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Updated: May 5, 2026

Human Liver Microphysiological System for Assessing Drug-Induced Liver Toxicity In Vitro
Published on: January 31, 2022
Managing the risk of drug-induced liver injury
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.
Abstract:
In clinical trials, bosentan was shown to cause significant drug-induced liver injury (DILI) in some patients. Because it is not possible to identify those at higher risk for DILI, all patients to be treated with bosentan must enroll in a program requiring documentation of liver blood testing before they can receive the drug. Because this program is costly and is perceived as onerous, a genetic test capable of identifying susceptible individuals would probably be rapidly adopted by physicians.
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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