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Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON

Phase 3. Interferon Intolerant, Unwilling, or Ineligible. Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON. *Note: Published in tandem with FUSION Trial (GT 2,3 and prior failure with PEG). Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

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Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option) POSITRON

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  1. Phase 3 Interferon Intolerant, Unwilling, or Ineligible Sofosbuvir in HCV Genotype 2, 3 (PEG not an Option)POSITRON *Note: Published in tandem with FUSION Trial (GT 2,3 and prior failure with PEG) Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  2. Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Design Source: Jacobson I,et al. N Engl J Med. 2013;368:1867-77.

  3. Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Design 0 12 24 Week Sofosbuvir+ RBV 12 weeks N =207 SVR12 Placebo12 weeks N =71 SVR12 Drug DosingSofosbuvir: 400 mg once dailyWeight-Based Ribavirin (in 2 divided doses): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  4. Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Reasons for Interferon Ineligibility Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  5. Sofosbuvir + Ribavirin for HCV GT 2 or 3 (PEG not an option)POSITRON Trial: Duration on Prior Interferon Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  6. Sofosbuvir for HCV Infection GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin POSITRON: Patients with HCV RNA <25 IU/ml by Study Timepoint 202/204 202/202 161/207 Placebo arm: 0% for each timepointAbbreviations: SOF = sofosbuvir; RBV = ribavirin Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  7. Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin POSITRON: SVR12 by HCV Genotype 101/109 60/98 Placebo arm: 0% for each timepoint Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  8. Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin POSITRON: SVR12 by Liver Disease 142/176 19/31 Placebo arm: 0% for each timepoint Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  9. Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON: Results with Sofosbuvir + Ribavirin POSITRON: SVR12 by Liver Disease and Genotype 85/92 16/17 57/84 3/14 Placebo arm: 0% for each timepoint Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  10. Sofosbuvir + Ribavirin for HCV GT 2,3 (PEG not an option)POSITRON Trial: Conclusions *Note: This conclusion pertains to both the POSITRON and FUSION trials, which were published in tandem Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  11. 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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