Outcome, n (%)a | GEMINI-1/-2 (pooled analysis) | GS-US-380-1489 | GS-US-380-1490 | |||
---|---|---|---|---|---|---|
DTG + 3TC (N = 716) | DTG + TDF/FTC (N = 717) | BIC/FTC/TAF (N = 314) | DTG/ABC/3TC (N = 315) | DTG + TAF/FTC (N = 325) | BIC/FTC/TAF (N = 320) | |
HIV-1 RNA < 50 copies/mLb | 584 (81.6) | 599 (83.5) | 256 (81.5) | 265 (84.1) | 273 (84.0) | 262 (81.9) |
HIV-1 RNA ≥ 50 copies/mLb | 23 (3.2) | 21 (2.9) | 2 (0.6) | 9 (2.9) | 10 (3.1) | 15 (4.7) |
Change in CD4 + cell count from baseline, mean (SD), cells/µL | 300 (203.5) | 298 (227.1) | 299 (224.9) | 317 (219.5) | 289 (218.5) | 278 (236.6) |
Discontinuations | 134 (18.7) | 123 (17.2) | 54 (17.2) | 48 (15.2) | 47 (14.5) | 59 (18.4) |
AEs | 613 (85.6) | 625 (87.2) | 300 (95.5) | 304 (96.5) | 300 (92.3) | 291 (90.9) |
Grade 3–4 AEs | 83 (11.6) | 88 (12.3) | 50 (15.9) | 50 (15.9) | 43 (13.2) | 54 (16.9) |
Serious AEs | 76 (10.6) | 85 (11.9) | 41 (13.1) | 53 (16.8) | 40 (12.3) | 63 (19.7) |
Drug-related AEs | 146 (20.4) | 192 (26.8) | 94 (29.9) | 132 (41.9) | 95 (29.2) | 71 (22.2) |
Discontinuations due to AEs | 24 (3.4) | 25 (3.5) | 0 (0) | 5 (1.6) | 6 (1.8) | 6 (1.9) |