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

This study evaluates the efficacy of Ledipasvir-Sofosbuvir ± Ribavirin in treatment-naive patients with HCV genotype 1. The results show high rates of sustained virologic response (SVR) with different treatment durations and regimens. Resistance data and conclusions are also presented.

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

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  1. Phase 3 TreatmentNaïve Ledipasvir-Sofosbuvir +/- Ribavirin in HCV Genotype 1ION-1 Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.

  2. 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.

  3. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Study Design 0 12 24 36 Week GT-1Naive n =214 SVR12 LDV-SOF n =217 SVR12 LDV-SOF + RBV n =217 SVR12 GT-1Naive LDV-SOF n =217 SVR12 LDV-SOF + RBV Abbreviations: LDV-SOF= ledipasvir-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: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.

  4. 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.

  5. 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 Abbreviations: LDV-SOF= ledipasvir-sofosbuvir; RBV = ribavirin*Primary end-point by intention-to-treat analysis Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.

  6. 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 Note: subgroup results do not include patients who withdrew consent or were lost to follow-up Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.

  7. Ledipasvir-Sofosbuvir +/- Ribavirin in Treatment-Naïve HCV GT 1ION-1 Study: Resistance Data • NS5A resistant variants- Baseline resistance in 140 (16%) of 861 patients tested- SVR12 in 135 (96%) of 140 patients with NS5A resistance- 2 of the 3 patients with virologic failure had baseline NS5A resistance Source: Afdhal N, et al. N Engl J Med. 2014;370:1889-98.

  8. 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.

  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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