| 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. | |
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MedLine Citation:
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PMID: 19664015 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
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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. |
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Authors:
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C Rea; A Dunkerley; B Sørensen; S Rangarajan |
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Publication Detail:
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Type: Journal Article; Research Support, Non-U.S. Gov't Date: 2009-08-02 |
Journal Detail:
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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:
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Created Date: 2010-01-11 Completed Date: 2010-08-05 Revised Date: - |
Medline Journal Info:
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Nlm Unique ID: 9442916 Medline TA: Haemophilia Country: England |
Other Details:
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Languages: eng Pagination: 1237-42 Citation Subset: IM |
Affiliation:
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Haemostasis Research Unit, Centre for Haemophilia and Thrombosis, Guy's and St Thomas NHS Foundation Trust, London, UK. |
Export Citation:
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APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
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Adolescent Blood Coagulation Factor Inhibitors / pharmacokinetics*, therapeutic use Blood Coagulation Factors / pharmacokinetics*, therapeutic use Child Child, Preschool Cross-Over Studies Factor VIII / pharmacokinetics*, therapeutic use Half-Life Hemophilia A / drug therapy* Hemorrhage / drug therapy* Humans Male Retrospective Studies Time Factors Treatment Outcome |
| Chemical | |
Reg. No./Substance:
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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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