A comprehensive measures ensuring the safety of blood component transfusions

Introduction. Human immunodefi ciency virus (HIV), Hepatitis B and C viruses (HBV, HCV) are the major blood-borne infections. Donor blood components cannot be currently replaced with synthetic substitutes, which determines the necessity of improving the viral safety of blood component transfusions.Aim. To describe a multicomponent system for monitoring the viral safety of donor blood component transfusions. General fi ndings. Measures ensuring the safety of blood component transfusions include the maintenance of regular communication with donors, pre-donation laboratory tests, viral screening, production, storage and clinical use of blood products, as well as monitoring of blood transfusion results. The selection of donors from low-risk behaviour groups ensures the viral safety of blood transfusion procedures at the initial stages of blood production. A necessary condition for improving the safety of transfusions is additional examination of donor blood samples for antibodies against the hepatitis B core antigen. Algorithms are described for investigating the initial occurrence of infectious markers in blood transfusion recipients, a retrospective investigation in cases where viral infection markers are identifi ed in recurrent donors, as well as for the monitoring of the virological status of patients with blood system disorders. The implementation of these measures can increase the overall safety of blood transfusion.

octanate®: over 20 years of clinical experience in overcoming challenges in haemophilia A treatment

Treatment of haemophilia A with FVIII replacement has evolved over the past decades to adapt to the needs of patients. octanate®, a plasma-derived, double virus-inactivated, von Willebrand factor (VWF)-containing FVIII concentrate, has been used in clinics worldwide for over 20 years. First licensed in 1998 in Germany, octanate® is approved in over 80 countries for the prevention and treatment of bleeding and for surgical prophylaxis in patients with haemophilia A, and in over 40 countries for immune tolerance induction (ITI). The manufacturing process for octanate® was developed to ensure high viral safety and effectively eliminates both enveloped and nonenveloped viruses. Over the past 20 years, the excellent safety and efficacy of octanate® have been demonstrated in pivotal clinical trials in adult and paediatric previously treated patients (PTPs) for on-demand treatment, prophylaxis and as surgical cover. Importantly, octanate® has displayed low immunogenicity in previously untreated patients (PUPs), with only 9.8% of PUPs developing FVIII inhibitors. octanate® has also shown to be highly effective in inhibitor elimination when used as ITI therapy. In a population of patients with high risk of ITI failure, success was achieved in 79.2% of patients (70.8% complete success), even when using exceptionally stringent success criteria. No relapses were observed. Here we present an overview of the clinical data with octanate® that support its use in a range of patient populations and clinical indications.