title: Limited hepatitis B immunoglobulin with potent nucleos(t)ide analogue is a cost-effective prophylaxis against hepatitis B virus after liver transplantation.
abstract: BACKGROUND
  Prophylaxis against hepatitis B virus (HBV) recurrence after orthotopic liver transplantation (OLT) includes lifelong hepatitis B immunoglobulin (HBIG) and oral antiviral agent(s). In the presence of high-genetic-barrier nucleos(t)ide analogues, the need for lifelong HBIG is questioned. We evaluated the safety and cost-effectiveness of a limited HBIG course.
  
  
  METHODS
  OLT from 2006 to 2013 were reviewed. Patients with pre-OLT hepatitis B virus surface antigen who received HBV prophylaxis with 2 HBIG doses (anhepatic and first post-operative day; 10,000 units/dose) and potent nucleos(t)ide analogues were included. The primary end point was HBV recurrence (HBV-DNA detection).
  
  
  RESULTS
  Thirteen patients (primary transplants) were included, median Model for End-Stage Liver Disease score was 18, and there was no fulminant failure; HBV-DNA was detected in 4 patients at OLT. After OLT, 10 patients received entecavir and/or tenofovir. Median follow-up was 23 months. One recurrence occurred (7.7%) at month 13 (HBV-DNA: 14 IU/mL); the graft maintained excellent function. This minimal viremic expression is related to hepatocellular carcinoma recurrence with neoplastic replication carrying integrated HBV-DNA; thus, there is no defined HBV viral recurrence. No graft loss or patient death was related to HBV recurrence. The 1-year patient and graft survival rate was 84.6%. Cost-savings in the first year was $178,100 per patient when compared with Food and Drug Administration-approved HBIG dosing.
  
  
  CONCLUSIONS
  In the era of potent oral nucleos(t)ide analogues, a limited HBIG course appears to be cost-effective in preventing HBV recurrence.
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois.
authors.forename: G A
authors.initials: GA
authors.lastname: Singer
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois.
authors.forename: S
authors.initials: S
authors.lastname: Zielsdorf
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois.
authors.forename: V A
authors.initials: VA
authors.lastname: Fleetwood
authors.affiliation: Department of Pharmacy, Rush University Medical Center, Chicago, Illinois.
authors.forename: N
authors.initials: N
authors.lastname: Alvey
authors.affiliation: Department of Medicine, Section of Hepatology, Rush University Medical Center, Chicago, Illinois.
authors.forename: E
authors.initials: E
authors.lastname: Cohen
authors.affiliation: Department of Medicine, Section of Hepatology, Rush University Medical Center, Chicago, Illinois.
authors.forename: S
authors.initials: S
authors.lastname: Eswaran
authors.affiliation: Department of Medicine, Section of Hepatology, Rush University Medical Center, Chicago, Illinois.
authors.forename: N
authors.initials: N
authors.lastname: Shah
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois.
authors.forename: E Y
authors.initials: EY
authors.lastname: Chan
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois.
authors.forename: M
authors.initials: M
authors.lastname: Hertl
authors.affiliation: Department of Surgery, Section of Transplantation, Rush University Medical Center, Chicago, Illinois. Electronic address: Sameh_Fayek@rush.edu.
authors.forename: S A
authors.initials: SA
authors.lastname: Fayek
mesh_terms: D000225:Adenine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D000328:Adult; D000368:Aged; D000998:Antiviral Agents / Q000191:economics / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D016527:Drug Costs; D005260:Female; D006085:Graft Survival; D006147:Guanine / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D006509:Hepatitis B / Q000175:diagnosis / Q000517:prevention & control* / Q000601:surgery*; D006514:Hepatitis B Surface Antigens / Q000097:blood; D006801:Humans; D007136:Immunoglobulins / Q000191:economics / Q000627:therapeutic use*; D016031:Liver Transplantation; D008297:Male; D008875:Middle Aged; D063065:Organophosphonates / Q000191:economics / Q000627:therapeutic use; D012189:Retrospective Studies; D000068698:Tenofovir; D016896:Treatment Outcome; D014481:United States
chemical_list: D000998:Antiviral Agents; D006514:Hepatitis B Surface Antigens; D007136:Immunoglobulins; D063065:Organophosphonates; C413685:entecavir; D006147:Guanine; D000068698:Tenofovir; D000225:Adenine; C045213:hepatitis B hyperimmune globulin