title: Randomized trial of lamivudine versus hepatitis B immunoglobulin for long-term prophylaxis of hepatitis B recurrence after liver transplantation.
abstract: OBJECTIVE
  The long-term prophylaxis of hepatitis B after liver transplantation requires further optimization. In a randomized trial we investigated a regimen where the initially given hepatitis B immunoglobulin (HBIg) is replaced by long-term lamivudine treatment.
  
  
  METHODS
  Twenty-four liver transplant recipients (all HBsAg-positive/HBV DNA-negative before transplantation), who had received HBIg for at least 6 months without HBV recurrence, were randomized to receive lamivudine (n = 12) or HBIg (n = 12) for 52 weeks. The efficacy criteria involved seronegativity for HBsAg and undetectable HBsAg/ HBcAg in the liver.
  
  
  RESULTS
  Twenty-one of 24 patients completed the study without hepatitis B virus (HBV) recurrence (11 on HBIg, ten on lamivudine), while three patients became HBsAg-positive. Amongst those without HBV recurrence HBV DNA was detectable only by polymerase chain reaction, intermittently in serum and lymphocytes, and in liver specimens from six of eight patients receiving HBIg and five of seven receiving lamivudine. YMDD variant was found in four cases with no viral antigen expression. Eight patients continued lamivudine after the study and during an additional 6-22 months remained HBsAg-negative with normal graft function.
  
  
  CONCLUSIONS
  Substitution of HBIg with lamivudine is effective for prevention of HBV recurrence in low-risk liver transplant recipients and offers a convenient and cost-effective alternative for long-term HBV prophylaxis.
authors.affiliation: Institute of Hepatology, University College London and UCL Hospitals, UK. n.naoumov@ucl.ac.uk
authors.forename: N V
authors.initials: NV
authors.lastname: Naoumov
authors.forename: A R
authors.initials: AR
authors.lastname: Lopes
authors.forename: P
authors.initials: P
authors.lastname: Burra
authors.forename: L
authors.initials: L
authors.lastname: Caccamo
authors.forename: R M
authors.initials: RM
authors.lastname: Iemmolo
authors.forename: R A
authors.initials: RA
authors.lastname: de Man
authors.forename: M
authors.initials: M
authors.lastname: Bassendine
authors.forename: J G
authors.initials: JG
authors.lastname: O'Grady
authors.forename: B C
authors.initials: BC
authors.lastname: Portmann
authors.forename: G
authors.initials: G
authors.lastname: Anschuetz
authors.forename: C A
authors.initials: CA
authors.lastname: Barrett
authors.forename: R
authors.initials: R
authors.lastname: Williams
authors.forename: M
authors.initials: M
authors.lastname: Atkins
mesh_terms: D000328:Adult; D000998:Antiviral Agents / Q000627:therapeutic use*; D004279:DNA, Viral / Q000097:blood / Q000235:genetics / Q000302:isolation & purification; D005260:Female; D006509:Hepatitis B / Q000517:prevention & control* / Q000628:therapy / Q000821:virology; D006510:Hepatitis B Antibodies / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000187:drug effects / Q000235:genetics; D006801:Humans; D007136:Immunoglobulins / Q000627:therapeutic use*; D019259:Lamivudine / Q000627:therapeutic use*; D008099:Liver / Q000821:virology; D016031:Liver Transplantation / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009154:Mutation; D012008:Recurrence
chemical_list: D000998:Antiviral Agents; D004279:DNA, Viral; D006510:Hepatitis B Antibodies; D007136:Immunoglobulins; D019259:Lamivudine