Table 1.
Baseline characteristics of participants
| Characteristics | Overall (n = 426) | Normal ALT (n = 360) | Abnormal ALT (n = 66) | p‐value |
|---|---|---|---|---|
| Age, median years (IQR) | 25 (22 to 30) | 25 (22 to 30) | 25 (22 to 30) | 0.871 |
| Risk group, n (%) | ||||
| MSM | 399 (93.7) | 335 (93.1) | 64 (97.0) | 0.359 |
| Heterosexual male | 15 (3.5) | 13 (3.6) | 2 (3.0) | |
| Heterosexual female | 12 (2.8) | 12 (3.3) | – | |
| Education level, n (%) | ||||
| Primary school or lower | 11 (2.6) | 10 (2.8) | 1 (1.5) | 0.957 |
| Secondary school | 136 (31.9) | 116 (32.2) | 20 (30.3) | |
| Diploma | 30 (7.0) | 26 (7.2) | 4 (6.1) | |
| Bachelor degree or higher | 249 (58.5) | 208 (57.8) | 41 (62.1) | |
| HIV subtype, n (%) | ||||
| CRF01_AE | 330 (77.5) | 281 (78.1) | 49 (74.2) | 0.476 |
| B | 11 (2.6) | 10 (2.8) | 1 (1.5) | |
| 01AE/B | 61 (14.3) | 49 (13.6) | 12 (18.2) | |
| Other | 2 (0.5) | 1 (0.3) | 1 (1.5) | |
| Nontypeable/Unknown | 22 (5.2) | 19 (5.3) | 3 (4.6) | |
| Fiebig stage, n (%) | ||||
| I | 61 (14.3) | 59 (16.4) | 2 (3.0) | <0.001 |
| II | 106 (24.9) | 100 (27.8) | 6 (9.1) | |
| III | 180 (42.2) | 141 (39.2) | 39 (59.1) | |
| IV | 51 (12.0) | 40 (11.1) | 11 (16.7) | |
| V | 28 (6.6) | 20 (5.6) | 8 (12.1) | |
| VDRL+, n/N (%) | 51/400 (12.8) | 43/336 (12.8) | 8/64 (12.5) | 1.000 |
| Alcohol use, n (%) | 98 (23) | 81 (23) | 17 (26) | 0.633 |
| Drug use, n (%) | 85 (20.0) | 71 (20.0) | 14 (21.2) | 0.741 |
| ARS Present, n (%) | 329 (77.2) | 267 (74.2) | 62 (93.9) | <0.001 |
| CD4 count (cells/mm3), median (IQR) | 364 (265 to 495) | 368 (266 to 495) | 354 (231 to 515) | 0.394 |
| <200 | 43 (10.1) | 32 (8.9) | 11 (16.7) | 0.204 |
| 200 to 349 | 155 (36.4) | 135 (37.5) | 20 (30.3) | |
| 350 to 500 | 124 (29.1) | 107 (29.7) | 17 (25.8) | |
| >500 | 104 (24.4) | 86 (23.9) | 18 (27.3) | |
| CD4/CD8 ratio, median (IQR) | 0.70 (0.43 to 1.04) | 0.77 (0.49 to 1.11) | 0.42 (0.20 to 0.61) | <0.001 |
| CD4/CD8 ratio> 1 | 117 (27.5) | 111 (30.8) | 6 (9.1) | <0.001 |
| HIV‐RNA (log10copies/mL), median (IQR) | 5.9 (5.3 to 6.7) | 5.8 (5.2 to 6.6) | 6.4 (5.8 to 6.9) | <0.001 |
| <100,000 | 83 (19.5) | 79 (21.9) | 4 (6.1) | <0.001 |
| 100,000 to 999,999 | 148 (34.7) | 131 (36.4) | 17 (25.8) | |
| ≥1,000,000 | 195 (45.8) | 150 (41.7) | 45 (68.2) | |
| Initial antiretroviral therapy | ||||
| EFV/TDF/XTC | 288 (67.6) | 243 (67.5) | 45 (68.2) | 0.644 |
| EFV/TDF/XTC + RAL/MVC | 78 (18.3) | 66 (18.3) | 12 (18.2) | |
| DTG/TDF/XTC | 26 (6.1) | 22 (6.1) | 4 (6.1) | |
| DTG/TDF/XTC + MVC | 25 (5.9) | 22 (6.1) | 3 (4.6) | |
| EFV/TDF/FTC + Telmisartan | 6 (1.4) | 5 (1.4) | 1 (1.5) | |
| RAL/TDF/3TC | 1 (0.2) | 1 (0.3) | – | |
| TDF/FTC + MVC/RAL | 1 (0.2) | 1 (0.3) | – | |
| EFV/TDF/3TC + MVC | 1 (0.2) | – | 1 (1.5) | |
| Degree of ALT elevation | ||||
| Grade 1 (1.25 to < 2.5 × ULN) | – | – | 43 (65.2) | |
| Grade 2 (2.5 to < 5.0 × ULN) | – | – | 15 (22.7) | |
| Grade 3 (5.0 to < 10.0 × ULN) | – | – | 8 (12.1) | |
| Grade 4 (≥10.0 × ULN) | – | – | 0 (0) | |
EFV, efavirenz; IQR, interquartile range; MSM, men who have sex with men; MVC, maraviroc; RAL, raltegravir; TDF, tenofovir disoproxil fumarate; VDRL, venereal disease research laboratory test for syphilis; XTC, lamivudine (3TC) or emtricitabine (FTC).