Modulators of very low voriconazole concentrations in routine therapeutic drug monitoring

Ther Drug Monit. 2011 Feb;33(1):86-93. doi: 10.1097/FTD.0b013e31820530cd.

Abstract

Very low voriconazole concentrations are commonly observed during therapeutic drug monitoring. Possible mechanisms include inappropriate dose selection, rapid metabolism (as a result of genetic polymorphisms or enzyme induction), and also nonadherence. We aimed to develop a method to distinguish between rapid metabolism of and nonadherence to voriconazole by quantification of voriconazole metabolites. In addition, the relevance of common genetic polymorphisms of CYP2C19 was assessed. In a retrospective study, samples with voriconazole concentrations 0.2 μg/mL or less in routine therapeutic drug monitoring (as quantified by high-performance liquid chromatography) were evaluated. Voriconazole and its N-oxide metabolite were quantified in residual blood using a highly sensitive liquid chromatography-tandem mass spectroscopy method (lower limit of quantitation = 0.03 μg/mL). Genetic polymorphisms of CYP2C19 were determined by real-time polymerase chain reaction using the hybridization probe format and the polymerase chain reaction-random fragment length polymorphism format. A total of 747 routine therapeutic drug monitoring plasma/blood samples of 335 patients treated with systemic voriconazole were analyzed and in 18.7% of all samples, voriconazole concentrations 0.2 μg/mL or less were found. In 32 samples (30 patients) with adequate dosage and timing of blood withdrawal, nonadherence was strongly suspected in seven patients because voriconazole-N-oxide concentrations were below 0.03 μg/mL, which was not observed in a reference group of 51 healthy volunteers with controlled drug intake. In 10 patients, of whom EDTA blood was available, the ultrarapid metabolizer genotype (CYP2C19*1\*17, CYP2C19*17\*17) was found in 80% and its prevalence was significantly higher as compared to a reference group (P = 0.02). In conclusion, quantification of voriconazole-N-oxide allowed for detection of suspected nonadherence in one of four patients with very low voriconazole concentrations. In the remaining patients, ultrarapid metabolism resulting from the CYP2C19*17 polymorphism appears to play a major role. Thus, in the case of voriconazole therapy failure, both nonadherence and genetic factors have to be considered.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Antifungal Agents / adverse effects
  • Antifungal Agents / blood*
  • Antifungal Agents / metabolism*
  • Antifungal Agents / pharmacokinetics
  • Aryl Hydrocarbon Hydroxylases / genetics*
  • Aryl Hydrocarbon Hydroxylases / metabolism
  • Chromatography, High Pressure Liquid
  • Cytochrome P-450 CYP2C19
  • Drug Interactions
  • Drug Monitoring*
  • Drug Therapy, Combination
  • Enzyme Induction / genetics
  • Female
  • Genotype
  • Humans
  • Male
  • Medication Adherence*
  • Polymorphism, Genetic*
  • Pyrimidines / adverse effects
  • Pyrimidines / blood*
  • Pyrimidines / metabolism*
  • Pyrimidines / pharmacokinetics
  • Retrospective Studies
  • Treatment Outcome
  • Triazoles / adverse effects
  • Triazoles / blood*
  • Triazoles / metabolism*
  • Triazoles / pharmacokinetics
  • Voriconazole

Substances

  • Antifungal Agents
  • Pyrimidines
  • Triazoles
  • Aryl Hydrocarbon Hydroxylases
  • CYP2C19 protein, human
  • Cytochrome P-450 CYP2C19
  • Voriconazole