Article
Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in liver transplantation: An open, prospective, single-arm phase III study
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Authors
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Ali Yahyazadeh
- Klink für Allgemein-, Viszeral- und Transplantationschirurgie, Charité Universitätsmedizin Berlin, Berlin
| Published: | May 20, 2011 |
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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.
