Rizza S A, Nehra V, Temesgen Z
Division of Infectious Diseases, Mayo Clinic, Rochester, Minnesota, USA.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota, USA.
Drugs Today (Barc). 2017 Aug;53(8):447-451. doi: 10.1358/dot.2017.53.8.2687529.
The United States Food and Drug Administration recently approved sofosbuvir and the fixed-dose combination of ledipasvir/sofosbuvir for the treatment of hepatitis C virus (HCV) infection in children ages 12 to 17. These are the first direct-acting antiviral treatments approved for children and adolescents with HCV. Pharmacokinetic data confirm equivalent drug exposure in this population as that found in adults during clinical trials. The efficacy and safety of these drugs has been shown in clinical trials.
美国食品药品监督管理局最近批准了索磷布韦以及来迪帕司韦/索磷布韦固定剂量复方制剂用于治疗12至17岁儿童的丙型肝炎病毒（HCV）感染。这些是首批被批准用于患有HCV的儿童和青少年的直接抗病毒治疗药物。药代动力学数据证实，该人群的药物暴露量与成人临床试验中的情况相当。这些药物的疗效和安全性已在临床试验中得到证实。
