HIGHLIGHTS OF PRESCRIBING INFORMATION
These highlights do not include all the information needed to use MAVYRET safely and effectively. See full prescribing information for MAVYRET.
MAVYRET TM (glecaprevir and pibrentasvir) tablets, for oral use
Initial U.S. Approval: 2017
WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV SEE FULL PRESCRIBING INFORMATION FOR COMPLETE BOXED WARNING.
Hepatitis B virus (HBV) reactivation has been reported, in some cases resulting in fulminant hepatitis, hepatic failure, and death. (5.1)
INDICATIONS AND USAGE
MAVYRET is a fixed-dose combination of glecaprevir, a hepatitis C virus (HCV) NS3/4A protease inhibitor, and pibrentasvir, an HCV NS5A inhibitor, and is indicated for the treatment of patients with chronic HCV genotype (GT) 1, 2, 3, 4, 5 or 6 infection without cirrhosis and with compensated cirrhosis (Child-Pugh A). MAVYRET is also indicated for the treatment of adult patients with HCV genotype 1 infection, who previously have been treated with a regimen containing an HCV NS5A inhibitor or an NS3/4A protease inhibitor, but not both. (1)
DOSAGE AND ADMINISTRATION
Testing Prior to the Initiation of Therapy: Test all patients for HBV infection by measuring HBsAg and anti-HBc. (2.1)
Recommended dosage: Three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken orally once daily with food. (2.2)
See recommended treatment duration in tables below. (2.2)
Treatment-Naïve Patients
HCV Genotype Treatment Duration
No Cirrhosis Compensated Cirrhosis
(Child-Pugh A)
1, 2, 3, 4, 5, or 6 8 weeks 12 weeks
Treatment-Experienced Patients
Treatment Duration
HCV
Genotype Patients Previously
Treated With a
Regimen Containing: No
Cirrhosis Compensated
Cirrhosis
(Child-Pugh A)
1 An NS5A inhibitor1 without prior treatment with an NS3/4A protease inhibitor 16 weeks 16 weeks
An NS3/4A PI2 without prior treatment with an NS5A inhibitor 12 weeks 12 weeks
1, 2, 4, 5, or 6 PRS3 8 weeks 12 weeks
3 PRS3 16 weeks 16 weeks
In clinical trials, subjects were treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin.
In clinical trials, subjects were treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin
PRS=Prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor.
HCV/HIV-1 co-infection and patients with any degree of renal impairment: Follow the dosage recommendations in the tables above. (2.2)
Hepatic Impairment: MAVYRET is not recommended in patients with moderate hepatic impairment (Child-Pugh B); and is contraindicated in patients with severe hepatic impairment (Child-Pugh C). (2.3)
DOSAGE FORMS AND STRENGTHS
Tablets: 100 mg glecaprevir and 40 mg pibrentasvir. (3)
CONTRAINDICATIONS
Patients with severe hepatic impairment (Child-Pugh C). (4, 8.7, 12.3)
Coadministration with atazanavir and rifampin. (4)
WARNINGS AND PRECAUTIONS
Risk of Hepatitis B Virus Reactivation: Test all patients for evidence of current or prior HBV infection before initiation of HCV treatm |
