索非布韦和来地帕韦(Harvoni)治疗儿童丙型肝炎

Yoram Elitsur, MD
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摘要

目的:美国食品和药物管理局(FDA)最近批准了直接作用抗病毒(DAA)药物用于HCV感染儿童(FDA新闻发布,2017年4月7日)。我们描述了来自肯塔基州的前两名HCV感染儿童成功地用研究方案中的DAA药物治疗。方法:对2例儿童HCV感染病例进行回顾性分析。一旦达到青春期(12岁),两名儿童(一名naïve和一名有经验的儿童)接受Sofosbuvir和Ledipasvir (Harvoni)治疗8周并进行监测。观察治疗前后转氨酶及HCVRNA水平。结果:两名儿童从婴儿期开始就接受了丙型肝炎病毒感染的随访。两名儿童在治疗结束时均达到SVR,其中一名在治疗后12周达到SVR。第二例患者治疗后仍在随访中。结论:这是第一个使用非研究方案的DAA药物治疗儿童的报告。我们建议8周的治疗可能足以实现儿童的SVR。患者权益团体和政府机构应该向保险公司施压,要求批准对感染丙型肝炎病毒的儿童进行DAA治疗。
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Sofosbuvir and Ledipasvir (Harvoni) treatment for hepatitis C in Children
bjective: Direct Acting Antiviral (DAA) drugs have been recently approved by the Food and Drug Administraation for children with HCV infection (FDA news release, April 7, 2017). We describe the first two HCV- infected children from Kentucky treated successfully with DAA drugs from a research protocol. Methods: The charts of two children with HCV infections were reviewed. Once adolescent age was achieved (12 years), both children (one naïve and one experienced) were treated for eight weeks with Sofosbuvir and Ledipasvir (Harvoni) and were monitored. Their aminotransferases and HCVRNA levels were followed before and after treatment. Results: Both children were followed for their HCV infections since infancy. Both children achieved SVR at the end of therapy, one achieved SVR 12 weeks post therapy. The second patient is still on follow up post treatment. Conclusion: This is the first report of children treated with DAA drugs not under a research protocol. We suggest the eightweek treatment may be sufficient to achieve SVR in children. Patient advocacy groups and government agencies should pressure the insurance companies to approve DAA therapy for HCVinfected children.
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