{"title":"替沙吉维单-西gavimab可有效预防终末期肾病患者COVID-19感染","authors":"Noppakao Kongtal, Watchara Pichitsiri, Supinda Sirilak, Anyarin Wannakittirat, Busakorn Sontham, Sagoontee Inkate, Theerachai Thammathiwat","doi":"10.3390/v17091216","DOIUrl":null,"url":null,"abstract":"<p><p>Patients with end-stage kidney disease (ESKD) often exhibit suboptimal responses to COVID-19 vaccination. Tixagevimab-Cilgavimab, a neutralizing long-acting antibody (LAAB), has demonstrated effectiveness in preventing severe COVID-19 and hospitalization among immunocompromised populations. This study aimed to evaluate the efficacy and safety of Tixagevimab-Cilgavimab in ESKD patients receiving hemodialysis, peritoneal dialysis, or kidney transplantation. This single-center, retrospective cohort study was conducted at Naresuan University Hospital, Phitsanulok, Thailand, and included patients with end-stage kidney disease (ESKD) receiving maintenance hemodialysis, peritoneal dialysis, or kidney transplantation between June 2022 and June 2023, during the peak of the Omicron variant. Patients who received a single 150/150 mg dose of Tixagevimab-Cilgavimab were compared to those who did not, in terms of time to first COVID-19 infection and hospitalization within 6 months. Cox proportional hazards models were used to evaluate associations, adjusted for age, sex, type 2 diabetes, dyslipidemia, systolic and diastolic blood pressure, serum creatinine, number of COVID-19 vaccine doses, and prior COVID-19 infection. Safety was assessed by comparing creatine kinase (CK) levels before and after treatment using generalized estimating equations (GEE). Of 117 patients, 58 received Tixagevimab-Cilgavimab (mean age 59 ± 15 years); 92% were on dialysis and 8% had undergone kidney transplantation. COVID-19 infection occurred in 10.3% of the LAAB group versus 11.9% in the control group. In the adjusted Cox model, LAAB use was significantly associated with a reduced risk of COVID-19 infection (adjusted HR: 0.20; 95% CI: 0.04-0.95; <i>p</i> = 0.043). No variables were significantly associated with hospitalization, although LAAB use showed a non-significant trend toward reduced hospitalization risk (adjusted HR: 0.08; 95% CI: 0.01-1.56; <i>p</i> = 0.096). No local or systemic adverse effects were reported. CK levels remained unchanged after administration. Tixagevimab-Cilgavimab was effective in reducing the risk of COVID-19 infection among ESKD patients, without evidence of adverse effects, supporting its use as a prophylactic agent in this high-risk population.</p>","PeriodicalId":49328,"journal":{"name":"Viruses-Basel","volume":"17 9","pages":""},"PeriodicalIF":3.5000,"publicationDate":"2025-09-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474474/pdf/","citationCount":"0","resultStr":"{\"title\":\"Tixagevimab-Cilgavimab Effectively Prevents COVID-19 Infection in Patients with End-Stage Kidney Disease.\",\"authors\":\"Noppakao Kongtal, Watchara Pichitsiri, Supinda Sirilak, Anyarin Wannakittirat, Busakorn Sontham, Sagoontee Inkate, Theerachai Thammathiwat\",\"doi\":\"10.3390/v17091216\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><p>Patients with end-stage kidney disease (ESKD) often exhibit suboptimal responses to COVID-19 vaccination. Tixagevimab-Cilgavimab, a neutralizing long-acting antibody (LAAB), has demonstrated effectiveness in preventing severe COVID-19 and hospitalization among immunocompromised populations. This study aimed to evaluate the efficacy and safety of Tixagevimab-Cilgavimab in ESKD patients receiving hemodialysis, peritoneal dialysis, or kidney transplantation. This single-center, retrospective cohort study was conducted at Naresuan University Hospital, Phitsanulok, Thailand, and included patients with end-stage kidney disease (ESKD) receiving maintenance hemodialysis, peritoneal dialysis, or kidney transplantation between June 2022 and June 2023, during the peak of the Omicron variant. Patients who received a single 150/150 mg dose of Tixagevimab-Cilgavimab were compared to those who did not, in terms of time to first COVID-19 infection and hospitalization within 6 months. Cox proportional hazards models were used to evaluate associations, adjusted for age, sex, type 2 diabetes, dyslipidemia, systolic and diastolic blood pressure, serum creatinine, number of COVID-19 vaccine doses, and prior COVID-19 infection. Safety was assessed by comparing creatine kinase (CK) levels before and after treatment using generalized estimating equations (GEE). Of 117 patients, 58 received Tixagevimab-Cilgavimab (mean age 59 ± 15 years); 92% were on dialysis and 8% had undergone kidney transplantation. COVID-19 infection occurred in 10.3% of the LAAB group versus 11.9% in the control group. In the adjusted Cox model, LAAB use was significantly associated with a reduced risk of COVID-19 infection (adjusted HR: 0.20; 95% CI: 0.04-0.95; <i>p</i> = 0.043). No variables were significantly associated with hospitalization, although LAAB use showed a non-significant trend toward reduced hospitalization risk (adjusted HR: 0.08; 95% CI: 0.01-1.56; <i>p</i> = 0.096). No local or systemic adverse effects were reported. CK levels remained unchanged after administration. Tixagevimab-Cilgavimab was effective in reducing the risk of COVID-19 infection among ESKD patients, without evidence of adverse effects, supporting its use as a prophylactic agent in this high-risk population.