IQ DILI Consensus Opinion: Best Practices for Rechallenge Following Suspected Drug-Induced Liver Injury in Clinical Trials

Food and Drug Administration (FDA). Guidance for Industry on Drug-Induced Liver Injury: Premarketing Clinical Evaluation; [cited 2024 Mar 18] Available from: https://www.federalregister.gov/d/E9-18135.

Allouchery M, Beuvon C, Perault-Pochat MC, Roblot P, Puyade M, Martin M. Safety of immune checkpoint inhibitor resumption after interruption for immune-related adverse events, a narrative review. Cancers (Basel). 2022;14(4):955.

Powles T, Bracarda S, Chen M, Norry E, Compton N, Heise M, et al. Characterisation of liver chemistry abnormalities associated with pazopanib monotherapy: a systematic review and meta-analysis of clinical trials in advanced cancer patients. Eur J Cancer. 2015;51(10):1293–302.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Hunt CM, Papay JI, Rich DS, Abissi CJ, Russo MW. The evaluation of drug rechallenge: the casopitant Phase III program. Regul Toxicol Pharmacol. 2010;58(3):539–43.

Article  PubMed  Google Scholar 

Mondaca SP, Liu D, Flynn JR, Badson S, Hamaway S, Gounder MM, et al. Clinical implications of drug-induced liver injury in early-phase oncology clinical trials. Cancer. 2020;126(22):4967–74.

Article  CAS  PubMed  Google Scholar 

Pollack MH, Betof A, Dearden H, Rapazzo K, Valentine I, Brohl AS, et al. Safety of resuming anti-PD-1 in patients with immune-related adverse events (irAEs) during combined anti-CTLA-4 and anti-PD1 in metastatic melanoma. Ann Oncol. 2018;29(1):250–5.

Article  CAS  PubMed  Google Scholar 

Li M, Sack JS, Rahma OE, Hodi FS, Zucker SD, Grover S. Outcomes after resumption of immune checkpoint inhibitor therapy after high-grade immune-mediated hepatitis. Cancer. 2020;126(23):5088–97.

Article  CAS  PubMed  Google Scholar 

Patrinely JR Jr, McGuigan B, Chandra S, Fenton SE, Chowdhary A, Kennedy LB, et al. A multicenter characterization of hepatitis associated with immune checkpoint inhibitors. Oncoimmunology. 2021;10(1):1875639.

Article  PubMed  PubMed Central  Google Scholar 

Atallah E, Welsh SJ, O’Carrigan B, Oshaughnessy A, Dolapo I, Kerr AS, et al. Incidence, risk factors and outcomes of checkpoint inhibitor-induced liver injury: a 10-year real-world retrospective cohort study. JHEP Rep. 2023;5(10): 100851.

Article  PubMed  PubMed Central  Google Scholar 

Cohen JV, Dougan M, Zubiri L, Reynolds KL, Sullivan RJ, Misdraji J. Liver biopsy findings in patients on immune checkpoint inhibitors. Mod Pathol. 2021;34(2):426–37.

Article  CAS  PubMed  Google Scholar 

Li M, Sack JS, Bell P, Rahma OE, Srivastava A, Grover S, Zucker SD. Utility of liver biopsy in diagnosis and management of high-grade immune checkpoint inhibitor hepatitis in patients with cancer. JAMA Oncol. 2021;7(11):1711–4.

Article  PubMed  PubMed Central  Google Scholar 

Bessone F, Bjornsson ES. Checkpoint inhibitor-induced hepatotoxicity: role of liver biopsy and management approach. World J Hepatol. 2022;14(7):1269–76.

Article  PubMed  PubMed Central  Google Scholar 

Lazarus JV, Newsome PN, Francque SM, Kanwal F, Terrault NA, Rinella ME. Reply: a multi-society Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2024;79(3):E93–4.

Article  PubMed  Google Scholar 

Rinella ME, Lazarus JV, Ratziu V, Francque SM, Sanyal AJ, Kanwal F, et al. A multisociety Delphi consensus statement on new fatty liver disease nomenclature. Hepatology. 2023;78(6):1966–86.

Article  PubMed  Google Scholar 

American Psychological Association. One year later, a new wave of pandemic health concerns. American Psychological Association 2021 [cited 2024 Mar 11]; Available from: https://www.apa.org/news/press/releases/stress/2021/one-year-pandemic-stress.

Roberts A, Rogers J, Mason R, Siriwardena AN, Hogue T, Whitley GA, Law GR. Alcohol and other substance use during the COVID-19 pandemic: A systematic review. Drug Alcohol Depend. 2021;229(Pt A):109150. https://doi.org/10.1007/s40264-014-0183-6.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Maddrey WC. Hepatotoxicity: The adverse effects of drugs and other chemicals on the liver. Gastroenterology. 2000;118(5):984–5. https://doi.org/10.1016/S0016-5085(00)70192-2.

Article  Google Scholar 

Temple R. Hy’s law: predicting serious hepatotoxicity. Pharmacoepidemiol Drug Saf. 2006;15(4):241–3.

