Facteur VII active recombinant (NovoSeven®) : indications et limites

Recombinant activated factor VII (rFVIIa) is a pro-hemostatic agent initially developed for the treatment of hemophiliacs with allo-antibodies. For the last twenty years, the literature reporting the use of rFVIIa has involved about 500 international publications including about 2000 patients with miscellaneous diseases. The efficacy of rFVIIa is clearly established in some constitutional hemostasis disorders with post-transfusional allo-antibodies (Abs) (hemophilia A and B with inhibitors, Glanzmann thrombasthenia with allo-Abs to platelets). The usefulness of rFVIIa in acquired hemostasis disorders is well demonstrated in acquired hemophilia but it remains to be clarified in liver-related coagulation disorders. Promising results have been published in life-threatening hemorrhages occurring in either surgical, traumatological, neurologic or obstetrical settings. These publications open the way to controlled randomized clinical trials which should lead to further validation of both efficacy and safety of rFVIIa in these specific indications. Overall, thrombotic complications are very rare with a frequency ranging between 1 and 2%.