Classes
DEA Class; Rx
Common Brand Names; Mavyret
- HCV NS5A Inhibitors;
- HCV NS3/4A Protease Inhibitors
Description
Combination oral antiviral containing an HCV NS3/4A protease inhibitor and NS5A inhibitor
For the treatment of chronic HCV infections (all genotypes) in adults and pediatric patients 3 years and older without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Contraindicated in patients with moderate to severe hepatic impairment and in those with any history of prior hepatic decompensation
Indications
Indicated for patients with genotypes 1-6 without cirrhosis or with compensated cirrhosis
Treatment-experienced patients with genotype 1 previously treated with a regimen containing NS5A inhibitor or an NS3/4A protease inhibitor, but not both
Contraindications
Moderate or severe hepatic impairment (Child-Pugh B or C)
History of prior hepatic decompensation
Coadministration with atazanavir or rifampin
Adverse Effects
- Headache (9-17%)
- Fatigue (11-14%)
- Nausea (6-12%)
- Diarrhea (3-7%)
- Increased bilirubin, ≥2x ULN (3.5%)
- Pruritus (7%)
- Skin and SC tissue disorders: Angioedema
- Hepatobiliary disorders: Hepatic decompensation, hepatic failure
Warnings
Hepatitis B virus reactivation in patients coinfected with HCV/HBV may occur
Postmarketing cases of hepatic decompensation/failure, including those with fatal outcomes, have been reported
No dosage adjustment of required in people who inject drugs (PWID) or those who are on medication-assisted treatment (MAT) for opioid use disorder; safety and efficacy reported to be similar to those not reporting history of injection drug use
Pregnancy and Lactation
No adequate human data are available to establish whether or not glecaprevir/pibrentasvir poses a risk to pregnancy outcomes
Unknown if distributed in human breast milk
When administered to lactating rodents, glecaprevir and pibrentasvir were present in milk, without effect on growth and development observed in the nursing pups
Maximum Dosage
3 tablets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).
3 tablets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).
3 tablets/day or 6 oral pellet packets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).
12 years or weighing 45 kg or more: 3 tablets/day or 6 oral pellet packets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).
3 to 11 years weighing 30 to 44 kg: 5 oral pellet packets/day PO (glecaprevir 250 mg/day; pibrentasvir 100 mg/day).
3 to 11 years weighing 20 to 29 kg: 4 oral pellet packets/day PO (glecaprevir 200 mg/day; pibrentasvir 80 mg/day).
3 to 11 years weighing less than 20 kg: 3 oral pellet packets/day PO (glecaprevir 150 mg/day; pibrentasvir 60 mg/day).
younger than 3 years: Safety and efficacy have not been established.
Safety and efficacy have not been established.
Safety and efficacy have not been established.
How supplied
Glecaprevir/pibrentasvir
tablet
- 100mg/40mg
