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Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting
PURPOSE: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. PATIENTS AND METHODS: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India....
Autores principales: | , , , , , , , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Dove
2022
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Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9078344/ https://www.ncbi.nlm.nih.gov/pubmed/35535140 http://dx.doi.org/10.2147/IJGM.S349241 |
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author | Reddy, Pavan Kumar Patil, Saiprasad Khobragade, Akash Balki, Akash Raj, Aneesh Kalikar, Mrunalini Reddy, Raghavendra Shinde, Ravindra CR, Jayanthi Mutha, Abhinandan Boyilla, Nagaraju Rajadhyaksha, Girish C Karnik, Niteen Bhagat, Sagar Pendse, Amol Dhage, Priyanka Wu, Wen Rangwala, Shabbir Barkate, Hanmant |
author_facet | Reddy, Pavan Kumar Patil, Saiprasad Khobragade, Akash Balki, Akash Raj, Aneesh Kalikar, Mrunalini Reddy, Raghavendra Shinde, Ravindra CR, Jayanthi Mutha, Abhinandan Boyilla, Nagaraju Rajadhyaksha, Girish C Karnik, Niteen Bhagat, Sagar Pendse, Amol Dhage, Priyanka Wu, Wen Rangwala, Shabbir Barkate, Hanmant |
author_sort | Reddy, Pavan Kumar |
collection | PubMed |
description | PURPOSE: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. PATIENTS AND METHODS: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality. RESULTS: A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir. CONCLUSION: In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected. |
format | Online Article Text |
id | pubmed-9078344 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2022 |
publisher | Dove |
record_format | MEDLINE/PubMed |
spelling | pubmed-90783442022-05-08 Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting Reddy, Pavan Kumar Patil, Saiprasad Khobragade, Akash Balki, Akash Raj, Aneesh Kalikar, Mrunalini Reddy, Raghavendra Shinde, Ravindra CR, Jayanthi Mutha, Abhinandan Boyilla, Nagaraju Rajadhyaksha, Girish C Karnik, Niteen Bhagat, Sagar Pendse, Amol Dhage, Priyanka Wu, Wen Rangwala, Shabbir Barkate, Hanmant Int J Gen Med Clinical Trial Report PURPOSE: To evaluate the safety and efficacy of favipiravir, which is prescribed for the treatment of patients with mild-to-moderate coronavirus disease 2019 (COVID-19) in India. PATIENTS AND METHODS: This was a prospective, open-label, multicenter, single-arm postmarketing study conducted in India. Patients with mild-to-moderate COVID-19 received favipiravir (3600 mg [1800 mg orally twice daily] on the first day, followed by 800 mg orally twice daily, up to a maximum of 14 days) as a part of their treatment. The primary endpoints were to evaluate the safety of favipiravir by assessing the number of adverse events (AEs) and treatment-related AEs. The secondary endpoints were to evaluate the efficacy of favipiravir by assessing time to clinical cure, rate of clinical cure, time to pyrexia resolution, rate of oxygen requirement, and all-cause mortality. RESULTS: A total of 1083 patients were enrolled in this study from December 2020 to June 2021. Adverse events were reported in 129 patients (11.9%), 116 (10.7%) of whom had mild AEs. Dose modification or withdrawal of favipiravir treatment was reported in four patients (0.37%). The median time to clinical cure and pyrexia resolution was 7 and 4 days, respectively. A total of 1036 patients (95.8%) exhibited clinical cure by day 14. Oxygen support was required by 15 patients (1.4%). One death was reported, which was unrelated to favipiravir. CONCLUSION: In the real-world setting, favipiravir was well-tolerated, and no new safety signals were detected. Dove 2022-05-03 /pmc/articles/PMC9078344/ /pubmed/35535140 http://dx.doi.org/10.2147/IJGM.S349241 Text en © 2022 Reddy et al. https://creativecommons.org/licenses/by-nc/3.0/This work is published and licensed by Dove Medical Press Limited. The full terms of this license are available at https://www.dovepress.com/terms.php and incorporate the Creative Commons Attribution – Non Commercial (unported, v3.0) License (http://creativecommons.org/licenses/by-nc/3.0/ (https://creativecommons.org/licenses/by-nc/3.0/) ). By accessing the work you hereby accept the Terms. Non-commercial uses of the work are permitted without any further permission from Dove Medical Press Limited, provided the work is properly attributed. For permission for commercial use of this work, please see paragraphs 4.2 and 5 of our Terms (https://www.dovepress.com/terms.php). |
spellingShingle | Clinical Trial Report Reddy, Pavan Kumar Patil, Saiprasad Khobragade, Akash Balki, Akash Raj, Aneesh Kalikar, Mrunalini Reddy, Raghavendra Shinde, Ravindra CR, Jayanthi Mutha, Abhinandan Boyilla, Nagaraju Rajadhyaksha, Girish C Karnik, Niteen Bhagat, Sagar Pendse, Amol Dhage, Priyanka Wu, Wen Rangwala, Shabbir Barkate, Hanmant Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title | Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title_full | Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title_fullStr | Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title_full_unstemmed | Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title_short | Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients with Mild-to-Moderate COVID-19 in a Real-World Setting |
title_sort | evaluation of the safety and efficacy of favipiravir in adult indian patients with mild-to-moderate covid-19 in a real-world setting |
topic | Clinical Trial Report |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9078344/ https://www.ncbi.nlm.nih.gov/pubmed/35535140 http://dx.doi.org/10.2147/IJGM.S349241 |
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