PROSPECTIVE CLINICAL-TRIAL OF HIGH-PURITY FACTOR-VIII PREPARATIONS INHEMOPHILIACS

An assessment of the immune status of both HIV-positive and HIV-negati ve haemophiliacs showed hypo-responsive and anergic patients in both g roups. In HIV-positive patients, the immune suppression, in addition t o HIV itself, may be caused by other viral infections such as all type s of hepatitis as well as by factor VIII concentrates. The introductio n of new technologies for preparing factor VIII concentrates led to th e question of whether higher purity is associated with a protective ef fect on the immune system, which might improve the clinical course of HIV-positive patients. Factor VIII from two manufacturing processes wa s investigated, one prepared using an ion-exchange S/D step, and the o ther utilizing a monoclonal antibody step. It is concluded that changi ng the product, from the monoclonal antibody to the ion-exchange and v ice versa in the HIV-negative patients does not cause a change in the immune profiles.