HIGH CURE* RATES ACHIEVED WITH A SINGLE REGIMEN1

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

98

%

CURE* RATE (SVR12)

across 3 studies in GT 1–6 treatment naïve and GT 1, 2, 4–6 PRS-experienced, non-cirrhotic patients who received 8 weeks of treatment (n=745/763)

SVR12 range: 93-100% (ITT); 96-100% (mITT)1

mITT=ITT population modified to exclude subjects who did not achieve SVR12 for reasons other than virologic failure.

0.3% on-treatment virologic failure (n=2/763)
1% relapse (n=7/751)

hcp-efficacy-hero-01-2x

  • NO baseline viral load restrictions
  • NO dose adjustments for renal impairment
  • NO baseline resistance testing required
  • NO ribavirin

AASLD & IDSA GUIDELINES

MAVYRET is a recommended regimen for 8 weeks in GT 1–6 treatment-naïve, non-cirrhotic patients11

See guidelines for special population recommendations.


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


PRS-experienced = prior treatment experience with regimens containing interferon (IFN), pegylated interferon (pegIFN), ribavirin (RBV), and/or sofosbuvir (SOF), but no prior treatment experience with an NS5A inhibitor or HCV NS3/4A protease inhibitor.

SVR12 by GT and SUBGROUP

  • ITT
  • mITT
  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • 99%
  • GT 199.7%
  • 98%
  • GT 299%
  • 95%
  • GT 396%
  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • 93%
  • GT 4100%
  • 100%
  • GT 5100%
  • 100%
  • GT 6100%

Includes GT 1–6 treatment-naïve and GT 1, 2, 4–6 PRS-experienced* non-cirrhotic patients who received 8 weeks 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.

ITT = intent-to-treat.
mITT = ITT population modified to exclude subjects who did not achieve SVR12 for reasons other than virologic failure.

  • ITT
  • mITT
  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • 97%
  • Black100%
  • 96%
  • HCV RNA ≥6 million IU/ml98%
  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • 95%
  • F3 fibrosis score
    SVR12 varied by GT. Range: 89–100%
    95%
  • 96%
  • Proton Pump Inhibitor (PPI) use*100%


Post-hoc analysis includes GT 1–6 treatment-naive and GT 1, 2, 4–6 PRS-experienced non-cirrhotic patients who received 8 weeks of treatment

*Primary Investigator-reported PPI use.

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.

ITT = intent-to-treat.

mITT = ITT population modified to exclude subjects who did not achieve SVR12 for reasons other than virologic failure.

STUDY DESIGNS

MAVYRET FOR 8 OR 12 WEEKS IN GT 1 PATIENTS: Highlights from a clinical trial published in New England Journal of Medicine, 2018.
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.


SVR12 (ITT) IN 8 WEEKS


  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • GT 199.1%

Study summary

  • Randomized, open-label, multicenter, phase 3 (N=703)
  • Once-daily dose of 300-mg glecaprevir and 120-mg pibrentasvir (3 tablets, once daily, with food)
  • 8 or 12 weeks of treatment
  • Endpoints: SVR12 in the 12-week arm; SVR12 in the 8-week arm vs 12-week arm

8-week patient baseline characteristics (N=351)

  • 43% Genotype 1a
  • 48% Male
  • 18% Non-white race
  • 85% F0/F1 fibrosis score
  • 28% History of injection drug use

MAVYRET FOR 8 OR 12 WEEKS IN GT 3 PATIENTS: Highlights from a clinical trial published in New England Journal of Medicine, 2018.
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.


SVR12 (ITT) IN 8 WEEKS


  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • GT 395%

Study summary

  • Partially randomized, open-label, active-controlled, multicenter, phase 3 (N=505): 2:1 randomizaton of MAVYRET vs SOF 400 mg + DCV 60 mg for 12 weeks, and non-randomized MAVYRET for 8 weeks
  • Once-daily dose of 300-mg glecaprevir and 120-mg pibrentasvir (3 tablets, once daily, with food)
  • 8 or 12 weeks of treatment
  • Endpoints: SVR12 in the 8-week arm vs 12-week arm

8-week patient baseline characteristics (N=157)

  • 96% Genotype 3a
  • 59% Male
  • 15% Non-white race
  • 78% F0/F1 fibrosis score
  • 66% History of injection drug use

A randomized, open-label, multicenter, 4-part, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of MAVYRET with or without RBV in 691 treatment-naïve or treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 2–6-infected adults, without cirrhosis or with compensated cirrhosis. Part 2: GT 2, 3 non-cirrhotic patients were administered MAVYRET for 8 weeks and GT 3 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET with or without ribavirin for 12 weeks. Part 4: GT 2, 4–6 non-cirrhotic patients were administered MAVYRET for 8 weeks. Primary endpoints: SVR12 in each treatment arm and noninferiority of SVR12 for GT 2 (Part 4) to historical control with 12 weeks of sofosbuvir + ribavirin.

