Mavyret

MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor (PI), but not both

• Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc.
  
  
• See recommended treatment duration for patients 3 years and older in tables below.

• Treatment-naïve patients are those who have not received treatment for the current infection.

• Recommended dosage in adults:
  Three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food.
  
  
• Recommended dosage in pediatric patients 3 years and older:
  • Pediatric Patients 3 Years to Less than 12 Years Old:
    Dosing is based on weight. Refer to Table 3 of the full prescribing information for specific dosing guidelines based on body weight. Instructions for Use should be followed for preparation and administration of MAVYRET oral pellets.
    
    
  • Pediatric Patients 12 Years of Age and Older, or Pediatric Patients Weighing at Least 45 kg:
    three tablets taken at the same time orally once daily (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) with food.
  
  
  
• HCV/HIV-1 co-infection and patients with any degree of renal impairment:
  Follow the dosage recommendations in the tables above.
  
  
• Liver or Kidney Transplant Recipients:
  MAVYRET is recommended for 12 weeks in patients 3 years and older who are liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A PI or in genotype 3-infected patients who are PRS treatment-experienced.

MAVYRET is available as tablets or pellets for oral use.

• Tablets: pink, oblong-shaped, film-coated, and debossed with “NXT” on one side. Each tablet contains 100 mg glecaprevir and 40 mg of pibrentasvir.
  
  
• Oral pellets: pink and yellow coated pellets in unit-dose packets. Each packet contains 50 mg glecaprevir and 20 mg pibrentasvir.

No adequate human data are available to establish whether or not MAVYRET poses a risk to pregnancy outcomes. In animal reproduction studies, no adverse developmental effects were observed when the components of MAVYRET were administered separately during organogenesis at exposures up to 53 times (rats; glecaprevir) or 51 and 1.5 times (mice and rabbits, respectively; pibrentasvir) the human exposures at the recommended dose of MAVYRET

The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Glecaprevir was administered orally to pregnant rats (up to 120 mg/kg/day) and rabbits (up to 60 mg/kg/day) during the period of organogenesis (gestation days (GD) 6 to 18, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed in rats at dose levels up to 120 mg/kg/day (53 times the exposures in humans at the recommended human dose (RHD)).  In rabbits, the highest glecaprevir exposure achieved was 7% (0.07 times) of the exposure in humans at RHD. As such, data in rabbits during organogenesis are not available for glecaprevir systemic exposures at or above the exposures in humans at the RHD.

In the pre/post-natal developmental study in rats, glecaprevir was administered orally (up to 120 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures 47 times the exposures in humans at the RHD.

Pibrentasvir was administered orally to pregnant mice and rabbits (up to 100 mg/kg/day) during the period of organogenesis (GD 6 to 15, and GD 7 to 19, respectively). No adverse embryo-fetal effects were observed at any studied dose level in either species. The systemic exposures at the highest doses were 51 times (mice) and 1.5 times (rabbits) the exposures in humans at the RHD.

In the pre/post-natal developmental study in mice, pibrentasvir was administered orally (up to 100 mg/kg/day) from GD 6 to lactation day 20. No effects were observed at maternal exposures approximately 74 times the exposures in humans at the RHD.