Ensitrelvir in Hospitalized Patients with SARS-CoV-2 During the Omicron Epidemic: A Single-Center Observational Study.

IF 4.7 3区医学 Q1 INFECTIOUS DISEASES

Infectious Diseases and Therapy Pub Date : 2025-06-01 Epub Date: 2025-04-19 DOI:10.1007/s40121-025-01156-9

Masaya Yamato, Masahiro Kinoshita, Yuki Yoshida, Yudai Yamamoto, Rie Izuhara, Takuhiro Sonoyama

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引用次数: 0

Abstract

Introduction: Ensitrelvir, a novel oral 3C-like protease inhibitor targeting severe acute respiratory syndrome coronavirus 2, has been available in Japan since November 2022. This report presents patient characteristics and treatment outcomes of patients receiving ensitrelvir with comparison to remdesivir during the same period.

Methods: A single-center chart review was conducted at Rinku General Medical Center, one of four designated medical institutions for specific infectious diseases in Japan. All hospitalized patients with coronavirus disease 2019 (COVID-19) between November 2022 and August 2024 who received either ensitrelvir or remdesivir in accordance with the on-label dosage and administration were included in the review. Information on patient background, severity of COVID-19, mortality after initiation of either treatment, post-treatment virologic outcomes, and clinical outcomes were collected from electronic records. Day 28 mortality, time to discharge, and time to viral clearance were calculated with and without adjustment using the inverse probability of treatment weighting (IPTW) method.

Results: During the study period, 156 patients received ensitrelvir and 337 received remdesivir as initial treatments, with average ages of 76.8 and 75.7 years, respectively. For baseline severity, 24.4% of ensitrelvir recipients and 50.7% of remdesivir recipients had moderate to severe COVID-19. All-cause mortality at day 28 was 1.9% for ensitrelvir and 5.9% for remdesivir and the hazard ratio was 0.32 (95% CI 0.09-1.07). All-cause mortality after IPTW adjustment was 3.8% and 5.7%, respectively, and the hazard ratio was 0.66 (95% CI 0.19-2.29). Time to discharge was shorter with ensitrelvir, and viral clearance was similar between groups.

Conclusion: Ensitrelvir demonstrated a low day 28 mortality, even among patients with advanced age, immunosuppressive conditions, and moderate to severe COVID-19. These findings may suggest a potential role for ensitrelvir in the treatment of hospitalized patients with COVID-19.

Trial registration: This study was registered in UMIN Clinical Trials Registry (study ID UMIN000056047).

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在组粒流行期间，恩司替韦治疗住院的SARS-CoV-2患者：一项单中心观察研究。

Ensitrelvir是一种针对严重急性呼吸综合征冠状病毒2的新型口服3c样蛋白酶抑制剂，自2022年11月起在日本上市。本报告介绍了同一时期接受恩司他韦和瑞德西韦治疗的患者特征和治疗结果。方法：在日本指定的四家特定传染病医疗机构之一的林库综合医疗中心进行单中心图表回顾。所有在2022年11月至2024年8月期间接受恩西瑞韦或瑞德西韦治疗的2019冠状病毒病（COVID-19）住院患者均被纳入本综述。从电子记录中收集有关患者背景、COVID-19严重程度、开始治疗后死亡率、治疗后病毒学结局和临床结局的信息。采用治疗加权逆概率（IPTW）法计算有和没有调整的第28天死亡率、出院时间和病毒清除时间。结果：研究期间，156例患者接受ensitrelvir初始治疗，337例患者接受remdesivir初始治疗，平均年龄分别为76.8岁和75.7岁。基线严重程度方面，24.4%的恩司替韦接受者和50.7%的瑞德西韦接受者患有中度至重度COVID-19。第28天的全因死亡率，恩昔韦组为1.9%，瑞德西韦组为5.9%，风险比为0.32 （95% CI 0.09-1.07）。调整IPTW后的全因死亡率分别为3.8%和5.7%，风险比为0.66 （95% CI 0.19-2.29）。使用恩司他韦的患者出院时间较短，两组之间的病毒清除率相似。结论：Ensitrelvir显示出较低的第28天死亡率，即使在高龄、免疫抑制和中重度COVID-19患者中也是如此。这些发现可能提示恩司替韦在治疗COVID-19住院患者中的潜在作用。试验注册：本研究已在UMIN临床试验注册中心注册（研究ID为UMIN000056047）。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Infectious Diseases and Therapy Medicine-Microbiology (medical)

CiteScore

8.60

自引率

1.90%

发文量

136

审稿时长

6 weeks

期刊介绍： Infectious Diseases and Therapy is an international, open access, peer-reviewed, rapid publication journal dedicated to the publication of high-quality clinical (all phases), observational, real-world, and health outcomes research around the discovery, development, and use of infectious disease therapies and interventions, including vaccines and devices. Studies relating to diagnostic products and diagnosis, pharmacoeconomics, public health, epidemiology, quality of life, and patient care, management, and education are also encouraged. Areas of focus include, but are not limited to, bacterial and fungal infections, viral infections (including HIV/AIDS and hepatitis), parasitological diseases, tuberculosis and other mycobacterial diseases, vaccinations and other interventions, and drug-resistance, chronic infections, epidemiology and tropical, emergent, pediatric, dermal and sexually-transmitted diseases.