索非布韦/来地帕韦治疗青少年慢性丙型肝炎感染的缩短8周疗程

D. Serranti, I. Dodi, E. Nicastro, A. Cangelosi, S. Riva, S. Ricci, E. Bartolini, S. Trapani, Greta Mastrangelo, P. Vajro, L. D’Antiga, M. Resti, G. Indolfi
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引用次数: 13

摘要

Treatment-naïve,非肝硬化成人慢性丙型肝炎病毒(HCV)基因1型感染和病毒血症水平< 600万IU/mL可以有效地使用索非布韦/来地帕韦治疗8周。这项试点、前瞻性、开放标签、多中心研究的目的是评估这种缩短治疗过程在青少年(≥12岁)中的有效性和安全性。疗效终点为治疗结束后12周的持续病毒学应答(SVR12)。通过不良事件和临床/实验室数据评估安全性。连续14名青少年(中位年龄16.5岁,第一季度14.1-第三季度17.4;女性57.1%),垂直感染,入组治疗(2018年6月至2019年1月)。总体而言,治疗结束反应和SVR12均为100%。未见3-4级不良反应和严重不良反应。需要进一步的研究来证实缩短8周的sofosbuvir/ledipasvir治疗treatment-naïve、慢性HCV基因型感染且治疗前病毒血症水平< 600万IU/mL的非肝硬化青少年的最佳疗效。
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Shortened 8-Week Course of Sofosbuvir/Ledipasvir Therapy in Adolescents with Chronic Hepatitis C Infection.
Treatment-naïve, non-cirrhotic adults with chronic hepatitis C virus (HCV) genotype 1 infection and with viremia levels < 6 million IU/mL could be effectively treated with sofosbuvir/ledipasvir for 8 weeks. The aim of this pilot, prospective, open-label, multicentre study was to evaluate the efficacy and safety of this shortened treatment course in adolescents (≥ 12 years). The efficacy endpoint was sustained virological response 12 weeks after the end of treatment (SVR12). Safety was assessed by adverse events and clinical/laboratory data.Fourteen consecutive adolescents (median age 16.5 years, Q1 14.1- Q3 17.4; female 57.1%), vertically-infected, were enrolled and treated (June 2018 - January 2019). Overall, the end of treatment response and SVR12 were 100%. No grade 3-4 adverse event or a serious adverse event was observed.Further studies are needed to confirm the optimal efficacy of the shortened 8-week treatment with sofosbuvir/ledipasvir for treatment-naïve, non-cirrhotic adolescents with chronic HCV genotype 1 infection and pre-treatment viremia level < 6 million IU/mL.
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