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Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1 ION-3

Phase 3. Treatment Naïve. Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1 ION-3. Source: Kowdley K, et al. N Engl J Med. 2014;370:1879-88. Le dipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1 ION-3 Study: Features.

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Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1 ION-3

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  1. Phase 3 TreatmentNaïve Ledipasvir-Sofosbuvir for 8 or 12 weeks in HCV GT1ION-3 Source: Kowdley K, et al. N Engl J Med. 2014;370:1879-88.

  2. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Features Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  3. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Study Design 0 8 12 20 24 Week SVR12 n =215 GT-1 Naïve Non-cirrhotic LDV-SOF n =216 SVR12 LDV-SOF + RBV GT-1Naive n =216 SVR12 LDV-SOF Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Drug DosingLedipasvir-sofosbuvir (90/400 mg): fixed dose combination; one pill once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  4. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Baseline Characteristics Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  5. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Results ION-3: SVR 12* by Treatment Duration and Regimen 201/216 206/216 202/215 8-Week Regimen 12-Week Regimen Abbreviations: LDV-SOF= ledipasvir-sofosbuvir; RBV = ribavirin*Primary end-point by intention-to-treat analysis Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  6. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Results Source: Harvoni Prescribing Information. Gilead Sciences

  7. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Resistance Data • NS5B S282T variant (reduces susceptibility to sofosbuvir) - Not observed in any patients at baseline or after treatment by deep sequencing • NS5A resistant variants- Baseline resistance in 116 (18%) of 647 patients- SVR12 in 104 (90%) of 116 patients with NS5A resistance- Of the 23 patients who had viral relapse, 15 (65%) had NS5A-resistant variants at time of relapse Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  8. Ledipasvir-Sofosbuvir for 8 or 12 Weeks in Treatment-Naïve HCV GT 1ION-3 Study: Conclusions Source: Kowdley, K, et al. N Engl J Med. 2014;370:1879-88.

  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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