Regional Infectious Diseases Unit, North Manchester General Hospital and Faculty of Biology, Medicine & Health, University of Manchester, Manchester, UK.
Expert Rev Anti Infect Ther. 2022 Dec;20(12):1517-1527. doi: 10.1080/14787210.2022.2134118. Epub 2022 Oct 27.
There is a need to protect vulnerable individuals who do not respond to vaccination against severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2), particularly following the emergence of new variants. Tixagevimab/cilgavimab, the only monoclonal antibody combination authorized for pre-exposure prophylaxis of coronavirus disease 2019 (COVID-19), demonstrated efficacy in unvaccinated individuals in the PROVENT study.
This review focuses predominantly on real-world evidence examining the effectiveness and safety of tixagevimab/cilgavimab in populations who are immunocompromised and otherwise vulnerable. The ability of tixagevimab/cilgavimab to neutralize Omicron subvariants, the appropriate dosage in vulnerable populations, and the impact of prior vaccination on tixagevimab/cilgavimab effectiveness are also discussed.
The tixagevimab/cilgavimab combination is important in providing protection in people who either cannot have a full vaccination or respond poorly to COVID-19 vaccines. Abundant clinical data have emerged to inform clinical use in adults in need, although some additional data-formal pediatric and adolescent studies, plus information on optimal doses required to protect against emerging variants, and the ideal interval between tixagevimab/cilgavimab dosing and vaccination-would be welcomed. Importantly, despite the current effectiveness of tixagevimab/cilgavimab, we must recognize the possibility that resistant SARS-CoV-2 variants could emerge in the future.
需要保护那些对严重急性呼吸系统综合征冠状病毒 2（SARS-CoV-2）疫苗接种无反应的脆弱个体，尤其是在新变种出现之后。替沙格韦单抗/西加韦单抗是唯一一种被授权用于预防 2019 年冠状病毒病（COVID-19）的预先暴露的单克隆抗体组合，在 PROVENT 研究中，该组合在未接种疫苗的个体中显示出疗效。
本综述主要关注检查替沙格韦单抗/西加韦单抗在免疫功能低下和其他脆弱人群中的有效性和安全性的真实世界证据。还讨论了替沙格韦单抗/西加韦单抗对奥密克戎亚变种的中和能力、脆弱人群中的适当剂量以及先前接种对替沙格韦单抗/西加韦单抗有效性的影响。
替沙格韦单抗/西加韦单抗联合用药对于那些不能完全接种疫苗或对 COVID-19 疫苗反应不佳的人提供保护非常重要。已经出现了大量的临床数据来为有需要的成年人提供临床使用信息，尽管还需要一些额外的数据——正式的儿科和青少年研究，以及关于预防新出现变种所需的最佳剂量的信息，以及替沙格韦单抗/西加韦单抗给药和接种之间的理想间隔——这将是受欢迎的。重要的是，尽管替沙格韦单抗/西加韦单抗目前有效，但我们必须认识到未来可能会出现对 SARS-CoV-2 具有耐药性的变种。
