Table 3.
Virologic outcome at Week 24 and 48 according to the FDA Snapshot* analysis in the overall population
| Week 24 | Week 48 | |||||
|---|---|---|---|---|---|---|
| Outcomes, [n (%)] | VL ≤100 K HIV-1 | VL >100 K HIV-1 | VL ≤100 K HIV-1 | VL >100 K HIV-1 | ||
| Total | RNA copies/ml | RNA copies/ml | Total | RNA copies/ml | RNA copies/ml | |
| n = 313 | n = 182 | n = 131 | n = 313 | n = 182 | n = 131 | |
| Virologic response | 258 (82) | 157 (86) | 101 (77) | 253 (81) | 148 (81) | 105 (80) |
| Virologic failure | 36 (12) | 10 (5) | 26 (20) | 33 (11) | 14 (8) | 19 (15) |
| VL ≥50 HIV-1 RNA copies/ml | 22 (7) | 4 (2) | 18 (14) | 14 (4) | 5 (3) | 9 (7) |
| Discontinued drug due to lack of efficacy | 0 | 0 | 0 | 0 | 0 | 0 |
| Discontinued drug due to other reasons and last available VL ≥50 HIV-1 RNA copies/ml | 14 (4) | 6 (3) | 8 (6) | 19 (6) | 9 (5) | 10 (8) |
| No virologic data in the analysis window | 19 (6) | 15 (8) | 4 (3) | 27 (9) | 20 (11) | 7 (5) |
| Discontinued drug to AE | 14 (4) | 12 (7) | 2 (2) | 15 (5) | 13 (7) | 2 (2) |
| Discontinued drug for other reason and last VL <50 HIV-1 RNA copies/ml | 3 (1) | 2 (1) | 1 (1) | 10 (3) | 5 (3) | 5 (4) |
| Missing data during window but on drug | 2 (1) | 1 (1) | 1 (1) | 2 (1) | 2 (1) | 0 |
*Proportion of patients with VL <50 HIV-1 RNA copies/ml during Week 24 or Week 48 window; N number of patients; n number of patients with observations; AE adverse event, VL viral load.