| Abstract P056 – Table 1. Efficacy results at week 48 from the GEMINI‐1/‐2 and STAT studies by baseline viral load: ITT‐E populations. | ||||||||
|---|---|---|---|---|---|---|---|---|
| ≤100 000 copies/mL | >100 000 to ≤500 000 copies/mL | >500 000 to ≤1 000 000 copies/mL | >1 000 000 copies/mL | |||||
| DTG + 3TC | DTG + TDF/FTC | DTG + 3TC | DTG + TDF/FTC | DTG + 3TC | DTG + TDF/FTC | DTG + 3TC | DTG + TDF/FTC | |
| GEMINI‐1/‐2 | (N = 576) | (N = 564) | (N = 127) | (N = 138) | (N = 11) | (N = 14) | (N = 2) | (N = 1) |
| HIV‐1 RNA <50 copies/mL | 526 (91) | 531 (94) | 118 (93) | 126 (91) | 10 (91) | 11 (79) | 1 (50)a | 1 (100) |
| HIV‐1 RNA ≥50 copies/mL | 15 (3) | 9 (2) | 5 (4) | 3 (2) | 0 | 1 (7) | 0 | 0 |
| CD4+ cell count, cells/mm3 | ||||||||
| Baseline, mean (SD) | 488.0 | 484.8 | 364.2 | 387.4 | 289.2 | 276.1 | 142.0 | 27 |
| (219.6) | (213.7) | (186.2) | (185.2) | (98.7) | (166.6) | (169.7) | (NC) | |
| Change from baseline, mean (SD) [n] | 218.0 | 210.9 | 247.2 | 237.3 | 242.0 | 278.3 | NR [n = 1] | NR [n = 1] |
| (178.5) | (195.0) | (144.0) | (173.2) | (92.9) | (143.9) | |||
| [530] | [535] | [120] | [126] | [10] | [12] | |||
| ≤100 000 copies/mL | >100 000 to ≤500 000 copies/mL | >500 000 to ≤1 000 000 copies/mL | >1 000 000 copies/mL | |||||
| DTG/3TC | DTG/3TC | DTG/3TC | DTG/3TC | |||||
| STAT | (N = 79) | (N = 32) | (N = 9) | (N = 10) | ||||
| HIV‐1 RNA <50 copies/mL | 60 (76) | 23 (72) | 8 (89) | 8 (80) | ||||
| HIV‐1 RNA ≥50 copies/mLb | 8 (10) | 8 (25) | 1 (11) | 2 (20) | ||||
| CD4+ cell count, cells/mm3 | ||||||||
| Baseline, mean (SD) | 505.3 (302.6) | 266.3 (169.9) | 105.3 (102.2) | 388.9 (221.9) | ||||
| Change from baseline, mean (SD) [n] | 239.4 (219.9) [60] | 260.5 (153.9) [26] | 290.4 (183.8) [8] | 539.5 (333.2) [8] | ||||
aThe other participant withdrew from the study due to physician decision and had no virologic data at week 48;
bnon‐suppression at week 48 driven by study withdrawals (n = 6) and ART modifications (n = 10); three participants had data in window and HIV‐1 RNA ≥50 copies/mL (all in the >100 000 to ≤500 000 copies/mL VL category).