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.
Keywords: FAERS; Liver injury; Lopinavir-ritonavir; Novel coronavirus disease 2019.
【저자키워드】 Liver injury, Lopinavir-ritonavir, FAERS, Novel coronavirus disease 2019., 【초록키워드】 COVID-19, coronavirus disease, Coronavirus disease 2019, Chloroquine, Hydroxychloroquine, Lopinavir, Ritonavir, drugs, Remdesivir, risk, drug, novel coronavirus disease, Novel coronavirus, Patient, Liver injury, Reporting, novel, association, food, Evidence, Drug-induced liver injury, Lopinavir-ritonavir, Analysis, Injury, Odds ratio, evidence of, Adverse, 95% confidence interval, hydroxychloroquine/chloroquine, System, objective, Result, evaluate, reported, the patient, conducted, provided, calculated, CIs, patients treated, patients with COVID-19, with COVID-19, 【제목키워드】 adverse event, Patient, Lopinavir-ritonavir, Analysis, drug-induced, Drug administration,