The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey
Introduction: Favipiravir (FVP) is an antiviral and used to treat COVID-19. We aimed to document the safety and adverse events associated with FVP on the outcome of COVID-19 treatment. Methodology: The study included 225 adult patients with moderate COVID-19 infection (World Health Organization s...
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The Journal of Infection in Developing Countries
2023-11-01
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| Series: | Journal of Infection in Developing Countries |
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| Online Access: | https://jidc.org/index.php/journal/article/view/18041 |
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| author | Elif Tukenmez Tigen Buket Erturk Sengel Beste Ozben Hande Perk Gurun Baran Balcan Beliz Bilgili Fethi Gul Zekaver Odabasi Volkan Korten |
| author_facet | Elif Tukenmez Tigen Buket Erturk Sengel Beste Ozben Hande Perk Gurun Baran Balcan Beliz Bilgili Fethi Gul Zekaver Odabasi Volkan Korten |
| author_sort | Elif Tukenmez Tigen |
| collection | DOAJ |
| description |
Introduction: Favipiravir (FVP) is an antiviral and used to treat COVID-19. We aimed to document the safety and adverse events associated with FVP on the outcome of COVID-19 treatment.
Methodology: The study included 225 adult patients with moderate COVID-19 infection (World Health Organization scale-5). The adverse events (AEs) were evaluated using a grading scale supported by the Food and Drug Administration. Safety was assessed by the frequency of serious AEs.
Results: The AEs associated with FVP treatment were hepatotoxicity (87/225, 38.7%), weakness (32/225, 14.2%), nephrotoxicity (26/225, 11.6%), nausea (18/225, 8.0%), diarrhea (8/225, 3.6%), vomiting (5/225, 2.2%), and insomnia (4/225, 1.8%); rash was not detected. Hepatotoxicity was observed more frequently in patients who also developed nephrotoxicity (57.7% vs 36.2%, p = 0.03). The deceased patients were significantly older and had higher prevalence of hypertension, congestive heart failure (CHF), coronary artery disease, cancer, nephrotoxicity. and angiotensin- converting enzyme inhibitors/angiotensin receptor blocker use. While male gender (OR: 5.38 CI: 1.64-17.67) and CHF (OR: 6.8 CI: 1.92-24.74) were significantly associated with nephrotoxicity, age (OR: 1.06 CI: 1.02-1.10), cancer (OR: 3.9 CI: 1.10-14.22) and nephrotoxicity (OR: 5.5 CI: 1.74-17.74) were associated with mortality.
Conclusions: Serious AEs were detected at very low levels that would not require discontinuation of treatment or any AE-related death. Since SARS-CoV-2 itself and drug interactions may differ, FVP-related AEs might vary in COVID-19 patients. Our study shows that FVP can be used safely with a low AE profile. More extensive evidence is required to evaluate the long-term AEs of FVP.
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| format | Article |
| id | doaj-art-f6708ad01eca4e6e940b7be5f52d4e90 |
| institution | OA Journals |
| issn | 1972-2680 |
| language | English |
| publishDate | 2023-11-01 |
| publisher | The Journal of Infection in Developing Countries |
| record_format | Article |
| series | Journal of Infection in Developing Countries |
| spelling | doaj-art-f6708ad01eca4e6e940b7be5f52d4e902025-08-20T02:27:19ZengThe Journal of Infection in Developing CountriesJournal of Infection in Developing Countries1972-26802023-11-01171110.3855/jidc.18041The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, TurkeyElif Tukenmez Tigen0Buket Erturk Sengel1Beste Ozben2Hande Perk Gurun3Baran Balcan4Beliz Bilgili5Fethi Gul6Zekaver Odabasi7Volkan Korten8Marmara University, Pendik Training and Research Hospital, Department of Infectious Disease and Clinical Microbiology, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Infectious Disease and Clinical Microbiology, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Cardiology IstanbulMaltepe District Health Directorate, Public Health, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Chest Disease, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Anesthesiology, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Anesthesiology, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Infectious Disease and Clinical Microbiology, IstanbulMarmara University, Pendik Training and Research Hospital, Department of Infectious Disease and Clinical Microbiology, Istanbul Introduction: Favipiravir (FVP) is an antiviral and used to treat COVID-19. We aimed to document the safety and adverse events associated with FVP on the outcome of COVID-19 treatment. Methodology: The study included 225 adult patients with moderate COVID-19 infection (World Health Organization scale-5). The adverse events (AEs) were evaluated using a grading scale supported by the Food and Drug Administration. Safety was assessed by the frequency of serious AEs. Results: The AEs associated with FVP treatment were hepatotoxicity (87/225, 38.7%), weakness (32/225, 14.2%), nephrotoxicity (26/225, 11.6%), nausea (18/225, 8.0%), diarrhea (8/225, 3.6%), vomiting (5/225, 2.2%), and insomnia (4/225, 1.8%); rash was not detected. Hepatotoxicity was observed more frequently in patients who also developed nephrotoxicity (57.7% vs 36.2%, p = 0.03). The deceased patients were significantly older and had higher prevalence of hypertension, congestive heart failure (CHF), coronary artery disease, cancer, nephrotoxicity. and angiotensin- converting enzyme inhibitors/angiotensin receptor blocker use. While male gender (OR: 5.38 CI: 1.64-17.67) and CHF (OR: 6.8 CI: 1.92-24.74) were significantly associated with nephrotoxicity, age (OR: 1.06 CI: 1.02-1.10), cancer (OR: 3.9 CI: 1.10-14.22) and nephrotoxicity (OR: 5.5 CI: 1.74-17.74) were associated with mortality. Conclusions: Serious AEs were detected at very low levels that would not require discontinuation of treatment or any AE-related death. Since SARS-CoV-2 itself and drug interactions may differ, FVP-related AEs might vary in COVID-19 patients. Our study shows that FVP can be used safely with a low AE profile. More extensive evidence is required to evaluate the long-term AEs of FVP. https://jidc.org/index.php/journal/article/view/18041favipiravirsafetyadverse eventsCOVID-19hepatotoxicitynephrotoxicity |
| spellingShingle | Elif Tukenmez Tigen Buket Erturk Sengel Beste Ozben Hande Perk Gurun Baran Balcan Beliz Bilgili Fethi Gul Zekaver Odabasi Volkan Korten The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey Journal of Infection in Developing Countries favipiravir safety adverse events COVID-19 hepatotoxicity nephrotoxicity |
| title | The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey |
| title_full | The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey |
| title_fullStr | The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey |
| title_full_unstemmed | The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey |
| title_short | The safety and adverse event profile of favipiravir in the treatment of COVID-19 patients, Turkey |
| title_sort | safety and adverse event profile of favipiravir in the treatment of covid 19 patients turkey |
| topic | favipiravir safety adverse events COVID-19 hepatotoxicity nephrotoxicity |
| url | https://jidc.org/index.php/journal/article/view/18041 |
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