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.

AIM:

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.

CONCLUSION:

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: Franco Filipponi, Alessandro Franchello, Paola Carrai, Renato Romagnoli, Paolo De Simone, Michael K Woodward, Antonio Paez, Mauro Salizzoni
• Journal: Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver (Dig Liver Dis) Vol. 42 Issue 7 Pg. 509-14 (Jul 2010) ISSN: 1878-3562 [Electronic] Netherlands
• PMID: 19828386 (Publication Type: Clinical Trial, Journal Article, Multicenter Study)
• Copyright: (c) 2009 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

Chemical References

• Hepatitis B Antibodies
• Immunoglobulins
• Immunologic Factors
• igantibe
• hepatitis B hyperimmune globulin

Topics

• Aged
• Female
• Hepatitis B (immunology, prevention & control)
• Hepatitis B Antibodies
• Humans
• Immunization, Passive
• Immunoglobulins (administration & dosage, therapeutic use)
• Immunologic Factors (administration & dosage, pharmacokinetics)
• Injections, Intramuscular
• Liver Transplantation
• Male
• Middle Aged