Phase 2 Treatment Nave ElbasvirGrazoprevir Sofosbuvir in TreatmentNave
Phase 2 Treatment Naïve Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve HCV Genotype 1 or 3 C-SWIFT Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50.
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Features C-SWIFT Trial § Design: Open-label phase 2 trial to evaluate the efficacy and safety of short duration therapy with elbasvir-grazoprevir + sofosbuvir in treatment-naïve GT 1 or 3 infection, with or without cirrhosis § Entry Criteria - Chronic HCV genotype 1 (n = 102) or genotype 3 (n = 41) - Age 18 years or older - No prior HCV treatment - HCV RNA ≥ 10, 000 IU/m. L - ALT and AST <350 IU/L - Cirrhosis allowed § Primary End-Point: SVR 12 Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50.
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Study Design for GT 1 Week 0 4 n = 31 EBR-GZR + SOF n = 30 EBR-GZR + SOF n = 21 EBR-GZR + SOF 6 8 GT-1 Non-cirrhotic GT-1 Cirrhotic Abbreviations: EBR-GZR = elbasvir-grazoprevir; SOF = sofosbuvir Drug Dosing Elbasvir-grazoprevir (50/100 mg): fixed-dose combination; one pill once daily Sofosbuvir: 400 mg once daily Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50. 24
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Study Design for GT 3 Week GT-3 Non-cirrhotic GT-3 Cirrhotic 0 8 12 20 n = 15 EBR-GZR + SOF SVR 12 n = 14 EBR-GZR + SOF SVR 12 n = 12 EBR-GZR + SOF Abbreviations: EBR-GZR= grazoprevir-elbasvir; SOF = sofosbuvir Drug Dosing Grazoprevir/elbasvir (100/50 mg): fixed dose combination; one pill once daily Sofosbuvir 400 mg once daily Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50. 24 SVR 12
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Baseline Characteristics Genotype 1 Baseline Characteristic No cirrhosis Genotype 3 Cirrhosis No Cirrhosis 4 weeks (n = 31) 6 weeks (n = 30) 6 weeks (n = 20) 8 weeks (n = 21) 8 weeks (n = 15) 12 weeks (n = 14) 12 weeks (n = 12) Mean age, years 52 51 56 57 51 42 55 Male sex, % 65 63 65 62 73 57 83 White 97 93 100 95 100 100 Hispanic/Latino 29 47 65 48 40 57 50 1 a 84 87 80 76 -- -- -- 1 b 16 13 20 24 -- -- -- 3 -- -- 100 100 IL 28 B CC, % 36 27 30 24 40 21 50 Cirrhosis, % 0 0 100 3. 7 3. 1 1. 7 2. 4 3. 3 2. 6 2. 3 Race, % HCV Genotype, % HCV RNA, 106 IU/m. L (mean) Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50.
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Results for GT 1 C-SWIFT: SVR 12* for GT 1 by Treatment Duration and Cirrhosis Patients with SVR 12 (%) 100 86, 7 80 80, 0 81, 0 60 40 32, 0 20 0 10/30 26/30 16/20 17/21 4 weeks 6 weeks 8 weeks No Cirrhosis Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50. Cirrhosis
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Results for GT 3 C-SWIFT: SVR 12* for GT 3 by Treatment Duration and Cirrhosis Patients with SVR 12 (%) 100, 0 93, 0 80 83, 3 60 40 20 0 14/15 14/14 10/12 8 weeks 12 weeks No Cirrhosis Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50. Cirrhosis
Elbasvir-Grazoprevir + Sofosbuvir in Treatment-Naïve GT 1 or 3 C-SWIFT Study: Conclusions: “Data from this study support the use of 8 -week treatment regimens that maintain high efficacy, even for patients with HCV GT 3 infection. Retreatment of patients who failed short-duration therapy was achieved through extended treatment duration and addition of ribavirin. Source: Lawitz E, et al. Hepatology. 2017; 65: 439 -50.
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