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F/C AETC Faculty HIV/HCV

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

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  1. 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

  2. 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

  3. HCV TREATMENT IN TREATMENT NAIVE PATIENTS

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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

  16. Discussion

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