Gentile I, Viceconte G, Cuccurullo F, Pietroluongo D, D'Agostino A, Silvitelli M, Mercinelli S, Scotto R, Grimaldi F, Palmieri S, Gravetti A, Trastulli F, Moccia M, Buonomo A R
Department of Clinical Medicine and Surgery, Section of Infectious Diseases, University of Naples "Federico II", Naples, Italy.
Department of Clinical Medicine and Surgery, Hematology Unit, University of Naples "Federico II", Naples, Italy.
Ann Med. 2025 Dec;57(1):2439541. doi: 10.1080/07853890.2024.2439541. Epub 2024 Dec 11.
Immunocompromised patients are at high risk of developing persisting/prolonged COVID-19. Data on the early combined use of antivirals and monoclonal antibodies in this population are scarce.
We performed an observational, prospective study, enrolling immunocompromised outpatients with mild-to-moderate COVID-19, treated with a combination of sotrovimab plus one antiviral (remdesivir or nirmatrelvir/ritonavir) within 7 days from symptom onset. Primary outcome was hospitalization within 30 days. Secondary outcomes were: needing for oxygen therapy; development of persistent infection; death within 60 days and reinfection or relapse within 90 days.
We enrolled 52 patients. No patient was hospitalized within 30 days of disease onset, required oxygen administration, died within 60 days, or experienced a reinfection or clinical relapse within 90 days.The clearance rates were 67% and 97% on the 14th day after the end of therapy and at the end of the follow-up period, respectively.Factors associated with longer infection were initiation of therapy 3 days after symptom onset and enrollment for more than 180 days from the beginning of the study. However, only the latter factor was independently associated with a longer SARS-CoV-2 infection, suggesting a loss of efficacy of this strategy with the evolution of SARS-CoV-2 variants.
Early administration of combination therapy with a direct antiviral and sotrovimab seems to be effective in preventing hospitalization, progression to severe COVID-19, and development of prolonged/persisting SARS-CoV-2 infection in immunocompromised patients.
免疫功能低下的患者发生持续性/延长性新冠病毒病(COVID-19)的风险很高。关于该人群早期联合使用抗病毒药物和单克隆抗体的数据很少。
我们进行了一项观察性前瞻性研究,纳入症状出现后7天内接受索托维单抗联合一种抗病毒药物(瑞德西韦或奈玛特韦/利托那韦)治疗的轻至中度COVID-19免疫功能低下门诊患者。主要结局是30天内住院。次要结局包括:需要氧疗;持续性感染的发生;60天内死亡以及90天内再次感染或复发。
我们纳入了52例患者。没有患者在疾病发作后30天内住院、需要吸氧、在60天内死亡或在90天内经历再次感染或临床复发。治疗结束后第14天和随访期结束时的清除率分别为67%和97%。与感染持续时间较长相关的因素是症状出现3天后开始治疗以及从研究开始登记超过180天。然而,只有后一个因素与较长的严重急性呼吸综合征冠状病毒2(SARS-CoV-2)感染独立相关,这表明随着SARS-CoV-2变体的演变,该策略的疗效有所下降。
早期给予直接抗病毒药物和索托维单抗联合治疗似乎可有效预防免疫功能低下患者住院、进展为重症COVID-19以及发生延长性/持续性SARS-CoV-2感染。