Prospective, observational study of voriconazole therapeutic drug monitoring among lung transplant recipients receiving prophylaxis: factors impacting levels of and associations between serum troughs, efficacy, and toxicity

Antimicrob Agents Chemother. 2012 May;56(5):2371-7. doi: 10.1128/AAC.05219-11. Epub 2012 Feb 13.

Abstract

Voriconazole prophylaxis is common following lung transplantation, but the value of therapeutic drug monitoring is unknown. A prospective, observational study of lung transplant recipients (n = 93) receiving voriconazole prophylaxis was performed. Serum voriconazole troughs (n = 331) were measured by high-pressure liquid chromatography. The median initial and subsequent troughs were 1.91 and 1.46 μg/ml, respectively. The age of the patient directly correlated with initial troughs (P = 0.005). Patients that were ≥ 60 years old and cystic fibrosis patients were significantly more likely to have higher and lower initial troughs, respectively. In 95% (88/93) of patients, ≥ 2 troughs were measured. In 28% (25/88) and 32% (28/88) of these patients, all troughs were ≤ 1.5 μg/ml or >1.5 μg/ml, respectively. Ten percent (10/93) and 27% (25/93) of the patients developed invasive fungal infection (tracheobronchitis) and fungal colonization, respectively. The median troughs at the times of positive and negative fungal cultures were 0.92 and 1.72 μg/ml (P = 0.07). Invasive fungal infections or colonization were more likely with troughs of ≤ 1.5 μg/ml (P = 0.01) and among patients with no trough of >1.5 μg/ml (P = 0.007). Other cutoff troughs correlated less strongly with microbiologic outcomes. Troughs correlated directly with aspartate transferase levels (P = 0.003), but not with other liver enzymes. Voriconazole was discontinued due to suspected toxicity in 27% (25/93) of the patients. The troughs did not differ at the times of suspected drug-induced hepatotoxicity, central nervous system (CNS) toxicity, or nausea/vomiting and in the absence of toxicity. Voriconazole prophylaxis was most effective at troughs of >1.5 μg/ml. A cutoff for toxicity was not identified, but troughs of >4 μg/ml were rare. The data support a target range of >1.5 to 4 μg/ml.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Antifungal Agents / blood
  • Antifungal Agents / pharmacokinetics
  • Central Nervous System / drug effects
  • Central Nervous System / microbiology
  • Central Nervous System / pathology
  • Chromatography, High Pressure Liquid
  • Cystic Fibrosis / blood
  • Cystic Fibrosis / drug therapy
  • Cystic Fibrosis / microbiology
  • Cystic Fibrosis / pathology
  • Drug Monitoring*
  • Female
  • Fungi / drug effects*
  • Fungi / physiology
  • Humans
  • Liver / drug effects
  • Liver / microbiology
  • Liver / pathology
  • Lung / drug effects
  • Lung / microbiology
  • Lung / pathology
  • Lung Transplantation*
  • Male
  • Middle Aged
  • Mycoses / prevention & control*
  • Prospective Studies
  • Pulmonary Fibrosis / blood
  • Pulmonary Fibrosis / drug therapy
  • Pulmonary Fibrosis / microbiology
  • Pulmonary Fibrosis / pathology
  • Pyrimidines / blood
  • Pyrimidines / pharmacokinetics*
  • Treatment Outcome
  • Triazoles / blood
  • Triazoles / pharmacokinetics*
  • United States
  • Voriconazole

Substances

  • Antifungal Agents
  • Pyrimidines
  • Triazoles
  • Voriconazole