Background

Chronic hepatitis C virus (HCV) infection represents a crucial health problem in children that greatly influences their quality of life. Many efforts have been directed toward investing in effective drugs with a high safety profile and oral administration for better compliance.

Objectives

This study aims to assess the safety of a fixed-dose combination of ledipasvir/sofosbuvir plus drug efficacy and sustained virologic response (SVR) at 12 weeks after treatment discontinuation.

Method

One tablet (90 mg ledipasvir, 400 mg sofosbuvir) was administered to treatment-naïve children aged 12–18 years weighing at least 35 kg with chronic HCV infection for 6 months, genotype 4. Patients were divided into 2 groups, (1) without comorbidities (24 patients) and (2) with comorbidities (26 patients).

Results

At the end of the therapy, all patients (100%) had SVR and a significant reduction of liver enzymes with mild tolerable side effects.

Conclusion

Ledipasvir/sofosbuvir fixed-dose combination is a safe and highly effective therapeutic option in Egyptian children aged ≥ 12 years, with chronic HCV infection, genotype 4, either without or with comorbidities.

中文翻译：

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Ledipasvir/Sofosbuvir 治疗无和有合并症的初治儿童慢性丙型肝炎病毒感染的安全性和有效性

背景

慢性丙型肝炎病毒 (HCV) 感染是儿童严重的健康问题，极大地影响了他们的生活质量。许多努力都针对投资于安全性高的有效药物和口服给药以提高依从性。

目标

本研究旨在评估 ledipasvir/sofosbuvir 固定剂量组合的安全性以及药物疗效和停药后 12 周的持续病毒学应答 (SVR)。

方法

1 片（90 mg ledipasvir，400 mg sofosbuvir）被给予 12-18 岁体重至少 35 kg 患有慢性 HCV 感染 6 个月、基因型 4 的初治儿童。患者分为 2 组，（1）没有合并症（24 名患者）和（2）合并症（26 名患者）。

结果

治疗结束时，所有患者 (100%) 均获得 SVR，肝酶显着降低，副作用轻微且可耐受。

结论

Ledipasvir/sofosbuvir 固定剂量组合是一种安全且高效的治疗选择，适用于年龄 ≥ 12 岁、基因 4 型慢性 HCV 感染、无或有合并症的埃及儿童。