PMID- 35535140
OWN - NLM
STAT- PubMed-not-MEDLINE
LR  - 20231105
IS  - 1178-7074 (Print)
IS  - 1178-7074 (Linking)
VI  - 15
DP  - 2022
TI  - Evaluation of the Safety and Efficacy of Favipiravir in Adult Indian Patients 
      with Mild-to-Moderate COVID-19 in a Real-World Setting.
PG  - 4551-4563
LID - 10.2147/IJGM.S349241 [doi]
AB  - 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.
CI  - (c) 2022 Reddy et al.
FAU - Reddy, Pavan Kumar
AU  - Reddy PK
AD  - Critical Care Medicine, Care Hospital, Hyderabad, Telangana, India.
FAU - Patil, Saiprasad
AU  - Patil S
AD  - Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, 
      India.
FAU - Khobragade, Akash
AU  - Khobragade A
AD  - St. George's Hospital, Mumbai, Maharashtra, India.
FAU - Balki, Akash
AU  - Balki A
AD  - Shree Hospital & Critical Care Center, Nagpur, Maharashtra, India.
FAU - Raj, Aneesh
AU  - Raj A
AD  - NIMS Medicity, Trivandrum, Kerala, India.
FAU - Kalikar, Mrunalini
AU  - Kalikar M
AD  - Department of Pharmacology, Government Medical College, Nagpur, Maharashtra, 
      India.
FAU - Reddy, Raghavendra
AU  - Reddy R
AD  - Renova Neelima Hospitals, Hyderabad, Telangana, India.
FAU - Shinde, Ravindra
AU  - Shinde R
AD  - Respiratory Medicine, Dr Vasantrao Pawar Medical College, Nashik, Maharashtra, 
      India.
FAU - Cr, Jayanthi
AU  - Cr J
AD  - Bangalore Medical College, Bengaluru, Karnataka, India.
FAU - Mutha, Abhinandan
AU  - Mutha A
AD  - Siddhi Hospital, Nasik, Maharashtra, India.
FAU - Boyilla, Nagaraju
AU  - Boyilla N
AD  - Aster Prime Hospital, Hyderabad, Telangana, India.
FAU - Rajadhyaksha, Girish C
AU  - Rajadhyaksha GC
AD  - Department of Medicine, BYL Medical college & Nair Hospital, Mumbai, Maharashtra, 
      India.
FAU - Karnik, Niteen
AU  - Karnik N
AD  - Department of Medicine, LT Medical College & Sion Hospital, Mumbai, Maharashtra, 
      India.
FAU - Bhagat, Sagar
AU  - Bhagat S
AD  - Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, 
      India.
FAU - Pendse, Amol
AU  - Pendse A
AD  - Clinical Research Operations, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, 
      India.
FAU - Dhage, Priyanka
AU  - Dhage P
AD  - Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, India.
FAU - Wu, Wen
AU  - Wu W
AD  - Glenmark Pharmaceuticals Ltd., Waterford, UK.
FAU - Rangwala, Shabbir
AU  - Rangwala S
AD  - Clinical Research Operations, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, 
      India.
FAU - Barkate, Hanmant
AU  - Barkate H
AD  - Global Medical Affairs, Glenmark Pharmaceuticals Ltd., Mumbai, Maharashtra, 
      India.
LA  - eng
PT  - Case Reports
PT  - Clinical Trial
DEP - 20220503
PL  - New Zealand
TA  - Int J Gen Med
JT  - International journal of general medicine
JID - 101515487
PMC - PMC9078344
OTO - NOTNLM
OT  - COVID-19
OT  - SARS-CoV-2
OT  - antiviral
OT  - coronavirus
OT  - favipiravir
COIS- 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.
EDAT- 2022/05/11 06:00
MHDA- 2022/05/11 06:01
CRDT- 2022/05/10 01:46
PHST- 2021/11/13 00:00 [received]
PHST- 2022/03/09 00:00 [accepted]
PHST- 2022/05/10 01:46 [entrez]
PHST- 2022/05/11 06:00 [pubmed]
PHST- 2022/05/11 06:01 [medline]
AID - 349241 [pii]
AID - 10.2147/IJGM.S349241 [doi]
PST - epublish
SO  - Int J Gen Med. 2022 May 3;15:4551-4563. doi: 10.2147/IJGM.S349241. eCollection 
      2022.