SAFETY PROFILE DEMONSTRATED IN CLINICAL TRIALS


0.1% overall discontinuation rate of MAVYRET

OVERALL DISCONTINUATION RATE OF MAVYRET*
3 out of ~2300 patients discontinued treatment due to adverse reactions1,9

  • The most common adverse reactions (≥5% prevalence) were headache (13%), fatigue (11%), and nausea (8%) in patients treated with MAVYRET1
  • Most adverse reactions were mild in severity1
  • 1 subject experienced a serious adverse reaction1

IN CKD STAGE 4 AND 5 PATIENTS

  • 2% discontinuation rate due to adverse reactions (n=2/104)1,2
  • The most common adverse reactions (≥5% prevalence) were pruritus (17%), fatigue (12%), nausea (9%), asthenia (7%), and headache (6%)1
  • 90% of adverse reactions were mild to moderate in severity1

*Discontinuations in Expedition 2, Expedition 4 and Magellan 2 are not included in the overall rate.



No treatment-specific ALT monitoring required for patients without HBV infection

NO TREATMENT-SPECIFIC ALT MONITORING REQUIRED FOR PATIENTS WITHOUT HBV INFECTION1



LAB ABNORMALITIES:

<0.1%
ALT
≥ GRADE 3
(>5 × ULN; n=2/2367)9
  • No ALT elevations (>5 x ULN) in patients with compensated cirrhosis in phase 2 and 3 studies to date (n=0/308)9
0.40%
TOTAL BILIRUBIN
≥ GRADE 3
(>3 × ULN; n=9/2367)9
  • Elevations in total bilirubin (≥2 x ULN) occurred in 3.5% of MAVYRET subjects vs 0% in placebo. Across the phase 2 and 3 studies, elevations in total bilirubin occurred in 1.2% of subjects1

Lab abnormality data does not include Expedition 2 or Magellan 2.

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) week ending 1/5/2018 to week ending 2/8/2019, Weekly Sales Perspective (WSP) and Longitudinal Prescription Claims (LRx) week ending 12/29/2017 to week ending 2/1/2019. February 2019. (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. 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 April 22, 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