Clinical evaluation of a dried blood spot assay for atazanavir

Antimicrob Agents Chemother. 2010 Oct;54(10):4124-8. doi: 10.1128/AAC.00297-10. Epub 2010 Jul 26.

Abstract

Current procedures for obtaining and measuring plasma concentrations of HIV protease inhibitors (PIs) are technically challenging. Dried blood spot (DBS) assays offer a way to overcome many of the obstacles. We sought to develop a DBS assay for quantitation of the PI atazanavir (ATV) and to compare this method with a previously validated plasma assay. We prospectively enrolled 48 patients with well-controlled HIV disease who had been on ATV for at least 7 days. ATV was quantified from plasma by use of high-performance liquid chromatography (HPLC). A reversed-phase ultrahigh-performance liquid chromatography (UPLC) assay was utilized for DBS samples. The concentrations of ATV quantified in a DBS matrix showed very strong agreement with those measured in plasma (r(2) = 0.988). The mean difference in ATV concentration between the two methods was -10.8% (95% confidence interval [95% CI], -7.65% to -13.95%), indicating that the DBS method has a slight negative bias. A majority (97.8%) of the differences in concentration between the two assays fell within ±2 standard deviations. ATV concentrations were lower in subjects who had detectable HIV RNA in plasma (mean, 543 ng/ml) than in those with HIV RNA of <50 copies/ml (mean, 1,582 ng/ml) (P = 0.03, Wilcoxon rank-sum test). In conclusion, our study demonstrated that ATV quantitation in a DBS matrix is feasible and accurate. DBS use offers a convenient alternative for measuring plasma concentrations of ATV and may have utility in monitoring of drug concentrations in clinical practice and in future studies.

Publication types

  • Research Support, N.I.H., Extramural

MeSH terms

  • Adult
  • Atazanavir Sulfate
  • Biological Assay
  • Chromatography, High Pressure Liquid
  • Female
  • HIV Protease Inhibitors / blood*
  • Humans
  • Male
  • Middle Aged
  • Oligopeptides / blood*
  • Pyridines / blood*
  • Reproducibility of Results
  • Young Adult

Substances

  • HIV Protease Inhibitors
  • Oligopeptides
  • Pyridines
  • Atazanavir Sulfate