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

*Excludes liver or kidney transplant recipients.

GT 1–6

TREATMENT-NAÏVE

NON-CIRRHOTIC

GT 1–6

TREATMENT-NAÏVE

COMPENSATED CIRRHOTIC
(CHILD-PUGH A)

This dosing information does not include liver or kidney transplant recipients.


8 out of 10 HCV patients may be eligible for 8 weeks of MAVYRET

For GT 1–6 treatment-naïve, non-cirrhotic patients, based on a 2017 Nationwide Physician Chart Audit (N=4578).

Select dosing information, 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)
  • MAVYRET is contraindicated with atazanavir or rifampin and is not recommended with darunavir, lopinavir, ritonavir, and efavirenz
  • Carbamazepine, phenytoin, 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.

IPSOS METHODOLOGY:
Data derived by IPSOS Healthcare from January 2017 – December 2017. Every month, 150-155 specialty physicians nationwide answered questionnaires and provided chart audit on the next 4 chronic HCV patients seen. Data was analyzed for 4578 HCV-infected patients with an identified fibrosis score and genotype, who were under the care of a healthcare professional. These data exclude patients who are awaiting SVR or have achieved SVR. This analysis did not take into consideration liver or kidney transplant status.13








16-WEEK DOSING

GT 1

NS5A-EXPERIENCED
(NS3/4A PI-NAÏVE)

NON-CIRRHOTIC/
COMPENSATED CIRRHOTIC

  • 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.


Select dosing information, refer to full Prescribing Information for further dosing information.


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 (total daily dose: glecaprevir 300 mg and pibrentasvir 120 mg).

REFERENCES

REFERENCES and GLOSSARY

  1. MAVYRET [package insert]. North Chicago, IL: AbbVie, Inc.; 2018.

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

  3. Zeuzem S, Foster GR, Wang S, et al. Glecaprevir–pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. N Engl J Med. 2018;378(4):354-369.

  4. Data on file. AbbVie, Inc. IQVIA. National Prescription Audit (NPA), Weekly Sales Perspective (WSP), Longitudinal Prescription Claims (LRx). August 2018. (IQVIA, all rights reserved).

  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. SURVEYOR-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.

  11. American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. HCV Guidance: Recommendations for testing, managing, and treating hepatitis C. www.hcvguidelines.org. Updated May 24, 2018. Accessed September 11, 2018.

  12. Data on file. AbbVie, Inc. Source: BusinessOne Technologies, LLC as of January 2018, and is subject to change.

  13. Data on file. AbbVie, Inc. Ipsos Healthcare HCV USA Therapy Monitor (Jan 2017 – December 2017, all data collected online) © Ipsos 2018, all rights reserved.


GLOSSARY OF TERMS

AASLD & IDSA "HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C" recommended regimens = those that are favored for most patients in a given subgroup based on optimal efficacy, favorable tolerability and toxicity profiles, treatment duration, and pill burden
ALT = alanine transaminase
BOC = boceprevir
CKD = chronic kidney disease
Cure = sustained virologic response (SVR12); HCV RNA < LLOQ at 12 weeks after the end of treatment
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
PBM = Pharmacy Benefit Managers
pegIFN = pegylated interferon
PI = protease 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
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