Logo Annals of Transplantation Logo Annals of Transplantation Logo Annals of Transplantation

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

Add Comment 0 Comments

In Press

Original article  

Simultaneous Liver and Kidney Transplant in a Middle-Income Country: A Single-Center Experience

Ann Transplant In Press; DOI: 10.12659/AOT.947649  

Original article  

Outcomes of Combined Liver-Kidney Transplantation in Polycystic Liver and Kidney Disease

Ann Transplant In Press; DOI: 10.12659/AOT.947639  

Most Viewed Current Articles

03 Jan 2023 : Original article   6,881

Impact of Autologous Stem Cell Transplantation on Primary Central Nervous System Lymphoma in First-Line and...

DOI :10.12659/AOT.938467

Ann Transplant 2023; 28:e938467

15 Aug 2023 : Review article   6,826

Free-Circulating Nucleic Acids as Biomarkers in Patients After Solid Organ Transplantation

DOI :10.12659/AOT.939750

Ann Transplant 2023; 28:e939750

16 May 2023 : Original article   6,569

Breaking Antimicrobial Resistance: High-Dose Amoxicillin with Clavulanic Acid for Urinary Tract Infections ...

DOI :10.12659/AOT.939258

Ann Transplant 2023; 28:e939258

28 May 2024 : Original article   5,905

Effect of Dexmedetomidine Combined with Remifentanil on Emergence Agitation During Awakening from Sevoflura...

DOI :10.12659/AOT.943281

Ann Transplant 2024; 29:e943281

Your Privacy

We use cookies to ensure the functionality of our website, to personalize content and advertising, to provide social media features, and to analyze our traffic. If you allow us to do so, we also inform our social media, advertising and analysis partners about your use of our website, You can decise for yourself which categories you you want to deny or allow. Please note that based on your settings not all functionalities of the site are available. View our privacy policy.

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