title: Early Introduction of Subcutaneous Hepatitis B Immunoglobulin Following Liver Transplantation for Hepatitis B Virus Infection: A Prospective, Multicenter Study.
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.
authors.affiliation: 1 Hepatobiliary Surgery and Liver Transplantation, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy. 2 Liver Transplantation Center and General Surgery 2U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Torino, Italy. 3 Unità Operativa di Chirurgia Generale e dei Trapianti di Fegato e Multiorgano, Bologna, Italy. 4 Centro Trapianti di Fegato e Pancreas, Cagliari, Italy. 5 Hepato-Pancreato-Biliary Surgery and Liver Transplantation Unit, University of Modena and Reggio Emilia, Modena, Italy. 6 Chirurgia Epatobiliare e Trapianto Epatico Azienda Ospedaliera Universitaria di Padova-Unità Operativa di Chirurgia, Padova, Italy. 7 Struttura Complessa di Chirurgia Generale e dei Trapianti, Ospedale Niguarda, Milan, Italy. 8 Chirurgia Generale e Trapianto di Fegato, Bari, Italy. 9 Experimental Medicine and Surgery, Fondazione Policlinico Tor Vergata, Rome, Italy. 10 Unidad de Hepatología, Servicio de Medicina Digestiva, Hospital Universitari i Politècnic La Fe, Valencia, Spain. 11 Servicio de Cirugía General, Aparato Digestivo y Trasplante de Organos Abdominales, Hospital Universitario Doce de Octubre, Madrid, Spain. 12 Liver Unit, Hospital Clinic de Barcelona, Barcelona, Spain. 13 Institute of Liver Studies, King's College Hospital, London, United Kingdom. 14 NIHR Liver BRU, QE Hospital and Birmingham University, Birmingham, United Kingdom. 15 AP-HP Hôpital Paul-Brousse, Centre Hépato-Biliaire, Villejuif, France. 16 University Paris-Sud, UMR-S 1193, Villejuif, France. 17 Biotest AG, Dreieich, Germany.
authors.forename: Paolo
authors.initials: P
authors.lastname: De Simone
authors.forename: Renato
authors.initials: R
authors.lastname: Romagnoli
authors.forename: Francesco
authors.initials: F
authors.lastname: Tandoi
authors.forename: Paola
authors.initials: P
authors.lastname: Carrai
authors.forename: Giorgio
authors.initials: G
authors.lastname: Ercolani
authors.forename: Eugenia
authors.initials: E
authors.lastname: Peri
authors.forename: Fausto
authors.initials: F
authors.lastname: Zamboni
authors.forename: Laura
authors.initials: L
authors.lastname: Mameli
authors.forename: Fabrizio
authors.initials: F
authors.lastname: Di Benedetto
authors.forename: Umberto
authors.initials: U
authors.lastname: Cillo
authors.forename: Luciano
authors.initials: L
authors.lastname: De Carlis
authors.forename: Andrea
authors.initials: A
authors.lastname: Lauterio
authors.forename: Luigi
authors.initials: L
authors.lastname: Lupo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Tisone
authors.forename: Martin
authors.initials: M
authors.lastname: Prieto
authors.forename: Carmelo
authors.initials: C
authors.lastname: Loinaz
authors.forename: Antoni
authors.initials: A
authors.lastname: Mas
authors.forename: Abid
authors.initials: A
authors.lastname: Suddle
authors.forename: David
authors.initials: D
authors.lastname: Mutimer
authors.forename: Bruno
authors.initials: B
authors.lastname: Roche
authors.forename: Andrea
authors.initials: A
authors.lastname: Wartenberg-Demand
authors.forename: Gabriele
authors.initials: G
authors.lastname: Niemann
authors.forename: Heike
authors.initials: H
authors.lastname: Böhm
authors.forename: Didier
authors.initials: D
authors.lastname: Samuel
mesh_terms: D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood; D004334:Drug Administration Schedule; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control / Q000601:surgery*; D006510:Hepatitis B Antibodies / Q000097:blood; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006515:Hepatitis B virus; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D007279:Injections, Subcutaneous; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012008:Recurrence
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D006514:Hepatitis B Surface Antigens; D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin