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Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1

Phase 3. Treatment Naïve & Experienced. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1. Feld JJ, et al. N Engl J Med. 2015 ;373:2599-607. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1: Study Features.

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Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6 ASTRAL-1

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  1. Phase 3 TreatmentNaïve & Experienced Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1 Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  2. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Study Features Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  3. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Study Design 0 12 24 Week Treatment-naïve or experienced GT 1, 2, 4, 5* or 6 (N=740) Sofosbuvir-Velpatasvir N=624 SVR12 Placebo N=116 SVR12 Randomized 5:1 ratio for treatment to placebo. Stratified by cirrhosis and HCV genotype.*Genotype 5 patients (n=6) were assigned to active arm (and not randomized)Placebo recipients were eligible for deferred treatment with sofosbuvir-velpatasvir Drug DosingSofosbuvir-Velpatasvir (400/100 mg): fixed dose combination; one pill once daily Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  4. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Baseline Characteristics Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  5. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Baseline Characteristics Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  6. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Results ASTRAL-1: SVR12 Results by Genotype 618/624 206/210 117/118 104/104 116/116 34/35 41/41 Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  7. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Results ASTRAL-1: SVR12 Results by Genotype 1 Relapse 2 Lost to follow-up 1 Withdrew consent 1 Relapse 1 Death 618/624 206/210 117/118 104/104 116/116 34/35 41/41 Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  8. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Results ASTRAL-1: SVR12 Results by Cirrhosis & Treatment Experience 618/624 496/501 120/121 418/423 200/201 Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  9. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Resistance Baseline NS5A Resistance-Associated Variants and SVR12 Total, n=616 100 100% SVR12 99% SVR12 90 80 70 58% No NS5A RAVs N=359 42% NS5A RAVs N=257 60 SVR12 (%) 50 40 30 20 10 255/257 359/359 0 83/86 58/65 24/25 104/104 Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607. 9

  10. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Adverse Events Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

  11. Sofosbuvir-Velpatasvir in HCV Genotype 1, 2, 4, 5, or 6ASTRAL-1: Conclusion Source: Feld JJ, et al. N Engl J Med. 2015;373:2599-607.

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