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Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience

INTRODUCTION: Different antivirals are available for the treatment of outpatients with COVID-19. Our aim was to describe a real-world experience of outpatient management of COVID-19 subjects at high risk of progression. METHODS: This prospective observational study conducted in the University Hospit...

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Autores principales: Tiseo, Giusy, Barbieri, Chiara, Galfo, Valentina, Occhineri, Sara, Matucci, Tommaso, Almerigogna, Francesco, Kalo, Jona, Sponga, Pietro, Cesaretti, Mario, Marchetti, Gabriele, Forniti, Arianna, Caroselli, Claudio, Ferranti, Simone, Pogliaghi, Manuela, Polidori, Marina, Fabiani, Silvia, Verdenelli, Stefano, Tagliaferri, Enrico, Riccardi, Niccolò, Suardi, Lorenzo Roberto, Carmignani, Claudia, Batini, Serena, Puccetti, Luca, Iapoce, Riccardo, Menichetti, Francesco, Falcone, Marco
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer Healthcare 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9707131/
https://www.ncbi.nlm.nih.gov/pubmed/36441485
http://dx.doi.org/10.1007/s40121-022-00729-2
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author Tiseo, Giusy
Barbieri, Chiara
Galfo, Valentina
Occhineri, Sara
Matucci, Tommaso
Almerigogna, Francesco
Kalo, Jona
Sponga, Pietro
Cesaretti, Mario
Marchetti, Gabriele
Forniti, Arianna
Caroselli, Claudio
Ferranti, Simone
Pogliaghi, Manuela
Polidori, Marina
Fabiani, Silvia
Verdenelli, Stefano
Tagliaferri, Enrico
Riccardi, Niccolò
Suardi, Lorenzo Roberto
Carmignani, Claudia
Batini, Serena
Puccetti, Luca
Iapoce, Riccardo
Menichetti, Francesco
Falcone, Marco
author_facet Tiseo, Giusy
Barbieri, Chiara
Galfo, Valentina
Occhineri, Sara
Matucci, Tommaso
Almerigogna, Francesco
Kalo, Jona
Sponga, Pietro
Cesaretti, Mario
Marchetti, Gabriele
Forniti, Arianna
Caroselli, Claudio
Ferranti, Simone
Pogliaghi, Manuela
Polidori, Marina
Fabiani, Silvia
Verdenelli, Stefano
Tagliaferri, Enrico
Riccardi, Niccolò
Suardi, Lorenzo Roberto
Carmignani, Claudia
Batini, Serena
Puccetti, Luca
Iapoce, Riccardo
Menichetti, Francesco
Falcone, Marco
author_sort Tiseo, Giusy
collection PubMed
description INTRODUCTION: Different antivirals are available for the treatment of outpatients with COVID-19. Our aim was to describe a real-world experience of outpatient management of COVID-19 subjects at high risk of progression. METHODS: This prospective observational study conducted in the University Hospital of Pisa (January 2022–July 2022) included consecutive COVID-19 outpatients with at least one risk factor for disease progression. Patients received nirmatrelvir/ritonavir, molnupiravir, or 3-day remdesivir, according to the Italian Medicines Agency (AIFA) indications. All patients were followed up until 30 days from the first positive nasopharyngeal swab. The primary endpoint was a composite of death or hospitalization. Secondary endpoints were occurrence of adverse events and a negative test within 10 days from the first positive test. Multivariable analysis was performed to identify factors associated with death or hospitalization. RESULTS: Overall, 562 outpatients were included: 114 (20.3%) received molnupiravir, 252 (44.8%) nirmatrelvir/ritonavir, and 196 (34.9%) 3-day remdesivir. The composite endpoint occurred in 2.5% of patients and was more frequent in patients treated with remdesivir (5.1%) compared with molnupiravir (1.8%) or nirmatrelvir/ritonavir (0.8%, ANOVA among groups p = 0.012). On multivariable Cox regression analysis, presence of ≥ 3 comorbidities, hematological disease, gastrointestinal symptoms, and each-day increment from symptoms onset were factors associated with death or hospitalization, while antiviral treatment was not a predictor. Adverse events occurred more frequently in the nirmatrelvir/ritonavir group (49.2%). Nirmatrelvir/ritonavir compared with remdesivir was associated with a higher probability of having a negative test within 10 days from the first positive one. CONCLUSION: Death or hospitalization did not differ among high-risk COVID-19 outpatients treated with currently available antivirals. Safety and time to a negative test differed among the three drugs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00729-2.
