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Drug Name:


Generic Name and Formulations:
Glecaprevir, pibrentasvir 100mg/40mg; tabs.


Therapeutic Use:


Monograph added.

Indications for MAVYRET:

Chronic HCV genotypes 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with compensated cirrhosis. HCV genotype 1 infection in adults previously treated with an HCV NS5A inhibitor- or NS3/4A protease inhibitor-containing regimen, but not both.


Test for HBV infection prior to initiation. Take with food. ≥18yrs: 3 tabs once daily. Treatment-naive: treat for 8 weeks (no cirrhosis) or 12 weeks (compensated cirrhosis). Treatment-experienced (genotype 1): treat for 16 weeks if previously treated with an NS5A inhibitor (without prior NS3/4A protease inhibitor) or for 12 weeks if previously treated with an NS3/4A protease inhibitor (without prior NS5A inhibitor); (genotypes 1, 2, 4, 5, 6): treat for 8 weeks (no cirrhosis) or 12 weeks (compensated cirrhosis) if previously treated with regimens containing IFN, PEG-IFN, ribavirin, and/or sofosbuvir, but no prior treatment with an HCV NS3/4A protease inhibitor or NS5A inhibitor; (genotype 3): treat for 16 weeks (with or without compensated cirrhosis) if previously treated with regimens containing IFN, PEG-IFN, ribavirin, and/or sofosbuvir, but no prior treatment with an HCV NS3/4A protease inhibitor or NS5A inhibitor. HCV/HIV-1 co-infected with or without compensated liver disease or renal impairment including on hemodialysis: follow same dosage regimen. See full labeling.


<18yrs: not established.


Severe hepatic impairment (Child-Pugh C). Concomitant atazanavir or rifampin.


Risk of HBV reactivation in patients coinfected with HCV/HBV. Test all patients for HBV infection by measuring HBsAg and anti-HBc; if positive serologic evidence, monitor for hepatitis flare or HBV reactivation during and at post-treatment follow-up; treat if clinically indicated. Moderate hepatic impairment (Child-Pugh B): not recommended. Pregnancy. Nursing mothers.


See Contraindications. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May be antagonized by P-gp/CYP3A inducers (eg, carbamazepine, efavirenz, St. John's wort); concomitant use not recommended. May increase risk of ALT elevations with concomitant ethinyl estradiol-containing drugs (eg, combined oral contraceptives): not recommended. Concomitant darunavir, lopinavir, ritonavir: not recommended. Concomitant dabigatran etexilate; refer to its prescribing information for dose modification. Potentiates digoxin (reduce dose by ½); monitor. Concomitant use may potentiate atorvastatin, lovastatin, simvastatin: not recommended. May potentiate pravastatin (reduce dose by ½), rosuvastatin (limit max dose at 10mg), fluvastatin, or pitavastatin (use lowest effective dose of both these drugs). Patients requiring cyclosporine doses >100mg/day: not recommended.

Pharmacological Class:

HCV NS3/4A protease inhibitor + HCV NS5A inhibitor.

Adverse Reactions:

Headache, fatigue, serum bilirubin elevations; HBV reactivation.

Generic Availability:


How Supplied:

Carton—4-Week, 8-Week

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