Drug-Induced Liver Injury in Clinical Trials: As Rare as Hens’ Teeth

2009 ◽  
Vol 104 (5) ◽  
pp. 1159-1161 ◽  
Author(s):  
Timothy J Davern ◽  
Naga Chalasani
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Drug Induced ◽  
Drug Induced Liver Injury

scholarly journals Prevention and management of idiosyncratic drug-induced liver injury: Systematic review and meta-analysis of randomised clinical trials

2021 ◽  
Vol 164 ◽  
pp. 105404
Author(s):  
Hao Niu ◽  
Judith Sanabria-Cabrera ◽  
Ismael Alvarez-Alvarez ◽  
Mercedes Robles-Diaz ◽  
Simona Stankevičiūtė ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Liver Injury ◽  
Meta Analysis ◽  
Randomised Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

Using controlled clinical trials to learn more about acute drug-induced liver injury

Hepatology ◽  
2008 ◽  
Vol 48 (5) ◽  
pp. 1680-1689 ◽  
Author(s):  
Paul B. Watkins ◽  
Paul J. Seligman ◽  
John S. Pears ◽  
Mark I. Avigan ◽  
John R. Senior
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Controlled Clinical Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

Variation in Liver Biochemistries in Patients with Decompensated Cirrhosis: Implications for Assessing Drug-Induced Liver Injury in Clinical Trials

2016 ◽  
Vol 30 (2) ◽  
pp. 95-101 ◽  
Author(s):  
Marzena Jurek ◽  
Masoud Mokhtarani ◽  
John M. Vierling ◽  
Dion F. Coakley ◽  
Jitendra Ganju ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Decompensated Cirrhosis ◽  
Drug Induced ◽  
Drug Induced Liver Injury

scholarly journals Assessing Toxicity in Drug Trials in Liver Disease

2021 ◽  
Author(s):  
Morris Sherman
Keyword(s):  
Clinical Trials ◽  
Liver Disease ◽  
Liver Injury ◽  
Viral Hepatitis ◽  
Liver Diseases ◽  
New Drugs ◽  
Drug Trials ◽  
Drug Induced ◽  
Drug Induced Liver Injury

AbstractSince the early trials in viral hepatitis, more and more new drugs are being tested for use in various liver diseases. Since drug hepatotoxicity is a major cause of drugs under investigation not making it to market, the assessment of drug-induced liver injury in clinical trials of new drugs is crucial. This review will focus on the systems that are used to assess drug-induced liver injury in clinical trials and will discuss how some of these criteria are inappropriate or inaccurate in this function together with suggestions for improvement.

scholarly journals Overview of Causality Assessment for Drug-Induced Liver Injury (DILI) in Clinical Trials

Drug Safety ◽  
2021 ◽  
Author(s):  
Juliana Hey-Hadavi ◽  
Daniel Seekins ◽  
Melissa Palmer ◽  
Denise Coffey ◽  
John Caminis ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Liver Injury ◽  
Causality Assessment ◽  
Drug Induced ◽  
Drug Induced Liver Injury

scholarly journals Abacavir/Dolutegravir/Lamivudine (Triumeq)–Induced Liver Toxicity in a Human Immunodeficiency Virus–Infected Patient

2017 ◽  
Vol 4 (3) ◽  
Author(s):  
Erin S. Christensen ◽  
Rupali Jain ◽  
Alison C. Roxby
Keyword(s):  
Human Immunodeficiency Virus ◽  
Clinical Trials ◽  
Liver Injury ◽  
Infected Patient ◽  
Liver Toxicity ◽  
Late Onset ◽  
Close Monitoring ◽  
Drug Induced ◽  
Drug Induced Liver Injury ◽  
Immunodeficiency Virus

Abstract Drug-induced liver injury related to Triumeq (abacavir/lamivudine/dolutegravir) has not been reported in clinical trials. We report a case of hepatotoxicity related to Triumeq exposure in a human immunodeficiency virus–infected patient. Clinicians should remain aware of the risk for acute and late-onset hepatitis with these agents. Close monitoring is recommended.

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