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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

Reddy et al., International Journal of General Medicine, doi:10.2147/IJGM.S349241, CTRI/2020/11/029263
May 2022  
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Prospective single-arm study of 1,083 patients receiving favipiravir in India, showing one death and no new safety issues.
Reddy et al., 3 May 2022, prospective, India, peer-reviewed, 19 authors, study period December 2020 - June 2021, trial CTRI/2020/11/029263.
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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
Pavan Kumar Reddy, Saiprasad Patil, Akash Khobragade, Akash Balki, Aneesh Raj, Mrunalini Kalikar, Raghavendra Reddy, Ravindra Shinde, Jayanthi Cr, Abhinandan Mutha, Nagaraju Boyilla, Girish C Rajadhyaksha, Niteen Karnik, Sagar Bhagat, Amol Pendse, Priyanka Dhage, Wen Wu, Shabbir Rangwala, Hanmant Barkate
International Journal of General Medicine, doi:10.2147/ijgm.s349241
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.
Time to Resolution of Pyrexia The median time to resolution of pyrexia in the present study was 4 days. The Kaplan-Meier survival curve for time to resolution of pyrexia in the mITT population is presented in Figure 4 . Additional details on subgroups are provided in the Supplementary Results. Author Contributions All authors made a significant contribution to the work reported, whether that is in the conception, study design, execution, acquisition of data, analysis and interpretation, or in all these areas; took part in drafting, revising or critically reviewing the article; gave final approval of the version to be published; have agreed on the journal to which the article has been submitted; and agree to be accountable for all aspects of the work. Disclosure SP, SB, PD, AP, WW, SR, HB are full time employee of Glenmark Pharmaceuticals Ltd. PKR reports grants from Glenmark, during the conduct of the study. MK reports personal fees from Glenmark limited, during the conduct of the study. The authors report no other conflicts of interest in this work.
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