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Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study
Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A t...
Autores principales: | , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Frontiers Media S.A.
2023
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347402/ https://www.ncbi.nlm.nih.gov/pubmed/37456740 http://dx.doi.org/10.3389/fphar.2023.1205238 |
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author | Burhan, Erlina Syahruddin, Elisna Isbaniah, Fathiyah Desianti, Ginanjar Arum Fachrucha, Fanny Sari, Cut Yulia Indah Ismail, Efriadi Astuti, Puji Maruli, Muhammad Farhan Mubarak, Farhan Rengganis, Anggit Tresna Bilqis, Hazia Hanifa Taslim, Imammurahman Sastria, Evan Wiyarta, Elvan |
author_facet | Burhan, Erlina Syahruddin, Elisna Isbaniah, Fathiyah Desianti, Ginanjar Arum Fachrucha, Fanny Sari, Cut Yulia Indah Ismail, Efriadi Astuti, Puji Maruli, Muhammad Farhan Mubarak, Farhan Rengganis, Anggit Tresna Bilqis, Hazia Hanifa Taslim, Imammurahman Sastria, Evan Wiyarta, Elvan |
author_sort | Burhan, Erlina |
collection | PubMed |
description | Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression. Results: The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52–0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08–1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05–1.57). The rate of virologic conversion was not significantly different between the two groups. Conclusion: The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia. |
format | Online Article Text |
id | pubmed-10347402 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2023 |
publisher | Frontiers Media S.A. |
record_format | MEDLINE/PubMed |
spelling | pubmed-103474022023-07-15 Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study Burhan, Erlina Syahruddin, Elisna Isbaniah, Fathiyah Desianti, Ginanjar Arum Fachrucha, Fanny Sari, Cut Yulia Indah Ismail, Efriadi Astuti, Puji Maruli, Muhammad Farhan Mubarak, Farhan Rengganis, Anggit Tresna Bilqis, Hazia Hanifa Taslim, Imammurahman Sastria, Evan Wiyarta, Elvan Front Pharmacol Pharmacology Background: This study aimed to determine the real-world safety and effectiveness of remdesivir in hospitalized adult COVID-19 patients with moderate-to-critical disease in Indonesia. Methods: A multicenter, retrospective cohort study was conducted at four COVID-19 referral hospitals in Jakarta. A total of 587 patients were included, of whom 243 received remdesivir within 72 h of admission. The safety endpoints were the proportions of patients with any adverse event (AE), any grade 3 AE, and AE of each system organ class. The effectiveness endpoints were ICU admission >24 h from baseline, live discharge and mortality at day 14, live discharge and mortality at day 28, and virologic conversion. Patients who received remdesivir within 72 h of admission were considered the treatment group, and those who did not were the control group. Multivariate adjustments were performed using a modified Poisson regression. Results: The study found no significant differences in safety endpoints between the two groups. However, the effectiveness endpoints showed that remdesivir was associated with a decreased risk of ICU admission >24 h from baseline (RR 0.71, 95% CI 0.52–0.96), an increased probability of live discharge at day 14 (RR 1.37, 95% CI 1.08–1.74), and an increased probability of live discharge at day 28 (RR 1.28, 95% CI 1.05–1.57). The rate of virologic conversion was not significantly different between the two groups. Conclusion: The study concludes that remdesivir is safe and effective in the treatment of moderate-to-critical COVID-19 in a real-world setting in Indonesia. Frontiers Media S.A. 2023-06-30 /pmc/articles/PMC10347402/ /pubmed/37456740 http://dx.doi.org/10.3389/fphar.2023.1205238 Text en Copyright © 2023 Burhan, Syahruddin, Isbaniah, Desianti, Fachrucha, Sari, Ismail, Astuti, Maruli, Mubarak, Rengganis, Bilqis, Taslim, Sastria and Wiyarta. https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms. |
spellingShingle | Pharmacology Burhan, Erlina Syahruddin, Elisna Isbaniah, Fathiyah Desianti, Ginanjar Arum Fachrucha, Fanny Sari, Cut Yulia Indah Ismail, Efriadi Astuti, Puji Maruli, Muhammad Farhan Mubarak, Farhan Rengganis, Anggit Tresna Bilqis, Hazia Hanifa Taslim, Imammurahman Sastria, Evan Wiyarta, Elvan Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title | Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title_full | Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title_fullStr | Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title_full_unstemmed | Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title_short | Evaluation of safety and effectiveness of remdesivir in treating COVID-19 patients after emergency use authorization study |
title_sort | evaluation of safety and effectiveness of remdesivir in treating covid-19 patients after emergency use authorization study |
topic | Pharmacology |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10347402/ https://www.ncbi.nlm.nih.gov/pubmed/37456740 http://dx.doi.org/10.3389/fphar.2023.1205238 |
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