1 / 16

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.

halee-navarro
Download Presentation

F/C AETC Faculty HIV/HCV

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related