Table 1.
Maternal baseline characteristics by randomized group
| DTG+FTC/TAF | DTG+FTC/TDF | EFV/FTC/TDF | Total | |
|---|---|---|---|---|
| (N = 217) | (N = 215) | (N = 211) | (N = 643) | |
| Age (median years, range) | 26·8 (18·1–44·5) | 26·0 (18·1–44·0) | 26·6 (18·3–42·7) | 26·6 (18·1–44·5) |
| Country | ||||
| Zimbabwe | 82 (37·8%) | 84 (39·1%) | 83 (39·3%) | 249 (38·7%) |
| South Africa | 37 (17·1%) | 37 (17·2%) | 37 (17·5%) | 111 (17·3%) |
| Uganda | 37 (17·1%) | 37 (17·2%) | 36 (17·1%) | 110 (17·1%) |
| Brazil | 21 (9·7%) | 19 (8·8%) | 17 (8·1%) | 57 (8·9%) |
| Botswana | 16 (7·4%) | 18 (8·4%) | 17 (8·1%) | 51 (7·9%) |
| Tanzania | 15 (6·9%) | 13 (6·0%) | 15 (7·1%) | 43 (6·7%) |
| Thailand | 5 (2·3%) | 4 (1·9%) | 6 (2·8%) | 15 (2·3%) |
| United States | 2 (0·9%) | 2 (0·9%) | 0 (0·0%) | 4 (0·6%) |
| India | 2 (0·9%) | 1 (0·5%) | 0 (0·0%) | 3 (0·5%) |
| Race | ||||
| Black | 195 (89·9%) | 196 (91·2%) | 194 (91·9%) | 585 (91·0%) |
| Asian | 7 (3·2%) | 5 (2·3%) | 6 (2·8%) | 18 (2·8%) |
| White | 5 (2·3%) | 7 (3·3%) | 7 (3·3%) | 19 (3·0%) |
| Other | 10 (4·6%) | 6 (2·8%) | 4 (1·9%) | 20 (3·1%) |
| Unknown | 0 (0·0%) | 1 (0·5%) | 0 (0·0%) | 1 (0·2%) |
| Gestational age at study entry (median weeks, Q1, Q3) | 22·1 (18·4, 25·0) | 21·3 (18·1, 25·1) | 22·1 (18·3, 25·6) | 21·9 (18·3, 25·3) |
| Gestational age at study entry (categorized) | ||||
| 14–18 weeks | 58 (26·7%) | 64 (29·8%) | 59 (28·0%) | 181 (28·1%) |
| 19–23 weeks | 93 (42·9%) | 83 (38·6%) | 77 (36·5%) | 253 (39·3%) |
| 24–28 weeks | 66 (30·4%) | 68 (31·6%) | 75 (35·5%) | 209 (32·5%) |
| Hepatitis B surface antigen positive | 3 (1·4%) | 6 (2·8%) | 4 (1·9%) | 13 (2·0%) |
| Log10 HIV-1 RNA (median copies/mL, Q1, Q3) | 2·9 (2·2, 3·8) | 2·9 (2·1, 3·6) | 3·1 (2·3, 3·7) | 3·0 (2·2, 3·7) |
| HIV-1 RNA (median copies/mL, Q1, Q3) | 781·0 (147·0, 5,733·0) | 715·0 (128·0, 4,304·0) | 1,357·0 (198·0, 5,125·0) | 902·5 (152·0, 5,182·5) |
| HIV-1 RNA (copies/mL, categorized) | ||||
| <50 | 36 (16·7%) | 37 (17·3%) | 27 (13·0%) | 100 (15·7%) |
| <200 | 62 (28·7%) | 66 (30·7%) | 53 (25·4%) | 181 (28·3%) |
| CD4 (median cells/uL, Q1, Q3) | 467 (324, 624) | 481 (332, 642) | 439 (300, 616) | 466 (308, 624) |
| CD4 (cells/uL, categorized) | ||||
| <50 | 0 (0·0%) | 0 (0·0%) | 0 (0·0%) | 0 (0·0%) |
| 50-349 | 64 (29·8%) | 60 (27·9%) | 73 (35·1%) | 197 (30·9%) |
| 350-499 | 56 (26·0%) | 53 (24·7%) | 50 (24·0%) | 159 (24·9%) |
| 500-750 | 68 (31·6%) | 67 (31·2%) | 59 (28·4%) | 194 (30·4%) |
| > 750 | 27 (12·6%) | 34 (15·8%) | 26 (12·5%) | 87 (13·6%) |
| Weight (median kg, Q1, Q3) | 65·0 (56·7, 77·1) | 63·0 (56·3, 72·0) | 61·4 (55·4, 71·2) | 63·0 (56·2, 73·0) |
| BMI (median kg/cm2, Q1, Q3) | 25·1 (22·5, 29·4) | 24·5 (22·0, 28·1) | 24·3 (21·5, 28·3) | 24·7 (22·0, 28·4) |
| Creatinine Clearance (mean mL/min, SD) | 192·1 (59·6) | 186·6 (65·0) | 182·6 (56·2) | 187·2 (60·4) |
| Creatinine (mean mg/dL, SD) | 0·49 (0·09) | 0·49 (0·09) | 0·49 (0·10) | 0·49 (0·10) |
| Took prior TDF or (FTC/TDF) pre-exposure prophylaxis* | 1 (0·5%) | 2 (1·0%) | 0 (0·0%) | 3 (0·5%) |
| Received ART during a previous pregnancy / breastfeeding* | 1 (0·5%) | 0 (0·0%) | 1 (0·5%) | 2 (0·3%) |
| Received ART during current pregnancy prior to enrollment | 176 (81·1%) | 180 (83·7%) | 176 (83·4%) | 532 (82·7%) |
| Median # days of ART (range) | 6 (1–15) | 6 (1-14) | 6 (1-14) | 6 (1-15) |
| EFV/XTC/TDF** | 166 (76·5%) | 165 (76·7%) | 165 (78·2%) | 496 (77·1%) |
| DTG/XTC/TDF or TAF** | 7 (3·2%) | 8 (3·7%) | 6 (2·8%) | 21 (3·3%) |
| Other regimen | 3 (1·4%) | 7 (3·3%) | 5 (1·4%) | 14 (2·2%) |
*
All 3 women took less than 1 week of pre-exposure prophylaxis.
**
XTC indicates either FTC or lamivudine (3TC).