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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

Tang et al., International Journal of Clinical Pharmacy, doi:10.1007/s11096-021-01311-5
Jul 2021  
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Disproportionality analysis showing higher risk of liver injury with lopinavir/ritonavir for COVID-19 patients. Paxlovid combines nirmatrelvir and ritonavir.
Tang et al., 30 Jul 2021, peer-reviewed, 8 authors. Contact: tang.huilin@ufl.edu.
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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
Huilin Tang, Liyuan Zhou, Xiaotong Li, Alan C Kinlaw, Jeff Y Yang, Andrew M Moon, Edward L Barnes, Tiansheng Wang
International Journal of Clinical Pharmacy, doi:10.1007/s11096-021-01311-5
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 lopinavirritonavir 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 druginduced liver injury associated with lopinavir-ritonavir in patients with COVID-19.
Declarations Conflicts of interest HT is a consultant for Evidpro, LLC. The other authors have no conflict of interest to declare. Publisher's Note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.
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