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Glecaprevir/​Pibrentasvir

    Brands

    DEA Class; Rx

    Common Brand Names; Mavyret

    • HCV NS5A Inhibitors; 
    • HCV NS3/4A Protease Inhibitors

    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

    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

    Moderate or severe hepatic impairment (Child-Pugh B or C)

    History of prior hepatic decompensation

    Coadministration with atazanavir or rifampin

    • 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

    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

    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

    Adults

    3 tablets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).

    Geriatric

    3 tablets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).

    Adolescents

    3 tablets/day or 6 oral pellet packets/day PO (glecaprevir 300 mg/day; pibrentasvir 120 mg/day).

    Children

    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.

    Infants

    Safety and efficacy have not been established.

    Neonates

    Safety and efficacy have not been established.

    Glecaprevir/pibrentasvir

    tablet

    • 100mg/40mg