The severity of coronavirus disease 2019 (COVID-19) ranges from mild to death, with high morbidity and mortality rates reported amongst a vulnerable subset of patients termed high risk. While vaccines remain the primary option for COVID-19 prevention, neutralizing monoclonal antibodies (mAbs), such as bamlanivimab and etesevimab, have been shown to benefit certain subpopulations after exposure to severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Unlike vaccine-derived immunity that develops over time, administration of neutralizing mAbs is an immediate and passive immunotherapy, with the potential to reduce disease progression, emergency room visits, hospitalizations, and death. Bamlanivimab alone and together with etesevimab hold emergency use authorizations in several countries globally, with countries increasingly transitioning to the use of bamlanivimab and etesevimab together and other authorized mAbs on the basis of their evolving variant landscape, regulatory authorizations, and access to drugs. The current guidelines for the administration of bamlanivimab alone or together with etesevimab are informed by an iterative process of testing and development. Herein the rationale for these guidelines is provided by sharing the learnings that have been gathered throughout the development process of these mAbs. In addition, this review addresses the most common clinical questions received from health care professionals (HCPs) and patients regarding indicated population, dose, use with other medications and vaccines, duration of protection, and variants in clinical practice. As prevalence of SARS-CoV-2 variants can differ by country and state, prescribing HCPs should consider the prevalence of bamlanivimab and etesevimab resistant variants in their area, where data are available, regarding potential efficacy impact when considering treatment options.Trial Registration: ClinicalTrials.gov identifier: NCT04427501; NCT04411628; NCT04497987; NCT04634409.

中文翻译：

---

Bamlanivimab 和 Etesevimab 抗体治疗 SARS-CoV-2 的临床实用性叙述性综述。

2019 年冠状病毒病 (COVID-19) 的严重程度从轻度到死亡不等，在被称为高风险的脆弱患者子集中报告了高发病率和死亡率。虽然疫苗仍然是预防 COVID-19 的主要选择，但中和单克隆抗体 (mAb)，如 bamlanivimab 和 etesevimab，已被证明对暴露于严重急性呼吸综合征冠状病毒 2 (SARS-CoV-2) 的某些亚群有益。与随时间发展的疫苗衍生免疫不同，中和 mAb 的给药是一种即时和被动的免疫疗法，有可能减少疾病进展、急诊室就诊、住院和死亡。Bamlanivimab 单独和与 etesevimab 一起在全球多个国家获得紧急使用授权，随着各国越来越多地过渡到同时使用 bamlanivimab 和 etesevimab 以及其他授权的单克隆抗体，这是基于其不断变化的变异情况、监管授权和药物获取。单独或与 etesevimab 一起使用 bamlanivimab 的当前指南是通过反复的测试和开发过程得出的。在此，这些指南的基本原理是通过分享在这些 mAb 开发过程中收集的知识来提供的。此外，本综述还解决了从医疗保健专业人员 (HCP) 和患者那里收到的最常见的临床问题，这些问题涉及适用人群、剂量、与其他药物和疫苗的使用、保护持续时间以及临床实践中的变异。由于 SARS-CoV-2 变异的流行率因国家和州而异，处方 HCP 应考虑其所在地区的 bamlanivimab 和 etesevimab 耐药变异的流行率，如果有数据，在考虑治疗选择时，就潜在的疗效影响。 试验注册：临床试验.gov 标识符：NCT04427501；NCT04411628; NCT04497987；NCT04634409。