Hepatitis B immune globulin preparations and use in liver transplantation.

Hepatitis B immune globulin remains a central component of prophylaxis in HBV-infected patients undergoing liver transplantation. HBIG monotherapy given at a high dosage and indefinitely can prevent recurrence in 65% to 80% of patients. Because treatment failures occur and combination therapy using HBIG plus a nucleoside analog is more uniformly effective, the current standard of care is combination HBIG plus a nucleoside analog. These combination protocols have reduced the rate of virologic breakthrough to 10% or less. Several questions remain. The optimal dose and duration of HBIG use is unclear. Moreover, the development of resistance to lamivudine (and other nucleoside analogs) before transplantation increases the risk for virologic breakthrough post-transplantation. For patients with pre-transplant evidence of active HBV replication caused by the presence of nucleoside analog resistance, HBIG may be the main or only form of prophylaxis. For these patients, HBIG doses sufficient to maintain anti-HBs titers comparable to the days of HBIG monotherapy seem warranted. New HBIG formulations have made anti-HBs therapy more safe and tolerable to patients but the cost of the drug remains significant. The cost factor is particularly important in developing countries or countries with more limited resources for management of liver transplant recipients. Thus, there remains a need to develop and test new forms of anti-HBs therapy, so that effective but less expensive forms of immunoprophylaxis can be made available.