Compound adsorption device in pathogen reduction technology removes multiple drugs from plasma components.

BACKGROUND

Blood donor eligibility policies may exclude individuals based on medication use, but the donor health questionnaire may not reliably capture all prescriptions. This study evaluates the capacity of the compound adsorption device (CAD) within the INTERCEPT Blood System Pathogen Reduction Technology (PRT) for plasma to remove exogenous testosterone and high doses of two drugs on the FDA donor deferral list.

STUDY DESIGN AND

METHODS

Plasma was manufactured from male whole blood donors undergoing testosterone replacement therapy (TRT) or whole blood donors with no medication history to be supplemented with supratherapeutic concentrations of apixaban, a common anticoagulant, and escalating doses of emtricitabine and tenofovir (FTC&TFV) to note any saturating effects of removal. Plasma units were treated with INTERCEPT PRT only using the amotosalen and CAD steps without photochemical activation. Quantitative assays analyzed pre- and post-CAD samples. Statistical analysis was performed using a Wilcoxon signed-rank test and one-way ANOVA.

RESULTS

The CAD reduced the mean free and total testosterone by 75% (pre-CAD 107.4, post-CAD 26.8 pg/mL) and 74% (pre-CAD 352.2, post-CAD 85.7 ng/mL), respectively. Apixaban was removed below the limit of detection (pre-CAD mean 420, post-CAD mean <23 ng/mL). Regardless of the initial dose, FTC&TFV concentrations decreased by 100% and 98%, respectively.

CONCLUSION

The INTERCEPT PRT plasma kit CAD effectively removed multiple drug classes, suggesting a potential role in mitigating drug contamination in transfusable plasma products. These findings may support the reconsideration of some medication-based donor deferrals where the risk-benefit of donor safety and product efficacy favors collection.