通用名称

glecaprevir/pibrentasvir

儿科标签批准日期

2021/6/10 0:00:00

特定指示/秒

Chronic hepatitis C virus infection without cirrhosis or with compensated cirrhosis in pediatric patients 3 to 11 years weighing less than 45 kg

标签更改摘要

- Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 3 years and older is based on data from an open-label trial in 127 patients without cirrhosis aged 3 years to 17 years who were either treatment-naïve or treatment-experienced and received MAVYRET for 8, 12 or 16 weeks. - The adverse reactions observed in subjects 3 years to less than 18 years of age were consistent with those observed in clinical trials of MAVYRET in adults with the exception of vomiting, rash and abdominal pain upper which were observed more frequently in pediatric patients less than 12 years of age compared to 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 pediatric patients and adults - Safety and effectiveness in children less than 3 years of age have not been studied. - Information on dosing, adverse reactions, PK parameters, and clinical trial. - Postmarketing study.

治疗类别

Antivirals

立法类型

PREA + BPCA

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