Office of Readiness and Response, Centers for Disease Control and Prevention, Atlanta.
Booz Allen Hamilton, McLean, VA.
NEJM Evid. 2024 Oct;3(10):EVIDoa2400189. doi: 10.1056/EVIDoa2400189. Epub 2024 Sep 13.
During the ongoing outbreak of clade II (MPXV), many U.S. patients were prescribed tecovirimat, an antiviral drug that was made available under an expanded access Investigational New Drug (EA-IND) program. We evaluated EA-IND data to summarize characteristics of treated patients, outcomes, and serious adverse events (SAEs).
We evaluated data from patients prescribed tecovirimat from May 29, 2022, through July 10, 2023. Baseline patient characteristics, clinical courses, and outcomes were evaluated via intake forms, outcome forms, and patient diaries. Data were summarized in aggregate by human immunodeficiency virus (HIV) status and by comorbidities of special interest. Reported SAEs were also compiled.
Tecovirimat was prescribed for over 7100 patients in the United States, most often for lesions in sensitive anatomical areas, such as certain anogenital lesions (83.5%; 5135 out of 6148 patients), and pain (52.5%; 3227 out of 6148 patients). The demographic and clinical characteristics mirrored those of patients worldwide. Among the 7181 patients with returned intake forms, 1626 also had returned outcome forms (22.6%). Many patients with severe immunocompromise (e.g., HIV with CD4 counts <200 cells/μl) received multiple courses of tecovirimat (43.1%; 22 out of 51 patients), including intravenously, and often experienced poor outcomes (35.3%; 18 out of 51 patients). Overall, 223 SAEs and 40 deaths were reported. Most SAEs were among patients who were severely immunocompromised, one of whom experienced hallucinations after tecovirimat was administered at twice the standard dose.
Tecovirimat was used extensively. The returned EA-IND data suggest that life-threatening or protracted infections occurred in persons who were severely immunocompromised. SAEs were not commonly reported. The EA-IND data are not definitive; controlled clinical trial data are essential to elucidating if and how tecovirimat should be used.
在 II 型（MPXV）分支正在爆发期间，许多美国患者被开了特考韦瑞姆，一种抗病毒药物，根据扩大准入研究新药（EA-IND）计划提供。我们评估了 EA-IND 数据，以总结接受治疗的患者的特征、结局和严重不良事件（SAE）。
我们评估了 2022 年 5 月 29 日至 2023 年 7 月 10 日期间接受特考韦瑞姆治疗的患者的数据。通过摄入表格、结局表格和患者日记评估基线患者特征、临床过程和结局。根据人类免疫缺陷病毒（HIV）状况和特别关注的合并症，对数据进行了汇总。还汇编了报告的 SAE。
特考韦瑞姆在美国被开给了 7100 多名患者，最常用于治疗敏感解剖区域的病变，如某些生殖器病变（83.5%；5135 名患者中的 6148 名）和疼痛（52.5%；6148 名患者中的 3227 名）。人口统计学和临床特征与全球患者相似。在返回摄入表格的 7181 名患者中，1626 名患者也返回了结局表格（22.6%）。许多严重免疫功能低下的患者（例如，HIV 患者的 CD4 计数<200 个/μl）接受了多次特考韦瑞姆治疗（43.1%；51 名患者中的 22 名），包括静脉内治疗，且经常结局不佳（35.3%；51 名患者中的 18 名）。总体而言，报告了 223 例 SAE 和 40 例死亡。大多数 SAE 发生在严重免疫功能低下的患者中，其中一名患者在特考韦瑞姆以标准剂量的两倍给药后出现幻觉。
特考韦瑞姆被广泛使用。返回的 EA-IND 数据表明，在严重免疫功能低下的人群中发生了危及生命或长期感染。未报告常见的 SAE。EA-IND 数据并不确定；对照临床试验数据对于阐明特考韦瑞姆是否以及如何使用至关重要。
