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

Explore the efficacy and safety of Elbasvir-Grazoprevir in treatment-naïve HCV patients of genotype 1, 4, or 6 through the C-EDGE TN study. Detailed analysis of SVR12 results, drug dosing, baseline characteristics, and conclusions. Source: Zeuzem S. et al. Ann Intern Med. 2015;163:1-13.

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

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  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.

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