NO ANTI-HIV SEROCONVERSION AFTER REPLACEMENT THERAPY WITH PASTEURIZED F VIII CONCENTRATE. A STUDY OF 151 PATIENTS WITH HEMOPHILIA A OR VON WILLEBRAND'S DISEASE

Transmission of hepatitis viruses and HIV has proven to be a risk of replacement therapy in hemophilia. As regards F VIII products a concentrate (Hemate HS or P) in which viruses are inactivated by heat-treatment over 10 hours at 60° C in aqueous solution is available since 1979. Our clinical studies have shown that this product does not transmit HBV and HNANBV. As the product was manufactured by 80% from US plasma it was necessary to prove that it also does not transmit HIV. As it is, for ethical reasons, not possible to treat a control group with non-virus-inactivated F VIII, non-transmission of HIV can only proven if anti-HIV seroconversion does not occur in larger groups of patients treated exclusively with this virus-inactivated product.We collected data from 151 patients treated with Hemate HS (P) who had never before received blood or blood products. Therapy was started between Feb. 1979 and Jan. 1986 (median July 7,1983). The median length of observation till the last anti-HIV testing was 24 (3 - 83) months. 112 patients were observed longer than 13 months. The median total dosage was 17,000 (500 -2,155,375) IU of F VIII, the median patient age was 6 (0,5 - 68) years. In none of these patients anti-HIV seroconversion (ELISA test) was observed. According to the rule of three, the upper 95% confidence limit for a random sample of 60 cases with zero events would be 3/60 or 5%. For greater numbers of n cases, as in our study, the range of confidence narrows increasingly. The period of observation of this study is hitherto the longest.