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spelling pubmed-97071312022-11-29 Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience Tiseo, Giusy Barbieri, Chiara Galfo, Valentina Occhineri, Sara Matucci, Tommaso Almerigogna, Francesco Kalo, Jona Sponga, Pietro Cesaretti, Mario Marchetti, Gabriele Forniti, Arianna Caroselli, Claudio Ferranti, Simone Pogliaghi, Manuela Polidori, Marina Fabiani, Silvia Verdenelli, Stefano Tagliaferri, Enrico Riccardi, Niccolò Suardi, Lorenzo Roberto Carmignani, Claudia Batini, Serena Puccetti, Luca Iapoce, Riccardo Menichetti, Francesco Falcone, Marco Infect Dis Ther Original Research INTRODUCTION: Different antivirals are available for the treatment of outpatients with COVID-19. Our aim was to describe a real-world experience of outpatient management of COVID-19 subjects at high risk of progression. METHODS: This prospective observational study conducted in the University Hospital of Pisa (January 2022–July 2022) included consecutive COVID-19 outpatients with at least one risk factor for disease progression. Patients received nirmatrelvir/ritonavir, molnupiravir, or 3-day remdesivir, according to the Italian Medicines Agency (AIFA) indications. All patients were followed up until 30 days from the first positive nasopharyngeal swab. The primary endpoint was a composite of death or hospitalization. Secondary endpoints were occurrence of adverse events and a negative test within 10 days from the first positive test. Multivariable analysis was performed to identify factors associated with death or hospitalization. RESULTS: Overall, 562 outpatients were included: 114 (20.3%) received molnupiravir, 252 (44.8%) nirmatrelvir/ritonavir, and 196 (34.9%) 3-day remdesivir. The composite endpoint occurred in 2.5% of patients and was more frequent in patients treated with remdesivir (5.1%) compared with molnupiravir (1.8%) or nirmatrelvir/ritonavir (0.8%, ANOVA among groups p = 0.012). On multivariable Cox regression analysis, presence of ≥ 3 comorbidities, hematological disease, gastrointestinal symptoms, and each-day increment from symptoms onset were factors associated with death or hospitalization, while antiviral treatment was not a predictor. Adverse events occurred more frequently in the nirmatrelvir/ritonavir group (49.2%). Nirmatrelvir/ritonavir compared with remdesivir was associated with a higher probability of having a negative test within 10 days from the first positive one. CONCLUSION: Death or hospitalization did not differ among high-risk COVID-19 outpatients treated with currently available antivirals. Safety and time to a negative test differed among the three drugs. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1007/s40121-022-00729-2. Springer Healthcare 2022-11-28 2023-01 /pmc/articles/PMC9707131/ /pubmed/36441485 http://dx.doi.org/10.1007/s40121-022-00729-2 Text en © The Author(s) 2022 https://creativecommons.org/licenses/by-nc/4.0/Open AccessThis article is licensed under a Creative Commons Attribution-NonCommercial 4.0 International License, which permits any non-commercial use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by-nc/4.0/ (https://creativecommons.org/licenses/by-nc/4.0/) .
spellingShingle Original Research
Tiseo, Giusy
Barbieri, Chiara
Galfo, Valentina
Occhineri, Sara
Matucci, Tommaso
Almerigogna, Francesco
Kalo, Jona
Sponga, Pietro
Cesaretti, Mario
Marchetti, Gabriele
Forniti, Arianna
Caroselli, Claudio
Ferranti, Simone
Pogliaghi, Manuela
Polidori, Marina
Fabiani, Silvia
Verdenelli, Stefano
Tagliaferri, Enrico
Riccardi, Niccolò
Suardi, Lorenzo Roberto
Carmignani, Claudia
Batini, Serena
Puccetti, Luca
Iapoce, Riccardo
Menichetti, Francesco
Falcone, Marco
Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title_full Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title_fullStr Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title_full_unstemmed Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title_short Efficacy and Safety of Nirmatrelvir/Ritonavir, Molnupiravir, and Remdesivir in a Real-World Cohort of Outpatients with COVID-19 at High Risk of Progression: The PISA Outpatient Clinic Experience
title_sort efficacy and safety of nirmatrelvir/ritonavir, molnupiravir, and remdesivir in a real-world cohort of outpatients with covid-19 at high risk of progression: the pisa outpatient clinic experience
topic Original Research
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9707131/
https://www.ncbi.nlm.nih.gov/pubmed/36441485
http://dx.doi.org/10.1007/s40121-022-00729-2
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