Evidence map›Paper›PMID 34328585›Full record

ArticleInternational journal of clinical pharmacy2021

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

Open access · bronzeAbstract read
PubMed Full text at PMC Publisher
In one paragraph

Article in International journal of clinical pharmacy, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
2.6field-weighted citation impact, top 11% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

8 citing papers in PubMed, 16 citations in OpenAlex.

  1. Review
  2. Review
  3. Article
  4. COVID-19-Associated Liver Injury.Hepatic medicine : evidence and research · 2023
    Review
  5. Review
  6. Liver injury induced by COVID 19 treatment - what do we know?World journal of gastroenterology · 2022
    Review
  7. Article
  8. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors at 3 institutions in 2 countries.

Huilin Tang *Department of Pharmaceutical Outcomes and Policy, University of Florida College of Pharmacy, Gainesville, FL, USA. tang.huilin@ufl.edu.ORCID http://orcid.org/0000-0002-5814-6657
Liyuan Zhou *Department of Biostatistics, Gillings School of Global Public Health, University of North Carolina At Chapel Hill, Chapel Hill, NC, USA.
Xiaotong LiInstitute for Drug Evaluation, Peking University Health Science Center, Beijing, China.
Alan C KinlawDivision of Pharmaceutical Outcome and Policy, University of North Carolina School of Pharmacy, Chapel Hill, NC, USA.
Jeff Y YangDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina At Chapel Hill, Chapel Hill, NC, USA.
Andrew M MoonCenter for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina At Chapel Hill, Chapel Hill, NC, USA.
Edward L BarnesCenter for Gastrointestinal Biology and Disease, School of Medicine, University of North Carolina At Chapel Hill, Chapel Hill, NC, USA.
Tiansheng WangDepartment of Epidemiology, Gillings School of Global Public Health, University of North Carolina At Chapel Hill, Chapel Hill, NC, USA.
University of North Carolina at Chapel Hill · USPeking University · CNUniversity of Florida · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

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.

Indexed as

Adverse Drug Reaction Reporting SystemsAgedAnti-HIV AgentsChemical and Drug Induced Liver InjuryCOVID-19Drug CombinationsFemaleHIV InfectionsHumansLopinavirMaleMiddle AgedRitonavirUnited StatesUnited States Food and Drug AdministrationAnti-HIV AgentsDrug CombinationsLopinavirlopinavir-ritonavir drug combinationRitonavirFAERSLiver injuryLopinavir-ritonavirNovel coronavirus disease 2019

Identifiers

PMID34328585
PMCPMC8323539
OpenAlexW3163255733

What OpenQuestion holds

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Registered trials

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.