adult patients with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5 or 6 infection without cirrhosis or 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 (PI), but not both [see Dosage and Administration (2.2) and Clinical Studies (14)].
2 DOSAGE AND ADMINISTRATION
2.1 Testing Prior to the Initiation of Therapy
Test all patients for evidence of current or prior HBV infection by measuring hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (anti-HBc) before initiating HCV treatment with MAVYRET [see Warnings and Precautions (5.1)].
2.2 Recommended Dosage in Adults
MAVYRET is a fixed-dose combination product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet.
The recommended oral dosage of MAVYRET is three tablets (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) taken once daily with food [see Clinical Pharmacology (12.3)].
Tables 1 and 2 provide the recommended MAVYRET treatment duration based on the patient population in HCV mono-infected and HCV/HIV-1 co-infected patients with compensated liver disease (with or without cirrhosis) and with or without renal impairment including patients receiving dialysis.
Table 1. Recommended Duration for 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
Table 2. Recommended Duration for 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.
2.3 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) [see Contraindications (4), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
3 DOSAGE FORMS AND STRENGTHS
Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir. The tablets are pink, oblong-shaped, film-coated, and debossed with “NXT” on one side.
4 CONTRAINDICATIONS
MAVYRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) [see Dosage and Administration (2.3), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].
MAVYRET is contraindicated with atazanavir or rifa |
