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.,
Drug-induced liver injury associated with lopinavir-ritonavir in patients with COVID-19: a disproportionality..,
International Journal of Clinical Pharmacy, doi:10.1007/s11096-021-01311-5
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.
Abstract: International Journal of Clinical Pharmacy (2021) 43:1116–1122
https://doi.org/10.1007/s11096-021-01311-5
RESEARCH ARTICLE
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 Tang1 · Liyuan Zhou2 · Xiaotong Li3 · Alan C. Kinlaw4,5 · Jeff Y. Yang6 · Andrew M. Moon7,8 ·
Edward L. Barnes7,8 · Tiansheng Wang6
Received: 4 May 2021 / Accepted: 21 July 2021 / Published online: 30 July 2021
© The Author(s), under exclusive licence to Springer Nature Switzerland AG 2021
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 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.
Keywords FAERS · Liver injury · Lopinavir-ritonavir · Novel coronavirus disease 2019
Impacts on practice
• COVID-19 patients treated with lopinavir-ritonavir are
at increased risk of liver injury.
Huilin Tang and Liyuan Zhou contributed equally to this work
* Huilin Tang
tang.huilin@ufl.edu
1
Department of Pharmaceutical Outcomes and Policy,
University of Florida College of Pharmacy, Gainesville, FL,
USA
2
Department of Biostatistics, Gillings School of Global
Public Health, University of North Carolina At Chapel Hill,
Chapel Hill, NC, USA
3
Institute for Drug Evaluation, Peking University Health
Science Center, Beijing, China
4
Division of Pharmaceutical Outcome and Policy, University
of North Carolina School of Pharmacy, Chapel Hill, NC,
USA
13
Vol:.(1234567890)
5
Cecil G. Sheps Center for Health Services Research,
University of North Carolina At Chapel Hill, Chapel Hill,
NC, USA
6
Department of Epidemiology, Gillings School of Global
Public Health, University of North Carolina At Chapel Hill,
Chapel Hill, NC, USA
7
Center for Gastrointestinal Biology and Disease, School
of Medicine, University of North Carolina At Chapel Hill,
Chapel Hill, NC, USA
8
Division of Gastroenterology and Hepatology, Department
of Medicine, University of North Carolina At Chapel Hill,
Chapel Hill, NC, USA
International Journal of Clinical Pharmacy (2021) 43:1116–1122
• The risk of liver injury reinforces recent..
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