Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe, for the prophylaxis of viral B hepatitis after liver transplantation.
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.
Filipponi
Franco
F
U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy.
Franchello
Alessandro
A
Carrai
Paola
P
Romagnoli
Renato
R
De Simone
Paolo
P
Woodward
Michael K
MK
Paez
Antonio
A
Salizzoni
Mauro
M
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
D006510:Hepatitis B Antibodies; D007136:Immunoglobulins; D007155:Immunologic Factors; C553901:igantibe; C045213:hepatitis B hyperimmune globulin