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Susanne Beckebaum, Kerstin Herzer, Artur Bauhofer, William Gelson, Paolo De Simone, Robert de Man, Cornelius Engelmann, Beat Müllhaupt, Julien Vionnet, Mauro Salizzoni, Riccardo Volpes, Giorgio Ercolani, Luciano De Carlis, Paolo Angeli, Patrizia Burra, Jean-François Dufour, Massimo Rossi, Umberto Cillo, Ulf Neumann, Lutz Fischer, Gabriele Niemann, Luca Toti, Guiseppe Tisone
(Department of Gastroenterology and Hepatology, University Hospital Münster, Münster, Germany)
Ann Transplant 2018; 23:789-801
Long-term real-world data are relatively sparse regarding recurrence of chronic hepatitis B virus (HBV) infection after liver transplantation using hepatitis B immunoglobulin (HBIg) and nucleos(t)ide analogue (NUC) prophylaxis.
MATERIAL AND METHODS: Data from 371 adults transplanted for HBV-related disease at 20 European centers and given HBIg for ³12 months ± NUC therapy were analyzed retrospectively.
RESULTS: HBIg comprised Hepatect® (iv HBIgB; n=299), subcutaneous Zutectra® (sc HBIg, n=236), and other HBIg preparations (n=130); 93.5% received NUC therapy. Mean follow-up was 6.8±3.5 years. The primary efficacy variable, freedom from HBV recurrence, occurred in 95.7% of patients (95% CI [93.1%, 97.5%]). The observed incidence of recurrence was 16/371 (4.3%) (annual rate 0.65%); 5/16 patients with recurrence had discontinued HBIg and 7/16 had anti-HBs <100 IU/l. Excluding these 7 patients, the HBV recurrence rate was 2.4%. The recurrence rate while on HBIg therapy was 1 per 2069 months. In patients who discontinued HBIg, risk of HBV recurrence versus sc HBIg users was increased by 5.2-fold (1 per 1 603 versus 1 per 8379 treatment months). The annual rate of HBV-related hepatocellular carcinoma (HCC) recurrence was 1.7%.
CONCLUSIONS: These results support the long-term use of HBIg with NUC therapy as an effective management strategy to minimize risk of HBV recurrence and virus-related complications after liver transplantation.