Pharmacokinetics, coagulation factor consumption and clinical efficacy in patients being switched from full-length FVIII treatment to B-domain-deleted r-FVIII and back to full-length FVIII.

摘要: Summary.  Concerns have been raised regarding pharmacokinetic performance, efficacy and safety of B-domain-deleted recombinant FVIII (BDD rFVIII). The objective this study was to perform a retrospective survey half-life measurements, in patients with severe haemophilia A, switching treatment from full-length factor VIII (FL FVIII) BDD rFVIII then back FL FVIII. We hypothesized that would be equal regardless product total consumption bleeding frequency indistinguishable. report on inhibitor development outcome following surgery. Patients exposed were identified database. A analysis laboratory data medical notes undertaken. No significant difference detected between the measurements during switch (T/2 median 9.15 h, range 6.4–22) 9.7, 4.7–16.8) 9.0, 5.0–19.5). There no coagulation usage 4803 IU kg−1 year−1, 659–11 304; 5349, 1691–10 146), nor bleeds. Eleven received cover surgical procedures, reports excess bleeding. Thirty-three exposure one developed low titre inhibitor. found equivalent other products terms pharmacokinetics, clinical group.