Study population per recommended regimen:

  • GT
    2, 4-6
  • NON-CIRRHOTIC
  • TREATMENT-NAÏVE or
    PRS-EXPERIENCED
  • 8 WEEKS


12-week treatment

HIGH CURE* RATES IN GT 1–6 TREATMENT-NAÏVE, COMPENSATED CIRRHOTIC PATIENTS1


99

%

CURE* RATE (SVR12)

across 2 studies in GT 1–6 treatment-naïve and GT 1, 2, 4–6 PRS-experienced, compensated cirrhotic patients who received 12 weeks of treatment (n=184/186)

SVR12 range: 98-100%

0% on-treatment virologic failure (n=0/186)
0.5% relapse (n=1/183)

hcp-efficacy-hero-02-2x

  • NO baseline resistance testing required
  • NO treatment-specific ALT monitoring required for patients without HBV infection
  • NO ribavirin

AASLD & IDSA GUIDELINES

MAVYRET is a recommended regimen for 12 weeks in GT 1–6 treatment-naïve, compensated cirrhotic patients11

  • 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 and rifampin

*Cure = sustained virologic response (SVR12); HCV RNA < LLOQ at 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.

SVR12 by GT

SVR12 BY GENOTYPE1

  • ITT
  • 100
  • 80
  • 60
  • 40
  • 20
  • 0
  • GT 199%
  • GT 2100%
  • GT 398%
  • GT 4100%
  • GT 5100%
  • GT 6100%

Includes GT 1–6 treatment-naïve and GT 1, 2, 4–6 PRS-experienced* compensated cirrhotic patients who received 12 weeks of treatment.

*PRS-experienced = prior treatment experience with regimens containing IFN, pegIFN, RBV, and/or SOF, but no prior treatment experience with an NS5A inhibitor or HCV NS3/4A protease inhibitor.


STUDY DESIGNS

A randomized, open-label, multicenter, 4-part, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of MAVYRET with or without RBV in 691 treatment-naïve or treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 2–6-infected adults, without cirrhosis or with compensated cirrhosis. Part 3: GT 3 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET for 12 or 16 weeks. Primary endpoints: SVR12 in each treatment arm.

Study population per recommended regimen:

  • GT 3
  • COMPENSATED
    CIRRHOTIC
  • TREATMENT-NAÏVE
  • 12 WEEKS

A single-arm, open-label, phase 3 study to evaluate the efficacy and safety of MAVYRET for 12 weeks in 146 treatment-naïve or prior treatment-experienced (ie, interferon or pegylated interferon ± ribavirin, or sofosbuvir + ribavirin ± pegylated interferon) GT 1, 2, 4–6-infected adults with compensated cirrhosis. Primary endpoint: SVR12.

Study population per recommended regimen:

  • GT 1, 2, 4-6
  • COMPENSATED CIRRHOTIC
  • TREATMENT-NAÏVE or
    PRS-EXPERIENCED
  • 12 WEEKS

STUDY DESIGN

EXPEDITION 41

A single-arm, open-label, phase 3 study to evaluate the efficacy and safety of MAVYRET for 12 weeks in 104 treatment-naïve or prior treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 1–6-infected adults, without cirrhosis or with compensated cirrhosis who have severe renal impairment or ESRD. Primary endpoint: SVR12.

Study population:

  • GT 1-6
  • NON-CIRRHOTIC or COMPENSATED CIRRHOTIC
    with SEVERE RENAL IMPAIRMENT
    (CKD STAGES 4 and 5)
  • TREATMENT-NAÏVE or
    PRS-EXPERIENCED
  • 12 WEEKS

Patients with renal impairment should follow the same recommended treatment duration as patients without renal impairment.

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