PPT-Boceprevir with PEG + RBV in Genotype 1

SPRINT 1 Phase 2 Treatment Naïve Kwo PY et al Lancet 201037670516 Source Kwo PY et al Lancet 201037670516 Boceprevir for TreatmentNaïve HCV Genotype 1 SPRINT. for Patients with Prior Failure to PEG + RIB. PROVIDE. Phase . 3. Treatment. . Experienced. Vierling. JM, . et al. . J . Hepatol. . 2013;Dec 19 [. Epub. ahead of print].. Source: . Vierling. . JM, et al. J . Mark Sulkowski, MD. Associate Professor of Medicine . Johns Hopkins University School of Medicine . Limitations of PegIFN + Ribavirin . (with or without protease inhibitors). Antiviral activity is host + virus genotype dependent . RESPOND-2. Phase . 3. Treatment. . Experienced. Bacon BR, et al. N . Engl. J Med. 2011;364:1207-17.. Source: . Bacon BR, et al. N Engl J Med. 2011;364:1207-17.. Boceprevir for Retreatment of HCV Genotype 1 Infection . 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). 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. 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). Karen Roberts Nutrition CNS RSCH. Karen Matthews Nutrition CNS RSCH/MARS team . Introduction. Case study. PEG. RIG. NGT. Making a decision. Discharging . Conclusion . 49 year old male. unknown primary with TxN3 . Randomisation. Open-label. W8. * Liver biopsy or . Fibroscan. . > 12.5 . kPa. or . Fibrotest. . . >. 0.75 + APRI . > 2. Objective. Primary endpoint: SVR. 12 . (HCV RNA < 15 IU/mL), full analysis set . 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. DSV . placebo. Randomisation*. Partial blind. 18-70 years. Chronic HCV infection. Genotype 1 . Treatment-naïve. HCV RNA > 10,000 IU/ml. No cirrhosis. No HBV or HIV co-infection. * Randomisation 1:2 if genotype 1a (PEARL-IV) ; . . 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 . versus. . PEG . Mark Sulkowski, . MD. Professor of Medicine. Medical Director, Viral Hepatitis Center . Johns Hopkins University. Baltimore Maryland USA. Liver disease is the second leading specific causes of death amongst HIV-positive individuals in the D:A:D study. Mark Sulkowski, MD. Professor of Medicine. Johns Hopkins University. Baltimore Maryland 21212. Case . 57 . yo. woman with genotype 1a and bridging fibrosis. PROVE-1 study – treated with TVR x 12 . 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).