Risk of acute liver injury following the nirmatrelvir/ritonavir use
© 2023 The Authors. Liver International published by John Wiley & Sons Ltd..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2023 |
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| Erschienen: |
2023 |
| Enthalten in: |
Zur Gesamtaufnahme - volume:43 |
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| Enthalten in: |
Liver international : official journal of the International Association for the Study of the Liver - 43(2023), 12 vom: 10. Dez., Seite 2657-2667 |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Wong, Carlos King Ho [VerfasserIn] |
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| Links: |
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| Themen: |
7R9A5P7H32 |
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| Anmerkungen: |
Date Completed 29.11.2023 Date Revised 26.01.2024 published: Print-Electronic Citation Status MEDLINE |
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| doi: |
10.1111/liv.15673 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM359488579 |
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| 100 | 1 | |a Wong, Carlos King Ho |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Risk of acute liver injury following the nirmatrelvir/ritonavir use |
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| 500 | |a Date Completed 29.11.2023 | ||
| 500 | |a Date Revised 26.01.2024 | ||
| 500 | |a published: Print-Electronic | ||
| 500 | |a Citation Status MEDLINE | ||
| 520 | |a © 2023 The Authors. Liver International published by John Wiley & Sons Ltd. | ||
| 520 | |a BACKGROUND: Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were reported as adverse events of nirmatrelvir/ritonavir users in the EPIC-HR trial | ||
| 520 | |a AIM: To quantify the risk and severity of acute liver injury (ALI) associated with nirmatrelvir/ritonavir use | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a Research Support, Non-U.S. Gov't | |
| 650 | 4 | |a COVID-19 | |
| 650 | 4 | |a acute liver injury | |
| 650 | 4 | |a case series | |
| 650 | 4 | |a nirmatrelvir/ritonavir | |
| 650 | 7 | |a nirmatrelvir |2 NLM | |
| 650 | 7 | |a 7R9A5P7H32 |2 NLM | |
| 650 | 7 | |a Ritonavir |2 NLM | |
| 650 | 7 | |a O3J8G9O825 |2 NLM | |
| 650 | 7 | |a Antiviral Agents |2 NLM | |
| 700 | 1 | |a Mak, Lung Yi |e verfasserin |4 aut | |
| 700 | 1 | |a Au, Ivan Chi Ho |e verfasserin |4 aut | |
| 700 | 1 | |a Cheng, Wing Yiu |e verfasserin |4 aut | |
| 700 | 1 | |a So, Ching Hei |e verfasserin |4 aut | |
| 700 | 1 | |a Lau, Kristy Tsz Kwan |e verfasserin |4 aut | |
| 700 | 1 | |a Lau, Eric Ho Yin |e verfasserin |4 aut | |
| 700 | 1 | |a Cowling, Benjamin J |e verfasserin |4 aut | |
| 700 | 1 | |a Leung, Gabriel M |e verfasserin |4 aut | |
| 700 | 1 | |a Yuen, Man Fung |e verfasserin |4 aut | |
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