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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:  09/26/2019
 
Trade Name:  Mavyret
 
Generic Name or Proper Name (*):  glecaprevir and pibrentasvir
 
Indications Studied:  Chronic hepatitis C virus infection (HCV) 12 years and older or weighing at least 45 kg
 
Label Changes Summary:  *The treatment duration for chronic HCV for treatment-naïve patients was changed from 12 weeks to 8 weeks. *The new 8-week treatment duration for genotypes (GTs) 1,2,3,4,5 and 6 for treatment-naïve patients with compensated cirrhosis with Chronic Hepatitis C Virus (HCV) infection is supported by the EXPEDITION-8 study. *Information on dosing, and clinical trial. *New dosing regimen. *Postmarketing study.
 
PREA(P):  P
 
Sponsor:  AbbVie Inc.
 
NNPS:  FALSE
 
Therapeutic Category:  Antiviral
 
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