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Controlled prospective study of factor IX concentrate therapy and immunodeficiency
M B Hultin1, R J Dattwyler, R A Lipton
1Department of Medicine, State University of New York at Stony Brook.
American Journal of Hematology
|May 1, 1989
Summary
Patients treated with factor IX (FIX) concentrate showed a dose-related risk of human immunodeficiency virus (HIV) exposure. FIX concentrate was not intrinsically safer than factor VIII (FVIII) concentrate.
Area of Science:
- Hematology
- Immunology
- Virology
Background:
- Hemophilia treatment historically involved blood-derived clotting factor concentrates.
- Concerns arose regarding potential transmission of infectious agents, including human immunodeficiency virus (HIV), through these concentrates.
- Factor IX (FIX) and Factor VIII (FVIII) concentrates were primary treatments for hemophilia A and B, respectively.
Purpose of the Study:
- To prospectively compare the risk of HIV exposure in patients exclusively treated with FIX concentrate versus FVIII concentrate.
- To assess the safety profile of FIX concentrate relative to FVIII concentrate in the context of HIV transmission.
- To evaluate the impact of high-dose FIX concentrate treatment on T helper cell counts and HIV seropositivity.
Main Methods:
- A prospective study matching six patients treated exclusively with high-dose FIX concentrate (>40,000 units/yr) to six patients treated exclusively with FVIII concentrate and six normal male controls.
- Baseline evaluation included assessment of absolute T helper cell counts.
- Follow-up assessments monitored for HIV seropositivity and acquired immunodeficiency syndrome (AIDS) development.
Main Results:
- Both FIX- and FVIII-treated groups exhibited significantly decreased absolute T helper cell counts at baseline compared to normal controls.
- By August 1988, three of six FIX-treated patients developed AIDS, and two were HIV seropositive.
- Four of six FVIII-treated patients showed HIV seropositivity or disease, indicating a substantial risk in both treatment groups.
Conclusions:
- The study findings support a dose-related risk of HIV exposure associated with FIX concentrate treatment.
- Contrary to previous assumptions, FIX concentrate was not found to be intrinsically safer than FVIII concentrate regarding HIV transmission.
- High-dose FIX concentrate treatment may be linked to increased risk of HIV infection and immunodeficiency.