1. Safety Evaluation and Tolerability Overview of Favipiravir in the Management of COVID-19: A Real-Life Experience from Turkey
- Author
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Ayşe Özlem Mete, Ayşe Vahapoğlu, Tuba Okatar Erözcan, Kübra Koçak, Figen Sarıgül, Arzu Nazlı Zeka, Devrim Demir Dora, Filiz Güldaval, Bengü Özütürk, Ceyda Anar, Osman Petek, Zafer Adıgüzel, Vildan Avkan-Oğuz, Ata Nevzat Yalçın, Gülru Polat, Muzaffer Onur Turan, Ömer Demir, İlkay Karaoğlan, Derya Seyman, Yeşim Tunçok, Oğuz Kılınç, Ali Necati Gökmen, Dilara İnan, Ülkü Aygen Türkmen, Bünyamin Sertoğullarından, Şükran Köse, and Aydın Erenmemişoğlu
- Subjects
covid-19 ,favipiravir ,adverse event ,safety ,real-life ,turkey ,Medicine - Abstract
Introduction: Coronavirus diseases-2019 (COVID-19) have been ongoing for more than two years. Despite the scientific research conducted in this process, there is still no widely accepted definitive treatment for the disease. For treating COVID-19, using antiviral agents previously used for the treatment of other RNA-virus infections has been seen as a fast way to a solution, and favipiravir is one of the leading agents. This prospective, multicenter, observational study was designed to investigate the safety of favipiravir in 500 patients treated with favipravir for favipravir. Methods: This study was conducted as a multicenter prospective study. Eight different sites from four cities participated, and 500 patients were included in the study. Follow-up of laboratory parameters, adverse events (AEs), and amelioration of fever, dyspnea, and cough symptoms of the patients was recorded in a case report form. Results: A total of 475 patients from eight centers completed the study. A total of 401 AEs were reported in 206 (51.4%) patients, which were mild-to-moderate in the majority of cases. Serious AEs occurred in 5 patients and death occurred in 4 patients. From the first to the last measurement, serum alanine aminotransferase levels (31.9±27.7 vs. 47.2±49.7 U/L, p37.8 for 6.6% on day 3, 3.2% on day 5, and 0.6% on day 10), dyspnea (for 56.4% on day 5, 62.4% on day 7, and 81.2% on day 10), and cough (46.0% on day 5, 73.0% on day 7, and 87.3% on day 10) were noted in an increasingly higher percentage of patients with continued therapy. Conclusion: The current study provides real-life data of favipiravir, which is a unique option in Turkey for treating COVID-19 patients. The results revealed that favipiravir is a well-tolerated agent with a low side-effect profile. However, it needs to be evaluated with well-designed, dose-compared, randomized controlled studies for the evaluation of efficacy.
- Published
- 2024
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