Mavyret Oral Pellets Generic Name & Formulations
Glecaprevir, pibrentasvir 50mg/20mg; packets.
HCV NS3/4A protease inhibitor + HCV NS5A inhibitor.
Tabs—28, 56; Pellets—60
Mavyret Oral Pellets Indications
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.
Mavyret Oral Pellets Dosage and Administration
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 Oral Pellets Contraindications
Moderate to severe hepatic impairment (Child-Pugh B or C). History of prior hepatic decompensation. Concomitant atazanavir or rifampin.
Mavyret Oral Pellets Boxed Warnings
Risk of hepatitis B virus (HBV) reactivation in patients coinfected with HCV and HBV.
Mavyret Oral Pellets 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 Oral Pellets Pharmacokinetics
Mavyret Oral Pellets 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).
Mavyret Oral Pellets Adverse Reactions
Headache, fatigue, nausea, diarrhea, serum bilirubin elevations.
Mavyret Oral Pellets Clinical Trials
Mavyret Oral Pellets Note
Mavyret Oral Pellets Patient Counseling