Article  PubMed  Google Scholar 

Zimmerman HJ. Hepatotoxicity: the adverse effects of drugs and other chemicals on the liver. Lippincott Williams & Wilkins; 1999.

Google Scholar 

Chalasani N, Bjornsson E. Risk factors for idiosyncratic drug-induced liver injury. Gastroenterology. 2010;138(7):2246–59.

Article  CAS  PubMed  Google Scholar 

den Brinker M, Wit FW, Wertheim-van Dillen PM, Jurriaans S, Weel J, van Leeuwen R, et al. Hepatitis B and C virus co-infection and the risk for hepatotoxicity of highly active antiretroviral therapy in HIV-1 infection. AIDS. 2000;14(18):2895–902.

Article  Google Scholar 

Hwang SJ, Wu JC, Lee CN, Yen FS, Lu CL, Lin TP, Lee SD. A prospective clinical study of isoniazid-rifampicin-pyrazinamide-induced liver injury in an area endemic for hepatitis B. J Gastroenterol Hepatol. 1997;12(1):87–91.

Article  CAS  PubMed  Google Scholar 

Massart J, Begriche K, Moreau C, Fromenty B. Role of nonalcoholic fatty liver disease as risk factor for drug-induced hepatotoxicity. J Clin Transl Res. 2017;3(1):212–32. https://doi.org/10.18053/jctres.03.2017S1.006.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Lee BH, Koh WJ, Choi MS, Suh GY, Chung MP, Kim H, Kwon OJ. Inactive hepatitis B surface antigen carrier state and hepatotoxicity during antituberculosis chemotherapy. Chest. 2005;127(4):1304–11.

CAS  PubMed  Google Scholar 

Sulkowski MS, Thomas DL, Chaisson RE, Moore RD. Hepatotoxicity associated with antiretroviral therapy in adults infected with human immunodeficiency virus and the role of hepatitis C or B virus infection. JAMA. 2000Jan 5;283(1):74–80.

Article  CAS  PubMed  Google Scholar 

Wang JY, Liu CH, Hu FC, Chang HC, Liu JL, Chen JM, et al. Risk factors of hepatitis during anti-tuberculous treatment and implications of hepatitis virus load. J Infect. 2011;62(6):448–55.

Article  PubMed  Google Scholar 

Wong WM, Wu PC, Yuen MF, Cheng CC, Yew WW, Wong PC, et al. Antituberculosis drug-related liver dysfunction in chronic hepatitis B infection. Hepatology. 2000;31(1):201–6.

Article  CAS  PubMed  Google Scholar 

Russo MW, Watkins PB. Are patients with elevated liver tests at increased risk of drug-induced liver injury? Gastroenterology. 2004;126(5):1477–80.

Article  PubMed  Google Scholar 

Lewis JH. The rational use of potentially hepatotoxic medications in patients with underlying liver disease. Expert Opin Drug Saf. 2002;1(2):159–72.

Article  CAS  PubMed  Google Scholar 

Narumoto O, Suzuki J, Takeda K, Tamura A, Nagai H, Matsui H. Rechallenge of voriconazole successfully tolerated after hepatic toxicity. Respir Med Case Rep. 2020;31: 101191.

CAS  PubMed  PubMed Central  Google Scholar 

LiverTox. Clinical and Research Information on Drug-Induced Liver Injury/Protease Inhibitors (HCV). National Library of Medicine 2022 [cited 2024 Mar 18]; Available from: https://www.ncbi.nlm.nih.gov/books/NBK548887/.

LiverTox. Clinical and Research Information on Drug-Induced Liver Injury/Viekira Pak. National Library of Medicine 2022 [cited 2024 Mar 18]; Available from: https://www.ncbi.nlm.nih.gov/books/NBK548747/.

Food and Drug Administration (FDA). Meeting of the Gastrointestinal Drugs Advisory Committee Meeting Announcement. Food and Drug Administration (FDA) 2023 [cited 2024 Mar 18]; Available from: https://www.fda.gov/advisory-committees/committees-and-meeting-materials/may-19-2023-meeting-gastrointestinal-drugs-advisory-committee-meeting-announcement-05192023.

Palmer M, Kleiner DE, Goodman Z, Brunt E, Avigan MI, Regev A, et al. Liver biopsy for assessment of suspected drug-induced liver injury in metabolic dysfunction-associated steatohepatitis clinical trials: expert consensus from the Liver Forum. Aliment Pharmacol Ther. 2024;59(2):201–16.

Article  CAS  PubMed  Google Scholar 

van Golen RF, Olthof PB, Lionarons DA, Reiniers MJ, Alles LK, Uz Z, et al. FXR agonist obeticholic acid induces liver growth but exacerbates biliary injury in rats with obstructive cholestasis. Sci Rep. 2018;8(1):16529.

Article  PubMed  PubMed Central  Google Scholar 

Hirschfield GM, Mason A, Luketic V, Lindor K, Gordon SC, Mayo M, et al. Efficacy of obeticholic acid in patients with primary biliary cirrhosis and inadequate response to ursodeoxycholic acid. Gastroenterology. 2015;148(4):751-61.e8.

Article  CAS 

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