Managing the risk of drug-induced liver injury

P B Watkins1

  • 11] Hamner-University of North Carolina Institute for Drug Safety Sciences and Department of Medicine, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA [2] Department of Pharmacotherapy and Experimental Therapeutics, School of Pharmacy, University of North Carolina-Chapel Hill, Chapel Hill, North Carolina, USA.

Insights

Bosentan can cause liver injury, requiring mandatory monitoring for all patients. A genetic test to identify susceptible individuals could improve safety and reduce monitoring burdens.

Area of Science:

  • Pharmacogenomics
  • Hepatology
  • Clinical Pharmacology

Background:

  • Bosentan is associated with significant drug-induced liver injury (DILI).
  • Current risk stratification for bosentan-induced DILI is not possible.
  • Mandatory liver monitoring programs are required for bosentan treatment, posing logistical and financial challenges.

Purpose of the Study:

  • To explore the potential utility of a genetic test for identifying individuals susceptible to bosentan-induced liver injury.
  • To address the need for a more personalized approach to bosentan therapy.

Main Methods:

  • Review of clinical trial data on bosentan and DILI.
  • Analysis of the feasibility and potential impact of genetic screening.
  • Assessment of physician and patient perspectives on monitoring requirements.

Main Results:

  • Bosentan administration is linked to a risk of DILI in some patients.
  • The absence of reliable methods to predict susceptibility necessitates universal monitoring.
  • A genetic test could streamline patient selection and reduce the burden of current monitoring protocols.

Conclusions:

  • A genetic test for bosentan-induced DILI susceptibility would likely be well-received by clinicians.
  • Implementing genetic screening could optimize patient safety and treatment management.
  • Further research into genetic markers for bosentan hepatotoxicity is warranted.

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