Generic Name: glecaprevir + pibrentasvir

Pronunciation: N/A

Abbreviation: G/P or GLE + PIB

Other Market Name: N/A

Drug Class: Multi-Class Combination Drugs

Company: AbbVie

Approval Status: Approved

Generic Version Available: No

Experimental Code: ABT-493 + ABT-530


Drug Indication

This drug regimen was approved by the FDA to treat genotypes 1 through 6 in adults and children 12 years and older without cirrhosis or with compensated cirrhosis, including patients with moderate to severe kidney disease and those who are on dialysis. Mavyret is also approved for adult patients with HCV genotype 1 infection who have been previously treated with a regimen either containing an NS5A inhibitor or an NS3/4A protease inhibitor but not both. Although not officially approved to retreat other genotypes, Mavyret's product information provides details from clinical trials regarding retretment of genotypes 2 through 6. 


General Info

  • Mavyret was approved by the U.S. Food and Drug Administration on August 3, 2017 for the treatment of chronic hepatitis C infection in adults for genotypes 1 through 6.
  • Glecaprevir is an NS3/4A protease inhibitor; pibrentasvir is an NS5A inhibitor
  • Mavyret is designed for the retreatment of chronic hepatitis C infection in adults with all major genotypes (1-6), including those who failed previous therapy with direct-acting antivirals (DAAs). 
  • Mavyret is also designed to treat hepatitis C in people with severe kidney disease, including those on dialysis. 


Dosage

Adult Dose: The recommended oral dosage of Mavyret is 3 tablets taken at the same time once daily with food. Mavyret is formulated in a fixed-dose combination of glecaprevir (100mg) and pibrentasvir (40mg), so 3 pills once daily is a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg.

Pediatric Dose: Mavyret is indicated for the treatment of pediatric patients 12 years and older or weighing at least 45 kg, The recommended oral dosage of Mavyret is 3 tablets taken at the same time once daily with food. Mavyret is formulated in a fixed-dose combination of glecaprevir (100mg) and pibrentasvir (40mg), so 3 pills once daily is a total daily dose of glecaprevir 300 mg and pibrentasvir 120 mg.

Dosing Info: Treatment durations recommendations for Mavyret are determined by genotype and prior treatment experience. Generally, Mavyret is taken for 8 weeks in patients with no prior treatment expereince or cirrhosis. Patients with cirrhosis take Mavyret for 12 weeks. Genotype 1 patients with/without cirrhosis who were previously treated may be treated for up to 16 weeks.


Side Effects

The most common side effects reported in clinical trials were headache, fatigue and nausea.


Drug Interactions

  • Before taking this medication, tell your medical provider and pharmacist about any drugs, supplements and herbs you take, whether prescribed, over-the-counter or illicit. 
  • Mavyret should not be taken with atazanavir or rifampin. Mavyret interferes with some other drugs, most notably carbamazepine, efavirenz and St. John’s wort.  
  • Mavyret may interact with certain drugs and herbs that are metabolized in the liver and intestines such as St. John’s wort, cyclosporine, and rifampin. Additional drug-drug interactions may occur, and these are listed in Mavyret’s full prescribing informationPotential interactions are listed at hep-druginteractions.org.


Other Info

  • Warning: Patients who are coinfected with hepatitis B and C who take this medication may be at risk of hepatitis B virus (HBV) reactivation. Before taking this medication, be sure your doctor has tested you for evidence of current or prior hepatitis B virus infection.  HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in serious hepatitis flares, liver failure, and death. 
  • There are no adequate, well-controlled studies in pregnant women who have taken Mavyret. It should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
  • The safety of breast feeding while taking Mavyret has not been established.


For More Info: https://www.mavyret.com

Co-Pay Program Info: https://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment

Patient Assistance Program Info: https://www.hepmag.com/basics/hepatitis-c-basics/paying-hepatitis-c-treatment

Last Reviewed: May 2, 2019