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Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study

Background. Molnupiravir (MOL) and nirmatrelvir/ritonavir (NIR) were recently approved for the early treatment of COVID-19, but real-life data on tolerability, safety, and adverse events (AEs) are still scarce. Methods. We conducted a retrospective cohort study including all patients who were prescr...

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Autores principales: Mazzitelli, Maria, Mengato, Daniele, Sasset, Lolita, Ferrari, Anna, Gardin, Samuele, Scaglione, Vincenzo, Bonadiman, Nicola, Calandrino, Lucrezia, Cavinato, Silvia, Trivellato, Sabrina, Venturini, Francesca, Cattelan, Anna Maria
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2023
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9962206/
https://www.ncbi.nlm.nih.gov/pubmed/36851598
http://dx.doi.org/10.3390/v15020384
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author Mazzitelli, Maria
Mengato, Daniele
Sasset, Lolita
Ferrari, Anna
Gardin, Samuele
Scaglione, Vincenzo
Bonadiman, Nicola
Calandrino, Lucrezia
Cavinato, Silvia
Trivellato, Sabrina
Venturini, Francesca
Cattelan, Anna Maria
author_facet Mazzitelli, Maria
Mengato, Daniele
Sasset, Lolita
Ferrari, Anna
Gardin, Samuele
Scaglione, Vincenzo
Bonadiman, Nicola
Calandrino, Lucrezia
Cavinato, Silvia
Trivellato, Sabrina
Venturini, Francesca
Cattelan, Anna Maria
author_sort Mazzitelli, Maria
collection PubMed
description Background. Molnupiravir (MOL) and nirmatrelvir/ritonavir (NIR) were recently approved for the early treatment of COVID-19, but real-life data on tolerability, safety, and adverse events (AEs) are still scarce. Methods. We conducted a retrospective cohort study including all patients who were prescribed MOL and NIR at the Infectious Diseases Unit of Padua University Hospital, between January and May 2022. Demographic, clinical, and safety variables were recorded. Results. We included 909 patients, 48.3% males and 95.2% vaccinated against SARS-CoV-2. The median age was 73 (IQR: 62–82) years. MOL and NIR were prescribed in 407 (44.8%) and 502 (55.2%) patients, respectively. Overall, 124/909 (13.6%) patients experienced any AEs following antivirals intake: 98/124 (79%) patients reporting adverse events presented grade 1 AEs, 23/124 (18.5%) grade 2 AEs and 3 (2.5%) grade 3 AEs. Treatment discontinuation was recorded in 4.8% of patients. AEs were significantly higher in women, in patients treated with NIR compared to MOL and in people who were not vaccinated. Conclusions. In our real-life setting, AEs were higher than those reported by clinical trials, and were particularly associated with NIR use and with not being vaccinated. Further analyses are needed to better assess safety of oral antivirals and to define which patient’s profile may benefit most from MOL and NIR.
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spelling pubmed-99622062023-02-26 Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study Mazzitelli, Maria Mengato, Daniele Sasset, Lolita Ferrari, Anna Gardin, Samuele Scaglione, Vincenzo Bonadiman, Nicola Calandrino, Lucrezia Cavinato, Silvia Trivellato, Sabrina Venturini, Francesca Cattelan, Anna Maria Viruses Article Background. Molnupiravir (MOL) and nirmatrelvir/ritonavir (NIR) were recently approved for the early treatment of COVID-19, but real-life data on tolerability, safety, and adverse events (AEs) are still scarce. Methods. We conducted a retrospective cohort study including all patients who were prescribed MOL and NIR at the Infectious Diseases Unit of Padua University Hospital, between January and May 2022. Demographic, clinical, and safety variables were recorded. Results. We included 909 patients, 48.3% males and 95.2% vaccinated against SARS-CoV-2. The median age was 73 (IQR: 62–82) years. MOL and NIR were prescribed in 407 (44.8%) and 502 (55.2%) patients, respectively. Overall, 124/909 (13.6%) patients experienced any AEs following antivirals intake: 98/124 (79%) patients reporting adverse events presented grade 1 AEs, 23/124 (18.5%) grade 2 AEs and 3 (2.5%) grade 3 AEs. Treatment discontinuation was recorded in 4.8% of patients. AEs were significantly higher in women, in patients treated with NIR compared to MOL and in people who were not vaccinated. Conclusions. In our real-life setting, AEs were higher than those reported by clinical trials, and were particularly associated with NIR use and with not being vaccinated. Further analyses are needed to better assess safety of oral antivirals and to define which patient’s profile may benefit most from MOL and NIR. MDPI 2023-01-28 /pmc/articles/PMC9962206/ /pubmed/36851598 http://dx.doi.org/10.3390/v15020384 Text en © 2023 by the authors. https://creativecommons.org/licenses/by/4.0/Licensee MDPI, Basel, Switzerland. This article is an open access article distributed under the terms and conditions of the Creative Commons Attribution (CC BY) license (https://creativecommons.org/licenses/by/4.0/).
spellingShingle Article
Mazzitelli, Maria
Mengato, Daniele
Sasset, Lolita
Ferrari, Anna
Gardin, Samuele
Scaglione, Vincenzo
Bonadiman, Nicola
Calandrino, Lucrezia
Cavinato, Silvia
Trivellato, Sabrina
Venturini, Francesca
Cattelan, Anna Maria
Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title_full Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title_fullStr Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title_full_unstemmed Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title_short Molnupiravir and Nirmatrelvir/Ritonavir: Tolerability, Safety, and Adherence in a Retrospective Cohort Study
title_sort molnupiravir and nirmatrelvir/ritonavir: tolerability, safety, and adherence in a retrospective cohort study
topic Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9962206/
https://www.ncbi.nlm.nih.gov/pubmed/36851598
http://dx.doi.org/10.3390/v15020384
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