An efficacy and cost-effectiveness analysis of combination hepatitis B immune globulin and lamivudine to prevent recurrent hepatitis B after orthotopic liver transplantation compared with hepatitis B immune globulin monotherapy

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