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Glecaprevir/ Pibrentasvir (Mavyret)

[Glecaprevir/ Pibrentasvir (Mavyret) photo]

KEY POINTS

  • Glecaprevir/ pibrentasvir (Mavyret) is the combination of two direct-acting antivirals that work against hepatitis C virus (HCV)
    • Glecaprevir is a NS3/4A protease inhibitor. It interferes with proteolytic cleavage of HCV
    • Pibrentasvir is an NS5A-inhibitor. It inhibits HCV replication by blocking NS5A protein
  • FDA-approved in August 2017 for:
    • Treatment of chronic HCV infection due to genotype 1,2,3,4,5, or 6 without cirrhosis and with compensated cirrhosis (Child-Pugh A)
    • Treatment of adults with HCV genotype 1 infection previously treated with a regimen containing a HCV N5A-inhibitor or an NS3/4A protease inhibitor, but not both
  • Fixed dose tablet with glecaprevir 300mg + pibrentasvir 120mg
    • Dosed as 3 tablets once daily
    • Duration and regimen selection for HCV treatment will typically include: genotype (and resistance), cirrhosis status, and treatment history
    • Patients should receive proper screening prior to initiating therapy
      • Treatment duration is most commonly 12 weeks, but ranges from 8 to 16 weeks
  • Contraindicated in patients with Child-Pugh C
  • Contraindicated to be coadministered with rifampin and atazanavir
  • FDA Boxed Warning: beware hepatitis B virus reactivition in patients undergoing HCV therapy with direct-acting antivirals
  • Headache and fatigue have been the most common side effects in clinical trials
  • While a cost is not available at the time of last updating this page, it can be expected that this drug will be very expensive

RESOURCES

  • Glecaprevir/ Pibrentasvir (Mavyret) Package Insert
  • Glecaprevir/ Pibrentasvir (Mavyret) FDA Approval Release
  • Glecaprevir/ Pibrentasvir (Mavyret) Abbvie Approval Announcement
  • HCV Treatment Guidelines (American Association For The Study Of Liver Diseases)
  • Provision Of Clinical Pharmacist Services For Individuals With Chronic Hepatitis C Viral Infection (Pharmacotherapy 2014)
  • Hepatitis C Virus Resistance Testing in Genotype 1: The Changing Role in Clinical Utility (Annals of Pharmacotherapy 2017)
  • Glecaprevir and pibrentasvir for 12 weeks for hepatitis C virus genotype 1 infection and prior direct-acting antiviral treatment (Hepatology 2017)
  • Pharmacokinetic Interactions and Safety of Coadministration of Glecaprevir and Pibrentasvir in Healthy Volunteers (2017)

Photo source: www.nydailynews.com

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