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Sofosbuvir-Velpatasvir- Voxilaprevir in NS5A-Experienced GT 1-6 POLARIS-1

Phase 3. Treatment Experienced. Sofosbuvir-Velpatasvir- Voxilaprevir in NS5A-Experienced GT 1-6 POLARIS-1. Bourlière M, et al . N Engl J Med. 2017;376:2134-46. Sofosbuvir-Velpatasvir- Voxilaprevir in NS5A-Experienced GT 1-6 POLARIS-1: Study Features.

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Sofosbuvir-Velpatasvir- Voxilaprevir in NS5A-Experienced GT 1-6 POLARIS-1

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  1. Phase 3 Treatment Experienced Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-Experienced GT 1-6 POLARIS-1 BourlièreM, et al. N Engl J Med. 2017;376:2134-46.

  2. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Study Features Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  3. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Study Design 0 12 24 Week GT 1-6 with NS5A inhibitor experience* n = 415 Sofosbuvir-Velpatasvir- Voxilaprevir N=263 SVR12 Placebo N=152 SVR12 • GT 1 patients randomized 2:1 ratio (active:placebo). Stratified by presence of cirrhosis (target ≥30%). • Genotypes 2-6 were assigned to active arm (and not randomized). • Placebo recipients were eligible for deferred treatment with sofosbuvir-velpatasvir-voxilaprevir Drug DosingSofosbuvir-Velpatasvir-Voxilaprevir (400/100/100 mg): fixed dose combination; one pill once dailyPlacebo: one pill once daily Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  4. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-Experienced GT 1-6POLARIS-1:Baseline Characteristics Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  5. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Prior NS5A Treatment 133/263 70/263 30/263 33/263 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  6. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Results POLARIS-1: SVR12 Results by Genotype 97/101 45/45 5/5 74/78 20/22 1/1 6/6 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  7. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Results POLARIS-1: SVR 12 by Cirrhosis Status 253/263 140/142 113/121 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  8. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Results POLARIS-1: SVR 12 by Cirrhosis Status 6 Relapses 1 On-treatment failure 2 Withdrew consent 1 Lost to follow-up 6 Relapses 1 On-treatment failure 1 Withdrew consent 1 Withdrew consent 1 Lost to follow-up 253/263 140/142 113/121 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  9. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Results POLARIS-1: SVR12 by Baseline Resistance-Associated Substitutions (RAS) 9/9 70/72 42/43 120/124 199/205 2/2 83% of patients had baseline resistance-associated substitutions (RASs); 79% had NS5A RASs. None who relapsed had treatment-emergent RASs. Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  10. Sofosbuvir-Velpatasvir-Voxilaprevir in NS5A-ExperiencedGT 1-6POLARIS-1: Adverse Events Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  11. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-1 and POLARIS-4: Conclusions Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

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