Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study

Molnupiravir and nirmatrelvir were the first available oral antivirals (OAs) active against SARS-CoV-2. Trials evaluating the efficacy of OAs involved patients unvaccinated and infected with variants different from those currently circulating. We conducted a retrospective study on patients with conf...

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Main Authors: Ivan Gentile, Riccardo Scotto, Nicola Schiano Moriello, Biagio Pinchera, Riccardo Villari, Emilia Trucillo, Luigi Ametrano, Ludovica Fusco, Giuseppe Castaldo, Antonio Riccardo Buonomo, Federico II COVID Team
Format: Article
Language:English
Published: MDPI AG 2022-10-01
Series:Vaccines
Subjects:
Online Access:https://www.mdpi.com/2076-393X/10/10/1731
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author Ivan Gentile
Riccardo Scotto
Nicola Schiano Moriello
Biagio Pinchera
Riccardo Villari
Emilia Trucillo
Luigi Ametrano
Ludovica Fusco
Giuseppe Castaldo
Antonio Riccardo Buonomo
Federico II COVID Team
author_facet Ivan Gentile
Riccardo Scotto
Nicola Schiano Moriello
Biagio Pinchera
Riccardo Villari
Emilia Trucillo
Luigi Ametrano
Ludovica Fusco
Giuseppe Castaldo
Antonio Riccardo Buonomo
Federico II COVID Team
author_sort Ivan Gentile
collection DOAJ
description Molnupiravir and nirmatrelvir were the first available oral antivirals (OAs) active against SARS-CoV-2. Trials evaluating the efficacy of OAs involved patients unvaccinated and infected with variants different from those currently circulating. We conducted a retrospective study on patients with confirmed SARS-CoV-2 infection treated with OAs during the omicron surge in Italy in order to provide real-life data on the efficacy and safety of OAs during the omicron surge of the COVID-19 pandemic. Among 257 patients, 56.8% received molnupiravir, while 43.2% received nirmatrelvir/ritonavir. Patients in the molnupiravir group were older, had a lower body mass index, and had a higher rate of chronic heart disease than those treated with nirmatrelvir/ritonavir. Three hospitalizations were recorded in the molnupiravir (2.1%) group and one in the nirmatrelvir/ritonavir (0.9%) group. One patient treated with molnupiravir died. The median time to negativity was 8 days in the nirmatrelvir/ritonavir group vs. 10 days in the molnupiravir group, <i>p</i> < 0.01. We recorded 37 ADRs (mainly dysgeusia, diarrhea, and nausea) in 31 individuals (12.1%). Only two patients (0.8%) treated with molnupiravir terminated treatment due to ADRs. In conclusion, in a population of mostly vaccinated patients treated with OAs, we observed a low rate of hospitalization, death, and adverse drug reactions. These rates were lower than those reported in pivotal trials.
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spelling doaj.art-a63032da6acd49c3980b11788fa115972023-11-24T03:05:05ZengMDPI AGVaccines2076-393X2022-10-011010173110.3390/vaccines10101731Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life StudyIvan Gentile0Riccardo Scotto1Nicola Schiano Moriello2Biagio Pinchera3Riccardo Villari4Emilia Trucillo5Luigi Ametrano6Ludovica Fusco7Giuseppe Castaldo8Antonio Riccardo Buonomo9Federico II COVID TeamDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyDepartment of Molecular Medicine and Medical Biotechnologies, University of Naples Federico II, 80131 Naples, ItalyDepartment of Clinical Medicine and Surgery—Section of Infectious Diseases, University of Naples Federico II, 80131 Naples, ItalyMolnupiravir and nirmatrelvir were the first available oral antivirals (OAs) active against SARS-CoV-2. Trials evaluating the efficacy of OAs involved patients unvaccinated and infected with variants different from those currently circulating. We conducted a retrospective study on patients with confirmed SARS-CoV-2 infection treated with OAs during the omicron surge in Italy in order to provide real-life data on the efficacy and safety of OAs during the omicron surge of the COVID-19 pandemic. Among 257 patients, 56.8% received molnupiravir, while 43.2% received nirmatrelvir/ritonavir. Patients in the molnupiravir group were older, had a lower body mass index, and had a higher rate of chronic heart disease than those treated with nirmatrelvir/ritonavir. Three hospitalizations were recorded in the molnupiravir (2.1%) group and one in the nirmatrelvir/ritonavir (0.9%) group. One patient treated with molnupiravir died. The median time to negativity was 8 days in the nirmatrelvir/ritonavir group vs. 10 days in the molnupiravir group, <i>p</i> < 0.01. We recorded 37 ADRs (mainly dysgeusia, diarrhea, and nausea) in 31 individuals (12.1%). Only two patients (0.8%) treated with molnupiravir terminated treatment due to ADRs. In conclusion, in a population of mostly vaccinated patients treated with OAs, we observed a low rate of hospitalization, death, and adverse drug reactions. These rates were lower than those reported in pivotal trials.https://www.mdpi.com/2076-393X/10/10/1731COVID-19SARS-CoV-2molnupiravirnirmatrelvir/ritonavirhospitalizationadverse drug reactions
spellingShingle Ivan Gentile
Riccardo Scotto
Nicola Schiano Moriello
Biagio Pinchera
Riccardo Villari
Emilia Trucillo
Luigi Ametrano
Ludovica Fusco
Giuseppe Castaldo
Antonio Riccardo Buonomo
Federico II COVID Team
Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
Vaccines
COVID-19
SARS-CoV-2
molnupiravir
nirmatrelvir/ritonavir
hospitalization
adverse drug reactions
title Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
title_full Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
title_fullStr Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
title_full_unstemmed Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
title_short Nirmatrelvir/Ritonavir and Molnupiravir in the Treatment of Mild/Moderate COVID-19: Results of a Real-Life Study
title_sort nirmatrelvir ritonavir and molnupiravir in the treatment of mild moderate covid 19 results of a real life study
topic COVID-19
SARS-CoV-2
molnupiravir
nirmatrelvir/ritonavir
hospitalization
adverse drug reactions
url https://www.mdpi.com/2076-393X/10/10/1731
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