Table 5.
Safety Parameters over 48 Weeks
| DRV/r n=34 | ATV/r n=31 | |
|---|---|---|
| Adverse events, n (%) | ||
| Subjects with ≥1 AE | 31 (91.2) | 29 (93.5) |
| Subjects with ≥1 SAE | 5 (14.7) | 5 (16.1) |
| Subjects with ≥1 grade 3–4 AE | 3 (8.8) | 13 (41.9) |
| Subjects with ≥1 AE at least possibly related to study drug | 15 (44.1) | 22 (71.0) |
| Grade 2–4 AEs at least possibly related to study drug,an (%) | ||
| Hyperbilirubinemia | 0 | 3 (9.7) |
| Ocular icterus | 0 | 2 (6.5) |
| Pollakiuria | 0 | 2 (6.5) |
| Neutropenia | 0 | 1 (3.2) |
| Diarrhea | 1 (2.9) | 0 |
| Pancreatitis | 1 (2.9) | 0 |
| Dehydration | 1 (2.9) | 0 |
| Hypercholesterolemia | 1 (2.9) | 0 |
| Joint swelling | 0 | 1 (3.2) |
| Acute renal failure | 1 (2.9) | 0 |
| Dermatitis | 0 | 1 (3.2) |
| Leukocytoclastic vasculitis | 0 | 1 (3.2) |
| Grade 2–4 laboratory abnormalities, n (%) | ||
| Glucose | 4 (11.8) | 3 (9.7) |
| Total cholesterol | 3 (8.8) | 1 (3.2) |
| Neutrophils | 2 (5.9) | 4 (12.9) |
| Low-density lipoprotein (direct) | 2 (5.9) | 3 (9.7) |
| Aspartate aminotransferase | 2 (5.9) | 0 |
| Total bilirubin | 1 (2.9) | 27 (87.1) |
| Creatinine | 1 (2.9) | 1 (3.2) |
| Sodium | 1 (2.9) | 0 |
| Triglycerides | 0 | 1 (3.2) |
a
Adverse events reported as laboratory abnormalities are not included.
DRV/r, darunavir/ritonavir; ATV/r, atazanavir/ritonavir; AE, adverse event; SAE, serious adverse event.