The Use of Entecavir Following Liver Transplantation

Abstract

Purpose: We performed a retrospective review to assess the safety and tolerability of Entecavir (ETV) following liver transplantation. ETV was safe and tolerable over a median follow-up period of 10 months. Methods: Our institution performed 492 adult liver transplants between February 1995 and July 2006. 68 (14%) out of 492 patients were transplanted for hepatitis B virus (HBV) related hepatic decompensation. Excluded from our analysis were 6 patients who died prior to discharge. Post-transplant management data were available for 60 (97%) of the remaining patients. Standard post-transplant immunosuppression was instituted, and all patients received hepatitis B immune globulin (HBIG). A total of 9 patients, consisting of 7 men and 2 women (ages ranging between 39 and 72, median 61 years), received ETV and were monitored closely for development of recurrent HBV allograft infection, allograft rejection, and medication side-effects over median post-transplant duration of 10 months (range 4 to 18 months). Results:Table 1 summarizes post-transplant antiviral treatment regimens, both immediately post-transplant and at the end of follow-up period. Four (4) patients were started on ETV 0.5–1.0 mg daily, and an additional 5 patients were switched to ETV due to suspicion of adefovir (ADV)-induced renal insufficiency. In the ETV group (N = 9), 1 patient developed an episode of acute cellular rejection (ACR), and 1 patient developed recurrent hepatocellular carcinoma (HCC), but all 9 remained alive and negative for HBV surface antigen at the end of follow-up. ACR (N = 1, noncompliance) and recurrent HCC (N = 1, explant pathology showed vascular invasion) were not related to ETV use. Compared with other treatment regimens, ETV demonstrated a lower rate of clinical resistance than lamivudine (LAM) (0% vs. 12.9%, P= 0.26) and a favorable side effect profile than ADV (0% vs. 55.6%, P= 0.047).Table 1: Post-Transplant HBV TreatmentConclusion: Based on our limited experience, ETV is safe and well-tolerated in post-transplant patients. Primary prophylaxis with ETV (plus HBIG) is effective in preventing recurrent HBV allograft infection up to a median treatment follow-up of 10 months. We recommend a larger clinical trial to confirm the safety, tolerability and efficacy of ETV in post-transplant population.