gms | German Medical Science

128. Kongress der Deutschen Gesellschaft für Chirurgie

Deutsche Gesellschaft für Chirurgie

03.05. - 06.05.2011, München

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: An open, prospective, single-arm phase III study

Meeting Abstract

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  • Ali Yahyazadeh - Klink für Allgemein-, Viszeral- und Transplantationschirurgie, Charité Universitätsmedizin Berlin, Berlin

Deutsche Gesellschaft für Chirurgie. 128. Kongress der Deutschen Gesellschaft für Chirurgie. München, 03.-06.05.2011. Düsseldorf: German Medical Science GMS Publishing House; 2011. Doc11dgch429

DOI: 10.3205/11dgch429, URN: urn:nbn:de:0183-11dgch4295

Published: May 20, 2011

© 2011 Yahyazadeh.
This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by-nc-nd/3.0/deed.en). You are free: to Share – to copy, distribute and transmit the work, provided the original author and source are credited.


Outline

Text

Introduction: Hepatitis B re-infection prophylaxis is crucial for graft and recipient survival for transplanted patients and is administered routinely after liver transplantation for hepatitis B. The present study was conducted to investigate the efficacy, safety, and feasibility of home-treatment with a novel human hepatitis B immunoglobulin BT088 (Zutectra®) after weekly subcutaneous application in liver transplanted patients.

Materials and methods: 23 patients (5 female, 18 male, median age 51 years) were enrolled and switched from monthly i.v. to weekly s.c. hepatitis B immunoglobulin administration. During a period of 18 weeks (optional 24 wks) anti-HBs levels, signs of re-infection, adverse events and feasibility of self-administration were studied. After 8 weeks of training patients showing good compliance and stable antibody titres were allowed to start self-administration at home.

Results: All patients maintained a safety level of >100 U/l anti-HBs. No failure was noted, no re-infection occurred. 10 treatment-emergent events were assessed as related to study drug application (injection site hematoma, headache, abdominal pain, fatigue, hematuria). High numbers of self-administration (287 vs 122 by staff) demonstrated general feasibility of sc administration.

Conclusion: Weekly subcutaneous administration of BT088 (Zutectra®**) is effective, safe and presents an easy-to-apply treatment option for combined HBV re-infection prophylaxis in liver transplant patients.