Prospective clinical trial of high-purity factor VIII preparations in haemophiliacs.

An assessment of the immune status of both HIV-positive and HIV-negative haemophiliacs showed hypo-responsive and anergic patients in both groups. In HIV-positive patients, the immune suppression, in addition to HIV itself, may be caused by other viral infections such as all types of hepatitis as well as by factor VIII concentrates. The introduction of new technologies for preparing factor VIII concentrates led to the question of whether higher purity is associated with a protective effect on the immune system, which might improve the clinical course of HIV-positive patients. Factor VIII from two manufacturing processes was investigated, one prepared using an ion-exchange S/D step, and the other utilizing a monoclonal antibody step. It is concluded that changing the product, from the monoclonal antibody to the ion-exchange and vice versa in the HIV-negative patients does not cause a change in the immune profiles.