Generic name: PIBRENTASVIR 40mg, GLECAPREVIR 100mg
Dosage form: tablet, film coated
Medically reviewed by Drugs.com. Last updated on May 8, 2020.
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 Adult and Pediatric Patients 12 Years and Older or Weighing at Least 45 kg
The recommended oral dosage of MAVYRET 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)].
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.
|No Cirrhosis||Compensated Cirrhosis
|1, 2, 3, 4, 5, or 6||8 weeks||8 weeks|
Treated with 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|
Liver or Kidney Transplant Recipients
MAVYRET is recommended for 12 weeks in adult and pediatric patients 12 years and older or weighing at least 45 kg 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)].
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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More about Mavyret (glecaprevir / pibrentasvir)
- Side Effects
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- Drug class: antiviral combinations
- FDA Alerts (1)
- FDA Approval History