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) 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.

Endoscopic management of biliary leaks after T-tube removal in liver transplant recipients: nasobiliary drainage versus biliary stenting.

This study presents the long-term sequelae of endoscopic retrograde cholangiopancreatography (ERCP)-managed biliary leakage in patients who underwent orthotopic liver transplantation (OLT) and compares the relative efficacy, safety, and charges of nasobiliary drainage (NBD) versus biliary stenting (BS). We identified all orthotopic liver transplant recipients from January 1, 1993, to December 31, 1997, who had undergone ERCP for biliary leakage. Clinical outcome and charges were calculated on an intention-to-treat basis according to initial endoscopic therapy. Of the 1,166 adult OLTs performed during the study period, 442 patients underwent elective T-tube removal. ERCP was attempted in 69 patients (16%) who developed biliary leakage after T-tube removal. Three patients (5%) in whom initial ERCP was unsuccessful underwent surgery. NBD and BS were used as primary therapy in 45 (68%) and 21 patients (32%), respectively. Three patients initially treated with NBD required reendoscopy or surgery compared with 6 patients initially treated with BS (P <.05). Although not statistically significant, there was a trend toward greater expense in the BS group compared with the NBD group. ERCP is a safe and effective method of managing biliary leakage after T-tube removal in orthotopic liver transplant recipients. However, our results suggest NBD is the preferred method because recurrent leaks were more common in patients treated initially with BS. With prompt use of ERCP, surgery is rarely needed for this complication of OLT.