Table 3.
Clinical Trial Baseline Demographics and Clinical Characteristics
| Parameter | All ABC‐exposed patientsa (N=3063) | ABC/DTG/3TC subpopulationb (N=1494) | ABC/3TC subpopulationc (N=1569) |
|---|---|---|---|
| Age, yrs, median (min, max) | 38.0 (18.0, 80.0) | 39.0 (18.0, 80.0) | 37.0 (18.0, 75.0) |
| Sex, n (%) | |||
| Female | 699 (22.8) | 454 (30.4) | 245 (15.6) |
| Male | 2364 (77.2) | 1040 (69.6) | 1324 (84.4) |
| Race, n (%) | |||
| White | 2105 (68.7) | 987 (66.1) | 1118 (71.3) |
| Nonwhite | 956 (31.2) | 505 (33.8) | 451 (28.7) |
| Missing | 2 (0.1) | 2 (0.1) | 0 |
| Geographic region, n (%) | |||
| Europed | 911 (29.7) | 416 (27.8) | 495 (31.5) |
| North Americae | 1881 (61.4) | 881 (59.0) | 1000 (63.7) |
| South Americaf | 38 (1.2) | 34 (2.3) | 4 (0.3) |
| Rest of worldg | 233 (7.6) | 163 (10.9) | 70 (4.5) |
| ART status, n (%) | |||
| Naive | 2345 (76.6) | 975 (65.3) | 1370 (87) |
| Experienced | 718 (23.4) | 519 (34.7) | 199 (13) |
| Baseline values, median (range) | |||
| HIV‐1 RNA PCR, log10 copies/ml | 4.36 (1.59–6.93) | 4.02 (1.59–6.66) | 4.64 (1.59–6.93) |
| CD4+ cell count, cells/mm3 | 363.0 (10.0–1831.0) | 411.0 (19.0–1831.0) | 313.0 (10.0–1196.0) |
| CDC classification of HIV, n (%) | |||
| A: Asymptomatic, lymphadenopathy, or acute HIV | 2408 (78.6) | 1132 (79.2) | 1225 (78.1) |
| B: Symptomatic, not AIDS | 415 (13.6) | 190 (12.7) | 225 (14.3) |
| C: AIDS | 240 (7.8) | 121 (8.1) | 119 (7.6) |
| HIV risk factor, n (%) | |||
| Hemophilia‐associated injections | 1 (0) | 1 (0.1) | 0 |
| Heterosexual contact | 960 (31.4) | 600 (40.2) | 360 (22.9) |
| Homosexual contact | 1828 (59.7) | 788 (52.7) | 1040 (66.3) |
| Injectable drug use | 71 (2.3) | 40 (2.7) | 31 (2.0) |
| Occupational exposure | 7 (0.2) | 2 (0.1) | 5 (0.3) |
| Transfusion | 6 (0.2) | 3 (0.2) | 3 (0.2) |
| Other | 89 (2.9) | 6 (0.4) | 83 (5.3) |
| Missing | 101 (3.3) | 54 (3.6) | 47 (3.0) |
ABC = abacavir; AIDS = acquired immunodeficiency syndrome; ART = antiretroviral therapy; CAB = cabotegravir; CDC = Centers for Disease Control and Prevention; DRV = darunavir; DTG = dolutegravir; EFV = efavirenz; HIV = human immunodeficiency virus; PCR = polymerase chain reaction; RAL = raltegravir; RTV = ritonavir; 3TC = lamivudine.
aPatients exposed to ABC/3TC or ABC/DTG/3TC.
bPatients exposed to ABC/DTG/3TC or DTG+ABC/3TC.
cPatients exposed to ABC/3TC in combination with a non‐DTG anchor drug that was ATV+RTV, CAB, DRV+RTV, EFV, or RAL.
dEurope designated countries: Austria, Belgium, Denmark, France, Germany, Ireland, Italy, Latvia, Netherlands, Portugal, Romania, Spain, Switzerland, United Kingdom.
eNorth America designated countries: Canada, United States of America.
fSouth America designated countries: Argentina, Mexico, Puerto Rico.
gRest of world designated countries: Australia, Russia, South Africa, Thailand.