Efficacy, safety and pharmacokinetic profile of pasteurized intramuscular anti-hepatitis B immunoglobulin for the prophylaxis of hepatitis B virus recurrence after liver transplantation

Abstract

Background. Combined prophylaxis with hyperimmune human mmunoglobulins (HBIG) and anti-nucleoside analogues has greatly mproved the outcome of liver transplantation (LT) for hepatitis B virus HBV)-related disease. This result is usually achieved by maintaining a stable nti-HBs titre ≥150 U/l indefinitely. However, the optimal way of adminstration and schedule in order to optimize costs and patients’ compliance eeds further investigation. Methods. We assessed the efficacy in preventing HBV recurrence of newly introduced pasteurized intramuscular HBIG (Igantibe®, Grifols arcelona, Spain) administered at a standard dosage of 2000 IU every 14 ays. Anti-HBs were measured before each administration, and a stable nti-HBs titre from month 4 to 6 was considered as endpoint. The drug harmacokinetic profile was investigated, as well as its safety and tolerability. Results. Seventeen HBV transplant patients previously treated with ntravenous HBIG and lamivudine were switched to prophylaxis with the tudy drug plus lamivudine for 6 months. No patient showed HBV recurence or subclinical HBV infection by genomic analysis. Individual anti-HBs hrough titres were >150 IU/l at each time point (Table 1). The peak conentration was reached 4± 3 days from administration, and median half-life as 28 days (range 14–69). No changes in vital signs and laboratory tests, ncluding viral markers, were found. Conclusions. At the proposed schedule, Igantibe® was effective in aintaining a protective anti-HBs titre and preventing graft re-infection ost-transplantation. The drug was safe and well tolerated over a period f 6 months.