1. Phase 3
Treatment Experienced
Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE Treatment Experienced (TE)
Kwo P, et al. EASL Abstract P0886.

2. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE Study: Features
C-EDGE TE Trial
Design: Randomized, open label, parallel-group phase 3 trial examining the safety and efficacy of a fixed-dose combination of elbasvir-grazoprevir with or without ribavirin for 12 or 16 weeks in treatment-experienced patients with GT 1, 4, or 6 HCV and previous failure of peginterferon plus ribavirin
Entry Criteria - Chronic HCV Genotype 1, 4 or years or older - HCV RNA ≥10,000 IU/mL - History of peginterferon plus ribavirin treatment failure - Patients with compensated cirrhosis accepted
Primary End-Point: SVR12
Source: Kwo P et al. EASL Abstract P0886.

3. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE: Study Design
Week 12 16 24 28 36
GT 1, 4 or 6
Prior Treatment (n = 420)
n = 105
EBR-GZR
SVR12
n = 104
EBR-GZR + RBV
SVR12
n = 105
EBR-GZR
SVR12
n = 106
EBR-GZR + RBV
SVR12
Abbreviations: EBR-GZR = elbasvir-grazoprevir; RBV = ribavirin
Drug Dosing Elbasvir-grazoprevir (50/100 mg): fixed dose combination; one pill once daily Ribavirin (weight-based and divided bid): 800 to 1400 mg/day
N =14
Source: Kwo P et al. EASL Abstract P0886.

4. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE: Baseline Characteristics
12-Week Treatment
16-Week Treatment
EBR-GZR n=105
EBR-GZR + RBV
n=104
EBR-GZR n=105
n=106
Mean age, y (range)
56 (25–76)
56 (23–75)
55 (31–73)
55 (19–77)
Male sex, % 63 69 66 60
Race, %
White
Black
Asian 22 14 67 23 9 21 74
HCV Genotype, % 1a 1b 4 6 58 33 -- 28 46 5 55 36 8 2
Cirrhosis, % 35 34
HIV coinfection, %
Prior treatment response
Relapse, %
Partial response, % 20 47 37 42 44 38 41
Source: Kwo P et al. EASL Abstract P0886.

5. C-EDGE TE: SVR 12* by Treatment Duration and Regimen
Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE: Results
C-EDGE TE: SVR 12* by Treatment Duration and Regimen
97/105
98/104
97/105
103/106
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. EASL Abstract P0886.

6. C-EDGE TE: SVR 12* by Key Subgroups
Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE: Results
C-EDGE TE: SVR 12* by Key Subgroups
97/105
98/104
97/105
103/106
* Analysis per protocol: excluding patients who dropped out due to reasons other than virologic failure
Source: Kwo P et al. EASL Abstract P0886.

7. Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE TE: Results
Conclusions: “This is an ongoing, Phase III study among subjects
with HCV GT1 or 4 infection who failed prior PR therapy, including
large numbers of Black/African-American and cirrhotic patients.
Preliminary results showed a 12 week regimen of GZR/EBR FDC
was highly efficacious with respect to SVR4 among these hard-to-cure
patients, and had a favorable safety profile.”
Source: Kwo P et al. EASL Abstract P0886.