Document Detail

Pharmacokinetics, coagulation factor consumption and clinical efficacy in patients being switched from full-length FVIII treatment to B-domain-deleted r-FVIII and back to full-length FVIII.
MedLine Citation:
PMID:  19664015     Owner:  NLM     Status:  MEDLINE    
Concerns have been raised regarding pharmacokinetic performance, efficacy and safety of B-domain-deleted recombinant FVIII (BDD rFVIII). The objective of this study was to perform a retrospective survey of half-life measurements, efficacy and safety in patients with severe haemophilia A, switching treatment from full-length factor VIII (FL FVIII) to BDD rFVIII and then back to FL FVIII. We hypothesized that half-life of FVIII would be equal regardless of product and that total factor consumption and bleeding frequency would be indistinguishable. We report on inhibitor development and outcome following surgery. Patients with severe haemophilia A, exposed to BDD rFVIII were identified from a database. A retrospective analysis of laboratory data and medical notes was undertaken. No significant difference was detected between the half-life measurements during the switch from FL FVIII (T/2 median 9.15 h, range 6.4-22) to BDD rFVIII (T/2 median 9.7, range 4.7-16.8) and back to FL FVIII (T/2 median 9.0, range 5.0-19.5). There was no significant difference in coagulation factor usage (BDD rFVIII median 4803 IU kg(-1) year(-1), range 659-11 304; FL FVIII median 5349, range 1691-10 146), nor bleeds. Eleven received BDD rFVIII to cover surgical procedures, with no reports of excess bleeding. Thirty-three patients received significant exposure to BDD rFVIII and one developed a low titre inhibitor. BDD rFVIII was found to be equivalent to other FVIII products in terms of pharmacokinetics, clinical efficacy and safety in this study group.
C Rea; A Dunkerley; B Sørensen; S Rangarajan
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Publication Detail:
Type:  Journal Article; Research Support, Non-U.S. Gov't     Date:  2009-08-02
Journal Detail:
Title:  Haemophilia : the official journal of the World Federation of Hemophilia     Volume:  15     ISSN:  1365-2516     ISO Abbreviation:  Haemophilia     Publication Date:  2009 Nov 
Date Detail:
Created Date:  2010-01-11     Completed Date:  2010-08-05     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9442916     Medline TA:  Haemophilia     Country:  England    
Other Details:
Languages:  eng     Pagination:  1237-42     Citation Subset:  IM    
Haemostasis Research Unit, Centre for Haemophilia and Thrombosis, Guy's and St Thomas NHS Foundation Trust, London, UK.
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MeSH Terms
Blood Coagulation Factor Inhibitors / pharmacokinetics*,  therapeutic use
Blood Coagulation Factors / pharmacokinetics*,  therapeutic use
Child, Preschool
Cross-Over Studies
Factor VIII / pharmacokinetics*,  therapeutic use
Hemophilia A / drug therapy*
Hemorrhage / drug therapy*
Retrospective Studies
Time Factors
Treatment Outcome
Reg. No./Substance:
0/Blood Coagulation Factor Inhibitors; 0/Blood Coagulation Factors; 9001-27-8/Factor VIII

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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