Cargando…

Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center

During the current pandemic, the gap between fundamental research and clinical practice has been narrowing at a faster pace than ever before. While clinical trials play the main role of confirming the safety and efficacy of new drugs, a drug’s introduction into clinical practice creates the need for...

Descripción completa

Detalles Bibliográficos
Autores principales: Streinu-Cercel, Anca, Miron, Victor Daniel, Oană, Alina Alexandra, Irimia, Mădălina, Popescu, Ramona Ștefania, Dărămuș, Ioana Andreea, Moțoi, Maria Magdalena, Ceapraga, Gabriela Jana, Săndulescu, Oana
Formato: Online Artículo Texto
Lenguaje:English
Publicado: MDPI 2022
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502524/
https://www.ncbi.nlm.nih.gov/pubmed/36145286
http://dx.doi.org/10.3390/ph15091065
_version_ 1784795727251111936
author Streinu-Cercel, Anca
Miron, Victor Daniel
Oană, Alina Alexandra
Irimia, Mădălina
Popescu, Ramona Ștefania
Dărămuș, Ioana Andreea
Moțoi, Maria Magdalena
Ceapraga, Gabriela Jana
Săndulescu, Oana
author_facet Streinu-Cercel, Anca
Miron, Victor Daniel
Oană, Alina Alexandra
Irimia, Mădălina
Popescu, Ramona Ștefania
Dărămuș, Ioana Andreea
Moțoi, Maria Magdalena
Ceapraga, Gabriela Jana
Săndulescu, Oana
author_sort Streinu-Cercel, Anca
collection PubMed
description During the current pandemic, the gap between fundamental research and clinical practice has been narrowing at a faster pace than ever before. While clinical trials play the main role of confirming the safety and efficacy of new drugs, a drug’s introduction into clinical practice creates the need for further research in order to best position the use of the novel drug in terms of when, to whom, and how it would be best administered to achieve the best possible outcome under feasible clinical circumstances. We briefly present the results of a retrospective analysis of the characteristics of outpatients treated with molnupiravir in a tertiary care infectious disease hospital in Bucharest, Romania, between February and March 2022, when Romania was experiencing its fifth wave of COVID-19. A total of 46 outpatients received molnupiravir treatment and had complete clinical data available; of them, 56.5% (n = 20) were males and the median age was 48.5 years (IQR: 37.8, 67.0 years). A total of 54.2% (n = 26) of patients had at least one chronic condition. Of the 45 patients who underwent lung CT imaging evaluation, 13 (28.9%) showed changes suggestive of COVID-19 pneumonia. COVID-19 vaccination status was strongly protective for pneumonia (p = 0.002). All patients were symptomatic, and molnupiravir was initiated at a mean time from onset of symptoms of 3.5 (±1.5) days. At phone follow-up 5 days after the initial evaluation and initiation of molnupiravir treatment, all patients, except for one, confirmed a favorable course under treatment, with no worsening of COVID-19 severity and improvement in symptoms; none of them progressed to respiratory failure or required hospitalization. In conclusion, treatment was well tolerated and associated a favorable outcome of COVID-19 in routine practice in a clinical population that was slightly older and had a smaller burden of comorbidities and a higher rate of COVID-19 vaccination compared to that from the pivotal trial.
format Online
Article
Text
id pubmed-9502524
institution National Center for Biotechnology Information
language English
publishDate 2022
publisher MDPI
record_format MEDLINE/PubMed
spelling pubmed-95025242022-09-24 Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center Streinu-Cercel, Anca Miron, Victor Daniel Oană, Alina Alexandra Irimia, Mădălina Popescu, Ramona Ștefania Dărămuș, Ioana Andreea Moțoi, Maria Magdalena Ceapraga, Gabriela Jana Săndulescu, Oana Pharmaceuticals (Basel) Communication During the current pandemic, the gap between fundamental research and clinical practice has been narrowing at a faster pace than ever before. While clinical trials play the main role of confirming the safety and efficacy of new drugs, a drug’s introduction into clinical practice creates the need for further research in order to best position the use of the novel drug in terms of when, to whom, and how it would be best administered to achieve the best possible outcome under feasible clinical circumstances. We briefly present the results of a retrospective analysis of the characteristics of outpatients treated with molnupiravir in a tertiary care infectious disease hospital in Bucharest, Romania, between February and March 2022, when Romania was experiencing its fifth wave of COVID-19. A total of 46 outpatients received molnupiravir treatment and had complete clinical data available; of them, 56.5% (n = 20) were males and the median age was 48.5 years (IQR: 37.8, 67.0 years). A total of 54.2% (n = 26) of patients had at least one chronic condition. Of the 45 patients who underwent lung CT imaging evaluation, 13 (28.9%) showed changes suggestive of COVID-19 pneumonia. COVID-19 vaccination status was strongly protective for pneumonia (p = 0.002). All patients were symptomatic, and molnupiravir was initiated at a mean time from onset of symptoms of 3.5 (±1.5) days. At phone follow-up 5 days after the initial evaluation and initiation of molnupiravir treatment, all patients, except for one, confirmed a favorable course under treatment, with no worsening of COVID-19 severity and improvement in symptoms; none of them progressed to respiratory failure or required hospitalization. In conclusion, treatment was well tolerated and associated a favorable outcome of COVID-19 in routine practice in a clinical population that was slightly older and had a smaller burden of comorbidities and a higher rate of COVID-19 vaccination compared to that from the pivotal trial. MDPI 2022-08-27 /pmc/articles/PMC9502524/ /pubmed/36145286 http://dx.doi.org/10.3390/ph15091065 Text en © 2022 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 Communication
Streinu-Cercel, Anca
Miron, Victor Daniel
Oană, Alina Alexandra
Irimia, Mădălina
Popescu, Ramona Ștefania
Dărămuș, Ioana Andreea
Moțoi, Maria Magdalena
Ceapraga, Gabriela Jana
Săndulescu, Oana
Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title_full Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title_fullStr Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title_full_unstemmed Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title_short Real-World Use of Molnupiravir in the Treatment of Outpatients with SARS-CoV-2 Infection—A Patient Profile Based on the Experience of a Tertiary Infectious Disease Center
title_sort real-world use of molnupiravir in the treatment of outpatients with sars-cov-2 infection—a patient profile based on the experience of a tertiary infectious disease center
topic Communication
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9502524/
https://www.ncbi.nlm.nih.gov/pubmed/36145286
http://dx.doi.org/10.3390/ph15091065
work_keys_str_mv AT streinucercelanca realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT mironvictordaniel realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT oanaalinaalexandra realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT irimiamadalina realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT popescuramonastefania realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT daramusioanaandreea realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT motoimariamagdalena realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT ceapragagabrielajana realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter
AT sandulescuoana realworlduseofmolnupiravirinthetreatmentofoutpatientswithsarscov2infectionapatientprofilebasedontheexperienceofatertiaryinfectiousdiseasecenter