ABSTRACT

Introduction: Sofosbuvir/velpatasvir is a combination of direct-acting antivirals with pangenotypic activity for treatment of chronic hepatitis C virus infection. It was approved in 2020 for use in children aged 6–17 years and in June 2021 by the United States Food and Drug Administration for the age group 3–5 years.

Areas covered: A literature search of PUBMED and EMBASE was conducted on April 30th and updated on June 10th. Other citations were identified in references of available literature and from ClinicalTrials.gov. The aim of the present research was to outline and discuss the pharmacokinetics, clinical efficacy, tolerability and safety of sofosbuvir/velpatasvir, exploring its actual and potential use in children and adolescents with chronic hepatitis C virus infection.

Expert opinion: Five combinations of direct-acting antivirals, of whom three with pangenotypic activity, are now approved for children. No major differences in efficacy and safety profile have been described. Limited access to treatment still is a major issue, especially in low and middle-income countries.

摘要

简介： Sofosbuvir/velpatasvir 是一种具有泛基因型活性的直接作用抗病毒药物的组合，用于治疗慢性丙型肝炎病毒感染。它于 2020 年被批准用于 6-17 岁的儿童，并于 2021 年 6 月被美国食品和药物管理局批准用于 3-5 岁年龄组。

涵盖的领域： PUBMED 和 EMBASE 的文献检索于 4 月 30 日进行，并于 6 月 10 日更新。在现有文献的参考文献和 ClinicalTrials.gov 中确定了其他引文。本研究的目的是概述和讨论索非布韦/维帕他韦的药代动力学、临床疗效、耐受性和安全性，探索其在患有慢性丙型肝炎病毒感染的儿童和青少年中的实际和潜在用途。

专家意见：五种直接作用抗病毒药物的组合，其中三种具有泛基因型活性，现已获准用于儿童。没有描述疗效和安全性方面的重大差异。获得治疗的机会有限仍然是一个主要问题，尤其是在低收入和中等收入国家。