Drysdale Myriam, Chang Rose, Guo Tracy, Duh Mei Sheng, Han Jennifer, Birch Helen, Sharpe Catherine, Liu Daisy, Kalia Sarah, Van Dyke Melissa, DerSarkissian Maral, Gillespie Iain A
GSK, 79 New Oxford Street, London, WC1A 1DG, UK.
Analysis Group, Inc., Boston, MA, USA.
Infection. 2025 Mar 22. doi: 10.1007/s15010-025-02505-z.
To assess the impact of early sotrovimab treatment versus no treatment on the risk of developing post-acute sequelae of COVID-19 (PASC; long COVID) in patients (age ≥ 12 years) with COVID-19 at high risk for progression to severe disease.
Retrospective cohort study using the US National COVID Cohort Collaborative (N3C) data. Phase 1 identified and assessed multiple definitions of PASC; Phase 2 evaluated the effectiveness of sotrovimab for reducing the risk of PASC, utilizing definitions from Phase 1. Average treatment effect in the treated (ATT)-weighted Cox proportional hazards regression models were used to compare time to event for PASC between high-risk patients who received sotrovimab treatment between May 26, 2021 and April 5, 2022, and high-risk patients with COVID-19 diagnosed between May 26, 2021 and March 26, 2022 who did not receive any treatment for COVID-19 during the acute phase or any pre-exposure prophylaxis against SARS-CoV-2.
A total of 9,504 sotrovimab-treated and 619,668 untreated patients were included in the main analysis. Most baseline characteristics were balanced between the two cohorts after ATT weighting. The doubly robust ATT-weighted hazard ratio (95% confidence interval) was 0.92 (0.89-0.96) (p < 0.001), indicating that sotrovimab use was associated with a significantly lower risk of PASC. Results remained consistent in sensitivity analyses.
In patients at high risk for severe COVID-19, the benefits of early sotrovimab treatment may extend beyond the acute phase of COVID-19 and contribute to the prevention of PASC symptoms.
评估早期使用索托维单抗治疗与不治疗相比，对有进展为重症疾病高风险的新型冠状病毒肺炎（COVID-19）患者（年龄≥12岁）发生COVID-19急性后遗症（PASC；长新冠）风险的影响。
使用美国国家COVID队列协作组（N3C）数据进行回顾性队列研究。第1阶段确定并评估了PASC的多种定义；第2阶段利用第1阶段的定义评估索托维单抗降低PASC风险的有效性。采用治疗组平均治疗效果（ATT）加权Cox比例风险回归模型，比较2021年5月26日至2022年4月5日期间接受索托维单抗治疗的高风险患者，与2021年5月26日至2022年3月26日期间确诊为COVID-19且在急性期未接受任何COVID-19治疗或任何针对严重急性呼吸综合征冠状病毒2（SARS-CoV-2）的暴露前预防的高风险患者发生PASC的事件时间。
主要分析纳入了9504例接受索托维单抗治疗的患者和619668例未治疗的患者。ATT加权后，两个队列的大多数基线特征保持平衡。双重稳健的ATT加权风险比（95%置信区间）为0.92（0.89 - 0.96）（p < 0.001），表明使用索托维单抗与PASC风险显著降低相关。敏感性分析结果保持一致。
在COVID-19重症高风险患者中，早期使用索托维单抗治疗的益处可能超出COVID-19急性期，并有助于预防PASC症状。
