Table 1. Baseline Characteristics of 245 Included A5224s Study Participants.
| Variable | TDF/FTC
|
ABC/3TC
|
Total | ||
|---|---|---|---|---|---|
| EFV | ATV/r | EFV | ATV/r | ||
| n=65 | n=56 | n=64 | n=60 | n=245 | |
| Age, years | 40 (10) | 38 (10) | 39 (10) | 38 (10) | 39 (10) |
| Men | 55 (84%) | 48 (86%) | 51 (80%) | 54 (90%) | 208 (85%) |
| Race or ethnicity | |||||
| Black, non-Hispanic | 21 (32%) | 20 (36%) | 19 (30%) | 26 (43%) | 86 (35%) |
| White, non-Hispanic | 34 (52%) | 21 (38%) | 29 (45%) | 25 (42%) | 109 (44%) |
| Hispanic | 8 (12%) | 12 (21%) | 14 (22%) | 8 (13%) | 42 (17%) |
| Other | 2 (3%) | 3 (5%) | 2 (3%) | 1 (2%) | 8 (3%) |
| Weight, kg | 77 (16) | 80 (18) | 77 (15) | 78 (15) | 78 (16) |
| Body mass index, kg/m2 | 24.8 (4.1) | 26.1 (5.6) | 25.6 (4.8) | 25.5 (4.5) | 25.5 (4.7) |
| CD4 cell count, cells/μL | 248 (156) | 220 (149) | 230 (173) | 233 (182) | 233 (165) |
| HIV-RNA, log copies/mL* | 4.6 (0.7) | 4.7 (0.7) | 4.6 (0.6) | 4.7 (0.7) | 4.6 (0.7) |
| <100,000 copies/mL | 52 (80%) | 44 (79%) | 53 (83%) | 45 (75%) | 194 (79%) |
| Hepatitis B co-infection | 4 (6%) | 0 (0%) | 3 (5%) | 1 (2%) | 8 (3%) |
| Hepatitis C co-infection | 5 (8%) | 2 (4%) | 8 (13%) | 7 (12%) | 22 (9%) |
| Systolic blood pressure, mmHg | 120 (16) | 120 (9) | 123 (14) | 120 (13) | 121 (13) |
| Diastolic blood pressure, mmHg | 75 (9) | 75 (7) | 77 (10) | 76 (11) | 76 (9) |
| HOMA-IR | 1.2 (1.7) | 1.6 (2.2) | 1.6 (1.5) | 1.5 (1.5) | 1.5 (1.7) |
| eGFR, mL/min/1.732 | 107.1 (15.0) | 106.5 (21.4) | 106.1 (19.5) | 110.0 (16.4) | 107.4 (18.1) |
| < 90** | 9 (14%) | 15 (27%) | 15 (24%) | 7 (12%) | 46 (19%) |
| Dipstick proteinuria | 16 (25%) | 18 (33%) | 21 (33%) | 16 (27%) | 71 (29%) |
| Urine protein:creatinine, mg/g | (n=63) | (n=52) | (n=64) | (n=55) | (n=234) |
| Median (IQR) | 87 (67, 132) | 86 (61, 156) | 98 (70.50, 143.50) | 101 (75, 170) | 95 (67, 146) |
| ≥ 200mg/g | 10 (16%) | 10 (19%) | 11 (17%) | 12 (22%) | 43 (18%) |
| Urine albumin:creatinine, mg/g | (n=64) | (n=54) | (n=64) | (n=60) | (n=242) |
| Median (IQR) | 4.60 (3.10, 9.85) | 4.65 (3.10, 11.60) | 4.90 (3.10, 11.35) | 4.80 (3.20, 14.05) | 4.75 (3.20, 10.00) |
| ≥ 30mg/g | 6 (9%) | 6 (11%) | 5 (8%) | 10 (17%) | 27 (11%) |
Urine protein: creatinine and albumin: creatinine ratios are presented as median (interquartile range, IQR). All other data are presented as mean (standard deviation) or as number (percent). TDF/FTC, tenofovir disoproxil fumarate/emtricitabine; ABC/3TC, abacavir/lamivudine; EFV, efavirenz; ATV/r, atazanavir/ritonavir. Hepatitis B co-infection, surface antigen positive; Hepatitis C co-infection, antibody positive; HOMA-IR, homeostasis model assessment-insulin resistance; eGFR, estimated glomerular filtration rate as calculated by Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) creatinine equation; urine dipstick proteinuria, any non-negative protein result on baseline urinalysis.
HIV-1 RNA was measured at screening.
Two participants who met entry criteria based on Cockcroft-Gault creatinine clearance > 60mL/min but who had a CKD-EPI eGFR < 60 mL/min/1.73m2. Baseline data were missing for ≤ 3 participants for the following characteristics: Hepatitis B and C co-infection, eGFR, dipstick proteinuria, and urine albumin:creatinine ratio. Baseline data for urine protein:creatinine ratio were missing for 11 participants.