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Sofosbuvir-Velpatasvir in Genotype 3 ASTRAL-3

Phase 3. Treatment Naïve & Experienced. Sofosbuvir-Velpatasvir in Genotype 3 ASTRAL-3. *Published in tandem with ASTRAL-2 Trial. Foster GR, et al. N Engl J Med. 2015 ;373:2608-17. Sofosbuvir-Velpatasvir in HCV Genotype 3 ASTRAL-3: Study Features.

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Sofosbuvir-Velpatasvir in Genotype 3 ASTRAL-3

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  1. Phase 3 TreatmentNaïve & Experienced Sofosbuvir-Velpatasvir in Genotype 3ASTRAL-3 *Published in tandem with ASTRAL-2 Trial Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  2. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Study Features Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  3. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Study Design 0 12 24 36 Week Treatment-naïve or experienced GT 3 (N=552) SOF-VEL N=277 SVR12 SOF + RBV N=275 SVR12 *Randomization stratified by treatment experience and cirrhosis status. Abbreviations: SOF-VEL = sofosbuvir-velpatasvir; RBV = ribavirin Drug DosingSofosbuvir-velpatasvir (400/100 mg): fixed-dose combination; one pill once dailySofosbuvir: 400 mg once dailyRibavirin (weight-based and divided bid): 1000 mg/day if < 75 kg or 1200 mg/day if ≥ 75 kg Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  4. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Baseline Characteristics Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  5. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Results ASTRAL-3: SVR12 Results 264/277 221/275 264/277 221/275 P<0.001 for superiority of Sofosbuvir-Velpatasvir compared with Sofosbuvir + Ribavirin Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  6. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Results ASTRAL-3: SVR12 Results by Cirrhosis & Treatment Experience 160/163 141/156 40/43 33/45 31/34 22/31 33/37 22/38 Treatment Naïve Treatment-Experienced Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  7. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Resistance Baseline NS5A Resistance-Associated Variants and SVR12 Total, n=274 100 97% SVR12 90 88% SVR12 80 84% No BL NS5A RAVs N=231 70 60 16% BLNS5A RAVs N=43 SVR12 (%) 50 40 30 20 10 38/43 225/231 0 • SVR12 was 84% (21/25) in patients with Y93H Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  8. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Adverse Events Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

  9. Sofosbuvir-Velpatasvir in HCV Genotype 3ASTRAL-3: Conclusions Source: Foster GR, et al. N Engl J Med. 2015;373:2608-17.

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