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Clinical Trial
. 2022 May 3:15:4551-4563.
doi: 10.2147/IJGM.S349241. eCollection 2022.

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  1 , Saiprasad Patil  2 , Akash Khobragade  3 , Akash Balki  4 , Aneesh Raj  5 , Mrunalini Kalikar  6 , Raghavendra Reddy  7 , Ravindra Shinde  8 , Jayanthi Cr  9 , Abhinandan Mutha  10 , Nagaraju Boyilla  11 , Girish C Rajadhyaksha  12 , Niteen Karnik  13 , Sagar Bhagat  2 , Amol Pendse  14 , Priyanka Dhage  15 , Wen Wu  16 , Shabbir Rangwala  14 , Hanmant Barkate  2
Affiliations
Clinical Trial

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 et al. Int J Gen Med. .

Abstract

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.

Keywords: COVID-19; SARS-CoV-2; antiviral; coronavirus; favipiravir.

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Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Study design.
Figure 2
Figure 2
Time to clinical cure.
Figure 3
Figure 3
Rate of clinical cure at days 4, 7, 10, and 14.
Figure 4
Figure 4
Time to resolution of pyrexia.
See this image and copyright information in PMC

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