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Article: Risk of acute liver injury following the nirmatrelvir/ritonavir use

TitleRisk of acute liver injury following the nirmatrelvir/ritonavir use
Authors
Keywordsacute liver injury
case series
COVID-19
nirmatrelvir/ritonavir
Issue Date13-Jul-2023
PublisherWiley
Citation
Liver International, 2023, v. 43, n. 12, p. 2657-2667 How to Cite?
Abstract

Background: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were reported as adverse events of nirmatrelvir/ritonavir users in the EPIC-HR trial.

Aim: To quantify the risk and severity of acute liver injury (ALI) associated with nirmatrelvir/ritonavir use.

Methods: This self-controlled case-series study was conducted using electronic medical records of patients with confirmed diagnosis of SARS-CoV-2 infection between 26th February 2022 and 12th February 2023 in Hong Kong.

Results: Among 2 409 848 patients with SARS-CoV-2 infection during the study period, 153 853 were prescribed with nirmatrelvir/ritonavir, of whom 834 (.5%) had incident ALI (moderate: 30.5%; moderate to severe: 18.9%; severe or fatal: 5.8%). Compared with the non-exposure period, risk of ALI increased significantly during the pre-exposure period (IRR = 38.13, 95% CI = 29.29-49.62) and remained elevated during the five-day nirmatrelvir/ritonavir treatment (IRR = 20.75, 95% CI = 17.06-25.25) and during wash-out period (IRR = 16.27, 95% CI = 13.23-20.01). Compared to the pre-exposure period, risk of ALI was not increased during the five-day nirmatrelvir/ritonavir treatment period (IRR = .54, 95% CI = .43-.70). Compared to 5469 non-nirmatrelvir/ritonavir users with incident ALI, nirmatrelvir/ritonavir users had less severe ALI by the severity index (p < .001) and peak INR (1.7 vs. 2.3; p < .001). ALI cases with nirmatrelvir/ritonavir use had lower risk of all-cause death (29.1% vs. 39.1%; OR = .64; p < .001) and no increase in risk of liver decompensation (1.0% vs. 1.3%; OR = .62; p = .230) compared to non-users.

Conclusion: The risk of ALI associated with nirmatrelvir/ritonavir treatment for COVID-19 was elevated in the pre-exposure period, but not following nirmatrelvir/ritonavir initiation. ALI following nirmatrelvir/ritonavir treatment were mostly mild and less severe than ALI events in non-nirmatrelvir/ritonavir users.


Persistent Identifierhttp://hdl.handle.net/10722/337984
ISSN
2023 Impact Factor: 6.0
2023 SCImago Journal Rankings: 2.087
ISI Accession Number ID

 

DC FieldValueLanguage
dc.contributor.authorWong, Carlos King Ho-
dc.contributor.authorMak, Lung Yi-
dc.contributor.authorAu, Ivan Chi Ho-
dc.contributor.authorCheng, Wing Yiu-
dc.contributor.authorSo, Ching Hei-
dc.contributor.authorLau, Kristy Tsz Kwan-
dc.contributor.authorLau, Eric Ho Yin-
dc.contributor.authorCowling, Benjamin J-
dc.contributor.authorLeung, Gabriel M-
dc.contributor.authorYuen, Man Fung-
dc.date.accessioned2024-03-11T10:25:24Z-
dc.date.available2024-03-11T10:25:24Z-
dc.date.issued2023-07-13-
dc.identifier.citationLiver International, 2023, v. 43, n. 12, p. 2657-2667-
dc.identifier.issn1478-3223-
dc.identifier.urihttp://hdl.handle.net/10722/337984-
dc.description.abstract<p><strong>Background: </strong>Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were reported as adverse events of nirmatrelvir/ritonavir users in the EPIC-HR trial.</p><p><strong>Aim: </strong>To quantify the risk and severity of acute liver injury (ALI) associated with nirmatrelvir/ritonavir use.</p><p><strong>Methods: </strong>This self-controlled case-series study was conducted using electronic medical records of patients with confirmed diagnosis of SARS-CoV-2 infection between 26th February 2022 and 12th February 2023 in Hong Kong.</p><p><strong>Results: </strong>Among 2 409 848 patients with SARS-CoV-2 infection during the study period, 153 853 were prescribed with nirmatrelvir/ritonavir, of whom 834 (.5%) had incident ALI (moderate: 30.5%; moderate to severe: 18.9%; severe or fatal: 5.8%). Compared with the non-exposure period, risk of ALI increased significantly during the pre-exposure period (IRR = 38.13, 95% CI = 29.29-49.62) and remained elevated during the five-day nirmatrelvir/ritonavir treatment (IRR = 20.75, 95% CI = 17.06-25.25) and during wash-out period (IRR = 16.27, 95% CI = 13.23-20.01). Compared to the pre-exposure period, risk of ALI was not increased during the five-day nirmatrelvir/ritonavir treatment period (IRR = .54, 95% CI = .43-.70). Compared to 5469 non-nirmatrelvir/ritonavir users with incident ALI, nirmatrelvir/ritonavir users had less severe ALI by the severity index (p < .001) and peak INR (1.7 vs. 2.3; p < .001). ALI cases with nirmatrelvir/ritonavir use had lower risk of all-cause death (29.1% vs. 39.1%; OR = .64; p < .001) and no increase in risk of liver decompensation (1.0% vs. 1.3%; OR = .62; p = .230) compared to non-users.</p><p><strong>Conclusion: </strong>The risk of ALI associated with nirmatrelvir/ritonavir treatment for COVID-19 was elevated in the pre-exposure period, but not following nirmatrelvir/ritonavir initiation. ALI following nirmatrelvir/ritonavir treatment were mostly mild and less severe than ALI events in non-nirmatrelvir/ritonavir users.</p>-
dc.languageeng-
dc.publisherWiley-
dc.relation.ispartofLiver International-
dc.rightsThis work is licensed under a Creative Commons Attribution-NonCommercial-NoDerivatives 4.0 International License.-
dc.subjectacute liver injury-
dc.subjectcase series-
dc.subjectCOVID-19-
dc.subjectnirmatrelvir/ritonavir-
dc.titleRisk of acute liver injury following the nirmatrelvir/ritonavir use-
dc.typeArticle-
dc.description.naturepublished_or_final_version-
dc.identifier.doi10.1111/liv.15673-
dc.identifier.scopuseid_2-s2.0-85165189005-
dc.identifier.volume43-
dc.identifier.issue12-
dc.identifier.spage2657-
dc.identifier.epage2667-
dc.identifier.eissn1478-3231-
dc.identifier.isiWOS:001027258800001-
dc.identifier.issnl1478-3223-

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