Table 1.
Registration Trials of sofosbuvir (SOF)/velpatasvir (VEL)/voxilaprevir (VOX)
| Trial | POLARIS 1 | POLARIS 4 |
|---|---|---|
| Participants | 263 vs. 152 (placebo arm) | 333 (182 vs. 151) |
| Design | SOF/VEL/VOX vs. placebo | SOF/VEL/VOX vs. SOF/VEL |
| Duration | 12 weeks | 12 weeks |
| Genotypes | 1–6 | 1–4 |
| Compensated cirrhosis | 121 (46%)* in the active arm | 153 (46%) |
| Previous DAA experience | -NS5A inhibitor+NS3 inhibitor±NS5B inhibitor: 83 (32%) | -NS5B inhibitor+NS3 inhibitor 46 (25%) |
| -NS5A inhibitor+NS5B inhibitor 161 (61%) | -NS5B inhibitor 134 (74%) | |
| -NS5A inhibitor 18 (7%) | ||
| -SOF/VEL/VOX arm* | ||
| Overall SVR12 rate | 96% (253/263) | 98% (178/182) vs. 90% (136/151) |
| SVR per single GT | GT1 97% (146/150) | GT1a 98% (53/54) |
| GT1a 96% (97/101) | GT1b 96% (23/24) | |
| GT1b 100% (45/45) | GT2 100% (31/31) | |
| GT2 5/5 | GT3 96% (52/54) | |
| GT3 95% (74/78) | GT4 100% (19/19) | |
| GT4 91% (20/22) | ||
| GT5 1/1 | SOF/VEL/VOX arm* | |
| GT6 6/6 |
DAA, direct acting antiviral; SVR12, sustained virological response (SVR) at week 12; GT, genotype.
*
SOF/VEL/VOX Arm as written on the right.