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

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GT 1–6

TREATMENT-NAÏVE

NON-CIRRHOTIC

GT 1–6

TREATMENT-NAÏVE

COMPENSATED CIRRHOTIC
(CHILD-PUGH A)

GT 1

NS5A-EXPERIENCED
(NS3/4A PI-NAÏVE)*

NON-CIRRHOTIC/
COMPENSATED CIRRHOTIC

Refer to full Prescribing Information for further dosing information.


NO CHANGE IN DOSING REQUIRED FOR RENALLY IMPAIRED PATIENTS


  • MAVYRET is contraindicated in patients with severe hepatic impairment (Child-Pugh C) and is not recommended in patients with moderate hepatic impairment (Child-Pugh B)
  • Due to higher rates of virologic failure and treatment-emergent drug resistance, the data do not support treatment of GT 1 infected patients who are both NS3/4A protease inhibitor and NS5A inhibitor-experienced.

*In clinical trials, subjects were treated with prior regimens containing LDV and SOF or DCV with peglFN and RBV.

SIMPLE, ONCE-DAILY DOSING

Single-dose pack of MAVYRET

  • 3 tablets in a single-dose pack, taken once daily with food

Each MAVYRET tablet contains 100 mg of glecaprevir and 40 mg of pibrentasvir.

REFERENCES

REFERENCES and GLOSSARY

  1. MAVYRET [package insert]. North Chicago, IL: AbbVie Inc.; 2017.

  2. Data on file. ABVRRTl64686. AbbVie Inc.; 2017.

  3. 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.

  4. 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.

  5. Data on file. ABVRRTl64729. AbbVie Inc.; 2017.

  6. 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.

  7. 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.

  8. 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.

  9. Data on file. ABVRRTl64685. AbbVie Inc.; 2017.

  10. Data on file. ABVRRTl64836. AbbVie Inc.; 2017.

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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