Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe((R)), for the prophylaxis of viral B hepatitis after liver transplantation. 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] Journal article | | Title | Efficacy, safety, and pharmacokinetics of intramuscular hepatitis B immune globulin, Igantibe((R)), for the prophylaxis of viral B hepatitis after liver transplantation. | | Author(s) | Filipponi F, Franchello A, Carrai P, Romagnoli R, De Simone P, Woodward MK, Paez A, Salizzoni M | | Institution | U.O. Chirurgia Generale e trapianto di fegato, Azienda Ospedaliero- Universitaria Pisana, Pisa, Italy. | | Source | Dig Liver Dis 2009 Oct 12. | | 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((R)), 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 2000I.U. intramuscular Igantibe((R)) every 14 days for 6 months.
RESULTS: Mean trough serum HBsAb IgG titers from months 4 to 6 (primary efficacy variable) were protective (>/=150I.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((R)) were good, with only one adverse event.
CONCLUSION: Standard-dose intramuscular Igantibe((R)) 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. | | Language | ENG | | Pub Type(s) | JOURNAL ARTICLE
| | PubMed ID | 19828386 |
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