell M, Gerin J, Verme G, editors. Viral Hepatitis and Liver Disease. Turin: Edzioni Minerva Medica; 1997. p. 67-72.
32. Antoni B, Peterson D. Site-directed mutagenesis of the hepatitis B surface antigen gene. In: Zuckerman A, editor. Viral Hepatitis and Liver Disease. New York: Alan R. Liss; 1987. p. 313-7.
33. Vyas G, Rao K, Ibrahim A. Hepatitis-associated Australia antigen (HBsAg): A conformational antigen dependent on disulfide bonds. Science 1972;178:1300-1.
34. Bhatnagar PK, Papas E, Blum HE, et al. Immune response to synthetic peptide analogues of hepatitis B surface antigen specific for the a determinant. Proc Natl Acad Sci USA 1982;79: 4400-4.
35. Hawkins A, Gilson R, Gilbert N, et al. Hepatitis B virus surface mutations associated with infection after liver transplantation. J Hepatol 1996;24:8-14.
36. Nery J, Weppler D, Rodriguez M, et al. Efficacy of lamivudine in controlling hepatitis B virus recurrence after liver transplantation. Transplantation 1998;65:1615-21.
37. Perrillo R, Wright T, Rakela J, et al. A multicenter United States-Canadian trial to assess lamivudine monotherapy before and after liver transplantation for chronic hepatitis B. Hepatology 2001;33:424-32.
38. Bock CT, Tillmann HL, Torresi J, et al. Selection of hepatitis B virus polymerase mutants with enhanced replication by lamivudine treatment after liver transplantation. Gastroenterology 2002; 122:264-73.
39. Torresi J, Earnest-Silveira L, Civitico G, et al. Restoration of replication phenotype of lamivudine-resistant hepatitis B virus mutants by compensatory changes in the "fingers" subdomain of the viral polymerase selected as a consequence of mutations in the overlapping S gene. Virology 2002;299:88-99.
40. Mentha G, Giostra E, Negro F, et al. High-titered anti-HBs fresh frozen plasma for immunoprophylaxis against hepatitis B virus recurrence after liver transplantation. Transplant Proc 1997;29:2369-73.
41. Vyas G, Terrault N, Gandhi M, et al. Hepatitis B immune plasma (HBIP) an alternative to HBIG for immunotherapy in liver transplantation. Antivir Ther 2000;5:B44.
42. McMahon G, Ehrlich P, Moustafa Z, et al. Genetic alterations in the gene encoding the major HBsAg: DNA and immunological analysis of recurrent HBsAg derived from monoclonal antibody-treated liver transplant patients. Hepatology 1992;15:757-66.
43. Eren R, Ilan E, Nussbaum O, et al. Preclinical evaluation of two human anti-hepatitis B virus (HBV) monoclonal antibodies in the HBV-trimera mouse model and in HBV chronic carrier chimpanzees. Hepatology 2000;32:588-96.
44. Galun E, Eren R, Safadi R, et al. Clinical evaluation (phase I) of a combination of two human monoclonal antibodies to HBV: safety and antiviral properties. Hepatology 2002;35:673-9.