Experience with Optivate®, a new high purity concentrate of factor VIII with von Willebrand factor, in patients...

The efficacy and safety of Optivate(®) was assessed in 23 surgical operations, orthopaedic (12) including 5 revision arthroplasties, ophthalmic (1), ENT (1), dental (6), liver biopsy (2), and removal of portacath (1) on 15 teenagers and adults with severe haemophilia A. The preoperative dose was calculated to raise the FVIII concentration to 100 IU dL(-1). Subsequent doses were targeted to maintain at least 50 IU dL(-1). There were 11 major and 12 minor operations categorized as receiving intensive replacement therapy for ≥ 5 days or < 5 days respectively. The median preoperative dose was 50.4 (range 18.2-88.2) IU kg(-1). The median incremental recovery based on this first dose in 10 procedures (5 patients) was 2.9 (range 2.4-3.4 IU dL(-1) ) per IU kg(-1). The daily doses decreased during the first 4 days of the study. The patients in this study received 173 infusions in total. Outcome was 'good' or 'excellent' for 19 (83%) of 23 operations, 'uncertain' in three procedures because an antifibrinolytic agent was used as well and for one procedure outcome was not assessed. Tolerance was good. There were no excessive bleeds, no inhibitors and no virus transmissions.