PPT-MK3 MK3 + RBV

Randomisation Openlabel W8 Liver biopsy or Fibroscan gt 125 kPa or Fibrotest gt 075 APRI gt 2 Objective Primary endpoint SVR 12 HCV RNA lt 15 IUmL full analysis set . ATTAIN. SMV + TVR placebo. + PEG-IFN + RBV. TVR + SMV placebo + PEG-IFN + RBV. Randomisation*. 1 : 1. Double-blind. ≥ 18 years. HCV genotype 1. HCV RNA ≥ 10,000 IU. /ml. Null or partial responders to . PTV150/r + OBV + . DSV . + RBV. PTV150/r + . DSV . + RBV. 2-steps. Randomisation*. Open-label. W12. W8. W24. 18-70 years. Chronic HCV infection . Genotype 1. HCV RNA ≥ 50,000 IU/ml. Treatment-naïve . Morris Sherman MD . BCh. PhD FRCP(C) . Associate Professor of Medicine. University of Toronto. Protease Inhibitors . in Chronic . Hepatitis C:. An . Update. COMPLETE SLIDE DECK (Chapters 1 – 6). November 2012. John J. . Faragon. , . PharmD. , BCPS, AAHIV-P. Regional Pharmacy Director, NY/NJ AETC. Pharmacist, Albany Medical Center. Objectives. Discuss recent guidelines . changes for HIV infection. Using . patient cases, discuss the role of . -Ritonavir. -Ombitasvir . + Dasabuvir) . + RBV in . GT1. SAPPHIRE-II. Phase . 3. Treatment. . Experienced. Zeuzem. S, . et al. N . Engl. J Med. . 2014;370:1604-14.. Source: . Zeuzem. S, et al. N . OBV/PTV/r + . DSV . + RBV. OBV/PTV/r + . DSV . + RBV. Randomisation*. 1 : . 1. Open-label. 18-70 years. HCV genotype 1. HCV RNA ≥ 10,000 IU/ml. Naïve or pre-treated with PEG-IFN + RBV. HIV infection, on ATV/. Hepatol. 2016; 64:19-28. MALACHITE. TVR + PEG-IFN + RBV. Randomisation. Open-label. 18-65 years. HCV genotype 1. HCV RNA > 10,000 IU/ml. Naïve (MALACHITE-I). Failure to . prior PEG-IFN + RBV. (MALACHITE-II). RBV . versus. . PEG alfa-. 2a . versus. INF + RBV . APRICOT STUDY. Phase 3. Treatment. . Naïve, Chronic HCV and HIV. Torriani. FJ, . et. al. N . Engl. J Med. . 2004;351:438-50. . PEG . + . RBV . 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. N = 69. >. 18 years. Failure to SOF/VEL . or SOF/VEL + VOX . (LEPTON study). Any genotype. Compensated cirrhosis allowed. No HBV or HIV co-infection. Open-label. SOF/VEL: 400/100 mg FDC QD ; RBV: weight based in twice daily dose . N = 12. N = 13. W24. W16. SOF + EBR + GZR + RBV. > . 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 . Randomisation*. Open-label. >. 18 years. HCV genotype 1. HCV RNA ≥ 10,000 IU. /ml. Treatment naïve and . compensated cirrhosis (Child-Pugh A). or. Null responders to previous PEG-IFN + RBV, with or without cirrhosis. * 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.