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MAVYRET (glecaprevir/pibrentasvir)
  • MAVYRET (glecaprevir/pibrentasvir)
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INDICATION1

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.

IMPORTANT SAFETY INFORMATION

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 posttreatment 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

MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

US-MAVY-220242

REFERENCES AND GLOSSARY

REFERENCES

1. MAVYRET [package insert]. North Chicago, IL: AbbVie Inc. 

GLOSSARY OF TERMS

AASLD = American Association for the Study of Liver Diseases
ALT = alanine aminotransferase
APRI = aspartate aminotransferase (AST) to platelet ratio index
ART = antiretroviral therapy
CC = compensated cirrhotic
CDC = Centers for Disease Control and Prevention
CKD = chronic kidney disease
CPSFU = core population with sufficient follow-up
Cure = sustained virologic response (SVR12); HCV RNA DAA = direct-acting antiviral
DCV = daclatasvir
EC50 = 50% effective concentration
GT = genotype
HBV = hepatitis B virus
HCV = hepatitis C virus
HMG-CoA = hydroxymethylglutaryl coenzyme A
IDSA = Infectious Diseases Society of America
ITT = intent to treat
LLOQ = lower limit of quantification
MAT = medication-assisted treatment
mITT = modified intent to treat
NC = non-cirrhotic
NS = nonstructural protein
OTC = over the counter
PI = protease inhibitor
PPI = proton pump inhibitor
PrEP = pre-exposure prophylaxis
PRS-TE = prior treatment experience with regimens containing interferon, pegylated interferon, ribavirin, and/or sofosbuvir, but no prior treatment experience with an NS5A inhibitor or HCV NS3/4A protease inhibitor
PWID = people who inject drugs
RBV = ribavirin
Relapse = HCV RNA ≥LLOQ after end-of-treatment response among subjects who completed treatment
RT-PCR = reverse transcription polymerase chain reaction
SOF = sofosbuvir
SVR = sustained virologic response
SVR12 = sustained virologic response 12 weeks after the end of treatment
TE = treatment experienced
TN = treatment naïve
TW4 = treatment week 4

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Legal Notices/Privacy Policy. Copyright 2022, AbbVie Inc., North Chicago, Illinois, U.S.A. If you have any questions about AbbVie’s MAVYRET.com website that have not been answered, click here. This website and the information contained herein is intended for use by US residents only, is provided for informational purposes only and is not intended to replace a discussion with a healthcare provider. All decisions regarding patients must be made with a healthcare provider and consider the unique characteristics of each patient.

If you have any questions about this AbbVie Inc. website that have not been answered, contact us.

© 2022 AbbVie. All rights reserved
MAVYRET® and its design are registered trademarks of AbbVie Inc.

US-MAVY-210488

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Conversely, the presence of this link does not imply the linked site's endorsement of MAVYRET.com/hcp or AbbVie.

Do you wish to leave this site?

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No

US-MAVY-210488

You are leaving MAVYRET.com/hcp


You are leaving the AbbVie website and connecting to a site that is not under the control of AbbVie. AbbVie is not responsible for the contents of any such site or any further links from such site. AbbVie is providing these links to you only as a convenience, and the inclusion of any link does not imply the endorsement of the linked site by AbbVie. You should also be aware that the linked site may be governed by its own set of terms and conditions and privacy policy for which AbbVie has no responsibility.

Conversely, the presence of this link does not imply the linked site's endorsement of MAVYRET.com/hcp or AbbVie.

Do you wish to leave this site?

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US-MAVY-210488

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/

INDICATION1

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

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/

INDICATION1

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

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/

INDICATION1

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

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/

INDICATION1

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

INDICATION1

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.

IMPORTANT SAFETY INFORMATION

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 posttreatment 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

MAVYRET oral pellets are dispensed in unit-dose packets. Each packet contains 50 mg glecaprevir/20 mg pibrentasvir.

US-MAVY-220242