Long Term Nucleos(t)ide Analog Therapy after Immunglobuline Withdrawal in Liver Transplant Recipients to Prevent Recurrent Hepatitis B
Carmelo Loinaz1, Inmaculada Fernandez2, Oscar Caso1, Olga Hernandez2, Manuel Abradelo1, Marisa Manzano2, Felix Cambra1, Alvaro García-Sesma1, Jorge Calvo1, Iago Justo1, Alejandro Manrique1, Alberto Marcacuzco1, Carlos Jiménez1, Gregorio Castellano2.
1General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario Doce de Octubre, Madrid, Spain; 2Gastroenterology and Hepatology, Hospital Universitario Doce de Octubre, Madrid, Spain
Introduction: Prophylaxis of hepatitis B virus (HBV) recurrence after liver transplantation (LT) has been based on hepatitis B immunoglobulin (HBIG) and nucleos(t)ide analog (NA). Combining both agents is the most usual approach in Europe, and there is little experience on HBIG withdrawal and sole NA prophylaxis in our area. We show our approach since 2011evaluating the efficay and safety of entecavir (ETV) or tenofovir disiproxil fumarate (TDF) after discontinuation of HBIG in LT patients treated with HBIG since the operation.
Materials and Methods: Eligible for HBIG withdrawal were patients at low or intermediate risk of recurrence (fulminant HBV hepatitis, D virus coinfection, HBeAg negative cirrhotic patients with HBV DNA levels <300 copies/ml). After discontinuation they had ETV or TDF monotherrapy. Clinical (general condition and renal function) and laboratory follow-up (serum HBV markers) was conducted.
Results: Between 09-2011 and 06-2014, 58 LT recipients were converte to TDF (31, 53%) or ETV (27, 47%). All had received HBIG for at least 12 months after LT (mean 108.4 +/- 60.7 months, range 18-257), with or without NA. Mean follow-up after conversion was 65.2 +/- 9.5 months (range 13-75), including 3 patients that died of HBV unrelated causes, at 13, 44 and 45 months. Five patients (8.6%) developed transient detectable HBV surface antigen (HBsAg) at 7, 9, 13, 15 and 22 months after HBIG discontinuation, with undetectable HBV DNA, without clinical manifestations or recurrence. No adverse effects related to ETVor TDF use were observed, or dose reduction required.
Discussion: Our recent experience with more than 5 years average follow-up after discontinuation of HBIG after LT in HBV recipients, continued with NA monotherapy proved to be effective (low rate of HBsAg without detectable HBV DNA, no clinical or biochemical signs of recurrence) and safe (no apparent side effects or dose reduction required).
Conclusions: Tenofovir/Entecavir monotherapy after HBIG discontinuation in the prevention of hepatitis B in LT recipients with low or intermediate recurrence risk is safe and effective.
