Tsuzuki Shinya, Hayakawa Kayoko, Doi Yohei, Shinozaki Tomohiro, Uemura Yukari, Matsunaga Nobuaki, Terada Mari, Suzuki Setsuko, Asai Yusuke, Yamada Gen, Saito Sho, Shibata Taro, Kondo Masashi, Izumi Kazuo, Hojo Masayuki, Mizoue Tetsuya, Yokota Kazuhisa, Nakamura-Uchiyama Fukumi, Saito Fumitake, Sugiura Wataru, Ohmagari Norio
AMR Clinical Reference Center, National Center for Global Health and Medicine, 1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan.
Faculty of Medicine and Health Sciences, University of Antwerp, Antwerp, Belgium.
Infect Dis Ther. 2022 Jun;11(3):1075-1087. doi: 10.1007/s40121-022-00617-9. Epub 2022 Mar 21.
Several randomized controlled trials have compared the effectiveness of favipiravir with that of placebo. However, evidence regarding its effect on nonsevere, early-stage coronavirus disease 2019 (COVID-19) remains insufficient.
We used the COVID-19 Registry Japan, a nationwide registry of inpatients with COVID-19, for evaluating the effectiveness of favipiravir on patients with nonsevere, early-stage COVID-19. Eligible patients, who did not need supplementary oxygen therapy at admission, were classified according to two regimens (starting favipiravir therapy within 4 days from admission vs. no favipiravir during hospitalization) and were then compared using a three-step method (cloning, censoring, and weighting). The primary outcome was supplementary oxygen requirement during hospitalization, and the secondary outcomes were the need for invasive mechanical ventilation or extracorporeal membrane oxygenation (IMV/ECMO) and overall mortality at 30 days.
A total of 7654 cases were analyzed. The "start favipiravir" regimen did not show substantial differences in the primary outcome [hazard ratio 0.825, 95% confidence interval (CI) 0.657-1.04, p = 0.098] and both of the secondary outcomes [need for IMV/ECMO and overall 30-day mortality, hazard ratio 1.02 (95% CI 0.649-1.60) and 0.869 (95% CI 0.519-1.46), p = 0.929 and 0.594, respectively].
In this large cohort from a COVID-19 registry, favipiravir was not associated with a positive effect on the clinical outcome on patients with nonsevere, early-stage COVID-19, suggesting that it is not an essential drug for COVID-19 treatment.
多项随机对照试验比较了法匹拉韦与安慰剂的疗效。然而，关于其对非重症、早期2019冠状病毒病（COVID-19）疗效的证据仍然不足。
我们使用日本COVID-19登记系统，这是一个全国性的COVID-19住院患者登记系统，以评估法匹拉韦对非重症、早期COVID-19患者的疗效。符合条件的患者，即入院时不需要补充氧气治疗的患者，根据两种治疗方案进行分类（入院后4天内开始法匹拉韦治疗与住院期间不使用法匹拉韦），然后使用三步法（克隆、删失和加权）进行比较。主要结局是住院期间的补充氧气需求，次要结局是有创机械通气或体外膜肺氧合（IMV/ECMO）需求以及30天的全因死亡率。
共分析了7654例病例。“开始使用法匹拉韦”治疗方案在主要结局方面未显示出显著差异[风险比0.825，95%置信区间（CI）0.657-1.04，p = 0.098]，在两个次要结局方面也未显示出显著差异[IMV/ECMO需求和30天全因死亡率，风险比分别为1.02（95% CI 0.649-1.60）和0.869（95% CI 0.519-1.46），p分别为0.929和0.594]。
在这个来自COVID-19登记系统的大型队列中，法匹拉韦对非重症、早期COVID-19患者的临床结局没有积极影响，这表明它不是COVID-19治疗的必需药物。
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