Use of Sotrovimab in a cohort of pregnant women with a high risk of COVID 19 progression: a single-center experience.

IF 4.9 4区 医学 Q1 PARASITOLOGY Pathogens and Global Health Pub Date : 2023-07-01 Epub Date: 2023-03-10 DOI:10.1080/20477724.2023.2188839
Luisa Frallonardo, Antonella Vimercati, Roberta Novara, Cherola Lepera, Ilaria Ferrante, Giulia Chiarello, Rossana Cicinelli, Michele Mongelli, Gaetano Brindicci, Francesco Vladimiro Segala, Carmen Rita Santoro, Davide Fiore Bavaro, Nicola Laforgia, Ettore Cicinelli, Annalisa Saracino, Francesco Di Gennaro
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Abstract

Neutralizing monoclonal antibodies (mAbs) have been shown to reduce disease progression in patients with underlying predisposing conditions. Unfortunately, there is no evidence on the use of Sotrovimab in pregnant women. Herein we present a case series of pregnant women who received mAbs with Sotrovimab following the Italian Drug Agency (AIFA) indications. Since February 1, 2022 all pregnant women - regardless of gestational age - admitted to Obstetrics & Gynaecology of Policlinico University of Bari, with positive nasopharyngeal NAAT for SARS-CoV-2 were screened according to the AIFA indications for Sotrovimab and, if eligible, were proposed for treatment. Data on COVID-19, pregnancy, delivery, newborn outcomes, and adverse events were collected. From February 1 to May 15, 2022, 58 pregnant women were screened. Fifty (86%) patients were eligible, 19 of them (32.7%) denied their consent, in 18 cases (31%), the drug was temporarily unavailable, and the remaining 13 (22%) were treated with Sotrovimab. Out of these 13 patients, 6 (46%) were in the 3rd and 7 (54%) in the 2nd trimester of pregnancy. None of the 13 patients experienced adverse reactions due to Sotrovimab and all had a good clinical outcome. Furthermore, evaluating pre- and post-infusion clinical status and hematochemical profile, a reduction in D-dimers and an increase in SARS-CoV-2 antibodies (p < 0.01) during the 72 h following the infusion were observed. Our data, the first on the use of Sotrovimab in pregnant women, showed the safety and efficacy drug profile and its potential crucial role in preventing COVID-19 disease progression.

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在 COVID 19 进展风险较高的孕妇群体中使用索托维单抗:单中心经验。
中和单克隆抗体(mAbs)已被证明可以减少潜在易感疾病患者的疾病进展。遗憾的是,目前还没有证据表明索罗单抗可用于孕妇。在此,我们将介绍一组按照意大利药品管理局(AIFA)的适应症接受索罗单抗 mAb 治疗的孕妇病例。自 2022 年 2 月 1 日起,巴里大学 Policlinico 妇产科根据 AIFA 索特罗维奇单抗适应症对 SARS-CoV-2 鼻咽 NAAT 阳性的所有孕妇(不考虑孕龄)进行筛查,如果符合条件,则建议其接受治疗。收集了有关 COVID-19、妊娠、分娩、新生儿结局和不良事件的数据。2022 年 2 月 1 日至 5 月 15 日,58 名孕妇接受了筛查。50名(86%)患者符合条件,其中19名(32.7%)患者拒绝同意,18名(31%)患者暂时无法获得药物,其余13名(22%)患者接受了索托维单抗治疗。在这 13 名患者中,有 6 人(46%)处于妊娠期的第三个月,7 人(54%)处于妊娠期的第二个月。13 名患者中没有一人因使用索特罗维奇单抗而出现不良反应,临床疗效良好。此外,在对输注前后的临床状态和血液生化指标进行评估后发现,D-二聚体减少,SARS-CoV-2 抗体增加(P<0.05)。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Pathogens and Global Health
Pathogens and Global Health PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH-PARASITOLOGY
CiteScore
6.00
自引率
0.00%
发文量
60
审稿时长
6-12 weeks
期刊介绍: Pathogens and Global Health is a journal of infectious disease and public health that focuses on the translation of molecular, immunological, genomics and epidemiological knowledge into control measures for global health threat. The journal publishes original innovative research papers, reviews articles and interviews policy makers and opinion leaders on health subjects of international relevance. It provides a forum for scientific, ethical and political discussion of new innovative solutions for controlling and eradicating infectious diseases, with particular emphasis on those diseases affecting the poorest regions of the world.
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