The authors contributed equally to development of this paper.
Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study
Article first published online: 5 FEB 2011
© 2011 The Authors. Transplant International © 2011 European Society for Organ Transplantation
Volume 24, Issue 5, pages 441–450, May 2011
How to Cite
Yahyazadeh, A., Beckebaum, S., Cicinnati, V., Klein, C., Paul, A., Pascher, A. and Neuhaus, R. (2011), Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: an open, prospective, single-arm phase III study. Transplant International, 24: 441–450. doi: 10.1111/j.1432-2277.2011.01222.x
Conflicts of Interest The authors have declared no conflicts of interest.
- Issue published online: 5 APR 2011
- Article first published online: 5 FEB 2011
- Received: 29 June 2010 Revision requested: 1 August 2010 Accepted: 1 January 2011 Published online: 5 February 2011
- hepatitis B;
- hepatitis B immunoglobulin;
- liver transplantation;
- re-infection prophylaxis;
- subcutaneous application
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. Aim of the current study was the investigation of efficacy, safety and feasibility of home-treatment of a novel human hepatitis B immunoglobulin BT088 (Zutectra®) after weekly subcutaneous application in liver-transplanted patients. A total of 23 patients (5 female, 18 male, median age 51 years) were enrolled and switched from monthly IV to weekly SC hepatitis B immunoglobulin administration. During a period of 18 weeks (optional 24 weeks) 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. All patients maintained a safety level of >100 U/l anti-HBs. No failure was noted, no re-infection occurred. A total of 10 treatment-emergent events were assessed as related to study drug application (injection-site haematoma, headache, abdominal pain, fatigue and haematuria). High numbers of self-administration (287 vs. 122 by staff) demonstrated general feasibility of SC administration. Weekly subcutaneous administration of BT088 (Zutectra®– registered trade mark in the EU) is effective, safe and presents an easy-to-apply treatment option for combined hepatitis B virus re-infection prophylaxis in liver transplant patients (Eudra CT Number: 2005-003737-40).