通用名称

glecaprevir/pibrentasvir

儿科标签批准日期

2019/4/30 0:00:00

特定指示/秒

Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)

标签更改摘要

- Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. - Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. - The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. - In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. - Safety and effectiveness in children less than 12 years of age have not been studied. - Information on dosing, adverse reactions, PK parameters, and clinical trials. - Postmarketing study

治疗类别

Antivirals

立法类型

PREA + BPCA

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