The effect of monoclonal or ion‐exchange purified factor VIII concentrate on HIV disease progression: a prospective cohort comparison

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Abstract
The CD4 count has been reported to decline less rapidly in HIV‐infected haemophiliacs treated with monoclonally purified factor VIII concentrates than in those using intermediate‐purity concentrates. No survival advantage has been demonstrated for this effect, and it is unclear whether this effect occurs with all high‐purity concentrates. Two cohorts of patients with severe haemophilia A and HIV treated with either ion‐exchange‐purified or monoclonally‐purified concentrates were compared. The CD4 count, survival, AIDS‐defining illnesses, CDC category and anti‐retroviral therapy were recorded at 6‐monthly intervals for 3 years following the change from intermediate to high‐purity factor VIII. 116 patients were recruited, 37 of whom were treated with an ion‐exchange purified factor VIII concentrate at three centres, mean (SD) age 31.1 (12.2) years, and 79 were treated with monoclonally purified factor 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 v ion‐exchange) 0.30 v 0.16 × 109/l. The CD4 count declined in both arms to a median of (monoclonal v ion‐exchange) 0.16 v 0.08 × 109/l at the final 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 (monoclonal v ion exchange: −0.050 (0.008) v−0.034 (0.011) (CD4 count)1/2 per year, P = 0.24). No statistically significant difference in survival (log‐rank test: P = 0.33) was found. There was no difference in the proportion of individuals experiencing one or more AIDS‐defining illnesses (P = 0.32) or in the proportion progressing to CDC category IV (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 intermediate‐purity factor VIII concentrate, and there was no evidence of any difference between the two treatment groups.