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Mavyret Dosage

Medically reviewed by Drugs.com. Last updated on Jun 10, 2021.

Generic name: PIBRENTASVIR 40mg, GLECAPREVIR 100mg
Dosage form: tablet, film coated

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
Treatment Duration
HCV
Genotype
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
  1. In clinical trials, subjects were treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with (peg)interferon and ribavirin.
  2. In clinical trials, subjects were treated with prior regimens containing simeprevir and sofosbuvir, or simeprevir, boceprevir, or telaprevir with (peg)interferon and ribavirin.
  3. 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 greater
OR
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)].

2.5 Preparation and Administration of Oral Pellets

See the MAVYRET oral pellets full Instructions for Use for details on the preparation and administration.

  • The oral pellets should be taken together, with food, once daily. In addition, the oral pellets for the total daily dose should be sprinkled on a small amount of soft food with a low water content that will stick to a spoon and should be swallowed without chewing (e.g., peanut butter, chocolate hazelnut spread, cream cheese, thick jam, or Greek yogurt).
  • The entire mixture of food and oral pellets should be swallowed within 15 minutes of preparation; the oral pellets should not be crushed or chewed.
  • Liquids or foods that would drip or slide off the spoon are not recommended as the drug may dissolve quickly and become less effective.

2.6 Liver or Kidney Transplant Recipients

MAVYRET is recommended for 12 weeks in patients 3 years and older who are liver or kidney transplant recipients. A 16-week treatment duration is recommended in genotype 1-infected patients who are NS5A inhibitor-experienced without prior treatment with an NS3/4A protease inhibitor or in genotype 3-infected patients who are PRS treatment-experienced [see Clinical Studies (14.8)].

2.7 Hepatic Impairment

MAVYRET is contraindicated in patients with moderate or severe hepatic impairment (Child-Pugh B or C) or those with any history of prior hepatic decompensation [see Contraindications (4), Warnings and Precautions (5.2), Use in Specific Populations (8.7) and Clinical Pharmacology (12.3)].

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Further information

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