HIGH CURE* RATES ACHIEVED WITH A SINGLE REGIMEN1

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

dlb_hero-01_desk-2x

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)

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

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 = 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%


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 = 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

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
  • MAVYRET
  • 8 WEEKS

A randomized, open-label, multicenter, phase 3 study to evaluate the efficacy and safety of MAVYRET for 8 or 12 weeks in 703 treatment-naïve or prior treatment-experienced (ie, IFN or pegIFN ± RBV, or SOF + RBV ± pegIFN) GT 1-infected adults without cirrhosis and with or without HIV-1 coinfection. Primary endpoints: SVR12 in the 12-week ITT-PS population (ITT population excluding patients with HIV coinfection and patients with sofosbuvir experience); SVR12 in the 8-week arm compared with the 12-week arm in the ITT-PS and per-protocol ITT-PS populations (“per-protocol” excludes patients with premature discontinuation or virologic failure prior to week 8 and missing data in the SVR12 window).

Study population per recommended regimen:

  • GT 1
  • NON-CIRRHOTIC
    with/without HIV-1
    COINFECTION
  • MAVYRET
  • 8 WEEKS

A partially randomized, open-label, active-controlled, multicenter, phase 3 study to evaluate the efficacy and safety of MAVYRET for 8 or 12 weeks vs sofosbuvir + daclatasvir for 12 weeks in 505 treatment-naïve GT 3-infected adults without cirrhosis. Primary endpoints: demonstrate noninferiority in the percentage of subjects achieving SVR12 with 12 weeks of MAVYRET treatment to 12 weeks of treatment with sofosbuvir + daclatasvir, and demonstrate noninferiority of 8 weeks of MAVYRET treatment to 12 weeks of MAVYRET treatment.

Study population per recommended regimen:

  • GT 3
  • NON-CIRRHOTIC
  • MAVYRET
  • 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 liver monitoring required for patients without HBV infection
  • NO baseline resistance testing required

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 = 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
  • MAVYRET
  • 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
  • MAVYRET
  • 12 WEEKS

STUDY DESIGNS

MAGELLAN
Part 21

A randomized, open-label, multicenter, 2-part, phase 2 study to evaluate the efficacy, safety, and pharmacokinetics of MAVYRET with or without ribavirin for 12 or 16 weeks in 141 direct-acting antiviral-experienced GT 1, 4-infected adults without cirrhosis or with compensated cirrhosis. Part 2: GT 1, 4 patients without cirrhosis or with compensated cirrhosis were administered MAVYRET for 12 or 16 weeks. Primary endpoint: SVR12.

Study population per recommended regimen:

  • GT 1
  • COMPENSATED
    CIRRHOTIC/
    NON-CIRRHOTIC
  • MAVYRET
  • 16 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
  • COMPENSATED CIRRHOTIC/
    NON-CIRRHOTIC with RENAL
    IMPAIRMENT
    (CKD STAGE 4 and 5)
  • MAVYRET
  • 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.; 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.


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

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