COVID-19 进化的双克隆抗体治疗比较：一项多中心回顾性研究。
Comparison of Dual Monoclonal Antibody Therapies for COVID-19 Evolution: A Multicentric Retrospective Study.
机构信息
Laboratoire de Virologie, Hôpitaux Universitaires Pitié-Salpêtrière-Charles Foix, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Institut National de la Santé et de la Recherche Médicale, Sorbonne Université, Assitance Publique-Hôpitaux de Paris, 75013 Paris, France.
Département de Santé Publique, Hôpital Saint-Antoine, Institut Pierre Louis d'Epidémiologie et de Santé Publique, Institut Nationale de la Santé et de la Recherche Médicale, Sorbonne Université, Assistance Publique-Hôpitaux de Paris, 75012 Paris, France.
出版信息
Viruses. 2024 Sep 29;16(10):1542. doi: 10.3390/v16101542.
BACKGROUND
Neutralizing antibodies targeting the SARS-CoV-2 Spike protein reduce COVID-19-related risk of hospitalization, particularly in high-risk individuals. The COCOPREV-R study aimed to evaluate and compare clinical outcomes in high-risk SARS-CoV-2 patients treated with dual monoclonal antibody therapies and to identify associated virological factors.
METHODS
The COCOPREV-R study retrospectively collected real-world data from high-risk patients receiving Bamlanivimab/Etesevimab or Casirivimab/Imdevimab dual monoclonal antibody therapies (22 February 2021 to 15 June 2021).
RESULTS
The study included 1004 patients with COVID-19, of whom 691 received Bamlanivimab/Etesevimab and 313 received Casirivimab/Imdevimab. The alpha variant represented 90.1% of those for whom data were available. The risk of hospitalization within 30 days was lower with Bamlanivimab/Etesevimab (12.7%, CI 95% [9.9-16.3%]) compared to Casirivimab/Imdevimab (28.4%, CI 95% [22.7-35.1%) ( < 0.001). The 30-day mortality rates were comparable between both groups ( = 0.982). Analysis of SARS-CoV-2 PCR negativity showed no difference between the two treatment groups (95.2% [93.0-96.9%] and 93.5% [89.1-96.6%] until day 30, = 0.851 for Bamlanivimab/Etesevimab and Casirivimab/Imdevimab, respectively). Among persistently positive samples with available sequencing results ( = 43), Spike protein changes occurred only in Bamlanivimab/Etesevimab (42.9%) vs. Casirivimab/Imdevimab (0.0%) groups. Q493R (25.0%) and E484K (12.5%) were the most common mutations selected by Bamlanivimab/Etesevimab in follow-up samples. Other factors (immunodepression, comorbidities, and age) did not appear to be associated with the occurrence of Spike protein mutations.
CONCLUSIONS
A higher rate of hospitalization was seen with Casirivimab/Imdevimab (RONAPREVE) in comparison with Bamlanivimab/Etesevimab treatment, but with the emergence of Spike mutations only in the Bamlanivimab/Etesevimab group.
背景
针对 SARS-CoV-2 刺突蛋白的中和抗体可降低 COVID-19 相关住院风险，尤其是在高危人群中。COCOPREV-R 研究旨在评估和比较接受双单克隆抗体治疗的高危 SARS-CoV-2 患者的临床结局，并确定相关病毒学因素。
方法
COCOPREV-R 研究回顾性收集了 2021 年 2 月 22 日至 2021 年 6 月 15 日期间接受巴姆洛单抗/依替巴肽或卡西米单抗/西多福韦双单克隆抗体治疗的高危患者的真实世界数据。
结果
该研究纳入了 1004 例 COVID-19 患者，其中 691 例接受巴姆洛单抗/依替巴肽治疗，313 例接受卡西米单抗/西多福韦治疗。α 变异株占可提供数据的患者的 90.1%。与卡西米单抗/西多福韦组（28.4%[95%CI 22.7-35.1%]）相比，巴姆洛单抗/依替巴肽组 30 天内住院风险较低（12.7%[95%CI 9.9-16.3%]）（<0.001）。两组 30 天死亡率相当（=0.982）。对 SARS-CoV-2 PCR 阴性结果的分析显示，两组之间无差异（第 30 天分别为 95.2%[93.0-96.9%]和 93.5%[89.1-96.6%]）（巴姆洛单抗/依替巴肽和卡西米单抗/西多福韦分别为 0.851）。在可提供测序结果的持续阳性样本中（=43），仅在巴姆洛单抗/依替巴肽组（42.9%）中观察到 Spike 蛋白变化，而在卡西米单抗/西多福韦组（0.0%）中未观察到（=0.0%）。巴姆洛单抗/依替巴肽组随访样本中最常见的突变是 Q493R（25.0%）和 E484K（12.5%）。其他因素（免疫抑制、合并症和年龄）似乎与 Spike 蛋白突变的发生无关。
结论
与巴姆洛单抗/依替巴肽治疗相比，卡西米单抗/西多福韦（RONAPREVE）治疗的住院率更高，但仅在巴姆洛单抗/依替巴肽组出现 Spike 突变。
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