Objective: To study the effect of either ion-exchange (high purity, HPC) or affinity chromatograhpy purified (ultra-high purity, UPC), plasma-derived factor VIII concentrates on the circulating lymphocyte subsets in hemophilia A patients.

Methods: Multicenter, follow-up, study. Thirty-seven patients from 4 Spanish Hemophilia Units, previously treated with intermediate- purity concentrates, were given either HPC or UPC. Lymphocyte subsets and basic analytical profile were performed every 4 months, and clinical and epidemiological data were recorded through the following 3 years. 17 patients had been treated with HPC and 20 with UPC. Ages ranged from 5 to 16 years(median, 11.5), and no differences were found between groups at start in any of the parameters studied. Lymphocyte subsets including CD4+, CD8+, natural killer (NK), cytotoxic and activated cells have been analyzed by double direct immunofluorescence in the flow cytometer. Variations of the different subsets were analyzed by the Kaplan-Meier estimates, and curves compared by the log rank test, Peto-Prentice and Gehan-Breslow methods.

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