Department of Pediatric Hepatology, Gastroenterology and Nutrition, National Liver Institute, Menoufia University, Menoufia, Egypt.
Microbiology and Immunology Department, Faculty of Medicine, Zagazig University, Zagazig, El-Sharkiya, Egypt.
J Pediatr. 2020 Apr;219:106-110. doi: 10.1016/j.jpeds.2019.12.034. Epub 2020 Jan 31.
To evaluate the safety and efficacy of shortened 8-week regimen of ledipasvir/sofosbuvir (LED/SOF) combination therapy in treatment-naïve children without cirrhosis aged 4-10 years of age with chronic hepatitis C virus (HCV) infection.
This observational single arm prospective study included 30 treatment-naïve children (20 males) with proved chronic HCV fulfilling inclusion criteria. Their body weights ranged from 17 to 26 kg. Four patients were excluded from the study. All the included children received a single oral dose of LED/SOF 45/200 mg for 8 weeks. Body weight, HCV-RNA, complete blood count, and liver function tests were monitored at 0, 2, 4, and 8 weeks and sustained virologic response was evaluated after 12 weeks after treatment (SVR12). The emergence of any side effects was also monitored.
The most common risk factor (53.3%) was an parent or sibling with HCV infection. Twenty-nine patients (96.7%) were negative for HCV-RNA by week 2 of treatment and 1 patient became negative by week 4. The end of treatment response and SVR12 were 100%. Transaminases levels declined and returned to normal levels by week 2. Major side effects were fatigue in 90% (27/30) and headache in 76.7% (23/30). Side effects were minimal, tolerable, and did not interfere with daily activity or necessitate treatment discontinuation.
A shortened 8-week regimen of LED/SOF (45/200 mg) is safe and effective with 100% SVR12 in treatment-naïve children with cirrhosis aged 4-10 years with chronic HCV infection genotype 4.
评估无肝硬化的 4-10 岁初治儿童慢性丙型肝炎病毒（HCV）感染患者接受为期 8 周的短疗程雷迪帕韦/索磷布韦（LED/SOF）联合治疗的安全性和疗效。
这是一项观察性、单臂、前瞻性研究，纳入了 30 名符合纳入标准的初治儿童（20 名男性）。他们的体重在 17-26kg 之间。有 4 名患者被排除在研究之外。所有纳入的儿童均接受 LED/SOF 45/200mg 单剂口服治疗，疗程 8 周。在 0、2、4 和 8 周时监测体重、HCV-RNA、全血细胞计数和肝功能，治疗 12 周后评估持续病毒学应答（SVR12）。还监测了任何不良反应的发生情况。
最常见的危险因素（53.3%）是父母或兄弟姐妹感染 HCV。29 名患者（96.7%）在治疗第 2 周时 HCV-RNA 转为阴性，1 名患者在第 4 周时转为阴性。治疗结束时的应答率和 SVR12 均为 100%。转氨酶水平在第 2 周下降并恢复正常。主要副作用为 90%（27/30）的乏力和 76.7%（23/30）的头痛。副作用轻微，可耐受，不影响日常活动，也无需停药。
对于基因型 4 的 4-10 岁无肝硬化的初治儿童慢性 HCV 感染患者，采用雷迪帕韦/索磷布韦（45/200mg）的 8 周短疗程治疗方案安全有效，SVR12 可达 100%。
