Table 4.
Frequency of laboratory abnormalities during the course of RPV or EFV treatment
| Parameter Adverse event | RPV N (%) | EFV N (%) | p-value* |
|---|---|---|---|
| Haemoglobina (N with data: RPV = 691; EFV = 108) | |||
| Below normal range | 149 (21.6%) | 41 (38.0%) | 0.001 |
| Normal range | 488 (70.6%) | 63 (58.3%) | |
| Above normal range | 54 (7.8%) | 4 (3.7%) | |
| ALTb (N with data: RPV = 1111; EFV = 183) | |||
| Normal range | 666 | 94 | |
| Above normal range | 445 (40.1%) | 89 (48.6%) | 0.03 |
| Above 3 times the normal range | 85 (11.3%) | 18 (16.1%) | 0.15 |
| ASTc (N with data: RPV = 997; EFV = 156) | |||
| Normal range | 596 | 85 | |
| Above normal range | 401 (40.2%) | 71 (45.5%) | 0.21 |
| Above 3 times the normal range | 69 (10.4%) | 13 (13.3%) | 0.39 |
| ALPd (N with data: RPV = 718; EFV = 127) | |||
| Normal range | 603 | 79 | |
| Above normal range | 115 (16.0%) | 48 (37.8%) | < 0.0001 |
| Above 3 times the normal range | 2 (0.3%) | 4 (4.8%) | 0.003 |
| Bilirubine (N with data: RPV = 1014; EFV = 156) | |||
| Normal range | 913 | 150 | |
| Above normal range | 101 (10.0%) | 6 (3.9%) | 0.01 |
| Above 2 times the normal range | 29 (3.1%) | 3 (2.0%) | 0.61 |
| Plateletsf (N with data: RPV = 880; EFV = 127) | |||
| Normal range | 731 | 112 | |
| Below normal range | 149 (17.0%) | 15 (11.8%) | 0.16 |
| Below 100 109/L | 58 (7.4%) | 3 (2.6%) | 0.07 |
aHaemoglobin normal range: (Men: 14.0 < g/dl < 18.0; Women: 12.0 < g/dl < 16.0)
bALT normal range: (Men: U/L < 50; Women: U/L < 40)
cAST normal range: (Men: U/L < 40; Women: U/L < 34)
dALP normal range: (Men: U/L < 128; Women: U/L < 98)
eBilirubin normal range: (mg/dL < 1.4; μmol/L < 25.0)
fPlatelets normal range: (140 < 109/L < 400)
&Considering all values after baseline and while the person was still receiving the drug
*Chi-square p-value or Fisher exact test when < 5 events in the EFV group
*When two p-values are shown, they refer to separate 2 × 2 tables with the ‘Normal range’ category used as common comparator