1 / 10

Elbasvir-Grazoprevir in Treatment-Naïve HCV Genotype 1, 4 or 6 C-EDGE Treatment Naïve (TN)

Phase 3. Treatment Naïve. Elbasvir-Grazoprevir in Treatment-Naïve HCV Genotype 1, 4 or 6 C-EDGE Treatment Naïve (TN). Zeuzem S, et al. Ann Intern Med. 2015;163:1-13. Elbasvir-Grazoprevir in Treatment-Naïve HCV Genotype 1, 4 or 6 C-EDGE TN Study: Features.

ghayden
Download Presentation

Elbasvir-Grazoprevir in Treatment-Naïve HCV Genotype 1, 4 or 6 C-EDGE Treatment Naïve (TN)

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. Phase 3 TreatmentNaïve Elbasvir-Grazoprevirin Treatment-Naïve HCV Genotype 1, 4 or 6C-EDGE Treatment Naïve (TN) Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  2. Elbasvir-Grazoprevirin Treatment-Naïve HCV Genotype 1, 4 or 6C-EDGE TN Study: Features Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  3. Elbasvir-Grazoprevir in Treatment-Naïve HCV Genotype 1, 4 or 6C-EDGE TN: Study Design 0 12 16 40 24 28 Week Treatment-naïve GT 1, 4 or 6 (N=421) Elbasvir-Grazoprevir N=316 SVR12 Elbasvir-Grazoprevir Placebo N=105 SVR12 Randomized 3:1 ratio to immediate or deferred arm; stratified by cirrhosis, HCV genotype, subtypeAfter 4 weeks of follow-up, placebo recipients were unblinded and given elbasvir-grazopreviropen label Drug DosingElbasvir-Grazoprevir (50/100 mg): fixed dose combination; one pill once daily Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  4. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Baseline Characteristics Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  5. Elbasvir-Grazoprevirin Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Results C-EDGE TN: SVR12 Results by Genotype 299/316 144/157 129/131 18/18 8/10 Primary efficacy analysis included all patients who received ≥1 dose of drug. Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  6. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Results C-EDGE TN: SVR12 by Presence of Cirrhosis or High HCV RNA Level 231/246 68/70 94/94 205/222 Presence of Cirrhosis Baseline HCV RNA Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  7. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Results Baseline NS5A Resistance-Associated Variants and SVR12 in GT1 11/19 133/135 17/18 112/112 *Patients with baseline GT1a RAVs with a ≤5-fold shift to elbasvir: SVR12=90% (9 of 10) *Patients with baseline GT1a RAVs with a >5-fold shift to elbasvir: SVR12=22% (2 of 9) Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  8. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Results Baseline NS3/4A Resistance-Associated Variants and SVR12 in GT1 83/86 58/65 24/25 104/104 Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  9. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Adverse Events § Neither death was considered to be study-related. Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

  10. Elbasvir-Grazoprevir in Treatment-Naïve HCV GT 1, 4 or 6C-EDGE TN: Conclusions Source: Zeuzem S, et al. Ann Intern Med. 2015;163:1-13.

More Related