Blind Jill E, Ghosh Sumit, Niese Taylor D, Gardner Julia C, Stack-Simone Stephanie, Dean Abigail, Washam Matthew
Department of Pharmacy, Nationwide Children's Hospital, Columbus, OH, USA.
Department of Research Safety, Abigail Wexner Research Institute at Nationwide Children's Hospital, Columbus, OH, USA.
Antimicrob Steward Healthc Epidemiol. 2024 Jan 31;4(1):e15. doi: 10.1017/ash.2024.1. eCollection 2024.
This comprehensive literature scoping review outlines available infection prevention and control (IPC) methods for viral-mediated gene therapies and provides one IPC strategy for the healthcare setting based on a single-center recommendation.
A team of experts in pharmacy, healthcare epidemiology, and biosafety with experience in viral-mediated gene therapy was assembled within a pediatric hospital to conduct a comprehensive literature scoping review. The comprehensive review included abstracts and full-text articles published since 2009 and utilized prespecified search terms of the five viral vectors of interest: adenovirus (AV), retrovirus (RV), adeno-associated virus (AAV), lentivirus (LV), and herpes simplex virus (HSV). Case reports, randomized controlled trials, and bench research studies were all included, while systematic reviews were excluded.
A total of 4473 case reports, randomized control trials, and benchtop research studies were identified using the defined search criteria. Chlorine compounds were found to inactivate AAV and AV, while alcohol-based disinfectants were ineffective. There was a relative paucity of studies investigating surface-based disinfection for HSV, however, alcohol-based disinfectants were effective in one study. Ultraviolent irradiation was also found to inactivate HSV in numerous studies. No studies investigated disinfection for LV and RV vectors.
The need to define IPC methods is high due to the rapid emergence of viral-mediated gene therapies to treat rare diseases, but published clinical guidance remains scarce. In the absence of these data, our center recommends a 1:10 sodium hypochlorite solution in clinical and academic environments to ensure complete germicidal activity of viral-mediated gene therapies.
本综合性文献范围综述概述了病毒介导基因治疗可用的感染预防与控制（IPC）方法，并基于单中心建议为医疗机构提供了一种IPC策略。
一家儿童医院组建了一个由在病毒介导基因治疗方面有经验的药学、医疗保健流行病学和生物安全专家组成的团队，进行综合性文献范围综述。该综合性综述包括自2009年以来发表的摘要和全文文章，并使用了预先指定的有关五种感兴趣的病毒载体的检索词：腺病毒（AV）、逆转录病毒（RV）、腺相关病毒（AAV）、慢病毒（LV）和单纯疱疹病毒（HSV）。纳入了病例报告、随机对照试验和实验室研究，排除了系统评价。
使用既定检索标准共识别出4473篇病例报告、随机对照试验和实验室研究。发现氯化合物可使AAV和AV失活，而酒精类消毒剂无效。关于HSV基于表面消毒的研究相对较少，不过在一项研究中酒精类消毒剂是有效的。在众多研究中还发现紫外线照射可使HSV失活。没有研究调查LV和RV载体的消毒情况。
由于用于治疗罕见病的病毒介导基因治疗迅速涌现，因此对定义IPC方法的需求很高，但已发表的临床指南仍然稀缺。在缺乏这些数据的情况下，我们中心建议在临床和学术环境中使用1:10的次氯酸钠溶液，以确保病毒介导基因治疗具有完全的杀菌活性。
