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F/C AETC Faculty HIV/HCV. Thursday May 8, 2014 | 1:30- 2:30pm (EDT) Facilitator/ Presenter Dushyantha T. Jayaweera , MD, MRCOG (UK), FACP University of Miami Case Discussant Patrick Marsh, MD University of South Florida Maribel Gonzalez, RN, ARNP University of South Florida.

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F/C AETC Faculty

HIV/HCV

  • Thursday May 8, 2014 | 1:30- 2:30pm (EDT)

  • Facilitator/ Presenter

  • Dushyantha T. Jayaweera, MD, MRCOG (UK), FACP

  • University of Miami

  • Case Discussant

  • Patrick Marsh, MD

  • University of South Florida

  • Maribel Gonzalez, RN, ARNP

  • University of South Florida


HIV Case Conference:Highlights from EASL

  • Dushyantha T. Jayaweera MD, MRCOG (UK), FACP

    • Associate Vice Provost for Human Subject Research & Professor of Medicine, University of Miami, Miller School of Medicine, Division of Infectious Diseases

  • Faculty Member, Florida/Caribbean AIDS Education and Training Center


  • Hcv treatment in treatment naive patients

    HCV TREATMENT IN TREATMENT NAIVE PATIENTS


    Sapphire i study design
    SAPPHIRE-I Study: Design

    Double-Blind

    ABT-450/r/ABT-267 qd +

    ABT-333 bid + RBV bid

    (n=473)

    • Phase 3 Study

    • Double-Blind

    • Key eligibility criteria

    • HCV genotype 1

    • Treatment-naïve

    • No cirrhosis

    • No HIV or HBV

    Open-Label

    Placebo*

    (n=158)

    ABT-450/r/ABT-267 qd +

    ABT-333 bid + RBV bid

    (n=158)

    0 12 24

    Week

    Feld J, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O60.


    Sapphire 1 study interim results
    SAPPHIRE-1 Study: Interim Results

    SVR12 Rates

    3D Regimen + RBV

    • Virologic relapse: 1.7%

    • 3D regimen + RBV was well-tolerated

    • Discontinuations due to adverse events: 0.6%

    • Most commonly reported adverse events

      • Fatigue

      • Headache

      • Nausea

    98%

    96%

    95%

    Patients (Percentage)

    1b

    (n=151)

    Overall

    (n=473)

    1a

    (n=322)

    Genotype

    Feld J, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O60.


    Pearl iii study design
    PEARL-III Study: Design

    ABT-450/r/ABT-267 qd + ABT-333 bid+ RBV bid (n=210)

    • Phase 3 Study

    • Double-Blind

    • Placebo-controlled

    • Key eligibility criteria

    • HCV genotype 1

    • Treatment-naïve

    • No cirrhosis

    • No HIV or HBV

    ABT-450/r/ABT-267 qd + ABT-333 bid+ RBV Placebo (n=209)

    0 12 24

    Week

    Ferenci P, et al. 49th EASL; London, England; April 9-13, 2014. Abst. P1299.


    Pearl iii study svr12 and virologic failure rates
    Pearl-III Study: SVR12 and Virologic Failure Rates

    3D Regimen + RBV

    99%

    99%

    Patients (Percentage)

    No RBV

    (n=209)

    With RBV

    (n=210)

    0.5%

    0%

    With RBV

    (n=210)

    No RBV

    (n=209)

    SVR12

    Virologic Failure

    Ferenci P, et al. 49th EASL; London, England; April 9-13, 2014. Abst. P1299.


    Pearl iii study safety results

    Ferenci P, et al. 49th EASL; London, England; April 9-13, 2014. Abst. P1299.

    Pearl-III Study: Safety Results

    • 3D regimen + RBV was well tolerated

    • Discontinuations due to adverse events

      • With RBV: 0%

      • No RBV: 0%

    • Most commonly reported adverse events

      • Headache

      • Fatigue


    Ion 1 study design
    ION-1 Study: Design 2014. Abst. P1299

    Wk 12

    Wk 24

    Wk 36

    Wk 0

    LDV/SOF

    SVR12

    • GT 1 HCV treatment-naïve patients in Europe and USA

    • Broad inclusion criteria

      • Targeted 20% enrollment of patients with cirrhosis

      • No upper age or BMI limit

      • Platelet count ≥50,000/mm3, no neutrophil minimum

    • 865 patients randomized 1:1:1:1 across four arms

    • Stratified by HCV subtype (1a or 1b) and cirrhosis

    LDV/SOF + RBV

    SVR12

    LDV/SOF

    SVR12

    LDV/SOF + RBV

    SVR12

    Mangia A, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O164.


