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