title: Tenofovir/entecavir monotherapy after hepatitis B immunoglobulin withdrawal is safe and effective in the prevention of hepatitis B in liver transplant recipients.
abstract: OBJECTIVE
  Combination of hepatitis B immunoglobulin (HBIG) and a nucleos(t)ide analog (NA) is considered the standard of care for prophylaxis of hepatitis B virus (HBV) recurrence after liver transplantation (LT). However, use of lifelong HBIG has significant limitations. We evaluated the efficacy and safety of entecavir (ETV) or tenofovir disoproxil fumarate (TDF) after withdrawal of HBIG in patients who had been under HBIG-regimen prophylaxis post LT.
  
  
  METHODS
  Patients at low risk of recurrence were eligible for HBIG discontinuation (fulminant HBV hepatitis, co-infection with hepatitis D virus, and hepatitis B e antigen-negative cirrhotic patients with HBV DNA levels <300 copies/mL). All patients had received HBIG, with or without NA, for at least 12 months after LT. After HBIG discontinuation, they continued with ETV or TDF monotherapy. Patients were followed up with HBV serum markers and evaluation of renal function.
  
  
  RESULTS
  Between September 2011 and June 2014, 58 liver transplant recipients were converted to TDF (31, 53%) or ETV (27, 47%). Mean follow-up after conversion was 28 ± 5 months (range 13-36 months). Five patients (8.6%) developed detectable hepatitis B surface antigen at 7, 9, 13, 15, and 22 months after HBIG discontinuation. However, in every case seroconversion was transitory, serum HBV DNA was undetectable, with no clinical manifestations of HBV recurrence. No adverse effects were observed or dose reductions required associated with ETV or TDF.
  
  
  CONCLUSIONS
  Maintenance therapy with newer NAs, after discontinuation of HBIG prophylaxis, was safe and effective, with a low rate of serological recurrence and no evident clinical, biochemical, or virological consequences.
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: I
authors.initials: I
authors.lastname: Fernández
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Loinaz
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: O
authors.initials: O
authors.lastname: Hernández
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Abradelo
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: Manrique
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: J
authors.initials: J
authors.lastname: Calvo
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: M
authors.initials: M
authors.lastname: Manzano
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: A
authors.initials: A
authors.lastname: García
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: F
authors.initials: F
authors.lastname: Cambra
authors.affiliation: Department of Gastroenterology and Hepatology, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: G
authors.initials: G
authors.lastname: Castellano
authors.affiliation: Department of General and Digestive Surgery and Abdominal Transplantation, Hospital Universitario "12 de Octubre", Madrid, Spain.
authors.forename: C
authors.initials: C
authors.lastname: Jiménez
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000627:therapeutic use*; D004334:Drug Administration Schedule; D005260:Female; D005500:Follow-Up Studies; D006147:Guanine / Q000031:analogs & derivatives* / Q000627:therapeutic use; D006509:Hepatitis B / Q000209:etiology / Q000517:prevention & control*; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications / Q000517:prevention & control*; D011446:Prospective Studies; D012008:Recurrence; D000068698:Tenofovir / Q000627:therapeutic use*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000998:Antiviral Agents; D007136:Immunoglobulins; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir; C045213:hepatitis B hyperimmune globulin
keywords: entecavir; hepatitis B prophylaxis; hepatitis B recurrence; liver transplantation; nucleo(s)tide analog; tenofovir