3-YEAR RANDOMIZED STUDY OF HIGH-PURITY OR INTERMEDIATE-PURITY FACTOR-VIII CONCENTRATES IN SYMPTOM-FREE HIV-SEROPOSITIVE HEMOPHILIACS - EFFECTS ON IMMUNE STATUS

The availability of monoclonal-antibody-purified factor VIII (FVIII) c oncentrates allows us to test the hypothesis, based on in vitro observ ations, that their use in HIV seropositive haemophiliacs would result in a difference in the rate of deterioration of immune function. We de signed a multicentre, prospective, randomised, controlled study of sym ptom-free HIV-infected patients with haemophilia A who were assigned t o receive either an intermediate-purity or monoclonal-antibody-purifie d product. All had CD4 lymphocyte counts of 100-600/muL, were negative for hepatitis B surface antigen, had not received any antiretroviral or immunomodulating drugs before study entry, and had previously recei ved replacement therapy with intermediate purity FVIII concentrates. U se of antiretroviral therapy was permitted. 60 patients were recruited and 30 were assigned to each group. 35 completed the 3 year study, 20 in the monoclonal arm and 15 in the intermediate-purity arm. Among th ose completing the study, there were no differences between the two gr oups in the occurrence of AIDS-defining diagnoses (1 in each group). T here were, however, striking and significant differences in terms of c hanges in absolute CD4 counts. The group receiving monoclonal-antibody -purified concentrates had essentially stable counts while a significa nt drop was observed in the group receiving intermediate-purity FVIII. These differences were independent of the use of antiretroviral thera py. These observations support the use of high-purity concentrates in the treatment of symptom-free HIV-positive patients with haemophilia A , and they should be taken into account along with cost, by doctors ma king therapeutic decisions.