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Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2

Phase 3. Treatment Experienced. Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2. Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV GT 1 ION-2 Study: Features.

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Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-2

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  1. Phase 3 TreatmentExperienced Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1ION-2 Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  2. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV GT 1ION-2 Study: Features Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  3. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV GT 1ION-2 Study: Study Design 0 12 24 36 Week n =109 SVR12 GT-1Experienced LDV-SOF n =111 SVR12 LDV-SOF + RBV n =109 SVR12 GT-1Experienced LDV-SOF n =111 SVR12 LDV-SOF + RBV 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 N =14 Abbreviations: LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  4. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV GT 1ION-2 Study: Baseline Characteristics Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  5. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-experienced HCV GT 1ION-2 Study: Results ION-2: SVR 12by Treatment Duration and Regimen 102/109 107/111 108/109 110/111 12-Week Regimen 24-Week Regimen LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  6. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-experienced HCV GT 1ION-2 Study: Results ION-2: SVR12 by Treatment Regimen and Liver Disease 83/87 19/22 89/89 18/22 86/87 22/22 88/89 22/22 12-Week Treatment 24-Week Treatment Source: Jacobson I, et al. N Engl J Med. 2013;368:1867-77.

  7. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-experienced HCV GT 1ION-2 Study: Resistance Data • S282T variants - No resistance detected at baseline • NS5A resistant variants- Baseline resistance in 62 (14%) of 439 patients tested- SVR12 in 55 (89%) of 62 patients with resistance • NS3/4A resistant variants- Baseline resistance in 163 (71%) of 228 patients tested- SVR12 in 159 (98%) of 228 patients with resistance Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  8. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Experienced HCV GT 1ION-2 Study: Conclusions Source: Afdhal N, et al. N Engl J Med. 2014;370:1483-93.

  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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