Table 6.
Second Generation INSTIs: Virologic Outcomes at Week 48 (FDA Snapshot)
| SPRING-2 | SINGLE | GEMINI-1 and -2 | GS-US-380–1489 | GS-US-380–1490 | FLAIR | ATLAS | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| DTG + 2 NRTIs n = 411 | RAL + 2 NRTIs n = 411 | DTG + ABC/ 3TC n = 414 | EFV/ FTC/ TDF n = 419 | DTG/ 3TC n = 716 | DTG + FTC/ TDF n = 717 | DTG/ABC/3TC n = 315 | BIC/ FTC/ TAF n = 314 | DTG + FTC/ TAF n = 325 | BIC/ FTC/ TAF n = 320 | CAB n = 283 | CAR n = 283 | CAB n = 308 | CAR n = 308 | |
| HIV-1 RNA < 50 copies/mL | 361 (88%) | 351 (85%) | 364 (88%) | 338 (81%) | 655 (91%) | 669 (93%) | 293 (93%) | 290 (92%) | 302 (93%) | 286 (89%) | 265 (94%) | 264 (93%) | 285 (93%) | 294 (95%) |
| Difference, % (95% CI) | 2.5 (−2.2, 7.1) | 7.4 (2.5, 12.3; P = 0.003) | −1.7 (−4.4, 1.1) | −0.6 (−4.8, 3.6; P = 0.78) | −3.5 (−7.9, 1; P = 0.12) | −0.4 (−2.8, 2.1) | 0.7 (−1.2, 2.5) | |||||||
| HIV-1 RNA ≥ 50 copies/mL | 8 (2%) | 5 (1%) | 6 (1%) | 5 (1%) | 8 (1%) | 5 (1%) | 8 (2.5%) | 3 (1%) | 4 (1%) | 14 (4%) | 6 (2%) | 7 (2%) | 5 (2%) | 3 (1%) |
| No virologic data | 30 (7%) | 29 (7%) | 29 (7%) | 55 (13%) | 41 (6%) | 35 (5%) | 14 (4%) | 21 (7%) | 19 (6%) | 20 (6%) | 12 (4%) | 12 (4%) | 18 (6%) | 11 (4%) |
| INSTI Resistance Mutations Detected | None | T97T/A, E138E/D, V151V/I, N155H | None | N/A | None | None | None | None | None | None | Q148R; G140R | None | N155H; N155H + R263K | None |
| Reference | [92] | [93] | [96] | [97] | [98] | [99] | [100] | |||||||
Dash (-) indicates that information was not reported in the study results
3TC lamivudine, ABC abacavir, ATV atazanavir, BIC bictegravir, CAR current antiretroviral regimen, CI confidence interval, COBI cobicistat; DTG dolutegravir, EFV efavirenz, EVG elvitegravir, FTC emtricitabine, NRTI nucleoside reverse transcriptase inhibitor, RTV ritonavir, RAL raltegravir, TAF tenofovir alafenamide, TDF tenofovir disoproxil fumarate