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)1

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
1% relapse (n=7/751)1

hcp-efficacy-hero-01-2x

  • NO ribavirin1
  • NO baseline viral load restrictions1
  • NO baseline resistance testing required1
  • NO dose adjustments for renal impairment1

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


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 HCV NS3/4A PI or NS5A inhibitor.

ITT = intent-to-treat, mITT = modified 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 HCV NS3/4A PI or NS5A inhibitor.

ITT = intent-to-treat, mITT = modified 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.
Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. Zeuzem S, Foster GR, Wang S, et al. 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.
Glecaprevir-pibrentasvir for 8 or 12 weeks in HCV genotype 1 or 3 infection. Zeuzem S, Foster GR, Wang S, et al. 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 nonrandomized 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 ribavirin
  • NO treatment-specific ALT monitoring required for patients without HBV infection
  • NO baseline resistance testing required

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 HCV NS3/4A PI or NS5A 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 DESIGNS

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 STAGE 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), 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