Abstract：
BACKGROUND: Antivirals and monoclonal antibodies lower the risk of progression in immunocompromised patients. However, combination therapy with both types of agents has not been studied.
METHODS: This was a single-centre, prospective, cohort study. All immunocompromised patients who received treatment for mild-to-moderate COVID-19 from 1 January 2022 to 30 October 2022 were enrolled. The primary endpoint was COVID-19 progression at 90 days, defined as hospital admission or death due to COVID-19 and/or seronegative persistent COVID-19.
RESULTS: A total of 304 patients were included: 43 patients (14.1%) received sotrovimab plus a direct-acting antiviral, and 261 (85.9%) received monotherapy. Primary outcome occurred more frequently after monotherapy (4.6% vs. 0%, P=0.154). Among patients with anti-spike immunoglobulin G (anti-S IgG) titre <750 BAU/mL, COVID-19 progression was more common after monotherapy (23.9% vs. 0%, P=0.001), including more frequent COVID-related admission (15.2% vs. 0%, P=0.014) and seronegative persistent COVID-19 (10.9% vs. 0%, P=0.044). Combination therapy was associated with lower risk of progression (odds ratio [OR] 0.08, 95% confidence interval [95% CI] 0.01-0.64). Anti-S IgG titre <750 BAU/mL and previous anti-CD20 were associated with higher risk of progression (OR 13.70, 95% CI 2.77-67.68; and OR 3.05, 95% CI 1.20-10.94, respectively).
CONCLUSIONS: In immunocompromised patients, combination therapy with sotrovimab plus an antiviral may be more effective than monotherapy for SARS-CoV2.
METHODS: This was a single-centre, prospective, cohort study. All immunocompromised patients who received treatment for mild-to-moderate COVID-19 from 1 January 2022 to 30 October 2022 were enrolled. The primary endpoint was COVID-19 progression at 90 days, defined as hospital admission or death due to COVID-19 and/or seronegative persistent COVID-19.
RESULTS: A total of 304 patients were included: 43 patients (14.1%) received sotrovimab plus a direct-acting antiviral, and 261 (85.9%) received monotherapy. Primary outcome occurred more frequently after monotherapy (4.6% vs. 0%, P=0.154). Among patients with anti-spike immunoglobulin G (anti-S IgG) titre <750 BAU/mL, COVID-19 progression was more common after monotherapy (23.9% vs. 0%, P=0.001), including more frequent COVID-related admission (15.2% vs. 0%, P=0.014) and seronegative persistent COVID-19 (10.9% vs. 0%, P=0.044). Combination therapy was associated with lower risk of progression (odds ratio [OR] 0.08, 95% confidence interval [95% CI] 0.01-0.64). Anti-S IgG titre <750 BAU/mL and previous anti-CD20 were associated with higher risk of progression (OR 13.70, 95% CI 2.77-67.68; and OR 3.05, 95% CI 1.20-10.94, respectively).
CONCLUSIONS: In immunocompromised patients, combination therapy with sotrovimab plus an antiviral may be more effective than monotherapy for SARS-CoV2.
摘要：
背景：抗病毒药物和单克隆抗体可降低免疫功能低下患者的进展风险。然而,尚未研究两种药物的联合治疗。
方法：这是一个单中心，prospective,队列研究。所有从2022年1月1日至2022年10月30日接受轻中度COVID-19治疗的免疫功能低下患者均被纳入。主要终点是90天的COVID-19进展，定义为因COVID-19和/或血清阴性持续性COVID-19而入院或死亡。
结果：共包括304名患者：43名患者（14.1％）接受了索特罗病毒加直接作用的抗病毒药物，261（85.9％）接受单药治疗。单一疗法后主要结局发生频率更高（4.6％vs.0%,P=0.154）。在抗标免疫球蛋白G（抗SIgG）滴度<750BAU/mL的患者中，单一疗法后COVID-19进展更为常见（23.9%与0%,P=0.001),包括更频繁的COVID相关入院(15.2%vs.0%,P=0.014）和血清阴性持续性COVID-19（10.9%vs.0%,P=0.044)。联合治疗与较低的进展风险相关(比值比[OR]0.08,95%置信区间[95%CI]0.01-0.64)。抗SIgG滴度<750BAU/mL和先前的抗CD20与更高的进展风险相关（分别为OR13.70，95％CI2.77-67.68；和OR3.05，95％CI1.20-10.94）。
结论：在免疫功能低下的患者中，sotrovimab加抗病毒药物的联合治疗可能比单一治疗SARS-CoV2更有效.
方法：这是一个单中心，prospective,队列研究。所有从2022年1月1日至2022年10月30日接受轻中度COVID-19治疗的免疫功能低下患者均被纳入。主要终点是90天的COVID-19进展，定义为因COVID-19和/或血清阴性持续性COVID-19而入院或死亡。
结果：共包括304名患者：43名患者（14.1％）接受了索特罗病毒加直接作用的抗病毒药物，261（85.9％）接受单药治疗。单一疗法后主要结局发生频率更高（4.6％vs.0%,P=0.154）。在抗标免疫球蛋白G（抗SIgG）滴度<750BAU/mL的患者中，单一疗法后COVID-19进展更为常见（23.9%与0%,P=0.001),包括更频繁的COVID相关入院(15.2%vs.0%,P=0.014）和血清阴性持续性COVID-19（10.9%vs.0%,P=0.044)。联合治疗与较低的进展风险相关(比值比[OR]0.08,95%置信区间[95%CI]0.01-0.64)。抗SIgG滴度<750BAU/mL和先前的抗CD20与更高的进展风险相关（分别为OR13.70，95％CI2.77-67.68；和OR3.05，95％CI1.20-10.94）。
结论：在免疫功能低下的患者中，sotrovimab加抗病毒药物的联合治疗可能比单一治疗SARS-CoV2更有效.
