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Clinical Trial
. 2016 Jul;100(7):1507-12.
doi: 10.1097/TP.0000000000001171.

Early Introduction of Subcutaneous Hepatitis B Immunoglobulin Following Liver Transplantation for Hepatitis B Virus Infection: A Prospective, Multicenter Study

Paolo De Simone  1 , Renato Romagnoli, Francesco Tandoi, Paola Carrai, Giorgio Ercolani, Eugenia Peri, Fausto Zamboni, Laura Mameli, Fabrizio Di Benedetto, Umberto Cillo, Luciano De Carlis, Andrea Lauterio, Luigi Lupo, Giuseppe Tisone, Martin Prieto, Carmelo Loinaz, Antoni Mas, Abid Suddle, David Mutimer, Bruno Roche, Andrea Wartenberg-Demand, Gabriele Niemann, Heike Böhm, Didier Samuel
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Free article
Clinical Trial

Early Introduction of Subcutaneous Hepatitis B Immunoglobulin Following Liver Transplantation for Hepatitis B Virus Infection: A Prospective, Multicenter Study

Paolo De Simone et al. Transplantation. 2016 Jul.
Free article

Erratum in

Abstract

Background: Subcutaneous administration of hepatitis B immunoglobulin (HBIg) is effective in preventing hepatitis B virus (HBV) recurrence after liver transplantation, but early conversion to subcutaneous administration is undocumented.

Methods: In a prospective study, patients transplanted for terminal liver disease due to HBV infection who were HBV DNA-negative at transplant were switched by week 3 posttransplantation from intravenous to subcutaneous HBIg (500 or 1000 IU weekly or fortnightly, adjusted according to serum anti-HBs trough level) if they were HBsAg- and HBV-DNA negative at time of switch. All patients concomitantly received nucleos(t)ide analogue antiviral therapy. Primary endpoint was failure rate by month 6, defined as serum anti-HBs of 100 IU/L or less or HBV reinfection despite serum anti-HBs greater than 100 IU/L.

Results: Of 49 patients treated, 47 (95.9%) continued treatment until month 6. All patients achieved administration by a caregiver or self-injection by week 14. No treatment failures occurred. Mean anti-HBs declined progressively to month 6, plateauing at a protective titer of approximately 290 IU/L. All patients tested for HBV DNA remained negative (45/45). Only 1 adverse event (mild injection site hematoma) was assessed as treatment-related.

Conclusions: Introduction of subcutaneous HBIg administration by week 3 posttransplantation, combined with HBV virostatic prophylaxis, is effective and convenient for preventing HBV recurrence.

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