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- Title
Clinical assessment of Optivate.
- Authors
Dmoszynska, A.; Kuliczkowski, K.; Hellmann, A.; Trelinski, J.; Kloczko, J.; Baglin, T.; Hay, C.; O'Shaughnessy, D.; Zawilska, K.; Makris, M.; Shaikh-Zaidi, R.; Gascoigne, E.; Dash, C.
- Abstract
Factor VIII (FVIII) concentrates have revolutionized the treatment of patients with haemophilia A. Concerns over the transmission of viral infections through these products have been addressed through stringent, donor-screening procedures and robust antiviral manufacturing steps. Bio Products Laboratory has developed a high-purity FVIII product with von Willebrand factor, Optivate. Its safety, tolerability and efficacy as prophylaxis and treatment of bleeds have been established in long-term studies. Seventy previously treated patients with severe haemophilia A, with ≥20 exposure days, were recruited into two long-term, multicentre, open-label studies. The protocols were virtually identical. Patients received Optivate either prophylactically or on-demand. A mean of 159.0 EDs were experienced over 11 320 infusions. Under both conditions, Optivate was well tolerated. Only 10% of patients experienced a treatment-related adverse event; the most commonly reported were headache (4% of patients) and dizziness (3% of patients). The mean number of bleeds/patient over the 2 year treatment period was 23.5 during prophylactic use and 70.4 during on-demand use. In patients treated prophylactically, clinical responses to breakthrough bleeds were rated by physicians as excellent or good and as very helpful or helpful by patients in 95% of bleeds. Clinical responses for on-demand patients were rated as excellent or good by physicians and helpful or very helpful by the patients for 91% of bleeds. There were no viral transmissions or inhibitors. The studies confirm the clinical efficacy and safety of Optivate in both prophylactic and on-demand management of patients with haemophilia A.
- Subjects
BLOOD coagulation factor VIII; HEMOPHILIA; BIO Products Laboratory Ltd.; VON Willebrand factor; PHARMACOKINETICS
- Publication
Haemophilia, 2011, Vol 17, Issue 3, p456
- ISSN
1351-8216
- Publication type
Article
- DOI
10.1111/j.1365-2516.2010.02446.x