通用名称

bictegravir/emtricitabine/tenofovir alafenamide

儿科标签批准日期

2021/10/7 0:00:00

特定指示/秒

HIV-1 infected pediatric patients weighing at least 14 kg

标签更改摘要

- Safety and effectiveness have been established as a complete regimen for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in pediatric patients weighing at least 14 kg who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of BIKTARVY. - Use in pediatric patients weighing at least 14 kg is supported by the following: - trials in adults - an open-label trial in three age-based cohorts of virologically-suppressed pediatric patients - o Cohort 1: 12 to less than 18 years of age and weighing at least 35 kg receiving BIKTARVY through Week 48 (N=50), - o Cohort 2: 6 to less than 12 years of age and weighing at least 25 kg receiving BIKTARVY through Week 24 (N=50), and - o Cohort 3: at least 2 years of age and weighing at least 14 to less than 25 kg through Week 24 (N=22). No pediatric patients 2 years of age were enrolled; of the 6 pediatric patients who were 3 years of age at enrollment, 3 patients weighed between 14 to less than 15 kg. - Safety and efficacy in these pediatric patients were similar to that in adults, and there was no clinically significant change in exposure for the components of BIKTARVY. - For children unable to swallow a whole tablet, the tablet can be split and each part taken separately as long as all parts are ingested within approximately 10 minutes. - Safety and effectiveness in pediatric patients weighing less than 14 kg have not been established. - Information on dosing, clinical studies. - Postmarketing study.

治疗类别

Antivirals

立法类型

PREA + BPCA

产品说明书链接