Search

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. Subsequent doses were targeted to maintain at least 50 IU dL. 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. The median incremental recovery based on this first dose in 10 procedures (5 patients) was 2.9 (range 2.4-3.4 IU dL) per IU kg. 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. [ABSTRACT FROM AUTHOR]

Optivate is a high purity factor VIII/von Willebrand factor (FVIII/VWF) concentrate, which is manufactured using two antiviral processes: solvent/detergent and terminal dry heating (80°C for 72 h). A multicentre, non-randomized open-label study in 15 patients was conducted to test the pharmacokinetics (PK) of Optivate. PK variables were analysed for the patients' prior FVIII product (PK1), their first dose of Optivate (PK2) and at 3 months therapy (PK3). Mean non-compartmental half-lives (h) were 14.1, 12.4 and 12.1, respectively ( P = 0.45), mean clearances (mL h kg) were 3.6, 3.2 and 3.1, respectively ( P = 0.051), MRTs (h) were 19.0, 17.3 and 17.4, respectively ( P = 0.39) and mean AUC (h IU mL) were 14.3, 15.4 and 16.6, respectively ( P = 0.051) and mean AUC (h IU mL) were 15.9, 16.4 and 17.9, respectively ( P = 0.18). The recovery data from this PK study was aggregated with recovery data collected from another study, with similar design but devoid of the other PK measurements. A total of 309 recoveries were conducted in 70 patients. The overall mean recovery per subject across 27 Optivate batches was 2.7 IU dL per IU kg. There were no clinical differences between Optivate and other FVIII products, and except for volume of distribution (Vd), no statistically significant differences were seen with respect to any of the other PK variables, or in recovery between weeks 0 and 12. Therefore, the PK of FVIII is not affected by the processes used to manufacture Optivate, which can be expected to be effective in the management of patients with haemophilia A. [ABSTRACT FROM AUTHOR]