Table 1:
Baseline Characteristics of Switch Study by Arms
| Switch Study Baseline Values | ||||
|---|---|---|---|---|
| EFV/FTC/TDF Continuation Arm (N = 10) | EVG/COBI/FTC/TDF Switch Arm (n=22) | P-ValueƗ | Effect SizeƗƗ | |
| Demographic and Clinical Parameters | ||||
| Age, years | 48 (44, 57) | 50 (39, 58) | 0.82 | −0.03 |
| Male, n (%) | 10 (100%) | 20 (90%) | 1.00 | 0.17 |
| Body Mass Index, kg/m2 | 27.1 (25.1, 28.8) | 26.7 (24.5, 30.8) | 0.95 | 0.01 |
| Neck Circumference, inches | 15.6 (15.2, 16.2) | 15.6 (15.0, 15.8) | 0.87 | 0.02 |
| Caucasian, n (%) | 6 (60%) | 10 (46%) | 0.70 | −0.13 |
| Nadir CD4+ T-Cells, cells/μL^ | 298 (130, 429) | 255 (124, 422) | 0.74 | 0.06 |
| CD4+ T-Cells, cells/μL | 672 (566, 935) | 610 (444, 768) | 0.50 | 0.11 |
| CD4+ T-Cell Percent | 39 (33, 49) | 39 (28, 44) | 1.00 | 0 |
| CD4/CD8 Ratio | 1.1 (0.8, 1.4) | 1.1 (0.8, 1.6) | 0.82 | −0.04 |
| Sleep Parameters | ||||
| Sleep Efficiency | 81.9 (75.6, 88.8) | 81.9 (75.5, 86.9) | 0.88 | −0.02 |
| Sleep Maintenance Efficiency | 86.7 (77.2, 91.6) | 86.1 (81.5, 92.9) | 0.64 | −0.08 |
| Sleep Latency, minutes | 7.7 (3.5, 13.0) | 12.7 (9.5, 20.0) | 0.11 | −0.27 |
| Wake after Sleep Onset (WASO), percent | 13.3 (7.4, 24.8) | 13.9 (6.8, 19.2) | 0.66 | 0.07 |
| Spontaneous Arousal Index (SAI) | 5.7 (4.5, 7.7) | 6.9 (4.4, 9.9) | 0.48 | −0.12 |
| REM Latency, minutes | 126 (99, 179) | 113 (76, 159) | 0.58 | 0.09 |
| REM Sleep, percent | 15.2 (13.2, 20.6) | 18.9 (12.3, 22.4) | 0.74 | −0.05 |
| Stage 3 Sleep, percent | 2.4 (1.1, 6.2) | 4.5 (0, 9.6) | 0.88 | −0.02 |
| Apnea-Hypopnea Index (AHI) | 2.7 (1.5, 5.5) | 6.3 (1.3, 12.9) | 0.25 | −0.20 |
| Respiratory Effort Related Arousals (RERA) | 1.1 (0.9, 6.4) | 4.7 (1.4, 12.7) | 0.09 | −0.29 |
| Respiratory Disturbance Index (RDI) | 6.9 (2.6, 10.0) | 14.4 (3.6, 21.3) | 0.16 | −0.24 |
| Obstructive Sleep Apnea, n (%) based on RDI | 6 (60%) | 13 (59%) | 0.98 | −0.01 |
| Epworth Sleepiness Scale | 5.5 (3.0, 8.0) | 6.5 (5.0, 8.0) | 0.63 | −0.08 |
| PSQI Total Score | 8.5 (5.0, 12.0) | 6.0 (4.0, 8.0) | 0.12 | 0.27 |
| Neuropsychological Z-scores | ||||
| NPZ Global | −0.06 (−0.17, 0.15) | 0.05 (−0.47, 0.55) | 0.91 | −0.01 |
| NPZ Learning and Memory | 0.09 (−0.76, 0.40) | 0.02 (−0.98, 0.58) | 0.95 | 0.01 |
| NPZ Executive Function | 0.17 (0.01, 0.43) | 0.35 (−0.80, 0.69) | 0.47 | −0.12 |
| NPZ Working Memory | −0.52 (−0.66, −0.11) | 0.05 (−0.72, 0.50) | 0.15 | −0.25 |
| NPZ Psychomotor Speed | 0.50 (0.35, 0.87) | 0.43 (−0.10, 0.89) | 0.64 | 0.08 |
Median (quartile 1, quartile 3) presented for continuous variables; n (%) presented for categorical variables.
PSQI = Pittsburgh Sleep Quality Index. REM = Rapid Eye Movement.
^
By patient report. All parameters were comparable between the 2 arms.
Ɨ
Wilcoxon Rank Sum test used to compare continuous variables, Fisher’s exact test used to compare categorical variables.
ƗƗ
Wilcoxon Z statistic transformed to effect size rW, rW = Z/√N.