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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:  08/22/2019
Trade Name:  Tybost
Generic Name or Proper Name (*):  cobicistat
Indications Studied:  HIV-1 infection in pediatric patients weighing = 35 kg
Label Changes Summary:  *Safety and effectiveness co -administered with atazanavir and two nucleoside reverse transcriptase inhibitors for the treatment of HIV-1 infection have been established in virologically suppressed pediatric patients weighing at least 35 kg. *Use for this indication is supported by evidence from adequate and well-controlled studies in adults, and by pharmacokinetic, safety, and virologic data from an open-label trial in virologically suppressed, HIV-1 infected pediatric patients 12 years and older. *Safety through 48 weeks was similar to that in antiretroviral treatment-naïve adults. *Safety and effectiveness in combination with atazanavir in pediatric patients weighing less than 35 kg have not been established. *Safety and effectiveness in combination with darunavir in pediatric patients have not been established. *Information on dosing, PK parameters, adverse reactions, and clinical trial. *Postmarketing study.
BPCA(B) and PREA(P):  B,P
Sponsor:  Gilead Sciences, Inc.
Therapeutic Category:  Antiviral