TREAT ALL GENOTYPES WITH A SINGLE REGIMEN. HIGH CURE* RATES DEMONSTRATED IN CLINICAL TRIALS.1

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

dlb_hero-01_desk-2x

OVERALL

98

%

CURE* RATE (SVR12)

per the USPI, in GT 1–6 patients who took the recommended regimen for 8, 12, or 16 weeks (n=1034/1060)

SVR12 varied by GT and prior treatment experience. Range: 92%-100% (ITT); 94%-100% (mITT)

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


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

TRIAL POPULATIONS INCLUDED:

Genotype 1-6

Genotype 1–6

Non-cirrhotic or compensated cirrhotic

Non-cirrhotic or compensated cirrhotic

Treatment-naïve or experienced

Treatment-naïve or experienced

Renally impaired

Renally impaired

Due to higher rates of virologic failure and treatment-emergent drug resistance, the data do not support treatment of GT 1 infected patients who are both NS3/4A protease inhibitor and NS5A inhibitor-experienced.

Treatment-experienced = GT 1–6 patients with prior interferon (IFN), pegylated interferon (pegIFN), ribavirin (RBV), and/or sofosbuvir (SOF) experience; GT 1 patients with prior NS5A or HCV NS3/4A protease inhibitor experience, but not both.

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ADDITIONAL SVR12 DATA

ENDURANCE 1: Efficacy in Treatment-Naïve and PRS-experienced With HCV Genotype 1 Infection and Without Cirrhosis

SVR12
Genotype 1 | MAVYRET
8 weeks | (N=351)
99% (348/351)
Outcome for subjects without SVR12
On-treatment VF
Relapse
Other*
<1% (1/351)
(0/349)
<1% (2/351)
*Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure
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SURVEYOR 2 (PART 2 AND PART 4): Efficacy in Treatment-Naïve and PRS-experienced Adults With HCV Genotypes 2, 4, 5, or 6 Infection Without Cirrhosis

SVR12
MAVYRET | 8 weeks
GT 2
(Part 2 and Part 4)
N=197
GT 4
(Part 4)
N=46
GT 5
(Part 4)
N=2
GT 6
(Part 4)
N=10
98% (193/197) 93% (43/46) 100% (2/2) 100% (10/10)
Outcome for subjects without SVR12
On-treatment VF
Relapse
Other*
(0/197) (0/46) (0/2) (0/10)
1% (2/195) (0/45) (0/2) (0/10)
1% (2/197) 7% (3/46) (0/2) (0/10)
*Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure

EXPEDITION 1: Efficacy in Treatment-Naïve and PRS-experienced Adults With HCV Genotype 1, 2, 4, 5, or 6 Infection With Compensated Cirrhosis

SVR12
MAVYRET | 12 weeks | (N=146)
Total all GTs
(N=146)
GT 1
(N=90)
GT 2
(N=31)
99% (145/146) 99% (89/90) 100% (31/31)
Outcome for subjects without SVR12
On-treatment VF
Relapse
(0/146) (0/90) (0/31)
<1% (1/144) 1% (1/88) (0/31)
VF = virologic failure
SVR12
MAVYRET | 12 weeks | (N=146)
GT 4
(N=16)
GT 5
(N=2)
GT 6
(N=7)
100% (16/16) 100% (2/2) 100% (7/7)
Outcome for subjects without SVR12
On-treatment VF
Relapse
(0/16) (0/2) (0/7)
(0/16) (0/2) (0/7)
VF = virologic failure

ENDURANCE 3: Efficacy in Treatment-Naïve, HCV Genotype 3-Infected Subjects Without Cirrhosis

SVR12
MAVYRET
8 weeks* | (N=157)
94.9% (149/157)
Outcome for subjects without SVR12
On-treatment VF
Relapse
Other
1% (1/157)
3% (5/150)
1% (2/157)
*MAVYRET 8 weeks was a non-randomized treatment arm.
Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure

