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Sofosbuvir + RBV in Treatment-Naïve Genotypes 2,3 FISSION Trial*

Phase 3. Treatment Naïve. Sofosbuvir + RBV in Treatment-Naïve Genotypes 2,3 FISSION Trial*. *Note: Published in NEJM in tandem with NEUTRINO Trial (Genotypes 1,4,5,6). Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

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Sofosbuvir + RBV in Treatment-Naïve Genotypes 2,3 FISSION Trial*

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  1. Phase 3 TreatmentNaïve Sofosbuvir + RBV in Treatment-Naïve Genotypes 2,3FISSION Trial* *Note: Published in NEJM in tandem with NEUTRINOTrial (Genotypes 1,4,5,6) Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  2. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Features Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  3. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Design Week 0 12 24 36 Sofosbuvir + RBV (weight-based) N =256 SVR12 Peginterferon + RBV (fixed-dose) N =243 SVR12 Drug DosingSofosbuvir: 400 mg once dailyPeginterferon alfa-2a: 180 µg once weeklyWeight-based Ribavirin (in 2 divided doses): 1000 mg/day if < 75kg or 1200 mg/day if ≥ 75kgFixed-dose Ribavirin (in 2 divided doses): 800 mg/day Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  4. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Results FISSION: HCV RNA <25 IU/ml by Study Timepoint (GT 2, 3 Combined) 249/250 158/236 249/253 217/243 170/253 162/243 RBV = Ribavirin; PEG = Peginterferon Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  5. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Results FISSION: SVR12 by Genotype 170/253 162/243 68/70 52/67 102/183 110/176 RBV = Ribavirin; PEG = Peginterferon Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  6. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Results FISSION: SVR12 by Presence of Cirrhosis 147/204 143/193 23/49 19/50 RBV = Ribavirin; PEG = Peginterferon Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  7. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Adverse Effects Source: Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  8. Sofosbuvir + Ribavirin for Treatment-Naïve HCV GT 2 or 3FISSION Trial: Conclusions Source:Lawitz E, et al. N Engl J Med. 2013;368:1878-87.

  9. This slide deck is from the University of Washington’s Hepatitis C Online and Hepatitis Web Study projects. Hepatitis C Onlinewww.hepatitisc.uw.edu Hepatitis Web Studyhttp://depts.washington.edu/hepstudy/ Funded by a grant from the Centers for Disease Control and Prevention.

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