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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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Pediatric Labeling Date:  10/03/2019
 
Trade Name:  Descovy
 
Generic Name or Proper Name (*):  emtricitabine and tenofovir alafenamide
 
Indications Studied:  Pre-exposure prophylaxis (PrEP) to reduce the risk of HIV-1 infection
 
Label Changes Summary:  *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.
 
PREA(P):  P
 
Sponsor:  Gilead Sciences
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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