Orthotopic
liver transplantation (OLT) for hepatitis B virus (HBV)
infection was limited until recently by poor graft and patient outcomes caused by recurrent HBV. Long-term immunoprophylaxis with
hepatitis B immune globulin (
HBIG) dramatically improved post-OLT survival, but recurrent HBV still occurred in up to 36% of the recipients. More recently, combination
HBIG and
lamivudine has been shown to effectively prevent HBV recurrence in patients post-OLT. The aim of the current study is to determine long-term outcome and cost-effectiveness of using combination
HBIG and
lamivudine compared with
HBIG monotherapy in patients who undergo OLT for HBV. A retrospective chart review identified 59 patients administered combination
HBIG and
lamivudine and 12 patients administered
HBIG monotherapy as primary prophylaxis against recurrent HBV.
Lamivudine, 150 mg/d, was administered orally indefinitely.
HBIG was administered under a standard protocol (10,000 IU intravenously during the anhepatic phase, then 10,000 IU/d intravenously for 7 days, then 10,000 IU intravenously monthly) indefinitely. A decision-analysis model was developed to evaluate the potential economic impact of prophylaxis against HBV with combination
therapy compared with monotherapy. Recurrent HBV was defined as the reappearance of
hepatitis B surface antigen (
HBsAg) after its initial disappearance post-OLT. In the combination-therapy group, no patient redeveloped serum
HBsAg or HBV
DNA during mean follow-ups of 459 and 416 days, respectively. In the monotherapy group, 3 patients (25%) had reappearance of
HBsAg in serum during a mean follow-up of 663 days. Combination
therapy resulted in a dominant, cost-effective strategy with an average cost-effectiveness ratio of $252,111/recurrence prevented compared with $362,570/recurrence prevented in the monotherapy strategy. Combination prophylaxis with
HBIG and
lamivudine is highly effective in preventing recurrent HBV, may protect against the emergence of resistant mutants, and is significantly more cost-effective than
HBIG monotherapy with its associated rate of recurrent HBV.