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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:  04/30/2019
 
Trade Name:  Mavyret
 
Generic Name or Proper Name (*):  glecaprevir and pibrentasvir
 
Indications Studied:  Chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or with compensated cirrhosis (Child-Pugh A)
 
Label Changes Summary:  *Expanded the indication to adolescents 12 years and older or weighing at least 45 kilograms (kg); previously approved in adults. *Safety, efficacy, and pharmacokinetics in HCV GT1, 2, 3, or 4 infected pediatric patients 12 years and older or weighing at least 45 kg is based on data from an open-label trial in 47 subjects without cirrhosis aged 12-18 years who were either treatment naïve (n=36) or treatment experienced (n=11) and received Mavyret for 8 or 16 weeks. *The safety and efficacy results observed in this trial were consistent with those observed in clinical studies of Mavyret in adults. *In pediatric patients with cirrhosis, history of a kidney and/or liver transplant, or HCV GT5 or 6 infection, the safety and efficacy of Mavyret are supported by the comparable glecaprevir and pibrentasvir exposures observed between adolescents and adults. *Safety and effectiveness in children less than 12 years of age have not been studied. *Information on dosing, adverse reactions, PK parameters, and clinical trials. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
BPCA(B) and PREA(P):  B, P
 
Sponsor:  AbbVie
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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