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dosing1

Simple, once-daily dosing1

MAVYRET Packaging

3 TABLETS

taken at the same time, once daily with food

Not actual size

  • Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg)
  • MAVYRET is dispensed in a 4-week (monthly) carton. Each weekly carton contains seven daily-dose wallets. Each monthly carton contains four weekly cartons.
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Safety Considerations
  • 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.
  • MAVYRET is contraindicated with atazanavir or rifampin.
  • Postmarketing cases of hepatic decompensation/failure, some fatal, have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens, including MAVYRET. The median time to onset for MAVYRET was 27 days. The majority had moderate or severe hepatic impairment prior to initiating therapy, including some with compensated cirrhosis at baseline but with a prior decompensation event. Rare cases were reported in patients without cirrhosis or with compensated cirrhosis; many of these patients had evidence of portal hypertension. In patients with compensated cirrhosis or evidence of advanced liver disease, perform hepatic laboratory testing as clinically indicated; and monitor for signs and symptoms of hepatic decompensation such as the presence of jaundice, ascites, hepatic encephalopathy, and variceal hemorrhage. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.
  • Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.
BASED ON THE TREATMENT-NAïVE SUBSET OF A NATIONWIDE
PHYSICIAN AUDIT OF HCV-INFECTED PATIENTS (n=3345),

98% of treatment-naïve patients may be eligible for 8 weeks of treatment1,2

Chart Audit Methodology
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MAVYRET 8-WEEK TREATMENT

GT 1-6

Treatment-naïve, non-cirrhotic

Treatment-naïve, compensated cirrhotic (Child-Pugh A)

Liver or kidney transplant recipients are not eligible for an 8-week regimen.

Refer to the full Prescribing Information for additional dosing durations in other patient populations.

Per the MAVYRET Prescribing Information, no dose adjustments are required for HIV-1 co-infected and/or renally-impaired patients without cirrhosis or with compensated cirrhosis

AASLD and IDSA Guidelines

AASLD is a registered trademark of the American Association for the Study of Liver Diseases and IDSA is a registered trademark of the Infectious Diseases Society of America.

AASLD and IDSA have not endorsed, and are not sponsors of, or otherwise affiliated with MAVYRET or AbbVie, Inc.

Other dosing and administration considerations1

If a dose is missed and it is:

  • Less than 18 hours from the usual time that MAVYRET should have been taken – advise the patient to take the dose as soon as possible and then to take the next dose at the usual time
  • More than 18 hours from the usual time that MAVYRET should have been taken – advise the patient not to take the missed dose and to take the next dose at the usual time

Additional Dosing Information:

  • HCV/HIV-1 co-infection and patients with any degree of renal impairment: Follow the recommended dosage as detailed
  • 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 PI or in genotype 3-infected patients who are PRS treatment-experienced.

MAVYRET storage

  • Store at or below 30°C (86°F)
Dosing information for treatment-experienced patients

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg 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 12 years and older or weighing at least 45 kg 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.

 

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

 

CONTRAINDICATIONS

  • 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.
  • MAVYRET is contraindicated with atazanavir or rifampin.

 

WARNINGS AND PRECAUTIONS

Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease


  • Postmarketing cases of hepatic decompensation/failure, some fatal, have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens, including MAVYRET. The median time to onset for MAVYRET was 27 days. The majority had moderate or severe hepatic impairment prior to initiating therapy, including some with compensated cirrhosis at baseline but with a prior decompensation event. Rare cases were reported in patients without cirrhosis or with compensated cirrhosis; many of these patients had evidence of portal hypertension. In patients with compensated cirrhosis or evidence of advanced liver disease, perform hepatic laboratory testing as clinically indicated; and monitor for signs and symptoms of hepatic decompensation such as the presence of jaundice, ascites, hepatic encephalopathy, and variceal hemorrhage. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.

 

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Certain Drugs

  • Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.

 

ADVERSE REACTIONS

Most common adverse reactions observed with MAVYRET:

  • >10% of subjects: headache and fatigue

US-MAVY-190705

References and glossary

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older...

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg with chronic hepatitis C virus (HCV) genotype 1, 2, 3, 4, 5, or 6 infection without cirrhosis or with

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older...

INDICATION1

MAVYRET is indicated for the treatment of adult and pediatric patients 12 years and older or weighing at least 45 kg 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 12 years and older or weighing at least 45 kg 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.

 

IMPORTANT SAFETY INFORMATION1

WARNING: RISK OF HEPATITIS B VIRUS REACTIVATION IN PATIENTS COINFECTED WITH HCV AND HBV: Test all patients for evidence of current or prior hepatitis B virus (HBV) infection before initiating treatment with MAVYRET. HBV reactivation has been reported in HCV/HBV coinfected patients who were undergoing or had completed treatment with HCV direct-acting antivirals and were not receiving HBV antiviral therapy. Some cases have resulted in fulminant hepatitis, hepatic failure, and death. Monitor HCV/HBV coinfected patients for hepatitis flare or HBV reactivation during HCV treatment and post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

 

CONTRAINDICATIONS

  • 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.
  • MAVYRET is contraindicated with atazanavir or rifampin.

 

WARNINGS AND PRECAUTIONS

Risk of Hepatic Decompensation/Failure in Patients with Evidence of Advanced Liver Disease


  • Postmarketing cases of hepatic decompensation/failure, some fatal, have been reported in patients treated with HCV NS3/4A protease inhibitor-containing regimens, including MAVYRET. The median time to onset for MAVYRET was 27 days. The majority had moderate or severe hepatic impairment prior to initiating therapy, including some with compensated cirrhosis at baseline but with a prior decompensation event. Rare cases were reported in patients without cirrhosis or with compensated cirrhosis; many of these patients had evidence of portal hypertension. In patients with compensated cirrhosis or evidence of advanced liver disease, perform hepatic laboratory testing as clinically indicated; and monitor for signs and symptoms of hepatic decompensation such as the presence of jaundice, ascites, hepatic encephalopathy, and variceal hemorrhage. Discontinue MAVYRET in patients who develop evidence of hepatic decompensation/failure.

 

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Certain Drugs

  • Carbamazepine, efavirenz, and St. John’s Wort may significantly decrease plasma concentrations of glecaprevir and pibrentasvir, leading to reduced therapeutic effect of MAVYRET. The use of these agents with MAVYRET is not recommended.

 

ADVERSE REACTIONS

Most common adverse reactions observed with MAVYRET:

  • >10% of subjects: headache and fatigue

US-MAVY-190705