SURVEYOR 2, PART 3: Efficacy in Treatment-Naïve or PRS-experienced, HCV Genotype 3-Infected Adults Without Cirrhosis or With Compensated Cirrhosis

SVR12
Treatment-Naïve with
Compensated Cirrhosis
PRS-experienced without Cirrhosis or with Compensated Cirrhosis
MAVYRET | 12 weeks | (N=40) MAVYRET | 16 weeks | (N=69)
98% (39/40) 96% (66/69)
Outcome for subjects without SVR12
On-treatment VF
Relapse
Other*
(0/40) 1% (1/69)
(0/39) 3% (2/68)
3% (1/40) (0/69)
SVR by cirrhosis status
Without Cirrhosis
With Compensated Cirrhosis
NA 95% (21/22)
98% (39/40) 96% (45/47)
*Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure

EXPEDITION 4: Treatment-Naïve and PRS-experienced Adults With Chronic Kidney Disease Stage 4 and 5 and Chronic HCV Infection Without Cirrhosis or With Compensated Cirrhosis

SVR12
MAVYRET | 12 weeks | (N=104)
98% (102/104)
Outcome for subjects without SVR
On-treatment VF
Relapse
Other*
0% (0/104)
0% (0/100)
2% (2/104)
*Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure

MAGELLAN 1: Efficacy in HCV Genotype 1-Infected Adults Who Are NS3/4A PI-experienced or NS5A Inhibitor-experienced, Without Cirrhosis or With Compensated Cirrhosis

SVR12
Genotype 1
PI-experienced* (NS5A
Inhibitor-Naïve)
Genotype 1
NS5A Inhibitor-experienced
(PI-Naïve)
MAVYRET
12 weeks
(N=25)
MAVYRET
16 weeks
(N=17)
92% (23/25) 94% (16/17)
Outcome for subjects without SVR
On-treatment VF
Relapse
Other
(0/25) 6% (1/17)
(0/25) (0/16)
8% (2/25) (0/17)
*Includes subjects who were treated with a regimen containing an NS3/4A PI (simeprevir with sofosbuvir, or simeprevir, boceprevir, or telaprevir with pegylated interferon and ribavirin) and without prior treatment with an NS5A inhibitor.
Includes subjects who were treated with a regimen containing an NS5A inhibitor (ledipasvir with sofosbuvir or daclatasvir with pegylated interferon and ribavirin) and without prior treatment with an NS3/4A PI.
Includes subjects who discontinued due to adverse event, lost to follow-up, or subject withdrawal.
VF = virologic failure

STUDY DESIGNS

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

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
  • MAVYRET
  • 12 WEEKS

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

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 1: GT 1 non-cirrhotic patients were administered MAVYRET with or without RBV for 12 weeks. 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
  • 12/16 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

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 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. 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
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  • GT 3
  • COMPENSATED
    CIRRHOTIC/
    NON-CIRRHOTIC
  • MAVYRET
  • 12 or 16 WEEKS

TREAT ALL GENOTYPES IN AS FEW AS 8 WEEKS1

8-week treatment

FOR GT 1–6 TREATMENT-NAÏVE, NON-CIRRHOTIC PATIENTS

  • 12 weeks for GT 1–6 treatment-naïve, compensated cirrhotic patients
  • 16 weeks for GT 1 NS5A-experienced (NS3/4A PI-naïve), non-cirrhotic and compensated cirrhotic patients

In clinical trials, subjects were treated with prior regimens containing ledipasvir and sofosbuvir or daclatasvir with pegylated interferon and ribavirin.

SAFETY PROFILE DEMONSTRATED IN CLINICAL TRIALS

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0.1%

OVERALL DISCONTINUATION RATE DUE TO ADVERSE REACTIONS1,9

  • The most common adverse reactions (>10% prevalence) were headache (13%) and fatigue (11%) in patients treated with MAVYRET1
  • Most adverse reactions were mild in severity1
  • 1 subject experienced a serious adverse reaction1

FOR AN OVERVIEW OF MAVYRET, DOWNLOAD THE PRODUCT SUMMARY

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