    Ion 1 study svr12 absence of cirrhosis vs cirrhosis
    ION-1 Study: SVR12 - Absence of Cirrhosis vs Cirrhosis 2014. Abst. P1299

    Cirrhosis

    Absence of Cirrhosis

    SVR12 (Percentage)

    179/180

    32/34

    178/184

    33/33

    181/184

    31/33

    179/181

    36/36

    LDV/SOF

    LDV/SOF + RBV

    LDV/SOF

    LDV/SOF + RBV

    12 Weeks

    24 Weeks

    Error bars represent 95% confidence intervals.

    Mangia A, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O164.


    Ion 1 study svr12 absence of cirrhosis vs cirrhosis1
    ION-1 Study: SVR12 - Absence of Cirrhosis vs Cirrhosis 2014. Abst. P1299

    Absence of Cirrhosis

    Cirrhosis

    SVR12 (Percentage)

    179/180

    32/34

    178/184

    33/33

    181/184

    31/33

    179/181

    36/36

    LDV/SOF

    LDV/SOF + RBV

    LDV/SOF

    LDV/SOF + RBV

    12 Weeks

    24 Weeks

    Error bars represent 95% confidence intervals.

    Mangia A, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O164.


    Ion 3 study design
    ION-3 Study: Design 2014. Abst. P1299

    Wk 12

    Wk 24

    Wk 36

    Wk 0

    • GT 1 treatment-naïve patients without cirrhosis

    • Broad inclusion criteria

      • No upper age or BMI limit

      • Opiate substitution therapy allowed

    • 647 patients randomized 1:1:1 across three arms

    • Stratified by HCV subtype (1a or 1b)

    LDV/SOF

    SVR12

    LDV/SOF + RBV

    SVR12

    LDV/SOF

    SVR12

    Kowdley K, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O56.


    Ion 3 study results non inferiority comparison
    ION-3 Study Results – 2014. Abst. P1299Non-Inferiority Comparison

    p=0.52

    SVR12 (Percentage)

    202/215

    201/216

    206/216

    LDV/SOF

    LDV/SOF + RBV

    LDV/SOF

    8 Weeks

    12 Weeks

    Error bars represent 95% confidence intervals.

    Kowdley K, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O56.


    Study design mk 5172 100 mg qd mk 8742 50 mg qd rbv in 253 pte
    Study Design: MK-5172 (100 mg QD) + 2014. Abst. P1299 MK-8742 (50 mg QD) ± RBV in 253 Pte

    Follow-up

    n = 31

    + RBV

    + RBV

    Follow-up

    n = 29

    No RBV

    No RBV

    TN + Cirrhosis

    n=123

    Follow-up

    n = 32

    + RBV

    + RBV

    Follow-up

    n = 31

    No RBV

    No RBV

    Follow-up

    n = 32

    + RBV

    + RBV

    Follow-up

    n = 33

    No RBV

    No RBV

    PR-Nulls ± Cirrhosis

    n=130

    Follow-up

    n = 33

    + RBV

    + RBV

    Follow-up

    n = 32

    No RBV

    No RBV

    D1

    TW4

    TW8

    TW12

    TW18

    FU4

    FU8

    SVR12

    SVR24

    Lawitz E, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O61.


    Efficacy of mk 5172 mk 8742 rbv in treat na ve pte cirrhosis 12w vs18w
    Efficacy of MK-5172 + MK-8742 ± RBV 2014. Abst. P1299in Treat-Naïve Pte + Cirrhosis:12W vs18W

    • *Excludes patients who have not yet reached the FU4 time point

    • 12 week arms include 97% of FU8 results

    2831

    29

    29

    32

    32

    28

    31

    30

    31

    29

    29

    31

    32

    31

    31

    28

    31

    28

    29

    30

    31*

    29

    30*

    TW4

    FU4/8

    TW12

    Breakthrough

    Relapse

    Lawitz E, et al. 49th EASL; London, England; April 9-13, 2014. Abst. O61.

    Discontinuation


    Discussion

    Discussion 2014. Abst. P1299


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