What is the role of recombinant FVIII products in the treatment of hemophilia A?

Updated: Jun 05, 2020
  • Author: Douglass A Drelich, MD; Chief Editor: Srikanth Nagalla, MBBS, MS, FACP  more...
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In June 2014 the FDA approved a long-acting recombinant FVIII–Fc fusion protein (rFVIIIFc) product (Eloctate) for control of bleeding episodes, management of perioperative bleeding, and routine prophylaxis in patients with hemophilia A. For routine prophylaxis, rVFIIIFC is infused every 4 days, whereas other available recombinant FVIII products are administered every 2-3 days. [54, 55]

The rFVIIIFc product was developed by fusing rFVIII to the Fc portion of IgG1, which allows a naturally occurring pathway to prolong the product's duration of action. FDA approval was based on a study in 164 patients with hemophilia A in which the median rate of bleeding episodes with prophylactic use of rFVIIIFc was 1.6 per year, compared with 33.6 per year in patients receiving on-demand treatment. [54, 55] In an open-label extension study of rFVIIIFc in 211 patients, with included up to 5 years of follow-up, no inhibitors were observed, annualized bleed rates remained low in patients on individualized prophylaxis, and most patients maintained extended-dosing intervals (median of 3.5 days). [56]

Other rFVIII products are also approved by the FDA for routine prophylaxis (eg, NovoEight, Kogenate, Nuwiq, Adynovate, Kovaltry, Afstyla, Jivi). Adynovate and Jivi are pegylated rFVIII products that allow less frequent administration. For prophylaxis, Jivi is administered every 5 days and Adynovate is administered 2 times per week.

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