Recombinant Factor VII for Patients with Intracerebral Hemorrhage

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Recombinant Factor VII for Patients with Intracerebral Hemorrhage

Highly selected patients with ICH benefited from rFVIIa, but these results must be balanced against the drug's thromboembolic risks and high cost.

Recombinant activated factor VII (rFVIIa; trade name, NovoSeven) is FDA-approved for use in patients with hemophilia A or B who have inhibitors to factors VIII and IX. However, the drug has also been used -- in both practice settings and small trials -- for bleeding patients in other clinical circumstances. In this industry-supported, international randomized trial, researchers examined whether rFVIIa improves outcomes in patients with intracerebral hemorrhage.

The trial involved 399 patients with spontaneous intracerebral hemorrhage documented by computed tomographic scans within 3 hours of symptom onset. Patients received single injections of rFVIIa (at doses of 40, 80, or 160 µg/kg) or placebo within 1 hour after diagnosis. According to repeat CT at 24 hours, hemorrhage volume increased by 29% after placebo, but by only 11% after the highest rFVIIa dose (a significant difference). Hemorrhage volumes in the lower-dose groups were between placebo and high-dose rFVIIa values. The proportions of patients who died or were severely disabled at 90 days were significantly lower in each of the three rFVIIa groups (55%, 49%, and 54%) than in the placebo group (69%). Serious adverse arterial thromboembolic events occurred more often among rFVIIa recipients than among placebo recipients (5% vs. 0%).

Comment: In this study, rFVIIa improved 90-day clinical outcomes of patients with intracerebral hemorrhage. However, an editorialist regards these results as "preliminary." Because of numerous exclusion criteria, only a minority of patients with intracerebral hemorrhage were enrolled in this study; thus, generalizability remains an issue. Appropriate patient selection is another important issue because of the thromboembolic risks and the extraordinary expense of rFVIIa: At the currently listed Average Wholesale Price (US$2.04/µg), a 160-µg/kg dose would cost more than $20,000 for a 70-kg person.

— Allan S. Brett, MD

Published in Journal Watch General Medicine March 8, 2005