Viral infections:

Indications for: MAVYRET

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

Adults and Children:

<3yrs: not established. Test for HBV infection prior to initiation. Take with food. Sprinkle contents of oral pellets on soft food with a low water content, then swallow whole (eg, peanut butter, chocolate hazelnut spread, cream cheese, thick jam, Greek yogurt). ≥3yrs (<20kg): 150mg/60mg (pellets) once daily; (20–<30kg): 200mg/80mg (pellets) once daily; (30–<45kg): 250mg/100mg (pellets) once daily; (≥45kg or ≥12yrs): 300mg/120mg (tabs or give pellets if unable to swallow) once daily. Treatment-naive: treat for 8 weeks. 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 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 if previously treated with regimens containing 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. Liver or kidney transplant: treat for 12 weeks; (genotype 1): treat for 16 weeks if NS5A inhibitor-experienced (without prior NS3/4A protease inhibitor); (genotype 3): treat for 16 weeks if prior treatment experience with regimens containing PEG-IFN, ribavirin, and/or sofosbuvir; see full labeling.

MAVYRET Contraindications:

Moderate to severe hepatic impairment (Child-Pugh B or C). History of prior hepatic decompensation. Concomitant atazanavir or rifampin.

Boxed Warning:

Risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.

MAVYRET Warnings/Precautions:

HBV reactivation has occurred in HCV/HBV coinfected patients. 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. Serious liver-related medical/surgical comorbidities. Obtain LFTs as clinically indicated in patients with compensated cirrhosis or evidence of advanced liver disease (eg, portal hypertension); monitor for hepatic decompensation/failure; discontinue if occurs. Pregnancy. Nursing mothers.

MAVYRET Classification:

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

MAVYRET Interactions:

See Contraindications. Concomitant certain immunosuppressants or chemotherapeutic agents: may increase risk of HBV reactivation. May be antagonized by P-gp/CYP3A inducers (eg, carbamazepine, phenytoin, 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. Monitor INR with warfarin, blood glucose in diabetics, or drug levels of concomitant CYP450 substrates with a narrow therapeutic index (eg, certain immunosuppressants).

Adverse Reactions:

Headache, fatigue, nausea, diarrhea, serum bilirubin elevations.

Generic Drug Availability:


How Supplied:

Tabs—28, 56; Pellets—60