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Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic

INTRODUCTION: When the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic began, there were no effective treatments assessed by clinical trials. In this context, in France, the French Public Health Council issued, from 5 March, 2020, several proposed recommendations for the therap...

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Autores principales: Lory, Pauline, Combret, Sandrine, Michot, Joelle, Veyrac, Gwenaelle, Chouchana, Laurent, Grandvuillemin, Aurélie
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9618454/
https://www.ncbi.nlm.nih.gov/pubmed/36376122
http://dx.doi.org/10.1016/j.therap.2022.10.066
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author Lory, Pauline
Combret, Sandrine
Michot, Joelle
Veyrac, Gwenaelle
Chouchana, Laurent
Grandvuillemin, Aurélie
author_facet Lory, Pauline
Combret, Sandrine
Michot, Joelle
Veyrac, Gwenaelle
Chouchana, Laurent
Grandvuillemin, Aurélie
author_sort Lory, Pauline
collection PubMed
description INTRODUCTION: When the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic began, there were no effective treatments assessed by clinical trials. In this context, in France, the French Public Health Council issued, from 5 March, 2020, several proposed recommendations for the therapeutic management of this new disease. This included the use of combination lopinavir/ritonavir, which is usually indicated as HIV treatment. Thanks to the reporting of adverse drug reactions (ADRs) to the French Regional Pharmacovigilance Centers, several safety signals including hepatobiliary and cardiovascular were quickly identified. OBJECTIVE: This study aimed to compare the ADRs reported with lopinavir/ritonavir used in its usual indication prior to the pandemic with the ADRs reported with the coronavirus disease 2019 (COVID-19) indication. METHODS: Cases of ADRs were extracted from the French Pharmacovigilance Database. ADRs were compared between the two periods: pre-COVID (1985 to 31 December 2019) and COVID (1 January 2020 to 21 July 2020). RESULTS: Patients with COVID-19 were found to have a different safety profile, with significantly more damage to the liver (43% of ADRs), heart (10.6%) and kidneys (7.1%). The ADRs reported before the pandemic were mainly gastrointestinal and cutaneous. CONCLUSIONS: This different safety profile may be related to the effect of the virus on the organs, the patient profile (age, medical history…) and the drugs associated with lopinavir/ritonavir. Our study should serve as a reminder that the safety profile of a drug can depend on its use. Spontaneous reporting and pharmacovigilance have a critical role in alerting health professionals to “new” ADRs reported with well-known drugs.
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spelling pubmed-96184542022-10-31 Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic Lory, Pauline Combret, Sandrine Michot, Joelle Veyrac, Gwenaelle Chouchana, Laurent Grandvuillemin, Aurélie Therapie Pharmacovigilance INTRODUCTION: When the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic began, there were no effective treatments assessed by clinical trials. In this context, in France, the French Public Health Council issued, from 5 March, 2020, several proposed recommendations for the therapeutic management of this new disease. This included the use of combination lopinavir/ritonavir, which is usually indicated as HIV treatment. Thanks to the reporting of adverse drug reactions (ADRs) to the French Regional Pharmacovigilance Centers, several safety signals including hepatobiliary and cardiovascular were quickly identified. OBJECTIVE: This study aimed to compare the ADRs reported with lopinavir/ritonavir used in its usual indication prior to the pandemic with the ADRs reported with the coronavirus disease 2019 (COVID-19) indication. METHODS: Cases of ADRs were extracted from the French Pharmacovigilance Database. ADRs were compared between the two periods: pre-COVID (1985 to 31 December 2019) and COVID (1 January 2020 to 21 July 2020). RESULTS: Patients with COVID-19 were found to have a different safety profile, with significantly more damage to the liver (43% of ADRs), heart (10.6%) and kidneys (7.1%). The ADRs reported before the pandemic were mainly gastrointestinal and cutaneous. CONCLUSIONS: This different safety profile may be related to the effect of the virus on the organs, the patient profile (age, medical history…) and the drugs associated with lopinavir/ritonavir. Our study should serve as a reminder that the safety profile of a drug can depend on its use. Spontaneous reporting and pharmacovigilance have a critical role in alerting health professionals to “new” ADRs reported with well-known drugs. Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. 2022-10-31 /pmc/articles/PMC9618454/ /pubmed/36376122 http://dx.doi.org/10.1016/j.therap.2022.10.066 Text en © 2022 Société française de pharmacologie et de thérapeutique. Published by Elsevier Masson SAS. All rights reserved. Since January 2020 Elsevier has created a COVID-19 resource centre with free information in English and Mandarin on the novel coronavirus COVID-19. The COVID-19 resource centre is hosted on Elsevier Connect, the company's public news and information website. Elsevier hereby grants permission to make all its COVID-19-related research that is available on the COVID-19 resource centre - including this research content - immediately available in PubMed Central and other publicly funded repositories, such as the WHO COVID database with rights for unrestricted research re-use and analyses in any form or by any means with acknowledgement of the original source. These permissions are granted for free by Elsevier for as long as the COVID-19 resource centre remains active.
spellingShingle Pharmacovigilance
Lory, Pauline
Combret, Sandrine
Michot, Joelle
Veyrac, Gwenaelle
Chouchana, Laurent
Grandvuillemin, Aurélie
Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title_full Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title_fullStr Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title_full_unstemmed Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title_short Safety profile of the lopinavir/ritonavir combination before and during the SARS-CoV-2 pandemic
title_sort safety profile of the lopinavir/ritonavir combination before and during the sars-cov-2 pandemic
topic Pharmacovigilance
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9618454/
https://www.ncbi.nlm.nih.gov/pubmed/36376122
http://dx.doi.org/10.1016/j.therap.2022.10.066
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