Patients’ characteristics at last available update (31 December 2018)
| Variables | Overall n=4139 (%) | Treatment-experienced n=3658 (%) | Naive n=481 (%) | P values |
| Male, n (%) | 2979 (72.5) | 2609 (71.7) | 370 (78.7) | 0.001 |
| Age (years), median (IQR) | 50.4 (42.2–55.6) | 51.0 (43.8–56.0) | 41.3 (33.2–50.4) | <0.001 |
| Risk factor, n (%) | <0.001 | |||
| MSM | 1540 (37.9) | 1310 (36.4) | 230 (50.1) | |
| Eterosexual | 1572 (38.7) | 1416 (39.3) | 156 (34.0) | |
| IDU | 753 (18.5) | 712 (19.8) | 41 (9.0) | |
| Other/Unknown | 196 (4.9) | 164 (4.6) | 32 (6.9) | |
| HCVc Ab positive, n (%) | 833 (21.2) | 804 (22.8) | 29 (7.3) | <0.001 |
| HBsAg positive, n (%) | 107 (2.7) | 96 (2.7) | 11 (2.7) | ns |
| CDC stage C, n (%) | 837 (26.9) | 774 (28.0) | 63 (17.8) | <0.001 |
| Years from HIV diagnosis, median (IQR) | 14.0 (5.4–23.1) | / | / | |
| Zenith HIV-RNA (log10 copies/mL), median (IQR) | 4.82 (4.29–5.37) | 4.82 (4.29–5.36) | 5.05 (4.57–5.56) | <0.001 |
| Nadir CD4+ (cells/mmc), median (IQR) | 194.0 (61.0–324.0) | 191.0 (58.0–312.0) | 272.0 (94.5–488.5) | <0.001 |
| BL CD4+ (cell/mmc), median (IQR) | 583 (365-810) | 601 (400-823) | 330 (110-560) | <0.001 |
| Years on cART, median (IQR) | 10.6 (4.0–18.5) | / | / | |
| Time on virological suppression (months), median (IQR) | 43.9 (8.4–97.0) | / | / | |
| Virologically suppressed patients at baseline, n (%) | 2222 (80.4) | / | / | |
| Previous virological failure, n (%) | 1183 (44.9) | / | / | |
| Therapies before switch, n (%) | / | |||
| 2NRTI+PI | 944 (25.9) | |||
| 2NRTI+INI | 835 (22.9) | |||
| 2NRTI+NNRTI | 702 (19.2) | / | ||
| Mono/Dual | 763 (20.9) | |||
| Others | 405 (11.1) | |||
| Reasons for previous treatment discontinuation, n (%) | / | |||
| Virological failure | 209 (5.7) | |||
| Treatment Intensification | 106 (2.9) | |||
| Dyslipidaemia | 247 (6.8) | / | ||
| Proactive switch/Simplification | 1773 (48.5) | |||
| GI toxicity | 170 (4.6) | |||
| Renal toxicity | 113 (3.1) | |||
| Neurological toxicity | 34 (0.9) | |||
| Osteopoenia/Osteoporisis | 61 (1.7) | |||
| Other toxicity | 44 (1.2) | |||
| Hypersensitivity | 20 (0.5) | |||
| Drug–drug interactions | 155 (4.2) | |||
| Other/Unknown | 723 (19.8) |
GI, gastrointestinal; INI, integrase inhibitor; NNRTI, non-nucleoside reverse transcriptase inhibitor ; NRTI, nucleoside reverse transcriptase inhibitor ; PI, protease inhibitor.