Mavyret

MAVYRET- pibrentasvir and glecaprevir tablet, film coated
MAVYRET- pibrentasvir and glecaprevir pellet
AbbVie Inc.

1 INDICATIONS AND USAGE

MAVYRET is indicated for the treatment of adult and pediatric patients 3 years and older 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 indicated for the treatment of adult and pediatric patients 3 years and older 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 Treatment Duration in Patients 3 Years and Older

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 [see Contraindications ( 4) and Clinical Studies ( 14)]. Refer to Drug Interactions ( 7) for dosage recommendations for concomitant HIV-1 antiviral drugs.

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	8 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 (PI)	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 (peg)interferon and ribavirin. In clinical trials, subjects were treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin. PRS=Prior treatment experience with regimens containing (peg)interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an HCV NS3/4A PI or NS5A inhibitor.

2.3 Recommended Dosage in Adults

MAVYRET tablets are a fixed combination drug product containing glecaprevir 100 mg and pibrentasvir 40 mg in each tablet.

The recommended oral dosage of MAVYRET in adults is 3 tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg) [see Clinical Pharmacology ( 12.3)].

2.4 Recommended Dosage in Pediatric Patients 3 Years of Age and Older

The recommended dosage of MAVYRET in pediatric patients 3 to less than 12 years of age is based on weight. MAVYRET oral pellets are recommended for pediatric patients 3 to less than 12 years old weighing less than 45 kg. MAVYRET oral pellets in packets are a fixed combination drug product containing glecaprevir 50 mg and pibrentasvir 20 mg in each packet.

The recommended dosage of MAVYRET in pediatric patients 12 years of age and older, or in pediatric patients weighing at least 45 kg, is three tablets taken at the same time once daily with food (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

The dosages for pediatric patients are shown in Table 3.

Table 3: Recommended Dosage in Pediatric Patients 3 Years of Age and Older
Body Weight (kg) or Age (yrs)	Daily Dose of glecaprevir/ pibrentasvir	Dosing of MAVYRET
Less than 20 kg	150 mg/60 mg per day	Three 50 mg/20 mg packets of oral pellets once daily
20 kg to less than 30 kg	200 mg/80 mg per day	Four 50 mg/20 mg packets of oral pellets once daily
30 kg to less than 45 kg	250 mg/100 mg per day	Five 50 mg/20 mg packets of oral pellets once daily
45 kg and greaterOR 12 years of age and older	300 mg/120 mg per day	Three 100 mg/40 mg tablets once daily1 (see Recommended Dosage in Adults)
1 Pediatric patients weighing 45 kg and greater who are unable to swallow tablets may take six 50 mg/20 mg packets of oral pellets once daily. Dosing with oral pellets has not been studied for pediatric patients weighing greater than 45 kg [see Clinical Pharmacology ( 12.3) ].