Table 4 Frequency of laboratory abnormalities during the course of RPV or EFV treatment

Parameter Adverse event	RPV N (%)	EFV N (%)	p-value*
Haemoglobin^a (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%)
ALT^b (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
AST^c (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
ALP^d (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
Bilirubin^e (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
Platelets^f (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

ISSN: 1742-6405