Table 1.
Baseline Demographics and Clinical Characteristics in the ITT-E Population
| Characteristics | DTG/3TC (n = 246) | CAR (n = 247) | Overall (N = 493) |
|---|---|---|---|
| Age | |||
| Median (range), y | 45 (22–74) | 45 (23–83) | 45 (22–83) |
| Age ≥50 years, n (%) | 98 (40) | 95 (38) | 193 (39) |
| Female, n (%) | 108 (44) | 84 (34) | 192 (39) |
| Race, n (%) | |||
| African American/African heritage | 45 (18) | 48 (19) | 93 (19) |
| Asian | 31 (13) | 39 (16) | 70 (14) |
| White | 149 (61) | 144 (58) | 293 (59) |
| Other racesa | 21 (9) | 16 (6) | 37 (8) |
| CD4+ cell count, median (range), cells/mm3 | 675 (154–2089) | 668 (94–1954) | 669 (94–2089) |
| CD4+ cell count, n (%) | |||
| <500 cells/mm3 | 60 (24) | 63 (26) | 123 (25) |
| ≥500 cells/mm3 | 185 (75) | 184 (74) | 369 (75) |
| Duration of ART before day 1, median (range), mo | 63 (4–240) | 71 (12–253) | … |
| Baseline third agent class received at screening, n (%) | |||
| NNRTI | 123 (50) | 124 (50) | 247 (50) |
| INSTI | 98 (40) | 98 (40) | 196 (40) |
| PI | 25 (10) | 25 (10) | 50 (10) |
| NNRTIs received at screening in ≥30% of participants | |||
| EFV | 79 (32) | 73 (30) | 152 (31) |
| INSTIs received at screening, n (%) | |||
| DTG | 45 (18) | 41 (17) | 86 (17) |
| EVG + COBI | 24 (10) | 27 (11) | 51 (10) |
| BIC | 24 (10) | 26 (11) | 50 (10) |
| RAL | 6 (2) | 4 (2) | 10 (2) |
| NRTIs received at screening in ≥30% of participants | |||
| FTC | 149 (61) | 156 (63) | 305 (62) |
| TDFb | 109 (44) | 109 (44) | 218 (44) |
| 3TC | 96 (39) | 89 (36) | 185 (38) |
| TAF | 83 (34) | 91 (37) | 174 (35) |
| Weight, median (range), kg | 73 (43–154) | 75 (36–160) | 74 (36–160) |
| BMI, median (range), kg/m2 | 25 (18–51) | 26 (14–69) | 25 (14–69) |
Abbreviations: ART, antiretroviral therapy; BIC, bictegravir; BMI, body mass index; CAR, current antiretroviral regimen; COBI, cobicistat; DTG, dolutegravir; EFV, efavirenz; EVG, elvitegravir; FTC, emtricitabine; INSTI, integrase strand transfer inhibitor; ITT-E, intention-to-treat–exposed; NNRTI, nonnucleoside reverse transcriptase inhibitor; NRTI, nucleoside reverse transcriptase inhibitor; PI, protease inhibitor; RAL, raltegravir; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate; 3TC, lamivudine.
aIncludes American Indian or Alaska Native or individuals of multiple races.
bIncludes tenofovir disoproxil succinate (DTG/3TC, n = 1; CAR, n = 3).