Ensitrelvir for the treatment of COVID-19: Final analysis of a post-marketing surveillance from Japan

IF 1.5 4区医学 Q3 INFECTIOUS DISEASES Journal of Infection and Chemotherapy Pub Date : 2024-12-03 DOI:10.1016/j.jiac.2024.12.003

Noriko Hayashi , Eri Tsukimura , Eriko Ogura

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Abstract

Background

Ensitrelvir received approval in Japan for emergency use in the management of patients with coronavirus disease (COVID-19) in November 2022. A post-marketing surveillance (PMS) was conducted to evaluate the safety and effectiveness of ensitrelvir in Japanese real-world clinical practice, and the interim analysis results (data cutoff: July 20, 2023) have been published. This report describes the final analysis of the PMS for ensitrelvir in a Japanese clinical setting.

Methods

A continuous survey method was used for this PMS (November 2022 to December 2023), and the observation period was 28 days from the start date of ensitrelvir administration. Patients with COVID-19 who received ensitrelvir for the first time and provided written informed consent to collect and use their data were included in this survey. The outcomes included patient characteristics, adverse drug reactions (ADRs), and time to resolution of COVID-19 symptoms.

Results

A total of 3760 and 3638 patients were included in the safety and effectiveness analysis sets, respectively. In the safety analysis set, the mean ± standard deviation age was 43.6 ± 17.7 years, 48.5 % were male, 97.5 % had mild COVID-19, and 73.4 % had a vaccination history. Of the 379 ADRs reported, 374 were not serious and 5 were serious. None of the ADRs resulted in sequelae or death. The median time to resolution of fever and all symptoms was 36.0 and 156.0 h, respectively.

Conclusion

This PMS including >3000 patients suggested the safety of ensitrelvir for the treatment of patients with COVID-19 in Japan, with no new safety concern.

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用于治疗COVID-19的恩司他韦：日本上市后监测的最终分析。

背景：Ensitrelvir于2022年11月在日本获得批准，用于紧急治疗冠状病毒病（COVID-19）患者。在日本进行了上市后监测（PMS），以评估ensitrelvir在现实世界临床实践中的安全性和有效性，中期分析结果（数据截止日期：2023年7月20日）已经公布。本报告描述了在日本临床环境中对恩司他韦的经前综合征的最终分析。方法：采用连续调查法（2022年11月~ 2023年12月），观察期为开始给药之日起28 d。首次接受ensitrelvir治疗并提供收集和使用其数据的书面知情同意书的COVID-19患者被纳入本调查。结果包括患者特征、药物不良反应（adr）和COVID-19症状消退的时间。结果：共有3760例患者和3638例患者分别被纳入安全性和有效性分析集。在安全性分析集中，平均±标准差年龄为43.6±17.7岁，48.5%为男性，97.5%为轻度COVID-19, 73.4%为疫苗接种史。报告的379例不良反应中，374例不严重，5例严重。没有一例不良反应导致后遗症或死亡。发热和所有症状消退的中位时间分别为36.0和156.0小时。结论：本PMS包括bbbb3000例患者，提示ensitrelvir在日本治疗COVID-19患者的安全性和有效性，无新的安全性问题。

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来源期刊

Journal of Infection and Chemotherapy INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY

CiteScore

4.10

自引率

4.50%

发文量

303

审稿时长

47 days

期刊介绍： The Journal of Infection and Chemotherapy (JIC) — official journal of the Japanese Society of Chemotherapy and The Japanese Association for Infectious Diseases — welcomes original papers, laboratory or clinical, as well as case reports, notes, committee reports, surveillance and guidelines from all parts of the world on all aspects of chemotherapy, covering the pathogenesis, diagnosis, treatment, and control of infection, including treatment with anticancer drugs. Experimental studies on animal models and pharmacokinetics, and reports on epidemiology and clinical trials are particularly welcome.