title: Pharmacokinetics and efficacy of intravenous or intramuscular hepatitis B immunoglobulins in prophylaxis of hepatitis B after liver transplantation.
abstract: OBJECTIVE
  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 5000 IU of iv-HBIg every four weeks and 15 patients 2160 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, 2160/12 mL (16 patients) or 2000 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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Unit of Gastroenterology and Hepatology, San Giovanni Battista Hospital, Turin, Italy. alfredomarzano@yahoo.it
authors.forename: A
authors.initials: A
authors.lastname: Marzano
authors.forename: A
authors.initials: A
authors.lastname: Marengo
authors.forename: P
authors.initials: P
authors.lastname: Andreone
authors.forename: R
authors.initials: R
authors.lastname: Volpes
authors.forename: D
authors.initials: D
authors.lastname: Canova
authors.forename: C
authors.initials: C
authors.lastname: Cursaro
authors.forename: A
authors.initials: A
authors.lastname: Riili
authors.forename: B
authors.initials: B
authors.lastname: Fiorentino
authors.forename: M
authors.initials: M
authors.lastname: Bacci
authors.forename: S
authors.initials: S
authors.lastname: Guazzini
authors.forename: P
authors.initials: P
authors.lastname: Burra
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use; D004334:Drug Administration Schedule; D005260:Female; D006509:Hepatitis B / Q000378:metabolism / Q000517:prevention & control*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus / Q000276:immunology; D006801:Humans; D007136:Immunoglobulins / Q000008:administration & dosage* / Q000009:adverse effects / Q000378:metabolism; D007273:Injections, Intramuscular; D007275:Injections, Intravenous; D019259:Lamivudine / Q000627:therapeutic use; D008103:Liver Cirrhosis / Q000601:surgery; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000627:therapeutic use; D000091402:Prohibitins; D011446:Prospective Studies; D018894:Reverse Transcriptase Inhibitors / Q000627:therapeutic use; D055502:Secondary Prevention
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D007136:Immunoglobulins; D063065:Organophosphonates; C000717328:PHB protein, human; D000091402:Prohibitins; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; C053001:adefovir; D000225:Adenine; C045213:hepatitis B hyperimmune globulin