</p>\",\"PeriodicalId\":49328,\"journal\":{\"name\":\"Viruses-Basel\",\"volume\":\"17 9\",\"pages\":\"\"},\"PeriodicalIF\":3.5000,\"publicationDate\":\"2025-09-06\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12474474/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Viruses-Basel\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3390/v17091216\",\"RegionNum\":3,\"RegionCategory\":\"医学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"VIROLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Viruses-Basel","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3390/v17091216","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"VIROLOGY","Score":null,"Total":0}
引用次数: 0
摘要
终末期肾病(ESKD)患者对COVID-19疫苗接种的反应通常不理想。Tixagevimab-Cilgavimab是一种中和性长效抗体(LAAB),已被证明在预防COVID-19重症和免疫功能低下人群住院方面有效。本研究旨在评估Tixagevimab-Cilgavimab在接受血液透析、腹膜透析或肾移植的ESKD患者中的疗效和安全性。这项单中心、回顾性队列研究是在泰国Phitsanulok的Naresuan大学医院进行的,研究对象包括在2022年6月至2023年6月期间接受维护性血液透析、腹膜透析或肾移植的终末期肾病(ESKD)患者,此时正值Omicron变异的高峰期。在首次感染COVID-19的时间和6个月内住院的时间方面,将接受单次150/150 mg剂量替沙吉维单抗的患者与未接受单次替沙吉维单抗的患者进行比较。采用Cox比例风险模型评估相关性,并对年龄、性别、2型糖尿病、血脂异常、收缩压和舒张压、血清肌酐、COVID-19疫苗剂量和既往COVID-19感染进行校正。通过使用广义估计方程(GEE)比较治疗前后肌酸激酶(CK)水平来评估安全性。117例患者中,58例接受替沙吉维单抗-西gavimab治疗(平均年龄59±15岁);92%接受透析治疗,8%接受肾移植。LAAB组的COVID-19感染发生率为10.3%,对照组为11.9%。在调整后的Cox模型中,LAAB的使用与COVID-19感染风险降低显著相关(调整后的HR: 0.20; 95% CI: 0.04-0.95; p = 0.043)。没有变量与住院有显著相关,但LAAB的使用显示出住院风险降低的非显著趋势(调整后HR: 0.08; 95% CI: 0.01-1.56; p = 0.096)。没有局部或全身不良反应的报道。给药后CK水平保持不变。Tixagevimab-Cilgavimab可有效降低ESKD患者感染COVID-19的风险,无不良反应证据,支持其在这一高危人群中作为预防药物使用。
Tixagevimab-Cilgavimab Effectively Prevents COVID-19 Infection in Patients with End-Stage Kidney Disease.
Patients with end-stage kidney disease (ESKD) often exhibit suboptimal responses to COVID-19 vaccination. Tixagevimab-Cilgavimab, a neutralizing long-acting antibody (LAAB), has demonstrated effectiveness in preventing severe COVID-19 and hospitalization among immunocompromised populations. This study aimed to evaluate the efficacy and safety of Tixagevimab-Cilgavimab in ESKD patients receiving hemodialysis, peritoneal dialysis, or kidney transplantation. This single-center, retrospective cohort study was conducted at Naresuan University Hospital, Phitsanulok, Thailand, and included patients with end-stage kidney disease (ESKD) receiving maintenance hemodialysis, peritoneal dialysis, or kidney transplantation between June 2022 and June 2023, during the peak of the Omicron variant. Patients who received a single 150/150 mg dose of Tixagevimab-Cilgavimab were compared to those who did not, in terms of time to first COVID-19 infection and hospitalization within 6 months. Cox proportional hazards models were used to evaluate associations, adjusted for age, sex, type 2 diabetes, dyslipidemia, systolic and diastolic blood pressure, serum creatinine, number of COVID-19 vaccine doses, and prior COVID-19 infection. Safety was assessed by comparing creatine kinase (CK) levels before and after treatment using generalized estimating equations (GEE). Of 117 patients, 58 received Tixagevimab-Cilgavimab (mean age 59 ± 15 years); 92% were on dialysis and 8% had undergone kidney transplantation. COVID-19 infection occurred in 10.3% of the LAAB group versus 11.9% in the control group. In the adjusted Cox model, LAAB use was significantly associated with a reduced risk of COVID-19 infection (adjusted HR: 0.20; 95% CI: 0.04-0.95; p = 0.043). No variables were significantly associated with hospitalization, although LAAB use showed a non-significant trend toward reduced hospitalization risk (adjusted HR: 0.08; 95% CI: 0.01-1.56; p = 0.096). No local or systemic adverse effects were reported. CK levels remained unchanged after administration. Tixagevimab-Cilgavimab was effective in reducing the risk of COVID-19 infection among ESKD patients, without evidence of adverse effects, supporting its use as a prophylactic agent in this high-risk population.
期刊介绍:
Viruses (ISSN 1999-4915) is an open access journal which provides an advanced forum for studies of viruses. It publishes reviews, regular research papers, communications, conference reports and short notes. Our aim is to encourage scientists to publish their experimental and theoretical results in as much detail as possible. There is no restriction on the length of the papers. The full experimental details must be provided so that the results can be reproduced. We also encourage the publication of timely reviews and commentaries on topics of interest to the virology community and feature highlights from the virology literature in the ''News and Views'' section. Electronic files or software regarding the full details of the calculation and experimental procedure, if unable to be published in a normal way, can be deposited as supplementary material.