Bilirubin-a potential marker of drug exposure in atazanavir-based antiretroviral therapy

AAPS J. 2011 Dec;13(4):598-605. doi: 10.1208/s12248-011-9299-0. Epub 2011 Sep 13.

Abstract

The objective of this work was to examine the atazanavir-bilirubin relationship using a population-based approach and to assess the possible application of bilirubin as a readily available marker of atazanavir exposure. A model of atazanavir exposure and its concentration-dependent effect on bilirubin levels was developed based on 200 atazanavir and 361 bilirubin samples from 82 patients receiving atazanavir in the NORTHIV trial. The pharmacokinetics was adequately described by a one-compartment model with first-order absorption and lag-time. The maximum inhibition of bilirubin elimination rate constant (I(max)) was estimated at 91% (95% CI, 87-94) and the atazanavir concentration resulting in half of I(max) (IC50) was 0.30 μmol/L (95% CI, 0.24-0.37). At an atazanavir/ritonavir dose of 300/100 mg given once daily, the bilirubin half-life was on average increased from 1.6 to 8.1 h. A nomogram, which can be used to indicate suboptimal atazanavir exposure and non-adherence, was constructed based on model simulations.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Atazanavir Sulfate
  • Bilirubin / blood*
  • Biomarkers / blood*
  • HIV Infections / blood
  • HIV Infections / drug therapy*
  • HIV Protease Inhibitors / pharmacokinetics*
  • HIV Protease Inhibitors / therapeutic use
  • Humans
  • Oligopeptides / pharmacokinetics*
  • Oligopeptides / therapeutic use
  • Pyridines / pharmacokinetics*
  • Pyridines / therapeutic use

Substances

  • Biomarkers
  • HIV Protease Inhibitors
  • Oligopeptides
  • Pyridines
  • Atazanavir Sulfate
  • Bilirubin