SAFETY PROFILE DEMONSTRATED IN CLINICAL TRIALS

dlb_hero-03_desk-2x
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0.1% overall discontinuation rate of MAVYRET

OVERALL DISCONTINUATION RATE OF MAVYRET
due to adverse reactions (n=3/2265) including a placebo-controlled trial1,9

  • 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 CKD stage 4 and 5 patients are not included in the overall rate.

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

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

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LAB ABNORMALITIES:

&lt;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
0.4%
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

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