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Glecaprevir - Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3 ENDURANCE-3

Phase 3. Treatment-Naïve. Glecaprevir - Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3 ENDURANCE-3. Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69. Glecaprevir - Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3 ENDURANCE-3: Study Features.

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Glecaprevir - Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3 ENDURANCE-3

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  1. Phase 3 Treatment-Naïve Glecaprevir-Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3ENDURANCE-3 Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  2. Glecaprevir-Pibrentasvir in Treatment-Naïve, Non-Cirrhotic GT 3ENDURANCE-3: Study Features Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  3. Glecaprevir-Pibrentasvir in Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3: Study Design 0 8 12 20 24 Week GLE-PIB GT-3 Naïve Non-cirrhotic n =233 SVR12 SOF + DCV n =115 SVR12 GLE-PIB n =157 SVR12 348 patients were randomized in 2:1 ratio to 12 weeks of GLE-PIB vs SOF + DCV. 157 were not randomized but assigned to 8 weeks of GLE-PIB. Abbreviations: GLE-PIB = glecaprevir-pibrentasvir; SOF = sofosbuvir; DCV = daclatasvir Drug DosingGlecaprevir-pibrentasvir: 300/120 mg once dailySofosbuvir 400 mgonce dailyplus Daclatasvir 60 mgonce daily Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  4. Glecaprevir-Pibrentasvirin Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3: Baseline Characteristics GLE-PIB= glecaprevir-pibrentasvir; SOF= sofosbuvir; DCV= daclatasvir; BMI = body mass index Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  5. Glecaprevir-Pibrentasvirin Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3 Study: Results ION-3: SVR 12 by Treatment Duration and Regimen (ITT Analysis) 111/115 149/157 222/233 12-Week Regimens 8-Week Regimen GLE-PIB = glecaprevir-pibrentasvir; SOF = sofosbuvir; DCV= daclatasvir ITT = Intent-to-treat Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  6. Glecaprevir-Pibrentasvirin Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3: Treatment Outcomes SVR = Sustained virologic response; GLE-PIB= glecaprevir-pibrentasvir; SOF= sofosbuvir; DCV= daclatasvir Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  7. Glecaprevir-Pibrentasvirin Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3: Resistance Analysis *Detected at 15% threshold by next-generation sequencing in samples that had sequences available at a key subset of amino acid positions: NS3: 36, 55, 56, 80, 155, 156, 166, 168; NS5A at 24, 28, 29, 30, 31, 32, 58, 92, 93 GLE-PIB= glecaprevir-pibrentasvir; SOF= sofosbuvir; DCV= daclatasvir Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  8. Glecaprevir-Pibrentasvirin Treatment-Naïve Non-Cirrhotic GT 3ENDURANCE-3: Adverse Events Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  9. Glecaprevir-Pibrentasvir for 8 or 12 weeks in Non-Cirrhotic GT 1*ENDURANCE-3: Conclusions *Note: ENDURANCE-3 was published in conjunction with ENDURANCE-1 Source: Zeuzem S, et al. N Engl J Med. 2018;378:354-69.

  10. 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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