PPT-SOF + EBR + GZR + RBV

N 12 N 13 W24 W16 SOF EBR GZR RBV gt 18 years HCV infection G enotype 1 or 4 Failure to a prior therapy with SOF RBV SMV or DCV or LDV with documented presence of NS5A or NS3 RASs at failure . Placebo. LDV/SOF + placebo. Randomisation*. 1 : 1. Double-blind. SIRIUS . Study. : LDV/SOF ± RBV for genotype 1 and cirrhosis with non response to prior PI therapy. Design. W24. W12. ≥ 18 years. Chronic HCV infection. 400/100 mg . qd. N = 500. N = 100. W12. Placebo. >. 18 years. Chronic HCV infection. Genotype 1, 2, 4, 5 or 6. Naïve or pre-treatment. with IFN-based regimen. Compensated cirrhosis allowed**. No HBV or HIV co-infection. With Or Without Ribavirin Is Safe and Efficacious in Liver Transplant Recipients With HCV Recurrence: . Interim Results of a European Multicenter Compassionate Use Program. Herzer K,. 1. . Welzel. . HCV WORLD CAB .  FEBRUARY 2014. BANGKOK, THAILAND. When to Treat HCV. . HCV Direct-Acting . Antivirals. (. DAAs. ) in . development. . OVERVIEW. Know your epidemic: what matters. . +/- Ribavirin in HCV Genotype 1, 4 or 6. C-EDGE Treatment Experienced (TE). Phase 3. . Treatment. . Experienced. Kwo. P, . et al. . EASL 2015. Abstract P0886.. Source: . Kwo. P et al. EASL 2015. Abstract P0886.. 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. * 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. 400/100/100 mg QD. N = 263. N = 152. W12. Placebo. >. 18 years. Chronic HCV infection. Genotype 1, 2, 3, 4, 5 or 6. NS5A inhibitor-experienced . for ≥ 4 weeks (exclusion if . discontinued due to an adverse. Randomisation. 1 : 1. 18-70 years. HCV genotype 1. Naïve or pre-treated. with IFN-based regimen. No cirrhosis. HCV RNA ≥ . 10.000 . IU. /ml. No prior therapy with PI. No HBV or HIV co-infection. OPTIMIST-1 Study: SMV SOF for genotype 1. C-WORTHY/D. GZR + EBR + RBV. GZR + EBR + RBV. N = 21. N = 20. Design. W12. W18. SVR. 12. >. 18 years. HCV genotype . 3. HCV RNA ≥ 10 000 IU/mL. Treatment naïve . No cirrhosis. No HBV or HIV co-infection. 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).