Value Evidence & Outcomes, GSK, Brentford, UK.
Department of Respiratory Medicine, Ghent University Hospital, Ghent, Belgium.
Acta Clin Belg. 2024 Jun;79(3):174-183. doi: 10.1080/17843286.2024.2381272. Epub 2024 Jul 31.
Sotrovimab, a dual-action, engineered human monoclonal antibody, has been demonstrated to significantly reduce the risk of hospitalisation and death in high-risk patients with COVID-19. Here, we describe the real-world use of, and outcomes from, sotrovimab treatment in Belgium during the Delta and Omicron waves among patients with COVID-19 at high risk of developing severe disease.
This was a multicentric, single-arm observational cohort study of non-hospitalised patients receiving outpatient sotrovimab treatment between 1 November 2021 and 2 August 2022 at nine hospitals in Belgium. The primary outcomes were all-cause and COVID-19-related hospitalisations and all-cause deaths during the 29-day acute follow-up period from first administration of sotrovimab.
A total of 634 patients were included (63.4% aged < 65 years; 50.3% male). A high proportion (67.7%; = 429/634) of patients were immunocompromised, with 36.9% ( = 234/634) actively treated for malignancy. During the 29-day acute period, 12.5% ( = 79/634) of sotrovimab-treated patients were hospitalised due to any cause (median duration 4 days; median time to hospitalisation 14 days) and 1.1% ( = 7/634) died due to any cause. The proportion of sotrovimab-treated patients experiencing COVID-19-related hospitalisation was highest during the Delta predominance and Delta/BA.1 codominance (both 6.3%) periods. During the BA.1 predominance, BA.1/BA.2 codominance and BA.2/BA.5 codominance periods, COVID-19-related hospitalisations were consistently low (all ≤2.7%).
This study indicated low rates of COVID-19-related hospitalisations and all-cause deaths in sotrovimab-treated patients in Belgium, including during Omicron subvariant periods, despite over two-thirds of the study population being immunocompromised.
索特罗维单抗是一种双作用的工程化人单克隆抗体，已被证明可显著降低 COVID-19 高危患者住院和死亡的风险。在这里，我们描述了在德尔塔和奥密克戎波期间，比利时在 COVID-19 高危患者中使用索特罗维单抗治疗的实际情况，以及这些患者的治疗结果。
这是一项多中心、单臂观察性队列研究，纳入了 2021 年 11 月 1 日至 2022 年 8 月 2 日期间在比利时 9 家医院接受门诊索特罗维单抗治疗的非住院患者。主要结局是在首次接受索特罗维单抗治疗后的 29 天急性随访期间，所有原因和 COVID-19 相关的住院和全因死亡。
共纳入 634 例患者（63.4%年龄<65 岁；50.3%为男性）。高比例（67.7%；429/634）的患者免疫功能低下，其中 36.9%（234/634）正在积极治疗恶性肿瘤。在 29 天的急性期内，12.5%（79/634）的索特罗维单抗治疗患者因任何原因住院（中位持续时间 4 天；中位住院时间 14 天），1.1%（7/634）因任何原因死亡。在德尔塔优势和德尔塔/BA.1 共同优势（均为 6.3%）期间，索特罗维单抗治疗患者发生 COVID-19 相关住院治疗的比例最高。在 BA.1 优势、BA.1/BA.2 共同优势和 BA.2/BA.5 共同优势期间，COVID-19 相关住院治疗一直很低（均≤2.7%）。
本研究表明，在比利时，索特罗维单抗治疗患者的 COVID-19 相关住院治疗和全因死亡发生率较低，包括在奥密克戎亚变体期间，尽管研究人群中有超过三分之二的患者免疫功能低下。
