Table 2.
Summary of treatment-emergent adverse events (all causalities), adverse events occurring in >5% of individuals and Grade 3/4 laboratory abnormalities.
| MVC + DRV/r (N = 396) N (%) | TDF/FTC + DRV/r (N = 401) N (%) | |
| Individuals with AEs | 360 (90.9) | 365 (91.0) |
| Individuals with SAEs | 41 (10.4) | 40 (10.0) |
| Individuals with Grade 3 or 4 AEs | 65 (16.4) | 71 (17.7) |
| Individuals discontinued due to AEs | 24 (6.1) | 24 (6.0) |
| Most common AEs (>5% of individuals in any group) | ||
| Diarrhoea | 89 (22.5) | 135 (33.7) |
| Nasopharyngitis | 48 (12.1) | 55 (13.7) |
| Upper respiratory tract infection | 40 (10.1) | 45 (11.2) |
| Rash | 38 (9.6) | 30 (7.5) |
| Nausea | 34 (8.6) | 45 (11.2) |
| Fatigue | 27 (6.8) | 46 (11.5) |
| Cough | 27 (6.8) | 30 (7.5) |
| Bronchitis | 25 (6.3) | 24 (6.0) |
| Gastroenteritis | 23 (5.8) | 17 (4.2) |
| Depression | 28 (7.1) | 30 (7.5) |
| Insomnia | 15 (3.8) | 25 (6.2) |
| Grade 3/4 laboratory abnormalities | ||
| Alanine aminotransferase | 9 (2.3) | 6 (1.5) |
| Total bilirubin | 3 (0.8) | 1 (0.3) |
| Creatine kinase | 18 (4.5) | 22 (5.5) |
| LDL cholesterol | 50 (12.6) | 24 (6.0) |
AE, adverse event; DRV/r, darunavir/ritonavir; LDL, low-density lipoprotein; MVC, maraviroc; SAE, serious adverse event; TDF/FTC, tenofovir/emtricitabine.