Azuly Hovav, Shafat Tali, Grupel Daniel, Porges Tzvika, Abuhasira Ran, Belkin Ana, Deri Ofir, Oster Yonatan, Zahran Shadi, Horwitz Ehud, Horowitz Netanel A, Khatib Hazim, Batista Marjorie Vieira, Cortez Anita Cassoli, Brosh-Nissimov Tal, Segman Yafit, Ishay Linor, Cohen Regev, Atamna Alaa, Spallone Amy, Chemaly Roy F, Ramos Juan Carlos, Chowers Michal, Rogozin Evgeny, Oren Noga Carmi, Keske Şiran, Barchad Orit Wolfovitz, Nesher Lior
Infectious Diseases Institute, Soroka University Medical Center, and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Clinical Research Center, Soroka University Medical Center and the Faculty of Health Sciences, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
Infect Dis Ther. 2025 Jan;14(1):167-180. doi: 10.1007/s40121-024-01089-9. Epub 2024 Dec 9.
Despite the declining public health emergency status, COVID-19 still poses significant risks, especially for immunocompromised individuals. We aimed to evaluate the effectiveness of tixagevimab-cilgavimab (T-C) prophylaxis in preventing severe COVID-19 in patients with hematologic malignancies (HM) treated with anti-CD20 therapy during the early Omicron variant phase of the pandemic.
The European Society of Clinical Microbiology and Infectious Diseases Study Group for Respiratory Viruses (ESGREV) conducted a multicenter retrospective cohort study involving 15 centers from 5 countries. The study included 749 patients with HM treated with anti-CD20 between February 15 and June 30, 2022, comparing 215 who received T-C prophylaxis to 534 who did not.
The study revealed a significant reduction in the risk of COVID-19 among patients who received T-C prophylaxis compared to those who did not (11.2% vs 23.4%, p < 0.001), with hazard ratio (HR) of 0.40 (95% CI 0.26-0.63), adjusted for age, sex, vaccination status, baseline HM malignancy and type of anti-CD-20. We also demonstrated a reduction for severe-critical diseases within all study populations, 1.4% vs 5.2%, p = 0.017, HR 0.26 (95% CI 0.08-0.84).
T-C prophylaxis effectively prevented COVID-19 and severe-critical COVID-19 in patients with HM treated with anti-CD20 monoclonal antibodies during the early Omicron variant phase of the pandemic. Even though T-C is ineffective against current variants, these findings highlight the importance of additional protective measures and the continued development of monoclonal antibodies to protect immunocompromised individuals to mitigate the impact of COVID-19 and other respiratory viral diseases.
尽管新冠疫情的公共卫生紧急状态有所下降，但新冠病毒疾病（COVID-19）仍然构成重大风险，尤其是对免疫功能低下的个体。我们旨在评估替沙格韦单抗-西加韦单抗（T-C）预防措施在大流行早期奥密克戎变异株阶段接受抗CD20治疗的血液系统恶性肿瘤（HM）患者中预防重症COVID-19的有效性。
欧洲临床微生物学和传染病学会呼吸道病毒研究组（ESGREV）进行了一项多中心回顾性队列研究，涉及来自5个国家的15个中心。该研究纳入了2022年2月15日至6月30日期间接受抗CD20治疗的749例HM患者，将215例接受T-C预防的患者与534例未接受T-C预防的患者进行比较。
研究显示，与未接受T-C预防的患者相比，接受T-C预防的患者感染COVID-19的风险显著降低（11.2%对23.4%，p<0.001），风险比（HR）为0.40（95%CI 0.26-0.63），对年龄、性别、疫苗接种状况、基线HM恶性肿瘤和抗CD-20类型进行了调整。我们还证明了所有研究人群中重症-危重症疾病的发生率有所降低，分别为1.4%和5.2%，p=0.017，HR为0.26（95%CI 0.08-0.84）。
在大流行早期奥密克戎变异株阶段，T-C预防措施有效地预防了接受抗CD20单克隆抗体治疗的HM患者感染COVID-19和重症-危重症COVID-19。尽管T-C对当前变异株无效，但这些发现凸显了额外保护措施的重要性，以及持续研发单克隆抗体以保护免疫功能低下个体、减轻COVID-19和其他呼吸道病毒疾病影响的重要性。
