Drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19: a disproportionality analysis of U.S. food and drug administration adverse event reporting system (FAERS) data

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  • Tang, Huilin
    • Other Affiliation: University of Florida College of Pharmacy
  • Zhou, Liyuan
    • Affiliation: Gillings School of Global Public Health, Department of Biostatistics
  • Li, Xiaotong
    • Other Affiliation: Peking University Health Science Center
  • Kinlaw, Alan C.
  • Yang, Jeff Y.
    • Affiliation: Gillings School of Global Public Health, Department of Epidemiology
  • Moon, Andrew M.
    • Affiliation: Center for Gastrointestinal Biology and Disease
  • Barnes, Edward L.
    • Affiliation: Center for Gastrointestinal Biology and Disease
  • Wang, Tiansheng
    • Affiliation: Gillings School of Global Public Health, Department of Epidemiology
Abstract
  • Background Liver injury has been documented independently in novel coronavirus disease 2019 (COVID-19) patients and patients treated with lopinavir-ritonavir. Objective to investigate the drug-induced liver injury associated with lopinavir-ritonavir among the patients with COVID-19. Methods We conducted a disproportionality analysis of US Food and Drug Administration Adverse Event Reporting System (FAERS) between 2020Q1 and 2021Q1 to evaluate the association between lopinavir-ritonavir and risk of drug-induced liver injury (or severe drug-induced liver injury) and calculated their reporting odds ratios (RORs) with 95% confidence intervals (CIs). Results A total of 3,425 cases of drug-induced liver injury were reported in 19,782 patients with COVID-19. The ROR for drug-induced liver injury was 2.99 (2.59–3.46), 3.16 (2.68–3.73), and 5.39 (4.63–6.26) when comparing lopinavir-ritonavir with all other drugs, hydroxychloroquine/chloroquine only, and remdesivir, respectively. For severe drug-induced liver injury, RORs for lopinavir-ritonavir provided evidence of an association compared with all other drugs (3.98; 3.15–5.05), compared with hydroxychloroquine/chloroquine only (5.33; 4.09–6.94), and compared with remdesivir (3.85; 3.03–4.89). Conclusions In the FAERS, we observed a disproportional signal for drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19.
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  • International Journal of Clinical Pharmacy
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  • English
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  • 2210-7703

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