Efficacy and Safety of Hepatitis B Virus Vaccination Following Hepatitis B Immunoglobulin Withdrawal After Liver Transplantation |
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| Affiliation: | 1. Division of Hepatobiliarypancreas (HBP) Surgery and Liver Transplantation, Department of Surgery, Korea University College of Medicine, Seoul, Republic of Korea;2. Department of Hepatobiliary Surgery and Liver Transplantation, Hospital Selayang, Selangor, Malaysia;3. Department of Surgery, St. Vincent''s Hospital, College of Medicine, The Catholic University of Korea, Seoul, Republic of Korea;1. Department of Critical Care and Anesthesia, National Center for Child Health and Development, Tokyo, Japan;2. Department of Anesthesiology and Intensive Care Medicine, Osaka University Graduate School of Medicine, Osaka, Japan;3. Department of Cardiovascular Surgery, Osaka University Graduate School of Medicine, Osaka, Japan;1. Department of Animal Biotechnology, Kyungpook National University, Sangju, Gyeongsangbuk-do, Republic of Korea;2. School of Medicine, Sungkyunkwan University, Gangnam-gu, Seoul, Republic of Korea;3. Gennbio Co Ltd, Gangnam-gu, Seoul, Republic of Korea;4. Department of Surgery, Samsung Medical Center, Seoul, Republic of Korea;5. Transplantation Research Center, Stem Cell & Regenerative Medicine Institute, Samsung Medical Center, Seoul, Republic of Korea;6. Department of Health Sciences & Technology, Samsung Advanced Institute for Health Sciences & Technology, Graduate School, Sungkyunkwan University, Seoul, Republic of Korea;7. Graduate School of International Agricultural Technology, Seoul National University, Gangwon-do, Republic of Korea;1. Division of Transplantation Surgery, CLINTEC, Karolinska Institute and Karolinska University Hospital, Huddinge, Stockholm, Sweden;2. Department of Biostatistics, Faculty of Medicine, Ankara University, Ankara, Turkey;1. Department of Medical Oncology, People''s Hospital of Zhengzhou, No.33 of Huanghe Road, Zhengzhou City, Henan Province, China;2. Department of Medical Oncology, The First Affiliated Hospital of Henan University, Kaifeng City, Henan Province, China;3. Blood Group Research Laboratory Henan Red Cross Blood Center, Zhengzhou City, Henan Province, China |
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| Abstract: | BackgroundHepatitis B immunoglobulin (HBIG) and oral nucleoside/nucleotide analogs have been the mainstay of hepatitis B virus (HBV) prophylaxis after liver transplantation. However, long-term HBIG administration could have disadvantages, such as an increase in medical costs and the development of mutant HBV strains. This study aimed to investigate the safety and efficacy of HBV vaccination after the withdrawal of HBIG after liver transplantation.MethodsThis prospective open-label single-arm observational clinical trial enrolled 41 patients who underwent liver transplantation between 2010 and 2016 because of a condition related to chronic HBV infection. At the time of enrollment, all patients had taken entecavir and discontinued HBIG administration. When hepatitis B surface antibody titer was undetectable after the withdrawal of HBIG, a recombinant HBV vaccine was injected intramuscularly at month 0, 1, and 6.ResultsAfter excluding 5 patients who dropped out and 2 patients who had a persistent hepatitis B surface antibody titer, 9 (26.5%) of 34 patients had a positive vaccination response. The median hepatitis B surface antibody titer at seroconversion was 86 (12-1000) IU/L, and those at the end of follow-up were 216 (30-1000) IU/L. No patients experienced HBV recurrence during the study period. Sex (female, odds ratio 32.91 [1.83-592.54], P = .018) and the dosing interval of HBIG before withdrawal (≥90 days, 16.21 [1.21-217.31], P = .035) were independent contributing factors for positive response to the vaccination.ConclusionHBV vaccination still deserves consideration as active immunoprophylaxis after liver transplantation because it could provide added immunity to nucleoside/nucleotide analogs monotherapy with excellent cost-effectiveness. |
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