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12 December 2017 : Original article  

A Multicenter Phase III Study to Evaluate the Efficacy and Safety of Hepabulin, a New Hepatitis B Immunoglobulin, in Liver Transplantation Recipients with Hepatitis B

Ho Joong Choi1ABCDEF, Dong Goo Kim1ABDFG*, Soon Il Kim2BF, Hee Jung Wang3BF, Jae Won Joh4BF, Kyung Suk Suh5BF, Seong Hoon Kim6BF

DOI: 10.12659/AOT.905898

Ann Transplant 2017; 22:740-748

Abstract

BACKGROUND: This study was performed to evaluate the effects and stability of the new hepatitis B immunoglobulin (HBIG), Hepabulin, in patients undergoing liver transplantation for hepatitis B.

MATERIAL AND METHODS: A total of 87 patients undergoing liver transplantation for hepatitis B-related liver disease were enrolled in this multicenter, phase III, open-label, single-arm study. Seventy (80.5%) of the 87 enrolled patients completed the study during the 52-week study period. Hepabulin (10,000 units) was intravenously injected intraoperatively, daily for 1 week, weekly for 1 month, and then once per month. Hepabulin was used as monotherapy without antiviral agents. Hepatitis B recurrence was defined as conversion from negativity for surface antigen after HBIG administration to positivity.

RESULTS: There were no cases of hepatitis B recurrence during the 52-week observation period. A total of 876 adverse events (AEs) that occurred during the study period were observed in 83 (95.4%) of 87 patients, and serious AEs were seen in 119 cases in 44 (50.6%) of the 87 patients. None of the AEs showed a relationship with this drug. Hepatitis B surface antigen (HBsAg) and hepatitis B e antigen (HBeAg) rapidly disappeared within 1 week after HBIG administration, but hepatitis B virus (HBV) DNA persisted for up to 8 weeks after surgery, which was related to HBV viral load. Hepatitis B surface antibody (HBsAb) was correlated with HBIG (Hepabulin) dose.

CONCLUSIONS: The new HBIG, Hepabulin, was shown to be safe and effective in preventing the recurrence of HBV after liver transplantation.

Keywords: Hepatitis B Antibodies, Hepatitis B virus, Liver Transplantation

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Annals of Transplantation eISSN: 2329-0358
Annals of Transplantation eISSN: 2329-0358