EFFECT OF INTERMEDIATE-PURITY AND HIGH-PURITY FACTOR-VIII CONCENTRATES ON IMMUNE FUNCTION IN HIV-SEROPOSITIVE HEMOPHILIACS AS ASSESSED BY QUANTITATIVE CD-4 COUNTS

Intermediate-purity factor VIII (FVIII) concentrates are believed to a dversely influence cellular immune function and accelerate HIV progres sion in haemophiliac patients. There are reports that cellular immunit y, as measured by serial CD4 lymphocyte counts, is better preserved in HIV-infected haemophiliacs who receive high-purity concentrates compa red with those receiving intermediate-or low-purity products. We retro spectively evaluated the rate of CD4 cell count decrease in 44 asympto matic HIV-seropositive severe haemophilia A patients whose purity of p rescribed FVIII concentrate was primarily determined by State of resid ence. Prior to January 1989 all study subjects received treatment with intermediate-or low-purity products. In January 1989 the patients fro m Mississippi (n = 15) began to exclusively receive a high-purity, mon oclonal antibody purified, plasma-derived product from their State Dep artment of Health. The Mississippi cohort was subsequently converted t o a high-purity, recombinant FVIII product in May 1993. Patients from Tennessee and Arkansas (n = 29) received intermediate-purity factor du ring the entire analysis period. Patients were monitored for an averag e of 68 months with an average of 11 CD4 cell count measurements. The rate of CD4 cell count decrease was derived from the calculated slope of a simple regression in order to account for large individual CD4 co unt fluctuations during the study period. There was no statistically s ignificant difference in starting CD4 cell count between the 2 study g roups. The rate of CD4 cell count decrease was 21.8 +/- 52.9 cells mu L-1 year(-1) and 17.0 +/- 32.6 cells mu L-1 year(-1) in the high-purit y FVIII group and intermediate-purity FVIII group, respectively (P = 0 .83). The difference in rate of CD4:CD8 ratio decrease between the two groups was also not statistically significant (P = 0.41). These data suggest that the use of the more costly, high-purity monoclonal antibo dy purified and recombinant FVIII concentrates does not influence the rate of decrease in CD4 cell count in HIV-seropositive haemophiliacs c ompared with concentrates of lower specific activity obtained using st andard chromatographic techniques.