Longitudinal CMV

该项目，缬更昔洛韦治疗对长期听力和听力损失的持久性的纵向研究， 先天性症状性发育不良儿童在婴儿期接受治疗后的神经发育结果 巨细胞病毒（CMV）疾病，将由大卫W。Kimberlin，MD.它使用了一个随机队列， 早期研究治疗有症状的先天性CMV疾病的婴儿，以确定是否 治疗对听力和发育结果的益处持续到2岁， 十年该研究被称为CASG 112试验，由协作抗病毒研究组进行 在2008年至2011年间招募了109名受试者。它记录了6个月的治疗时间， 与6周相比，症状性先天性CMV提供了上级听力和发育结局 抗病毒治疗，这些好处持续到2岁。但不为人知的是， 这些益处是否持续更长时间，以及是否有任何长期毒性， 在生命早期提供缬更昔洛韦治疗。 之前入组CASG 112研究的受试者即将年满12岁。我们会把他们 当他们12岁时进行听力和发育评估。返回主题也将 有青春期评估作为早期缬更昔洛韦治疗的潜在性腺毒性的标志， 以及对任何癌症发展的询问。 这项研究的结果将是重要的。如果这些对听力和发展的好处是持久的， 这表明治疗不需要超过6个月。另一方面，如果利益 6个月的治疗是不持久的（也就是说，如果他们随着时间的推移而减弱），这是同样的价值，因为它 照亮了需要进行的下一项研究，以评估可能12个月（甚至12个月）的治疗， 更长），加入或不加入第二种抗病毒药物如莱特莫韦。此外，如果长期毒性 从较早的缬更昔洛韦疗法中确定，这将对临床治疗产生直接影响。 有症状的先天性CMV疾病患者。最重要的是，知识将从中获得 根据目前的标准，对长期听力和发育结果进行纵向研究 治疗的持续时间（6个月），这将有利于儿童谁接受了这个疗程。

This project, A Longitudinal Study of the Durability of Valganciclovir Therapy on Long-Term Hearing and Neurodevelopmental Outcomes in Adolescents Treated During Infancy for Symptomatic Congenital Cytomegalovirus (CMV) Diseases, will be led by David W. Kimberlin, MD. It uses a randomized cohort from an earlier study of the treatment of infants with symptomatic congenital CMV disease to ascertain whether the treatment benefits on hearing and developmental outcomes seen to 2 years of age persist over the ensuing decade. That study, known as the CASG 112 trial, was conducted by the Collaborative Antiviral Study Group and enrolled 109 subjects between 2008 and 2011. It documented that a 6 month duration of treatment of symptomatic congenital CMV provided superior hearing and developmental outcomes compared with 6 weeks of antiviral treatment, and that these benefits persisted to 2 years of age. What is not known, though, is whether these benefits persist longer than this, and whether there are any longer-term toxicities from valganciclovir therapy provided very early in life. Subjects previously enrolled in the CASG 112 study are approaching their 12th birthday. We will bring them back when they are 12 years of age for hearing and developmental assessments. Returning subjects also will have a pubertal assessment as a marker for potential gonadotoxicity from the earlier valganciclovir therapy, and for inquiry about development of any cancers. The results of this study will be important. If these benefits on hearing and development are durable, it suggests that treatment does not need to be longer than 6 months duration. On the other hand, if the benefits of 6 months of treatment are not durable (that is, if they wane over time), this is of equal value because it illumines the next study that needs to be conducted to assesses treatment of perhaps 12 months (or even longer), with or without the addition of a second antiviral drug such as letermovir. Also, if longer-term toxicities from the earlier valganciclovir therapy are identified, this will have a direct impact on the clinical treatment of patients with symptomatic congenital CMV disease. Most importantly, knowledge will be gained from this longitudinal study of long-term hearing and developmental outcomes following what is now the standard duration of treatment (6 months) that will benefit children who have received this course of therapy.