PMID- 35945028
OWN - NLM
STAT- MEDLINE
DCOM- 20221107
LR  - 20221207
IS  - 1349-7235 (Electronic)
IS  - 0918-2918 (Print)
IS  - 0918-2918 (Linking)
VI  - 61
IP  - 21
DP  - 2022 Nov 1
TI  - The Assessment of the Efficacy and Safety of Favipiravir for Patients with 
      SARS-CoV-2 Infection: A Multicenter Non-randomized, Uncontrolled Single-arm 
      Prospective Study.
PG  - 3197-3204
LID - 10.2169/internalmedicine.9691-22 [doi]
AB  - Objective Among treatment options for coronavirus infectious disease 2019 
      (COVID-19), well-studied oral medications are limited. We conducted a multicenter 
      non-randomized, uncontrolled single-arm prospective study to assess the efficacy 
      and safety of favipiravir for patients with COVID-19. Methods One hundred 
      participants were sequentially recruited to 2 cohorts: cohort 1 (Day 1: 1,600 
      mg/day, Day 2 to 14: 600 mg/day, n=50) and cohort 2 (Day 1: 1,800 mg/day, Day 2 
      to 14: 800 mg/day, n=50). The efficacy endpoint was the negative conversion rate 
      of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and the odds 
      ratio (OR) of cohort 2 to cohort 1 for negative conversion on Day 10 was 
      calculated. Characteristics of all participants and profiles of adverse events 
      (AEs) were collected and analyzed. Results The mean age of participants was 
      62.8+/-17.6 years old. Thirty-four patients (34.0%) experienced worsening 
      pneumonia, 7 (7.0%) were intubated, and 4 (4.0%) died during the observation 
      period. Cohort 2 showed a higher negative conversion rate than cohort 1 [adjusted 
      OR 3.32 (95% confidence interval (CI), 1.17 to 9.38), p=0.024], and this 
      association was maintained after adjusting for the age, sex, body mass index, and 
      baseline C-reactive protein level. Regarding adverse events, hyperuricemia was 
      most frequently observed followed by an elevation of the liver enzyme levels 
      (all-grade: 49.0%, Grade >/=3: 12.0%), and cohort 2 tended to have a higher 
      incidence than cohort 1. However, no remarkable association of adverse events was 
      observed between patients <65 and >/=65 years old. Conclusion The antiviral 
      efficacy of favipiravir was difficult to interpret due to the limitation of the 
      study design. However, no remarkable issues with safety or tolerability 
      associated with favipiravir were observed, even in elderly patients with 
      COVID-19.
FAU - Yanagisawa, Kunio
AU  - Yanagisawa K
AD  - Infection Control and Prevention Center, Gunma University Hospital, Japan.
FAU - Takara, Katsuhiko
AU  - Takara K
AD  - Division of Nephrology, Fukaya Red Cross Hospital, Japan.
FAU - Suga, Hiroyuki
AU  - Suga H
AD  - Department of Pharmacy, Fukaya Red Cross Hospital, Japan.
FAU - Saito, Akio
AU  - Saito A
AD  - Division of Hematology, National Hospital Organization Shibukawa Medical Center, 
      Japan.
FAU - Hayashi, Toshimasa
AU  - Hayashi T
AD  - Division of Infectious Diseases, Japanese Red Cross Maebashi Hospital, Japan.
FAU - Igarashi, Tsuneo
AU  - Igarashi T
AD  - Division of Pediatrics, National Hospital Organization Takasaki General Medical 
      Center, Japan.
FAU - Tomizawa, Sachi
AU  - Tomizawa S
AD  - Clinical Investigation and Research Unit, Gunma University Hospital, Japan.
FAU - Saito, Etsuko
AU  - Saito E
AD  - Clinical Investigation and Research Unit, Gunma University Hospital, Japan.
FAU - Sumiyoshi, Hisako
AU  - Sumiyoshi H
AD  - Clinical Investigation and Research Unit, Gunma University Hospital, Japan.
FAU - Ohyama, Yoshiaki
AU  - Ohyama Y
AD  - Clinical Investigation and Research Unit, Gunma University Hospital, Japan.
FAU - Tokue, Yutaka
AU  - Tokue Y
AD  - Infection Control and Prevention Center, Gunma University Hospital, Japan.
FAU - Nakamura, Tetsuya
AU  - Nakamura T
AD  - Clinical Investigation and Research Unit, Gunma University Hospital, Japan.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
DEP - 20220810
PL  - Japan
TA  - Intern Med
JT  - Internal medicine (Tokyo, Japan)
JID - 9204241
RN  - EW5GL2X7E0 (favipiravir)
RN  - 0 (Antiviral Agents)
SB  - IM
MH  - Humans
MH  - Aged
MH  - Middle Aged
MH  - Aged, 80 and over
MH  - SARS-CoV-2
MH  - Prospective Studies
MH  - Treatment Outcome
MH  - Antiviral Agents/adverse effects
MH  - *COVID-19 Drug Treatment
PMC - PMC9683820
OTO - NOTNLM
OT  - COVID-19
OT  - efficacy
OT  - favipiravir
OT  - safety
COIS- The authors state that they have no Conflict of Interest (COI).
EDAT- 2022/08/10 06:00
MHDA- 2022/11/08 06:00
PMCR- 2022/11/01
CRDT- 2022/08/09 21:23
PHST- 2022/08/10 06:00 [pubmed]
PHST- 2022/11/08 06:00 [medline]
PHST- 2022/08/09 21:23 [entrez]
PHST- 2022/11/01 00:00 [pmc-release]
AID - 10.2169/internalmedicine.9691-22 [doi]
PST - ppublish
SO  - Intern Med. 2022 Nov 1;61(21):3197-3204. doi: 10.2169/internalmedicine.9691-22. 
      Epub 2022 Aug 10.