Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  01/27/2017
 
Trade Name:  Stribild
 
Generic Name or Proper Name (*):  elvitegravir, cobicistat, emtricitabine/tenofovir disoproxil fumarate
 
Indications Studied:  HIV in pediatric patients 12 years of age and older weighing at least 35 kg
 
Label Changes Summary:  *Expanded the indication to pediatric patients 12 years of age and older weighing at least 35 kg; previously approved in adults. *The PK, safety, and virologic and immunologic responses were evaluated in 50 treatment-naïve, HIV-1-infected subjects aged 12 to less than 18 years weighing at least 35 kg receiving Stribild through 48 weeks in an open-label trial. The safety and efficacy in these patients was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in pediatric patients less than 12 years of age or weighing less than 35 kg have not been established. *Clinical trials evaluating tenofovir DF in pediatric and adolescent patients were conducted. In HIV-1-infected subjects aged 2 years to less than 18 years, bone effects were similar to those observed in adult subjects and suggest increased bone turnover. Total body BMD gain was less in the tenofovir DF-treated HIV-1-infected pediatric subjects as compared to the control groups. In all pediatric trials, skeletal growth (height) appeared to be unaffected. *Information on clinical trials, adverse reactions, and PK parameters. *Postmarketing study.
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Gilead
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
-
-