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 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.
- 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.
Most common adverse reactions observed with MAVYRET:
- >10% of subjects: headache and fatigue
- MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2020.
GLOSSARY OF TERMS
AASLD = American Association for the Study of Liver Diseases
BMI = body mass index
CC = compensated cirrhotic
Cure = sustained virologic response (SVR12); HCV RNA <LLOQ at 12 weeks after the end of treatment
DCV = daclatasvir
DOD = department of defense
GT = genotype
HBV = hepatitis B virus
HCV = hepatitis C virus
HIV = human immunodeficiency virus
IDSA = Infectious Diseases Society of America
INR = international normalized ratio
ITT = intent-to-treat
LLOQ = lower limit of quantification
mITT = modified intent-to-treat (excludes patients with non-virologic failure)
NC = non-cirrhotic
NS3/4A = nonstructural proteins 3 and 4A
NS5A = nonstructural protein 5A
PI = protease inhibitor
PP = per-protocol; Excludes patients from the ITT population with virologic breakthrough or discontinuation prior to week 8, and those missing data in the SVR 12 window
PPI = proton pump inhibitor
PRS-experienced = 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
PS = Primary subset
RBV = ribavirin
Relapse = HCV RNA >LLOQ after end-of-treatment response among those who completed treatment
RNA = ribonucleic acid
SOF = sofosbuvir
SVR = sustained virologic response
SVR12 = sustained virologic response 12 weeks after the end of treatment
VA = Veterans Affairs