HEAT INACTIVATED HIGHLY PURIFIED FACTOR VIII CONCENTRATE IN THE TREATMENT OF HEMOPHILIACS

51 severe hemophiliacs who had previously been treated with not virus-inactivated intermediate purity factor VIII concentrates were divided into two groups according to their immunological status. Group A (n=23) consisted of patients with CD4/CD8 (helper/suppressor) T cell ratio of 1.0, group B (n=28) of . patients with a ratio of 1.0. In patients of group A treatment was switched in May 1983 to highly purified heat inactivated factor VIII concentrate (BEHRINGWERKE GmbH, Marburg) whereas patients of group B continued to receive intermediate purity factor VIII concentrate. In both groups laboratory tests (clinical investigation, routine liver function tests, differential blood count, lymphocyte subpopulations and quantitative immunoglobulin analysis) were performed in May 1983 and repeated 6, 12 and 18 months thereafter. In group A a significant reduction (p 0.005) of CD8 positive cells from 10587/μl (median) to 540/μl (18 months) was observed; no significant changes of CD8 positive cells occurred in group B. CD4/CD8 ratio rose from 0.58 to 0.86 in group A (p = 0.005) and remained unchanged in group B (1.38 versus 1.23). Serum IgG decreased in both groups but was more pronounced in group A. Thus treatment with heat inactivated highly purified factor VIII improved the immunological status of hemophiliacs with an inverse ratio. Retrospective analysis of antibodies to HIV, however, showed that most of the patients of group A were antibody positive (n=21), but the 2 negative patients remained negative. In group B of the 10 HIV negative patients one became positive, all others did not change. Whether this improvement of immunological laboratory findings is of clinical relevance, remains to be established, particularly with respect to the high incidence of antibody positive patients within group A.