Clinical Information

For patients with chronic hepatitis B virus (HBV) infection (hepatitis B surface [HBs] antigen-positive), outcomes following liver transplantation for end-stage liver disease are poor. Recurrent HBV disease is common and associated with decreased liver graft and patient survival (approximately 50% at 5 years). Studies have shown administration of hepatitis B immune globulin (HBIG) in the perioperative and early posttransplant periods could delay or prevent recurrent HBV infection in these transplant recipients.

Since mid-1990, intravenous or intramuscular administration of HBIG has become the standard of care for these liver transplant recipients in most liver transplant programs in the United States. Most therapy protocols administer HBIG in high doses (10,000 IU) during the perioperative period and first week after transplantation with the goal of achieving serum HBs antibody (anti-HBs) levels of above 500 mIU/mL. Serial levels of anti-HBs are obtained to determine the pharmacokinetics of HBIG in each patient to guide frequency of HBIG dosing.

During the first few weeks to months after transplantation, there is a high degree of variability in HBIG dosage required to achieve desirable serum anti-HBs levels among transplant recipients. Patients who were hepatitis B e antigen positive before transplantation usually require more HBIG to achieve the target anti-HBs levels, especially in the first week after transplantation.

Duration of HBIG therapy varies from 6 months to indefinite among different US liver transplant programs. Protocols providing less than 12 months of therapy usually combine HBIG with another effective anti-HBV agent such as lamivudine.