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Phase 3. Treatment Naïve. Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1 ION-1. Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1 ION-1 Study: Features.
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Phase 3 TreatmentNaïve Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1ION-1 Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Features Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Baseline Characteristics Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Study Design 0 12 24 36 Week n =214 SVR12 GT-1Naive LDV-SOF n =217 SVR12 LDV-SOF + RBV n =217 SVR12 GT-1Naive LDV-SOF n =217 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;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Results ION-1: SVR 12 by Treatment Duration and Regimen 211/214 211/217 212/217 215/217 12-Week Regimen 24-Week Regimen LDV= ledipasvir; SOF = sofosbuvir; RBV = ribavirin Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Results ION-1: SVR12 by Treatment Regimen and Liver Disease 179/179 32/33 178/178 33/33 181/182 31/32 179/179 36/36 12-Week Treatment 24-Week Treatment Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Conclusions Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.
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.