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

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1432-2277.2011.01222.x/abstract

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in

liver transplantation: an open, prospective, single-arm phase III study

Ali Yahyazadeh1, ne Beckebaum2,3, Vito Cicinnati2,3, Christian Klein3,

s 3, s Pascher1,‡, Ruth Neuhaus1,‡

Article first published online: 5 FEB 2011

DOI: 10.1111/j.1432-2277.2011.01222.x

© 2011 The Authors. Transplant International © 2011 European Society for Organ

Transplantation

Issue

Transplant International

Volume 24, Issue 5, pages 441–450, May 2011

Summary

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).

[Guest guest]

http://onlinelibrary.wiley.com/doi/10.1111/j.1432-2277.2011.01222.x/abstract

Efficacy and safety of subcutaneous human HBV-immunoglobulin (Zutectra®) in

liver transplantation: an open, prospective, single-arm phase III study

Ali Yahyazadeh1, ne Beckebaum2,3, Vito Cicinnati2,3, Christian Klein3,

s 3, s Pascher1,‡, Ruth Neuhaus1,‡

Article first published online: 5 FEB 2011

DOI: 10.1111/j.1432-2277.2011.01222.x

© 2011 The Authors. Transplant International © 2011 European Society for Organ

Transplantation

Issue

Transplant International

Volume 24, Issue 5, pages 441–450, May 2011

Summary

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).