Table 4 First Generation INSTIs: Virologic Outcomes at Week 48 (FDA Snapshot)
|  | STARTMRK | ONCEMRK | GS-US-236–0102 | GS-US-236–0103 | GS-US-292–0104/0111 | |||||
|---|---|---|---|---|---|---|---|---|---|---|
RAL + FTC/TDF n = 281 | EFV + TDF/ FTC n = 282 | RAL 1200 QD + TDF/ FTC n = 531 | RAL 400 BID + TDF/ FTC n = 266 | EVG/ COBI/ FTC/ TDF n = 348 | EFV/FTC/TDF n = 352 | EVG/ COBI/ FTC/ TDF n = 353 | ATV/RTV + FTC/ TDF n = 355 | EVG/ COBI/ FTC/ TAF n = 866 | EVG/ COBI/ FTC/ TDF n = 867 | |
HIV- 1 RNA < 50 copies/mL | 241 (86.1%) | 230 (81.9%) | 472 (89%)a | 235 (88%)a | 305 (87.6%) | 296 (84.1%) | 316 (89.5%) | 308 (86.8%) | 800 (92%) | 784 (90%) |
Difference, % (95% CI) | 4.2 (−1.9, 10.3) | −0.5 (−4.2, 5.2) | 3.6 (−1.6, 8.8) | 3.0 (−1.9, 7.8) | 2.0 (−0.7, 4.7) | |||||
HIV- 1 RNA ≥ 50 copies/mL | 27 (9.6%) | 39 (13.8%) | 29 (5%) | 16 (6%) | 25 (7.2%) | 25 (7.1%) | 19 (5.4%) | 19 (5.4%) | – | – |
No virologic data | – | – | 30 (6%) | 15 (6%) | 18 (5.2%) | 31 (8.8%) | 18 (5.1%) | 28 (7.9%) | 34 (4%) | 52 (6%) |
INSTI resistance mutations detected | E92Q + L74L/M + T97T/A + Y143Y/H; G140S + Q148H/R; Y143R | None | E92Q + L74M; N155H; N155H + V151I; N155H + I203M | None | E92Q; N155H; Q148R; T66I | None | E92Q + N155H + T66I; N155H; Q148R | None | E92Q N155H Q148R + T66I/A T66A | E92Q E92Q + Q148R Q148R |
References | [90] | [63] | [91] | [11] | [65] | |||||