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Updated: Mar 20, 2026
In Vitro Assay to Evaluate the Impact of Immunoregulatory Pathways on HIV-specific CD4 T Cell Effector Function
Published on: October 15, 2013
Effect of intermediate- and high-purity factor VIII concentrates on immune function in HIV-seropositive haemophiliacs
S R Deitcher1, J Tuller1, M Dugdale1
1The University of Tennessee Hemophilia Clinic and Division of Hematology-Oncology, The University of Tennessee, Memphis TN, USA.
Insights
High-purity Factor VIII (FVIII) concentrates did not significantly alter CD4 cell count decrease rates in HIV-positive hemophiliacs compared to intermediate-purity products. This study suggests purity does not impact immune function progression in this patient group.
Area of Science:
- Hematology
- Immunology
- Virology
Background:
- Intermediate-purity Factor VIII (FVIII) concentrates were suspected to negatively impact cellular immunity and accelerate HIV progression in hemophilia patients.
- Previous reports indicated better immune preservation (CD4 counts) in HIV-infected hemophiliacs using high-purity FVIII compared to lower-purity products.
Purpose of the Study:
- To retrospectively evaluate the rate of CD4 cell count decrease in asymptomatic HIV-seropositive severe hemophilia A patients based on the purity of their prescribed FVIII concentrate.
- To compare immune status progression between patients receiving high-purity FVIII and those receiving intermediate-purity FVIII.
Main Methods:
- Retrospective analysis of 44 asymptomatic HIV-seropositive severe hemophilia A patients.
- Patients were divided into two groups: one receiving high-purity FVIII (monoclonal antibody purified, then recombinant) and another receiving intermediate-purity FVIII.
- CD4 cell count decrease rates were calculated using simple regression slopes over an average monitoring period of 68 months.
Main Results:
- No statistically significant difference in starting CD4 cell counts was observed between the high-purity and intermediate-purity FVIII groups.
- The rate of CD4 cell count decrease was not significantly different between the groups (21.8 ± 52.9 cells/μL/year vs. 17.0 ± 32.6 cells/μL/year, P=0.83).
- The rate of CD4:CD8 ratio decrease also showed no statistically significant difference between the two treatment groups (P=0.41).
Conclusions:
- The use of high-purity FVIII concentrates (monoclonal antibody purified and recombinant) does not appear to influence the rate of CD4 cell count decline in HIV-seropositive hemophiliacs.
- Compared to lower-purity concentrates obtained via standard chromatography, higher-purity FVIII does not offer a significant advantage in preserving immune status as measured by CD4 counts.
Abstract:
Intermediate-purity factor VIII (FVIII) concentrates are believed to adversely influence cellular immune function and accelerate HIV progression in haemophiliac patients. There are reports that cellular immunity, as measured by serial CD4 lymphocyte counts, is better preserved in HIV-infected haemophiliacs who receive high-purity concentrates compared with those receiving intermediate- or low-purity products. We retrospectively evaluated the rate of CD4 cell count decrease in 44 asymptomatic HIV-seropositive severe haemophilia A patients whose purity of prescribed FVIII concentrate was primarily determined by State of residence. Prior to January 1989 all study subjects received treatment with intermediate- or low-purity products. In January 1989 the patients from Mississippi (n = 15) began to exclusively receive a high-purity, monoclonal antibody purified, plasma-derived product from their State Department of Health. The Mississippi cohort was subsequently converted to a high-purity, recombinant FVIII product in May 1993. Patients from Tennessee and Arkansas (n = 29) received intermediate-purity factor during the entire analysis period. Patients were monitored for an average 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 count fluctuations during the study period. There was no statistically significant difference in starting CD4 cell count between the 2 study groups. The rate of CD4 cell count decrease was 21.8 ± 52.9 cells μL(-1) year(-1) and 17.0 ± 32.6 cells μL(-1) year(-1) in the high-purity FVIII group and inter-mediate-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 antibody purified and recombinant FVIII concentrates does not influence the rate of decrease in CD4 cell count in HIV-seropositive haemophiliacs compared with concentrates of lower specific activity obtained using standard chromatographic techniques.
