tetano
Editor, Senior Moderator
Intern Med
. 2022 Aug 10.
doi: 10.2169/internalmedicine.9691-22. Online ahead of print.
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
Kunio Yanagisawa[SUP] 1 [/SUP], Katsuhiko Takara[SUP] 2 [/SUP], Hiroyuki Suga[SUP] 3 [/SUP], Akio Saito[SUP] 4 [/SUP], Toshimasa Hayashi[SUP] 5 [/SUP], Tsuneo Igarashi[SUP] 6 [/SUP], Sachi Tomizawa[SUP] 7 [/SUP], Etsuko Saito[SUP] 7 [/SUP], Hisako Sumiyoshi[SUP] 7 [/SUP], Yoshiaki Ohyama[SUP] 7 [/SUP], Yutaka Tokue[SUP] 1 [/SUP], Tetsuya Nakamura[SUP] 7 [/SUP]
Affiliations
Abstract
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 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, 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.
Keywords: COVID-19; efficacy; favipiravir; safety.
. 2022 Aug 10.
doi: 10.2169/internalmedicine.9691-22. Online ahead of print.
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
Kunio Yanagisawa[SUP] 1 [/SUP], Katsuhiko Takara[SUP] 2 [/SUP], Hiroyuki Suga[SUP] 3 [/SUP], Akio Saito[SUP] 4 [/SUP], Toshimasa Hayashi[SUP] 5 [/SUP], Tsuneo Igarashi[SUP] 6 [/SUP], Sachi Tomizawa[SUP] 7 [/SUP], Etsuko Saito[SUP] 7 [/SUP], Hisako Sumiyoshi[SUP] 7 [/SUP], Yoshiaki Ohyama[SUP] 7 [/SUP], Yutaka Tokue[SUP] 1 [/SUP], Tetsuya Nakamura[SUP] 7 [/SUP]
Affiliations
- PMID: 35945028
- DOI: 10.2169/internalmedicine.9691-22
Abstract
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 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, 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.
Keywords: COVID-19; efficacy; favipiravir; safety.