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Elbasvir-Grazoprevir Treatment in HCV Genotype 1, 4, or 6: C-EDGE TE Study Results

This presentation details the study on Elbasvir-Grazoprevir with or without Ribavirin in HCV Genotype 1, 4, or 6 Treatment-Experienced (TE) patients. The study design, drug dosing, baseline characteristics, and results including sustained virologic response (SVR) rates are discussed. Data on SVR rates based on regimen, treatment duration, and genotype subtype are presented. Also, outcomes in patients with baseline NS5A RAVs are highlighted. Source: Gastroenterology, 2017.

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Elbasvir-Grazoprevir Treatment in HCV Genotype 1, 4, or 6: C-EDGE TE Study Results

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  1. Phase 3 TreatmentExperienced Elbasvir-Grazoprevir+/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE Treatment Experienced (TE) Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  2. Elbasvir-Grazoprevir+/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE Study: Features Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  3. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Study Design 0 12 16 24 28 36 Week n =105 SVR12 GT1, 4 or 6 Prior Treatment (n = 420) EBR-GRZ SVR12 n =104 EBR-GRZ + RBV n =105 SVR12 EBR-GRZ n =106 SVR12 EBR-GRZ + RBV Abbreviations: EBR-GZR = elbasvir-grazoprevir; RBV = ribavirin Drug DosingElbasvir-grazoprevir (50/100 mg): fixed dose combination; one pill once dailyRibavirin (weight-based and divided bid): 800 to 1400 mg/day N =14 Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  4. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Baseline Characteristics Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  5. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Results C-EDGE TE: SVR 12*, by Genotype 356/370 32/36 4/4 * Analysis per protocol: excluding patients who dropped out due to reasons other than virologic failure Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  6. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Results C-EDGE TE: SVR 12* by Regimen and Treatment Duration (GT 1, 4, or 6) 97/105 98/104 97/105 104/106 12-Week Regimen 16-Week Regimen * Analysis per protocol: excluding patients who dropped out due to reasons other than virologic failure Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  7. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Results C-EDGE TE: SVR 12 by Regimen, Treatment Duration, and GT1 Subtype 55/60 34/34 56/60 28/29 45/48 46/47 55/55 37/37 12-Week Regimen 16-Week Regimen Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  8. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Results C-EDGE TE: SVR 12 in Patients with Baseline NS5A RAVs 6/10 4/4 6/9 4/5 3/6 11/12 6/6 9/9 12-Week Regimen 16-Week Regimen Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  9. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6C-EDGE TE: Results Source: Kwo P, et al. Gastroenterology. 2017;152:164-75.

  10. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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