PPT-≥ 18 years, HCV genotype 1-6

 18 years HCV genotype 16 HCV RNA gt 1 000 IUmL Treatmentnaïve TN or treatmentexperienced TE without DAA except SOF With or without cirrhosis Chronic kidney disease stage 3b 4 or 5 . 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 . HCV WORLD CAB .  FEBRUARY 2014. BANGKOK, THAILAND. When to Treat HCV. . HCV Direct-Acting . Antivirals. (. DAAs. ) in . development. . OVERVIEW. Know your epidemic: what matters. Warren W. . Kretzschmar. DPhil Genomic Medicine and Statistics. Wellcome. Trust Centre for Human . Genetics, Oxford. , UK . Supervisor: Jonathan . Marchini. C. ommonest . psychiatric disorder and the second ranking cause of morbidity world-. 400/100/100 mg QD. N = 501. N = 440. W8. SOF/VEL 400/100 mg QD. >. 18 years. Chronic HCV infection. Genotype 1, 2, 3, 4, 5 or 6. Treatment-naïve or . IFN-experienced. Compensated cirrhosis **. allowed . Patcha. . Incomserb. Measles RRL-SEAR. Thai-NIH. Accelerating Progress towards Measles and Rubella Elimination. Hotel Royal, Geneva, Switzerland, 21-23 June 2016. India. Nepal. D8, B3. Bhutan. Bangladesh. 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 . qd. + SOF 400 mg . qd. N = 40. W12. 18-70 years. Chronic HCV infection. Genotype 4. HCV RNA > 10 000 IU/ml. Naïve or pre-treatment. with PEG-IFN + RBV. Compensated cirrhosis allowed. No HBV or HIV co-infection. Tt. Tall. tt. Short. The answer is _______ because: . Review from Objective 1. Which of the following depicts a dominant genotype? (tall – dominant, short – recessive). Tt. Tall. tt. Short. The answer is _______ because: . HCV RNA ≥ 1000 IU/mL. Treatment-naïve or treatment-experienced with IFN or PEG-IFN . .  RBV or SOF RBV ± PEG-IFN. Compensated . cirrhosis *. No HBV or HIV co-infection. Design. W12. EXPEDITION-1 . 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. ASTRAL-1. Phase 3. . Treatment. . Naïve & Experienced. Feld JJ, . et al. . N . Engl. J Med. . 2015. ;373:2599-607.. Source: Feld . JJ. , et al. N . Engl. J Med. . 2015. ;373:2599-607.. Sofosbuvir-Velpatasvir. Markov Models of Haplotype Diversity. Justin Kennedy. Dissertation . Defense for . the Degree of Doctorate in Philosophy. Computer Science & Engineering Department. University of Connecticut. 1. Outline. mHCV Genotype II Key to symbols used Global Trade Item Number Manufacturer Reference Number Lot Number In Vitro Diagnostic Medical Device Internal Control Amplification Reagent Pack A Amp 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).