通用名称

emtricitabine/tenofovir alafenamide

儿科标签批准日期

2019/10/3 0:00:00

特定指示/秒

Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection

标签更改摘要

- Safety and effectiveness for HIV-1 PrEP in at-risk adolescents weighing at least 35 kg, excluding individuals at risk from receptive vaginal sex, is supported by data from an adequate and well-controlled trial for HIV-1 PrEP in adults with additional data from safety and pharmacokinetic studies in previously conducted trials with the individual drug products, FTC and TAF, with EVG+COBI, in HIV-1 infected adults and pediatric subjects. - While using DESCOVY for HIV-1 PrEP, HIV-1 testing should be repeated at least every 3 months, and upon diagnosis of any other STIs. Previous studies in at-risk adolescents indicated waning adherence to a daily oral PrEP regimen once visits were switched from monthly to quarterly visits. Adolescents may therefore benefit from more frequent visits and counseling. - Safety and effectiveness for HIV-1 PrEP in pediatric patients less than 35 kg have not been established. - Information on dosing, adverse reactions, PK parameters, and clinical trial.

治疗类别

Antivirals

立法类型

PREA Only

产品说明书链接