Table 1.
Baseline characteristics
| Randomized treatment | Study 1216 (baseline regimen RPV/FTC/TDF) | Study 1160 (baseline regimen EFV/FTC/TDF) | ||
|---|---|---|---|---|
| RPV/FTC/TAF (n = 316) | RPV/FTC/TDF (n = 314) | RPV/FTC/TAF (n = 438) | EFV/FTC/TDF (n = 437) | |
| Age (years) [median (IQR)] | 46 (37, 53) | 44 (36, 51) | 49 (42, 55) | 48 (41, 54) |
| Male [n (%)] | 275 (87) | 289 (92) | 373 (85) | 390 (89) |
| Race/ethnicity [n (%)] | ||||
| White | 238 (75) | 235 (75) | 291 (66) | 292 (67) |
| Black or African descent | 65 (21) | 54 (17) | 118 (27) | 120 (27) |
| Asian | 7 (2) | 17 (5) | 9 (2) | 8 (2) |
| Latino/Hispanic | 40 (13) | 53 (17) | 79 (18) | 78 (18) |
| Region [n (%)] | ||||
| USA | 222 (70) | 226 (72) | 351 (80) | 345 (79) |
| Non‐USAa | 94 (30) | 88 (28) | 87 (20) | 92 (21) |
| CD4 count (cells/μL) [median (IQR)] | 673 (521, 877) | 668 (525, 817) | 673 (507, 887) | 666 (505, 820) |
| Duration of baseline regimen at enrolment (years) [median (IQR)]b | 2.3 (1.5, 3.3) | 2.5 (1.6, 3.2) | 6.5 (4.5, 8.2) | 6.6 (4.1, 8.7) |
| CrCl (mL/min) [median (IQR)] | 104 (89, 120) | 100 (87, 120) | 110 (91, 132) | 108 (92, 133) |
| Proteinuria grade [n (%)] | ||||
| 1 | 31 (10) | 28 (9) | 26 (6) | 36 (8) |
| 2 | 0 | 1 (< 1) | 2 (< 1) | 1 (< 1) |
| 3 | 0 | 0 | 0 | 0 |
| Diabetes mellitus [n (%)] | 5 (2) | 10 (3) | 26 (6) | 24 (5) |
| Hypertension [n (%)] | 66 (21) | 55 (18) | 118 (27) | 122 (28) |
CrCl, creatinine clearance; EFV, efavirenz; FTC, emtricitabine; IQR, interquartile range; RPV, rilpivirine; TAF, tenofovir alafenamide; TDF, tenofovir disoproxil fumarate.
a
Includes Canada and Europe.
b
A single‐tablet regimen of RPV/FTC/TDF for Study 1216 and a single‐tablet regimen of EFV/FTC/TDF for Study 1160.