Pharmacokinetic studies on Wilfactin®, a von Willebrand factor concentrate with a low factor VIII content treated with three virus-inactivation/removal methods

Jenny Goudemand, I. Scharrer, E. Berntorp, C. A. Lee, A. Borel-Derlon, N. Stieltjes, C. Caron, J. M. Scherrmann, F. Bridey, Z. Tellier, A. B. Federici, P. M. Mannucci

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: In order to correct the primary von Willebrand factor (VWF) defect and avoid supra-physiologic plasma levels of factor VIII, a pure VWF concentrate almost devoid of FVIII was developed and used in France since 1989. Methods: The pharmacokinetic (PK) profile of the most recent version of this concentrate (Wilfactin®; LFB, Les Ulis, France), treated with three virus-inactivation/removal methods (solvent/detergent, 35 nm filtration, dry heat treatment), was investigated in 25 patients. Seventeen patients with various types of clinically severe von Willebrand disease (VWD) were included in a crossover, randomized trial carried out in five European centers and comparing Wilfactin® with concentrates containing both FVIII and VWF (FVIII/VWF). Eight type 3 VWD patients were included in another trial carried out in six French centers comparing Wilfactin® with its previous version (Facteur Willebrand-LFB®; LFB) that adopted one virus-inactivation method only. Results: For both the measurements evaluated in this study (VWF antigen, VWF:Ag; and VWF ristocetin co-factor activity, VWF:RCo), Wilfactin® had a PK profile similar to that of the FVIII/VWF concentrates and of Facteur Willebrand-LFB®. VWF:RCo and VWF:Ag recoveries were 2.1 ± 0.3 and 1.8 ± 0.3 per IU kg-1, respectively, and the half-lives were 12.4 ± 1.8 and 15.9 ± 1.5 h. The FVIII synthesis rate was 5.8 ± 1.0 IU dL-1 h-1, with a half-life of 15.8 ± 2.4 h. Conclusion: The PK of VWF and FVIII have not been altered by the three virus-inactivation/removal steps during the manufacturing of Wilfactin®.

Original languageEnglish
Pages (from-to)2219-2227
Number of pages9
JournalJournal of Thrombosis and Haemostasis
Volume3
Issue number10
DOIs
Publication statusPublished - Oct 2005

Keywords

  • Pharmacokinetic
  • Severe von Willebrand disease
  • Viral safety
  • Von Willebrand factor concentrate

ASJC Scopus subject areas

  • Medicine(all)

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