THE EFFECT OF MONOCLONAL OR ION-EXCHANGE PURIFIED FACTOR-VIII CONCENTRATE ON HIV DISEASE PROGRESSION - A PROSPECTIVE COHORT COMPARISON

The CD4 count has been reported to decline less rapidly in HIV-infecte d haemophiliacs treated with monoclonally purified factor VIII concent rates than in those using intermediate-purity concentrates. No surviva l advantage has been demonstrated for this effect, and it is unclear w hether this effect occurs with all high-purity concentrates. Two cohor ts of patients with severe haemophilia A and HIV treated with either i on-exchange-purified or monoclonally-purified concentrates were compar ed. The CD4 count, survival, AIDS-defining illnesses, CDC category and antiretroviral therapy were recorded at 6-monthly intervals for 3 yea rs following the change from intermediate to high-purity factor VIII. 116 patients were recruited, 37 of whom were treated with an ion-excha nge purified factor VIII concentrate at three centres, mean (SD) age 3 1.1 (12.2) years, and 79 were treated with monoclonally purified facto r VIII concentrate at two centres, mean (SD) age 29.8 (11.2)years. At the start of the study the median CD4 count was (monoclonal nu ion-exc hange) 0.30 v 0.16x10(9)/l. The CD4 count declined in both arms to a m edian of (monoclonal nu ion-exchange) 0.16 nu 0.08 x 10(9)/l at the fi nal visit. Analysis of the (CD4 count)(1/2) over time, using a random coefficients model, found that the mean (SE) rates of decline were not statistically significantly different in the two treatment groups (mo noclonal nu ion exchange: -0.050 (0.008) nu -0.034(0.011) (CD4 count)( 1/2) per year, P=0.24). No statistically significant difference in sur vival (log-rank test: P=0.33) was found. There was no difference in th e proportion of individuals experiencing one or more AIDS-defining ill nesses (P=0.32) or in the proportion progressing to CDC category TV (P =0.28) during the study. The CD4 count declined during the study at a rate similar to that previously reported in patients treated with inte rmediate-purity factor VIII concentrate, and there was no evidence of any difference between the two treatment groups.