Home treatment with recombinant activated factor VII in patients with factor VIII inhibitors: The advantages of early intervention

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Abstract

To evaluate the feasibility, efficacy and safety of home treatment with recombinant activated factor VII (rFVIIa), 10 inhibitor patients (all haemophiliacs except one acquired post-partum) self-administered up to four doses of 90 μg/kg rFVIIa every 3 ± 1 h. The response was rated by the patient as effective (haemorrhage stopped or decreased substantially), partially effective (reduced) or ineffective (unchanged or worsened). 45 haemarthroses and eight haematomas were treated within a median time of 1.0 h (range 0.3-11.9) from the onset of bleeding, with a median of two rFVIIa doses per course (range 1-4). rFVIIa was effective in 42 episodes (79%), partially effective in six (11%) and failed in five (10%). Compared with partially effective and ineffective treatments, effective treatments started earlier (median time: 0.6 v 2.7 h, P=0.02) and required a smaller number of doses (median: 1.5 v 3, P=0.007). The risk of a partially effective or ineffective treatment was smaller for treatments started within 6 h from the onset of bleeding than for those which started later (OR 0.24, 95% CI 0.09- 0.63). Mild side-effects were reported only after 3/113 self-infusions (2.6%). Early home treatment with rFVIIa is safe, feasible and effective, inducing and maintaining haemostasis with a small number of doses.

Original languageEnglish
Pages (from-to)22-26
Number of pages5
JournalBritish Journal of Haematology
Volume104
Issue number1
DOIs
Publication statusPublished - 1999

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Factor VIIa
Factor VIII
Hemorrhage
Therapeutics
Hemarthrosis
Hemostasis
Hematoma
recombinant FVIIa
Safety

Keywords

  • Haemophilia
  • Home treatment
  • Inhibitors
  • rFVIIa

ASJC Scopus subject areas

  • Hematology

Cite this

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title = "Home treatment with recombinant activated factor VII in patients with factor VIII inhibitors: The advantages of early intervention",
abstract = "To evaluate the feasibility, efficacy and safety of home treatment with recombinant activated factor VII (rFVIIa), 10 inhibitor patients (all haemophiliacs except one acquired post-partum) self-administered up to four doses of 90 μg/kg rFVIIa every 3 ± 1 h. The response was rated by the patient as effective (haemorrhage stopped or decreased substantially), partially effective (reduced) or ineffective (unchanged or worsened). 45 haemarthroses and eight haematomas were treated within a median time of 1.0 h (range 0.3-11.9) from the onset of bleeding, with a median of two rFVIIa doses per course (range 1-4). rFVIIa was effective in 42 episodes (79{\%}), partially effective in six (11{\%}) and failed in five (10{\%}). Compared with partially effective and ineffective treatments, effective treatments started earlier (median time: 0.6 v 2.7 h, P=0.02) and required a smaller number of doses (median: 1.5 v 3, P=0.007). The risk of a partially effective or ineffective treatment was smaller for treatments started within 6 h from the onset of bleeding than for those which started later (OR 0.24, 95{\%} CI 0.09- 0.63). Mild side-effects were reported only after 3/113 self-infusions (2.6{\%}). Early home treatment with rFVIIa is safe, feasible and effective, inducing and maintaining haemostasis with a small number of doses.",
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