{"title":"对患有轻度 COVID-19 的医护人员进行 Ensitrelvir 和对症治疗的比较研究:日本千叶县单中心回顾性分析","authors":"Jun Hirai , Yuki Hanai","doi":"10.1016/j.jiac.2025.102668","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Ensitrelvir, a novel oral antiviral targeting the 3CL protease of SARS-CoV-2, has demonstrated efficacy in reducing viral load in clinical trials. Rapid viral clearance in healthcare workers (HCWs) with mild COVID-19 is critical for symptom relief and minimizing secondary transmission. However, real-world evidence on ensitrelvir's effectiveness in this population is limited.</div></div><div><h3>Methods</h3><div>This single-center retrospective study analyzed 407 HCWs with mild COVID-19 treated with either ensitrelvir or symptomatic therapy. Viral load was assessed using reverse transcription-polymerase chain reaction cycle threshold (Ct) values. The primary endpoint was achieving a Ct > 30, indicating low infectivity, on days 5–8 or 9–12. Secondary endpoints included adverse events, hospitalization, disease progression, and all-cause mortality within 30 days of symptom onset. Multivariate logistic regression identified factors associated with achieving Ct > 30.</div></div><div><h3>Results</h3><div>Patients in the ensitrelvir group had significantly higher rates of achieving Ct > 30 on days 5–8 (38.0 % vs. 9.9 %, <em>p</em> < 0.01) and days 9–12 (77.8 % vs. 42.3 %, <em>p</em> < 0.01). Treatment with ensitrelvir was associated with a significantly higher likelihood of symptom improvement within 5–8 days compared to symptomatic therapy (<em>p</em> < 0.01). Multivariate analysis confirmed ensitrelvir as independently associated with Ct > 30 (adjusted odds ratio: 6.498; <em>p</em> < 0.01). No adverse events, hospitalizations, or mortality were observed.</div></div><div><h3>Discussion</h3><div>Ensitrelvir demonstrated superior viral clearance compared to symptomatic therapy, facilitating a safer and earlier return to work for HCWs. However, additional precautions, such as mask use, remain essential for HCWs working in high-risk environments, even after ensitrelvir treatment.</div></div><div><h3>Conclusions</h3><div>Ensitrelvir is a safe and effective option for reducing SARS-CoV-2 viral load in HCWs with mild COVID-19, supporting timely recovery and reducing infectivity.</div></div>","PeriodicalId":16103,"journal":{"name":"Journal of Infection and Chemotherapy","volume":"31 4","pages":"Article 102668"},"PeriodicalIF":1.9000,"publicationDate":"2025-02-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"Comparative study of ensitrelvir and symptomatic therapy in healthcare workers with mild COVID-19: A single center retrospective analysis in Chiba, Japan\",\"authors\":\"Jun Hirai , Yuki Hanai\",\"doi\":\"10.1016/j.jiac.2025.102668\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><div>Ensitrelvir, a novel oral antiviral targeting the 3CL protease of SARS-CoV-2, has demonstrated efficacy in reducing viral load in clinical trials. Rapid viral clearance in healthcare workers (HCWs) with mild COVID-19 is critical for symptom relief and minimizing secondary transmission. However, real-world evidence on ensitrelvir's effectiveness in this population is limited.</div></div><div><h3>Methods</h3><div>This single-center retrospective study analyzed 407 HCWs with mild COVID-19 treated with either ensitrelvir or symptomatic therapy. Viral load was assessed using reverse transcription-polymerase chain reaction cycle threshold (Ct) values. The primary endpoint was achieving a Ct > 30, indicating low infectivity, on days 5–8 or 9–12. Secondary endpoints included adverse events, hospitalization, disease progression, and all-cause mortality within 30 days of symptom onset. Multivariate logistic regression identified factors associated with achieving Ct > 30.</div></div><div><h3>Results</h3><div>Patients in the ensitrelvir group had significantly higher rates of achieving Ct > 30 on days 5–8 (38.0 % vs. 9.9 %, <em>p</em> < 0.01) and days 9–12 (77.8 % vs. 42.3 %, <em>p</em> < 0.01). Treatment with ensitrelvir was associated with a significantly higher likelihood of symptom improvement within 5–8 days compared to symptomatic therapy (<em>p</em> < 0.01). Multivariate analysis confirmed ensitrelvir as independently associated with Ct > 30 (adjusted odds ratio: 6.498; <em>p</em> < 0.01). No adverse events, hospitalizations, or mortality were observed.</div></div><div><h3>Discussion</h3><div>Ensitrelvir demonstrated superior viral clearance compared to symptomatic therapy, facilitating a safer and earlier return to work for HCWs. However, additional precautions, such as mask use, remain essential for HCWs working in high-risk environments, even after ensitrelvir treatment.</div></div><div><h3>Conclusions</h3><div>Ensitrelvir is a safe and effective option for reducing SARS-CoV-2 viral load in HCWs with mild COVID-19, supporting timely recovery and reducing infectivity.</div></div>\",\"PeriodicalId\":16103,\"journal\":{\"name\":\"Journal of Infection and Chemotherapy\",\"volume\":\"31 4\",\"pages\":\"Article 102668\"},\"PeriodicalIF\":1.9000,\"publicationDate\":\"2025-02-26\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Journal of Infection and Chemotherapy\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://www.sciencedirect.com/science/article/pii/S1341321X25000650\",\"RegionNum\":4,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q3\",\"JCRName\":\"INFECTIOUS DISEASES\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of Infection and Chemotherapy","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S1341321X25000650","RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q3","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}
Comparative study of ensitrelvir and symptomatic therapy in healthcare workers with mild COVID-19: A single center retrospective analysis in Chiba, Japan
Background
Ensitrelvir, a novel oral antiviral targeting the 3CL protease of SARS-CoV-2, has demonstrated efficacy in reducing viral load in clinical trials. Rapid viral clearance in healthcare workers (HCWs) with mild COVID-19 is critical for symptom relief and minimizing secondary transmission. However, real-world evidence on ensitrelvir's effectiveness in this population is limited.
Methods
This single-center retrospective study analyzed 407 HCWs with mild COVID-19 treated with either ensitrelvir or symptomatic therapy. Viral load was assessed using reverse transcription-polymerase chain reaction cycle threshold (Ct) values. The primary endpoint was achieving a Ct > 30, indicating low infectivity, on days 5–8 or 9–12. Secondary endpoints included adverse events, hospitalization, disease progression, and all-cause mortality within 30 days of symptom onset. Multivariate logistic regression identified factors associated with achieving Ct > 30.
Results
Patients in the ensitrelvir group had significantly higher rates of achieving Ct > 30 on days 5–8 (38.0 % vs. 9.9 %, p < 0.01) and days 9–12 (77.8 % vs. 42.3 %, p < 0.01). Treatment with ensitrelvir was associated with a significantly higher likelihood of symptom improvement within 5–8 days compared to symptomatic therapy (p < 0.01). Multivariate analysis confirmed ensitrelvir as independently associated with Ct > 30 (adjusted odds ratio: 6.498; p < 0.01). No adverse events, hospitalizations, or mortality were observed.
Discussion
Ensitrelvir demonstrated superior viral clearance compared to symptomatic therapy, facilitating a safer and earlier return to work for HCWs. However, additional precautions, such as mask use, remain essential for HCWs working in high-risk environments, even after ensitrelvir treatment.
Conclusions
Ensitrelvir is a safe and effective option for reducing SARS-CoV-2 viral load in HCWs with mild COVID-19, supporting timely recovery and reducing infectivity.
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.