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Isavuconazole Concentration in Real-World Practice: Consistency with Results from Clinical Trials

David Andes1, Laura Kovanda2, A Desai2

  • 1University of Wisconsin, Madison, Wisconsin, USA dra@medicine.wisc.edu.

Antimicrobial Agents and Chemotherapy
|May 9, 2018
PubMed

Insights

Routine therapeutic drug monitoring (TDM) may not be necessary for the antifungal isavuconazole. Real-world patient plasma concentrations closely matched clinical trial data, suggesting TDM is not typically required.

Area of Science:

  • Medical Mycology
  • Pharmacokinetics
  • Clinical Pharmacy

Background:

  • Voriconazole, posaconazole, and itraconazole require therapeutic drug monitoring (TDM) due to variable plasma concentrations.
  • This necessity for TDM was not apparent during their respective clinical trials.
  • The need for TDM in isavuconazole, another important antifungal, remained undetermined.

Purpose of the Study:

  • To determine if routine therapeutic drug monitoring (TDM) is necessary for isavuconazole.
  • To compare isavuconazole plasma concentrations in clinical practice with those from clinical trials.

Main Methods:

  • Analysis of 283 patient plasma samples from real-world isavuconazole use.
  • Comparison of observed concentration distributions with data from isavuconazole clinical trials.

Main Results:

  • Plasma concentration distributions for isavuconazole in clinical practice were nearly identical to those in clinical trials.
  • Over 90% of patients in both settings achieved concentrations above 1 μg/ml.

Conclusions:

  • Routine therapeutic drug monitoring (TDM) is likely not necessary for isavuconazole in most clinical situations.
  • Isavuconazole exhibits predictable pharmacokinetics, unlike some other azole antifungals.
  • Clinical trial data adequately predict real-world isavuconazole exposure.
Keywords:
isavuconazoletherapeutic drug monitoring

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