Summary
Factor VIII or factor IX replacement is frequently impossible in inhibitor-developing
hemophiliacs, because of the level of the inhibitor titer. Activated prothrombin complex
concentrates are one of the available options to treat the bleeding episodes in such
patients. However, the efficacy of these products and the associated thrombogenic
risk, particularly in prolonged administration such as employed during surgeries,
are important concerns for hemophilia care providers. We performed a multicenter retrospective
study to evaluate the use of FEIBA (Factor Eight Bypassing Activity) in France, and
data is presented on 433 bleeding episodes, including surgical procedures, concerning
60 patients from 15 hemophilia centers.
The efficacy was judged as good or excellent in 352 episodes (81.3%), poor in 73 episodes
(16.9%) and non-existent in 8 episodes (1.8%). Minor and major surgical procedures
were successfully performed using FEIBA as a second-line therapy after human or porcine
factor VIII, and in some occasions FEIBA was utilized as the only substitution product.
The tolerance was assessed as good in 428 episodes (98.8%), but in 5 cases adverse
effects were reported. Only 3 patients out of 52 regularly evaluated (5.8%) were HIV-seropositive,
and for two of them the seroconversion occurred prior to the first use of FEIBA. In
contrast, 80.4% of the patients were HCV-seropositive. An anamnestic response after
the administration of FEIBA was noted in 31.5% of cases. This study points out the
main features of the use of FEIBA in France, and particularly the low HIV seroprevalence
in the patients treated. The good efficacy and the excellent tolerance still confer
to this product a place to consider in the therapeutic options for the treatment of
inhibitor-developing hemophiliacs or in acquired hemophilia.
