Phase 3 Treatment Experienced Elbasvir-Grazoprevir +/- Ribavirin in HCV Genotype 1, 4 or 6 C-EDGE Treatment Experienced (TE) Kwo P, et al. EASL 2015. Abstract P0886.

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 6 - 18 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 2015. Abstract P0886.

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 2015. Abstract P0886.

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 2015. Abstract P0886.

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 2015. Abstract P0886.

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 2015. Abstract P0886.

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 2015. Abstract P0886.