Table 1.
Demographics and Baseline Characteristics by Availability of Historical Resistance Results at Screening and Overall: TANGO and SALSA Pooled ITT-E Population
| No Historical Resistance Results at Screening | Historical Resistance Results at Screening | Overall | ||||
|---|---|---|---|---|---|---|
| Parameter | DTG/3TC (n = 294) | CAR (n = 277) | DTG/3TC (n = 321) | CAR (n = 342) | DTG/3TC (n = 615) | CAR (n = 619) |
| Age, y | 42 (20–74) | 43 (20–83) | 42 (22–74) | 41 (18–73) | 42 (20–74) | 42 (18–83) |
| ≥50 y | 80 (27) | 85 (31) | 97 (30) | 102 (30) | 177 (29) | 187 (30) |
| Sex: female | 82 (28) | 76 (27) | 51 (16) | 41 (12) | 133 (22) | 117 (19) |
| Race | ||||||
| White | 201 (68) | 178 (64) | 244 (76) | 255 (75) | 445 (72) | 433 (70) |
| Black | 45 (15) | 48 (17) | 51 (16) | 58 (17) | 96 (16) | 106 (17) |
| Asian | 30 (10) | 34 (12) | 14 (4) | 18 (5) | 44 (7) | 52 (8) |
| Other racesa | 18 (6) | 17 (6) | 12 (4) | 11 (3) | 30 (5) | 28 (5) |
| Ethnicity | ||||||
| Hispanic/Latinx | 75 (26) | 71 (26) | 59 (18) | 50 (15) | 134 (22) | 121 (20) |
| Not Hispanic/Latinx | 219 (74) | 206 (74) | 262 (82) | 292 (85) | 481 (78) | 498 (80) |
| CD4+ cell count, cells/mm3 | 685 (154–2089) | 675 (94–1954) | 666 (133–1678) | 686 (122–1810) | 680 (133–2089) | 684 (94–1954) |
| <350 | 28 (10) | 23 (8) | 28 (9) | 24 (7) | 56 (9) | 47 (8) |
| ≥350 | 266 (90) | 254 (92) | 292 (91) | 318 (93) | 558 (91) | 572 (92) |
| CD4+/CD8+ ratio | 1.0 (0–3) | 1.0 (0–3) | 0.9 (0–4) | 1.0 (0–3) | 1.0 (0–4) | 1.0 (0–3) |
| Duration of ART before day 1, mo | 44 (7–240) | 47 (7–253) | 38 (4–233) | 44 (7–188) | 41 (4–240) | 45 (7–253) |
| Baseline third agent classb | ||||||
| INSTI | 154 (52) | 148 (53) | 233 (73) | 246 (72) | 387 (63) | 394 (64) |
| NNRTI | 113 (38) | 112 (40) | 61 (19) | 60 (18) | 174 (28) | 172 (28) |
| Protease inhibitor | 27 (9) | 17 (6) | 27 (8) | 36 (11) | 54 (9) | 53 (9) |
Data are presented as median (range) or No. (%).
Abbreviations: ART, antiretroviral regimen; CAR, current antiretroviral regimen; DTG/3TC, dolutegravir/lamivudine; INSTI, integrase strand transfer inhibitor; ITT-E, intention-to-treat exposed; NNRTI, nonnucleoside reverse transcriptase inhibitor.
aIncludes American Indian or Alaska Native, Native Hawaiian or other Pacific Islander, mixed White race, and individuals of multiple races.
bDue to rounding, total percentage might not equal 100%.