HBIg discontinuation with maintenance oral anti-viral therapy and HBV vaccination in liver transplant recipients.
BACKGROUND
Hepatitis B (HBV) is an uncommon indication for liver transplantation in the US accounting for approximately 5% of cases. Recurrence prophylaxis is typically long-term hepatitis B immune-globulin (HBIg) and an oral anti-HBV agent. Because of high HBIg costs and improving efficacy of new oral agents, there is increasing interest in HBIg discontinuation.


OBJECTIVE
To describe results of a protocol at our center including HBV vaccination and HBIg discontinuation.


METHODS
All patients received HBIg therapy and an oral anti-viral agent from the time of transplant. Patients transplanted for HBV with a stable post-operative clinical course underwent HBV vaccination and HBIg discontinuation. After HBIg discontinuation, patients were monitored for HBV recurrence for at least one year. Recurrence was defined as either viral (HBV-DNA 10(4) copies/ml on two consecutive occasions) or hepatitis (viral recurrence with elevated liver transaminases).


RESULTS
Of 1182 recipients, 36 (3%) had HBV. Twenty-four were excluded from the protocol, and the remaining 12 patients underwent HBIg withdrawal. Median age at HBIg discontinuation was 56 (range, 36-70) years, median time from transplant to HBIg discontinuation was 62.8 (range, 27.5-128) months, and median time of follow-up after discontinuation was 27.4 (range, 13-69) months. Of the 12 patients vaccinated, no patients maintained HBSAb >or= 10 IU/l at last follow-up. There was no viral or hepatitis recurrence and no deaths or graft loss.


CONCLUSIONS
HBIg discontinuation with maintenance oral anti-viral monotherapy is safe and effective for HBV liver transplant recipients. Vaccination is not effective in this population.
Division of Gastroenterology and Hepatology, University of Colorado Health Sciences Center, 1635 N Ursula, Aurora, CO 80045, USA. nicholas.weber@ucdenver.edu
Nicholas K
NK
Weber
Lisa M
LM
Forman
James F
JF
Trotter
D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000008:administration & dosage*; D004279:DNA, Viral / Q000032:analysis; D005260:Female; D005500:Follow-Up Studies; D017325:Hepatitis B Vaccines / Q000627:therapeutic use*; D006515:Hepatitis B virus / Q000235:genetics; D019694:Hepatitis B, Chronic / Q000188:drug therapy* / Q000635:transmission; D006801:Humans; D007116:Immunization, Passive; D007136:Immunoglobulins / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D055502:Secondary Prevention; D013997:Time Factors; D016896:Treatment Outcome; D014611:Vaccination / Q000379:methods*
D000998:Antiviral Agents; D004279:DNA, Viral; D017325:Hepatitis B Vaccines; D007136:Immunoglobulins; C045213:hepatitis B hyperimmune globulin