Abstract
Background
Favipiravir, an RNA-dependent RNA polymerase inhibitor (RdRp), is a broad-spectrum oral antiviral agent approved in India under emergency use authorization, for the treatment of mild-to-moderate coronavirus disease (COVID-19). The present study was planned to evaluate the effectiveness and safety of favipiravir in real-world clinical practice.
Materials and Methods
This was a multicentric, retrospective, single-arm study conducted across four centres in India, after obtaining permission from the independent ethics committee. Medical records were analysed to evaluate effectiveness and safety of patients who were prescribed favipiravir.
Results
The medical records of a total of 360 patients met the inclusion criteria, with 358 of them available for the final analysis. Males made up 58.46% of the study population. The average age of enrolled patients was 51.80 ± 16.45 years. The most common symptoms were fever, cough, and myalgia-fatigue. The median time to clinical cure and fever relief was five and four days, respectively. The average length of stay in the hospital was six days. In total, 8% of the patients experienced adverse events. Hepatic enzyme elevation, diarrhoea, decreased appetite, headache, fatigue, and giddiness were the common symptoms.
Conclusion
In our real-world study, favipiravir was found to have a clinical cure rate of more than 90% in mild-to-moderate COVID-19 patients. This supports the use of favipiravir in the treatment of COVID-19. Favipiravir was well tolerated, with only minimal side effects, which were transient in nature.
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Ethical Approval
The study was initiated after taking approval from the Independent ethics committee. (ECR/644/Inst/MH/2014/RR-17).
Acknowledgment
We would like to thank all the authors, and all the patients, who participated in this study, and Dr. Sagar Panchal for his assistance throughout the study process.
The abstract of this paper was presented at the National critical care conference in India, named Criticare 2021 conference, as a poster presentation with interim findings. The poster’s abstract was published in “Abstracts” in the Indian Journal of Critical Care Medicine. 2021; DOI: 10.5005/jp-journals-10071-23711.20.
Disclosure
Dr. Sagar Bhagat, Dr. Saiprasad Patil and Dr. Hanmant Barkate are employees of Glenmark Pharmaceutical and had helped in the data analysis and manuscript writing. Dr Shashank Joshi reports speaker fees from Glenmark, during the conduct of the study; advisor, speaker fees consultancy from Glenmark, Novo, Twin Health, Marico, PHFI, Astra Zeneca, Roche Diabetes Care, Abbott, Biocon, Novo Nordisk, Sanofi, Torrent, Zydus Cadila, Bayer Zydus, MSD, Boehringer Ingelheim, Franco India, Alkem, Cipla, outside the submitted work. The authors report no other conflicts of interest in this work.