Real-World Evidence

REAL-WORLD EVIDENCE SUPPORTS AN 8-WEEK REGIMEN OF MAVYRET14

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

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.



METHODOLOGY14

Real-world data are observable in nature, may be prospectively or retrospectively collected, and are not based on controlled clinical studies. Results from these cohorts may differ from those observed in clinical practice and are not presented in the MAVYRET prescribing information.

This TRIO Health Network study electronically collected data from providers and specialty pharmacies partners between August 2017 and April 2018. Of the 560 in the Total Population, the mean age was 52; 54% were male, 30% were white race, 58% were other or unspecified race, 11% F3 liver fibrosis (as reported by the physician), and 20% had an HCV RNA level >6MM IU/mL. Primary endpoint: PP sustained virologic response at 12 weeks post treatment (SVR12).

The design, study conduct, and financial support for the study were provided by AbbVie. AbbVie participated in the interpretation of data, review, and approval.


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