PMID- 38064405
OWN - NLM
STAT- MEDLINE
DCOM- 20240109
LR  - 20240109
IS  - 1972-2680 (Electronic)
IS  - 1972-2680 (Linking)
VI  - 17
IP  - 11
DP  - 2023 Nov 30
TI  - The safety and adverse event profile of favipiravir in the treatment of COVID-19 
      patients, Turkey.
PG  - 1549-1555
LID - 10.3855/jidc.18041 [doi]
AB  - INTRODUCTION: Favipiravir (FVP) is an antiviral and used to treat COVID-19. We 
      aimed to document the safety and adverse events associated with FVP on the 
      outcome of COVID-19 treatment. METHODOLOGY: The study included 225 adult patients 
      with moderate COVID-19 infection (World Health Organization scale-5). The adverse 
      events (AEs) were evaluated using a grading scale supported by the Food and Drug 
      Administration. Safety was assessed by the frequency of serious AEs. RESULTS: The 
      AEs associated with FVP treatment were hepatotoxicity (87/225, 38.7%), weakness 
      (32/225, 14.2%), nephrotoxicity (26/225, 11.6%), nausea (18/225, 8.0%), diarrhea 
      (8/225, 3.6%), vomiting (5/225, 2.2%), and insomnia (4/225, 1.8%); rash was not 
      detected. Hepatotoxicity was observed more frequently in patients who also 
      developed nephrotoxicity (57.7% vs 36.2%, p = 0.03). The deceased patients were 
      significantly older and had higher prevalence of hypertension, congestive heart 
      failure (CHF), coronary artery disease, cancer, nephrotoxicity. and angiotensin- 
      converting enzyme inhibitors/angiotensin receptor blocker use. While male gender 
      (OR: 5.38 CI: 1.64-17.67) and CHF (OR: 6.8 CI: 1.92-24.74) were significantly 
      associated with nephrotoxicity, age (OR: 1.06 CI: 1.02-1.10), cancer (OR: 3.9 CI: 
      1.10-14.22) and nephrotoxicity (OR: 5.5 CI: 1.74-17.74) were associated with 
      mortality. CONCLUSIONS: Serious AEs were detected at very low levels that would 
      not require discontinuation of treatment or any AE-related death. Since 
      SARS-CoV-2 itself and drug interactions may differ, FVP-related AEs might vary in 
      COVID-19 patients. Our study shows that FVP can be used safely with a low AE 
      profile. More extensive evidence is required to evaluate the long-term AEs of 
      FVP.
CI  - Copyright (c) 2023 Elif Tukenmez Tigen, Buket Erturk Sengel, Beste Ozben, Hande 
      Perk Gurun, Baran Balcan, Beliz Bilgili, Fethi Gul, Zekaver Odabasi, Volkan 
      Korten.
FAU - Tukenmez Tigen, Elif
AU  - Tukenmez Tigen E
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Infectious Disease and Clinical Microbiology, Istanbul.
FAU - Erturk Sengel, Buket
AU  - Erturk Sengel B
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Infectious Disease and Clinical Microbiology, Istanbul.
FAU - Ozben, Beste
AU  - Ozben B
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Cardiology Istanbul.
FAU - Perk Gurun, Hande
AU  - Perk Gurun H
AD  - Maltepe District Health Directorate, Public Health, Istanbul.
FAU - Balcan, Baran
AU  - Balcan B
AD  - Marmara University, Pendik Training and Research Hospital, Department of Chest 
      Disease, Istanbul.
FAU - Bilgili, Beliz
AU  - Bilgili B
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Anesthesiology, Istanbul.
FAU - Gul, Fethi
AU  - Gul F
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Anesthesiology, Istanbul.
FAU - Odabasi, Zekaver
AU  - Odabasi Z
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Infectious Disease and Clinical Microbiology, Istanbul.
FAU - Korten, Volkan
AU  - Korten V
AD  - Marmara University, Pendik Training and Research Hospital, Department of 
      Infectious Disease and Clinical Microbiology, Istanbul.
LA  - eng
PT  - Journal Article
DEP - 20231130
PL  - Italy
TA  - J Infect Dev Ctries
JT  - Journal of infection in developing countries
JID - 101305410
RN  - EW5GL2X7E0 (favipiravir)
SB  - IM
MH  - Adult
MH  - Humans
MH  - Male
MH  - *Chemical and Drug Induced Liver Injury
MH  - *COVID-19
MH  - COVID-19 Drug Treatment
MH  - *Neoplasms
MH  - SARS-CoV-2
MH  - Turkey/epidemiology
MH  - United States
MH  - Female
OTO - NOTNLM
OT  - COVID-19
OT  - adverse events
OT  - favipiravir
OT  - hepatotoxicity
OT  - nephrotoxicity
OT  - safety
COIS- No Conflict of Interest is declared
EDAT- 2023/12/08 18:42
MHDA- 2023/12/17 13:19
CRDT- 2023/12/08 13:13
PHST- 2023/02/06 00:00 [received]
PHST- 2023/04/20 00:00 [accepted]
PHST- 2023/12/17 13:19 [medline]
PHST- 2023/12/08 18:42 [pubmed]
PHST- 2023/12/08 13:13 [entrez]
AID - 10.3855/jidc.18041 [doi]
PST - epublish
SO  - J Infect Dev Ctries. 2023 Nov 30;17(11):1549-1555. doi: 10.3855/jidc.18041.