PPT-C-WORTHY Study Part D: grazoprevir + elbasvir + RBV in genotype 3

CWORTHYD GZR EBR RBV GZR EBR RBV N 21 N 20 Design W12 W18 SVR 12 gt 18 years HCV genotype 3 HCV RNA 10 000 IUmL Treatment naïve No cirrhosis No HBV or HIV coinfection. grazoprevir. . + . elbasvir. . in genotype 1 with Child-Pugh B cirrhosis. Jacobson IM. . EASL 2015, Abs. O008. Design. Child-Pugh B. GZR . 100 mg + . EBR . 50 mg. GZR 50 mg + EBR 50 mg. Non-cirrhotic. Design. C-SCAPE . Study. : . grazoprevir. ± . elbasvir. ± RBV . in . genotypes. 2, 4, 5 or 6. Treatment-naïve . Genotype 2. , 4, 5, 6. Non-cirrhotic, . HCV . monoinfected. Brown . A. . . J . Hepatol. Feld JJ. NEJM . 2014;370:1594-1603. SAPPHIRE-I . Study. : . o. mbitasvir/paritaprevir/ritonavir. . + . d. asabuvir. . + . ribavirin. . for genotype 1. Treatment regimens. Co-formulated . ombitasvir. X. J . Hepatology. 2015; 63: 564-72. C-SALVAGE Study: . grazoprevir. . + . elbasvir. + RBV in genotype 1 with failure to PI-based regimen. NS3 and NS5A RAVs identified by population sequencing at baseline and VF. in genotypes 1 or 3, with or without cirrhosis. >. 18 years. Chronic HCV infection. Genotype 1 or 3. HCV RNA > 10 000 IU. /ml. Treatment-naïve . Cirrhosis assessed by liver biopsy or noninvasive tests. * Liver biopsy or . Fibroscan. ≤. 12.5 . kPa. or . Fibrosure. ®. . <. 0.48 + APRI . ≤ 1. Objective. Primary endpoint: SVR. 12 . (HCV RNA < 15 IU/mL), full analysis set ≥ 1 dose of study drug. SOF + RBV. Randomisation*. 1 : 1 : 1. Open-label. BOSON . Study. : SOF + RBV . +. PEG-IFN . for genotypes 2 and 3. ≥ 18 years. Chronic HCV infection. Genotype 2, treatment-experienced with cirrhosis. in genotypes 1 or 3, with or without cirrhosis. >. 18 years. Chronic HCV infection. Genotype 1 or 3. HCV RNA > 10 000 IU. /ml. Treatment-naïve . Cirrhosis assessed by liver biopsy or noninvasive tests. 6; 386:1537-45. C-SURFER Study: . grazoprevir. . + . elbasvir. . in genotype 1 with chronic kidney disease. N = 111. GZR + EBR. Placebo. GZR + EBR (Intensive PK). N = 113. N = 11. GZR/EBR. W. 12. W16. ≥ 18 years. Chronic HCV infection. Genotype 1. Treatment-. naïve or . PEG-IFN RBV-. experienced . HCV RNA > 1,000 IU/ml. Chronic kidney disease with. eGFR. (MDRD) < 30 ml/min/1.73m. 2. (dialysis permitted). Ribavirin in PI-experienced HCV GT1. C-SALVAGE. Phase . 2 . Treatment. . Experienced. (1) . Buti. M, et al. . Clin. Infect Dis. 2016;62:32-6. (2) . Forns. X, et al. J . Hepatol. . 2015;63:564-72. Ephesians 4:1-3. Worthiness does not mean we earn or deserve grace. Worthiness means we meet God’s expectations. Illustrated. God gives elders the responsibility to shepherd. Rule well – worthy of double honor (I Tim. 5:17-18). C-EDGE Treatment Naïve (TN). Phase 3. . Treatment. . Naïve. Zeuzem. S, . et al. . Ann Intern Med. 2015;163:1-13.. Source: . Zeuzem. S, et al. Ann Intern Med. 2015;163:1-13. .. Elbasvir-Grazoprevir. Non . inferiority. of SOF + RBV : SVR. 12. (. 2-sided significance level of 5%, . lower margin of the . 95% CI for the difference = -15%, 95% power). SOF + RBV (weight based). PEG-IFN. a. -2a + RBV (fixed-dose).