Kamal Enas M, El-Shabrawi Mortada, El-Khayat Hisham, Yakoot Mostafa, Sameh Yehia, Fouad Yasser, Attia Dina
Department of Gastroenterology, Hepatology and Endemic Medicine, Minia University Hospitals, El Minia, Egypt.
Pediatric and Pediatrics Hepatology Department, Faculty of Medicine, Cairo University, Cairo, Egypt.
Liver Int. 2020 Feb;40(2):319-323. doi: 10.1111/liv.14308. Epub 2019 Dec 5.
BACKGROUND & AIMS: Treatment of children aged 3-6 genotype 4 is still limited by the interferon side effects. We aimed in this study to evaluate the effectiveness and safety of sofosbuvir/ledipasvir in children (3-6 years) genotype 4 chronic HCV-infected patients.
In total, 22 consecutive chronic HCV-infected patients (mean age 4.8 ± 0.9years, 19 males) were included in this prospective study. All patients received sofosbuvir 200 mg/ledipasvir 45 mg in a single oral daily dose. Patients were randomly subdivided into two groups according the duration of treatment into 8 and 12 weeks. All the clinical and laboratory data were collected. All the side effects were recorded from the patients or their parents. Follow-up were made at Week 4, 8 and 12 and 12 weeks after the end of treatment (SVR12).
The overall SVR12 rate was 100%. At Week 4, 9/11 patients in the 12-week group (81.8%; 95% CI: 52.3%-94.7%) achieved virologic negativity, vs 10/11 (90.9%; 95% CI: 62.3%-98.4%) in the 8-week group. At Week 8, 10/11 (90.8%; 95% CI: 62.3%-98.4%) in the 12-week group vs 11/11 (100%; 95% CI: 74.1%-100%) in the 8-week group were virologically negative. The reported side effects were cough, abdominal pain, nausea, vomiting and diarrhoea especially early in the treatment. The main complaint was difficulty in swallowing the tablets in the youngest patient at the beginning of the course of treatment. All patients were compliant to treatment.
Sofosbuvir/ledipasvir combination is safe and tolerable in the chronic infected HCV genotype 4 infected children (3-6 years). The 8-week treatment duration is similarly effective as the 12-week duration.
3至6岁4型基因型儿童的治疗仍受干扰素副作用的限制。本研究旨在评估索磷布韦/维帕他韦对3至6岁4型基因型慢性丙型肝炎病毒（HCV）感染患儿的有效性和安全性。
本前瞻性研究共纳入22例连续的慢性HCV感染患者（平均年龄4.8±0.9岁，19例男性）。所有患者每日口服一次索磷布韦200mg/维帕他韦45mg。根据治疗时长将患者随机分为两组，分别接受8周和12周的治疗。收集所有临床和实验室数据。记录患者或其家长报告的所有副作用。在第4周、第8周、第12周以及治疗结束后12周（SVR12）进行随访。
总体SVR12率为100%。在第4周时，12周治疗组的11例患者中有9例（81.8%；95%置信区间：52.3%-94.7%）实现病毒学转阴，而8周治疗组为11例中的10例（90.9%；95%置信区间：62.3%-98.4%）。在第8周时，12周治疗组的11例中有10例（90.8%；95%置信区间：62.3%-98.4%）病毒学转阴，8周治疗组则为11例中的11例（100%；95%置信区间：74.1%-100%）。报告的副作用包括咳嗽、腹痛、恶心、呕吐和腹泻，尤其是在治疗早期。主要问题是在治疗开始时年龄最小的患者吞咽片剂困难。所有患者均依从治疗。
索磷布韦/维帕他韦组合对3至6岁慢性感染HCV 4型基因型的儿童安全且耐受性良好。8周治疗疗程与12周疗程效果相似。
