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Mavyret Dosage

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

Medically reviewed on August 9, 2018.

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)].

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 [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 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 (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.

Liver or Kidney Transplant Recipients

‚ÄčMAVYRET is recommended for 12 weeks in 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)].

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)].

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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