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Descovy
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.