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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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slide1

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
slide2

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
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

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

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

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

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 – Non-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) + 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 ± RBVin 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

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