title: Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe, for the prophylaxis of viral B hepatitis after liver transplantation.
abstract: BACKGROUND
  Long-term prophylaxis of hepatitis B virus (HBV) positive liver transplanted subjects with intravenous hepatitis B immunoglobulin (HBIG) is effective, however use of intramuscular HBIG could be as effective with fewer adverse events and lower cost.
  
  
  OBJECTIVE
  We conducted a prospective, non-randomized, clinical study to assess the efficacy and safety of HBIG from Grifols, Igantibe, for the prophylaxis of HBV reactivation.
  
  
  METHODS
  Eighteen adult patients submitted to liver transplantation for HBV-related disease more than 18 months earlier were treated with doses of 2000 I.U. intramuscular Igantibe every 14 days for 6 months.
  
  
  RESULTS
  Mean trough serum HBsAb IgG titers from months 4 to 6 (primary efficacy variable) were protective (>or=150 I.U./L) at each time point. Individual measurements were also protective throughout the study. HBV replication remained negative for all available subjects until study completion. Pharmacokinetic analysis showed a half-life of 27 days and extensive exposure to the study drug. Safety and tolerability of intramuscular Igantibe were good, with only one adverse event.
  
  
  CONCLUSIONS
  Standard-dose intramuscular Igantibe administration proved efficacious in post-liver transplantation prophylaxis by attaining protective levels for up to 6 months, was safe and well tolerated. Pharmacokinetic analysis revealed a long half-life and extensive exposure.
authors.affiliation: U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy.
authors.forename: Franco
authors.initials: F
authors.lastname: Filipponi
authors.forename: Alessandro
authors.initials: A
authors.lastname: Franchello
authors.forename: Paola
authors.initials: P
authors.lastname: Carrai
authors.forename: Renato
authors.initials: R
authors.lastname: Romagnoli
authors.forename: Paolo
authors.initials: P
authors.lastname: De Simone
authors.forename: Michael K
authors.initials: MK
authors.lastname: Woodward
authors.forename: Antonio
authors.initials: A
authors.lastname: Paez
authors.forename: Mauro
authors.initials: M
authors.lastname: Salizzoni
mesh_terms: D000368:Aged; D005260:Female; D006509:Hepatitis B / Q000276:immunology / Q000517:prevention & control*; D006510:Hepatitis B Antibodies; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000008:administration & dosage / Q000627:therapeutic use*; D007155:Immunologic Factors / Q000008:administration & dosage / Q000493:pharmacokinetics*; D007273:Injections, Intramuscular; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged
chemical_list: D006510:Hepatitis B Antibodies; D007136:Immunoglobulins; D007155:Immunologic Factors; C553901:igantibe; C045213:hepatitis B hyperimmune globulin