Post-transplantation sequential entecavir monotherapy following 1-year combination therapy with hepatitis B immunoglobulin

Background: Combination therapy of intravenous hepatitis B immunoglobulin (ivHBIG) and nucleos(t)ide (NA) analogues is the best post-liver transplantation (LT) prophylactic measure for hepatitis B virus (HBV). However, to reduce the long-term drawbacks of ivHBIG, we evaluated the efficacy of sequential entecavir (ETV) monotherapy. Methods: Twenty-nine candidates with HBV-related liver disease were prospectively enrolled. The patients were selected if the patient was suitable for one of the following inclusion criteria: (1) NA-naïve patients except for ETV, and (2) negative HB e antigen (HBeAg) and undetectable HBV DNA at the time of LT. Post-LT HBV prophylaxis consisted of 1-year combination therapy with ETV (0.5 mg daily) plus ivHBIG per 5 weeks, followed by ETV monotherapy. The primary endpoint was the 2-year recurrence rate of HB. The median follow-up period was 31 months. Results: At the time of transplantation, HBeAg was positive in 21 % and HBV DNA was detectable in 52 % of the study participants. No HBV recurrence was reported during the first year. During the second year, HBV recurrence was noted in one who suffered from HCC recurrence without viral mutation. Recurrence free survival rates were 96.6 and 96.4 % at 1- and 2-year post-transplant by intention-to-treat analysis. One patient died of fungal infection. Conclusion: Sequential ETV monotherapy after 1-year combination therapy might be safe in NA-naïve replicators as well as non-replicators.