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

Goudemand, J ; Scharrer, I ; Berntorp, Erik LU ; Lee, CA ; Borel-Derlon, A ; Stieltjes, N ; Caron, C ; Scherrmann, JM ; Bridey, F and Tellier, Z , et al. (2005) In Journal of Thrombosis and Haemostasis 3(10). p.2219-2227
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 (R); 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 (R) with concentrates containing both FVIII and VWF... (More)
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 (R); 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 (R) 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 (R) with its previous version (Facteur Willebrand-LFB (R); 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 (R) had a PK profile similar to that of the FVIII/VWF concentrates and of Facteur Willebrand-LFB (R). 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 (R). (Less)
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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
Willebrand factor concentrate, von, viral safety, pharmacokinetic, severe von Willebrand disease
in
Journal of Thrombosis and Haemostasis
volume
3
issue
10
pages
2219 - 2227
publisher
Wiley-Blackwell
external identifiers
  • pmid:16194199
  • wos:000232443200014
  • scopus:28444472737
  • pmid:16194199
ISSN
1538-7933
DOI
10.1111/j.1538-7836.2005.01435.x
language
English
LU publication?
yes
id
3bf64bd4-1422-4c55-b0e4-e6e3a1a41df9 (old id 898809)
date added to LUP
2016-04-01 12:20:12
date last changed
2020-09-02 01:44:26
@article{3bf64bd4-1422-4c55-b0e4-e6e3a1a41df9,
  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 (R); 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 (R) 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 (R) with its previous version (Facteur Willebrand-LFB (R); 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 (R) had a PK profile similar to that of the FVIII/VWF concentrates and of Facteur Willebrand-LFB (R). 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 (R).},
  author       = {Goudemand, J and Scharrer, I and Berntorp, Erik and Lee, CA and Borel-Derlon, A and Stieltjes, N and Caron, C and Scherrmann, JM and Bridey, F and Tellier, Z and Federici, AB and Mannucci, PM},
  issn         = {1538-7933},
  language     = {eng},
  number       = {10},
  pages        = {2219--2227},
  publisher    = {Wiley-Blackwell},
  series       = {Journal of Thrombosis and Haemostasis},
  title        = {Pharmacokinetic studies on Wilfactin((R)), a von Willebrand factor concentrate with a low factor VIII content treated with three virus-inactivation/removal methods},
  url          = {http://dx.doi.org/10.1111/j.1538-7836.2005.01435.x},
  doi          = {10.1111/j.1538-7836.2005.01435.x},
  volume       = {3},
  year         = {2005},
}