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Sofosbuvir-Velpatasvir- Voxilaprevir in DAA-Experienced GT 1-6 POLARIS- 4

Phase 3. Treatment Experienced. Sofosbuvir-Velpatasvir- Voxilaprevir in DAA-Experienced GT 1-6 POLARIS- 4. Bourlière M, et al . N Engl J Med. 2017;376:2134-46. Sofosbuvir-Velpatasvir- Voxilaprevir in DAA-Experienced GT 1-6 POLARIS -4: Study Features.

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Sofosbuvir-Velpatasvir- Voxilaprevir in DAA-Experienced GT 1-6 POLARIS- 4

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  1. Phase 3 Treatment Experienced Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6 POLARIS-4 BourlièreM, et al. N Engl J Med. 2017;376:2134-46.

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

  3. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Study Study Design 0 12 24 Week GT 1-6 with prior DAA experience (no NS5A inhibitor) n = 333 Sofosbuvir-Velpatasvir- Voxilaprevir N=182 SVR12 Sofosbuvir-Velpatasvir N=151 SVR12 GT 1, 2, 3 patients randomized 1:1. Stratified by presence of cirrhosis.Genotypes 4 were assigned to active arm (and not randomized). No GT 5, 6 patients were enrolled. Drug DosingSofosbuvir-Velpatasvir-Voxilaprevir (400/100/100 mg): fixed dose combination; one pill once dailySofosbuvir-Velpatasvir (400/100 mg): fixed dose combination; one pill once daily Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  4. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-3POLARIS-4: Baseline Characteristics Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  5. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-3POLARIS-4: Prior HCV Treatment NS5B NS5B + NS3 Other Other NS5B included mericitabine (n=7); other NS5B+NS3 included deleobuvir+faldaprevir(n=14), mercitabine+danoprevir (n=8), and SOF+telaprevir (n=6); one patient without prior DAA exposure is excluded. Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  6. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Results POLARIS-4: Overall SVR12 by Treatment Arm 177/182 136/151 P<0.001 for superiority compared with prespecified 85% performance goal for SOF-VEL-VOX Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  7. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Results POLARIS-4: Overall SVR12 by Treatment Arm 1 Relapse 1 Death 1 Lost to follow-up 1 Breakthrough 14 Relapses 177/182 136/151 P<0.001 for superiority compared with prespecified 85% performance goal for SOF-VEL-VOX Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  8. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Results POLARIS-4: SVR12 by Genotype 53/54 39/44 23/24 21/22 31/31 32/33 51/54 44/52 19/19 0/0 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  9. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Results POLARIS-4: SVR12 by Cirrhosis Status 96/98 82/84 77/82 59/69 Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  10. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-6POLARIS-4: Results POLARIS-4: Overall SVR by Baseline RAS 84/89 67/75 83/83 63/70 39/39 29/32 40/40 32/34 4/4 2/4 N=22 patients had NS5B RASs – all went on to achieve SVR12. No treatment-emergent RASs noted in the viral relapser on SOF/VEL/VOX.In SOF/VEL group, 10/15 developed Y93H or Y93C. Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  11. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-3POLARIS-4: Adverse Events Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

  12. Sofosbuvir-Velpatasvir-Voxilaprevir in DAA-Experienced GT 1-3POLARIS-1 and POLARIS-4: Conclusions Source: Bourlière M, et al. N Engl J Med. 2017;376:2134-46.

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