PRESENT STATUS OF VIRUS SAFETY OF VIRUS-INACTIVATED FACTOR-VIII AND FACTOR-IX CONCENTRATES IN THE TREATMENT OF HEMOPHILIA

Based on the results of seven ICTH-controlled PUP studies only the virus-inactivating procedures by pasteurization (60 degrees C for 10h), tri-n-butylphosphate/detergent treatment, and vapor heating (60 degrees C for 10 h and 1,200 mbar) have prevented the haemophilic patients from infections with hepatitis B, C and HIV. After the disaster of the HIV infection in haemophilic patients at the beginning of the 80's the factor concentrates given today seem to be safe for virus infections during substitution therapy. To prove this high therapeutical standard there is a need for a prospective long-term pharmaco-vigilance study under the auspices of an independent body such as the Medical Advising Committee of the National Haemophilia Society or other scientific organisations.