MAVYRET: FOR CHRONIC HCV

TREAT ALL GENOTYPES
IN AS FEW AS 8 WEEKS

THE ONLY 8-WEEK PANGENOTYPIC REGIMEN FOR
TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS¹

*Cure = sustained virologic response (SVR12); HCV RNA <lower limit of quantification at 12 weeks after the end of treatment.

HIGH CURE* RATES

demonstrated in clinical trials across genotype 1–6

OVERALL DISCONTINUATION RATE DUE TO ADVERSE REACTIONS

Most common adverse
reactions (>10%
prevalence) were headache and fatigue

SIMPLE, ONCE-DAILY DOSING

3 tablets taken with food

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REVIEW 8-WEEK EFFICACY FOR TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS

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INDICATION

MAVYRET™ (glecaprevir and pibrentasvir) tablets are indicated for the treatment of adult patients 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 also indicated for the treatment of adult patients 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 post-treatment follow-up. Initiate appropriate patient management for HBV infection as clinically indicated.

CONTRAINDICATIONS

MAVYRET is contraindicated:

In patients with severe hepatic impairment (Child-Pugh C)
With the following drugs: atazanavir or rifampin

WARNINGS AND PRECAUTIONS

Risk of Reduced Therapeutic Effect Due to Concomitant Use of MAVYRET with Carbamazepine, Efavirenz-containing Regimens, or St. John's Wort

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
≥5% of subjects: headache, fatigue, and nausea

DROP PANELS INSIDE ME AS TABS

REFERENCES

REFERENCES and GLOSSARY

MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.
Data on file. ABVRRTl64686. AbbVie Inc.; 2017.
Zeuzem S, Feld J, Wang S, et al. ENDURANCE-I: A phase 3 evaluation of the efficacy and safety of 8- versus 12-week treatment with glecaprevir/pibrentasvir (formerly ABT-493/ABT-530) in HCV genotype 1 infected patients with or without HIV-1 co-infection and without cirrhosis. Poster presented at: The Liver Meeting® 2016. American Association for the Study of Liver Disease; November 11-15, 2016; Boston, MA.
Foster GR, Gane E, Asatryan A, et al. ENDURANCE-3: safety and efficacy of glecaprevir/pibrentasvir compared to sofosbuvir plus daclatasvir in treatment-naïve HCV genotype 3-infected patients without cirrhosis. Abstract presented at: 52nd Annual Meeting of the European Association for the Study of the Liver; April 19-23, 2017; Amsterdam, the Netherlands.
Data on file. ABVRRTl64729. AbbVie Inc.; 2017.
Kwo PY, Wyles DL, Wang S, et al. 100% SVR12 with ABT-493 + ABT-530 with or without ribavirin in treatment-naïve HCV genotype 3-infected patients with cirrhosis. Poster presented at: 51st Annual Meeting of the European Association for the Study of the Liver; April 16, 2016; Barcelona, Spain.
Wyles D, Poordad F, Wang S, et al. SURV EYOR-II, Part 3: efficacy and safety of glecaprevir/pibrentasvir (ABT-493/ABT-530) in patients with hepatitis C virus genotype 3 infection with prior treatment experience and/or cirrhosis. Poster presented at: The Liver Meeting® 2016. American Association for the Study of Liver Disease; November 11-15, 2016; Boston, MA.
Hassanein T, Wyles D, Wang S, et al. SURVEYOR-II, Part 4: glecaprevir/pibrentasvir demonstrates high SVR rates in patients with HCV genotype 2, 4, 5, or 6 infection without cirrhosis following an 8-week treatment duration. Poster presented at: 52nd Annual Meeting of the European Association for the Study of the Liver; April 19-23, 2017; Amsterdam, the Netherlands.
Data on file. ABVRRTl64685. AbbVie Inc.; 2017.
Data on file. ABVRRTl64836. AbbVie Inc.; 2017.

GLOSSARY OF TERMS

ALT = alanine transaminase
BOC = boceprevir
CKD = chronic kidney disease
Cure = sustained virologic response (SVR12); HCV RNA
DAA = direct-acting antiviral
DCV = daclatasvir
ESRD = end-stage renal disease
GT = genotype
HBV = hepatitis B virus
HCV = hepatitis C virus
HIV = human immunodeficiency virus
IFN = interferon
ITT = intent-to-treat
LDV = ledipasvir
LLOQ = lower limit of quantification
mITT = modified intent-to-treat
NS3/4A = nonstructural proteins 3 and 4A
NS5A = nonstructural protein 5A
pegIFN = pegylated interferon
PI = protease inhibitor
PRS = 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.
RAV = resistance-associated variant
RBV = ribavirin
Relapse = HCV RNA ≥ LLOQ after end-of-treatment response among those who completed treatment
RNA = ribonucleic acid
SMV = simeprevir
SOF = sofosbuvir
SVR = sustained virologic response
SVR12 = sustained virologic response 12 weeks after the end of treatment
TN = treatment-naïve
TVR = telaprevir
VF = virologic failure

– COLLAPSE

Tap for Important Safety Information about MAVYRET including Important Warning on Hepatitis B reactivation.

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