Table 3.
Adverse Events ≥ Grade 2 Occurring in at Least 5% of Subjects in any Group
| Treatment group | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| ATV/r | RAL | DRVr/r | ||||||||||
|
| ||||||||||||
| Adverse Effect | Grade | Total (%) | Grade | Total (%) | Grade | Total (%) | ||||||
| 2 | 3 | 4 | 2 | 3 | 4 | 2 | 3 | 4 | ||||
| Diarrhea | 35 | 11 | 0 | 46 (7.6) | 26 | 10 | 0 | 36 (6.0) | 46 | 6 | 0 | 52 (8.6) |
| Nausea | 36 | 8 | 1 | 45 (7.4) | 21 | 12 | 0 | 33 (5.5) | 29 | 12 | 0 | 41 (6.8) |
| Vomiting | 22 | 7 | 1 | 30 (5.0) | 15 | 9 | 0 | 24 (4.0) | 21 | 11 | 0 | 32 (5.3) |
| Abdominal pain | 13 | 17 | 1 | 31 (5.1) | 6 | 10 | 1 | 17 (2.8) | 13 | 14 | 2 | 29 (4.8) |
| Headache | 23 | 10 | 2 | 35 (5.8) | 35 | 7 | 0 | 42 (7.0) | 30 | 12 | 2 | 44(7.3) |
| Pain in extremity | 27 | 14 | 1 | 42 (6.9) | 31 | 14 | 0 | 45 (7.5) | 18 | 13 | 1 | 32 (5.3) |
| Arthralgia | 17 | 8 | 0 | 25 (4.1) | 17 | 4 | 1 | 22 (3.6) | 13 | 14 | 1 | 28 (4.7) |
| Back pain | 14 | 4 | 0 | 18 (3.0) | 21 | 10 | 0 | 31 (5.1) | 9 | 12 | 0 | 21 (3.5) |
| Fatigue | 32 | 6 | 1 | 39 (6.4) | 26 | 5 | 0 | 31 (5.1) | 26 | 7 | 0 | 33 (5.5) |
| Cough | 33 | 9 | 0 | 42 (6.9) | 32 | 8 | 0 | 40 (6.6) | 31 | 5 | 0 | 36 (6.0) |
| Dyspnea | 16 | 9 | 1 | 26 (4.3) | 16 | 12 | 0 | 28 (4.6) | 8 | 14 | 1 | 23 (3.8) |
| Pyrexia | 16 | 9 | 1 | 26 (4.3) | 25 | 10 | 0 | 35 (5.8) | 18 | 7 | 2 | 27(4.5) |
| Blood bilirubin increased | 22 | 217 | 47 | 286 (47.3) | 0 | 5 | 0 | 5 (<1) | 0 | 4 | 0 | 4 (<1) |
| Blood phosphorus decreased | 3 | 30 | 1 | 34 (5.6) | 4 | 24 | 1 | 29 (4.8) | 2 | 35 | 0 | 37 (6.2) |
| Blood glucose increased | 11 | 15 | 0 | 26 (4.3) | 15 | 9 | 2 | 26 (4.3) | 15 | 11 | 1 | 27 (4.5) |
ATV/r= atazanavir/ritonavir, RAL= raltegravir, DRV/r = darunavir/ritonavir
For clinical adverse effects, grade 2 = moderate, grade 3 = severe, Grade 4= potentially life-threatening For blood bilirubin increased grade 2 = 1.6–2.5 x upper limit of normal (ULN), grade 3 = 2.6–5.0 x ULN, grade 4 = >5.0 x ULN. For blood phosphorous decreased, grade 2 = 0.65–0.80 mmol/L, grade 3 = 0.32–0.64 mmol/L, grade 4 = <0.32 mmol/L. For blood glucose increased, grade 2 = 8.89–13.88 mmol/L, grade 3 = 13.89–27.75 mmol/L, grade 4 = >27.75 mmol/L