Hepatitis B immunoglobulin: new preparation. Prolongs survival after liver transplantation.
The main complication of liver transplantation for hepatitis B is viral re-infection of the graft. It occurs in 50-100% of patients in the absence of prevention, and reduces survival. The clinical evaluation dossier on hepatitis B immunoglobulin contains data from three retrospective studies. Hepatitis B immunoglobulin reduced the rate of graft infections and increased the survival time (measured between 2 and 5 years after grafting) by 15-30% in absolute terms. Treatment should probably be maintained indefinitely with an intravenous injection of 10,000 IU every two to three months, in order to keep anti-HBs antibody titres at adequate levels. In patients with signs of active hepatitis B virus replication, hepatitis B immunoglobulin alone cannot prevent graft infection. Such patients should receive also lamivudine. Hypersensitivity reactions during infusion are the main adverse effects. Hepatitis B immunoglobulin should now be standard treatment for preventing relapse after liver transplantation for hepatitis B.
D002986:Clinical Trials as Topic; D017277:Drug Approval; D004341:Drug Evaluation; D005602:France; D006085:Graft Survival / Q000187:drug effects* / Q000276:immunology; D006509:Hepatitis B / Q000188:drug therapy* / Q000276:immunology; D006510:Hepatitis B Antibodies / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000276:immunology; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000627:therapeutic use*; D016031:Liver Transplantation / Q000276:immunology* / Q000401:mortality; D016896:Treatment Outcome
D006510:Hepatitis B Antibodies; D007136:Immunoglobulins