通用名称

cobicistat

儿科标签批准日期

2019/8/22 0:00:00

特定指示/秒

HIV-1 infection in pediatric patients weighing ≥ 35 kg

标签更改摘要

- Safety and effectiveness co -administered with atazanavir and two nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection have been established in virologically suppressed pediatric patients weighing at least 35 kg. - Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients 12 years and older. - Safety through 48 weeks was similar to that in antiretroviral treatment-naïve adults. - Safety and effectiveness in combination with atazanavir in pediatric patients weighing less than 35 kg have not been established. - Safety and effectiveness in combination with darunavir in pediatric patients have not been established. - Information on dosing, PK parameters, adverse reactions, and clinical trial. - Postmarketing study

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接

书号

2.0 1.0

研究年龄

12 YEARS - 17 YEARS 12 YEARS - 17 YEARS

学习类型

Safety Efficacy,Safety,Pharmacokinetic

研究设计

Long-term Multicenter,Multicenter,Open-Label,Open-Label,Phase 2,Phase 2,Phase 3,Phase 3,Multicohort, Switch Study,Multicohort

登记的患者

17 22

患者分析

N/A 21

中心的数量

N/A N/A

国家数量

N/A 2

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

N/A N/A

亚裔学生总数

N/A 8

黑人总数

N/A 4

白人总数

N/A 7

夏威夷或太平洋岛民总数

N/A 0

美洲印第安人/阿拉斯加本地人总数

N/A 0

其他种族总计

N/A 2

未知种族总数

N/A 0

国家

N/A United States,Thailand