Table 3 Summary results from mixed model analysis of primary and secondary outcomes (change from baseline) with repeated measurements at 24 weeks and 48 weeks: between group comparison
Primary and secondary outcomes | Outcomes | Visit (weeks) | na, mean (SD) | Mixed model analysis | ||
|---|---|---|---|---|---|---|
Dolutegravir | Efavirenz | Difference (95% CI) | p-valueb | |||
Primary outcomes | Physical health summary | 24 | 86, 11.91 (13.11) | 88, 9.02 (10.88) | 0.16 (− 1.47, 1.79) | 0.8466 |
48 | 74, 15.41 (11.32) | 79, 12.62 (9.46) | 0.42 (− 1.31, 2.15) | 0.6316 | ||
Mental health summary | 24 | 87, 10.56 (15.84) | 86, 6.69 (15.26) | 1.69 (− 0.97, 4.35) | 0.2112 | |
48 | 75, 13.41 (16.74) | 76, 11.16 (14.34) | − 0.13 (− 2.97, 2.71) | 0.9277 | ||
Secondary outcomes | Role function | 24 | 89, 9.55 (29.07) | 90, 2.78 (21.67) | 1.11 (0.08, 2.13) | 0.0348 |
48 | 312, 10.90 (30.69) | 324, 3.09 (16.40) | − 0.01 (− 0.56, 0.55) | 0.9812 | ||
Physical function | 24 | 88, 19.60 (22.53) | 90, 11.39 (21.25) | 2.97 (1.20, 4.73) | 0.0010 | |
48 | 308, 20.45 (20.99) | 324, 16.05 (16.89) | 0.04 (− 0.96, 1.04) | 0.9441 | ||
Social function | 24 | 88, 12.73 (25.04) | 89, 9.21 (21.33) | − 0.25 (− 1.36, 0.86) | 0.6612 | |
48 | 304, 14.47 (25.09) | 320, 10.50 (20.52) | 0.25 (− 0.43, 0.94) | 0.4674 | ||
Pain | 24 | 89, 13.34 (28.00) | 90, 10.69 (22.37) | − 1.66 (− 4.54, 1.22) | 0.2570 | |
48 | 312, 17.15 (24.23) | 324, 12.19 (19.37) | 1.70 (− 0.72, 4.13) | 0.1686 | ||
General health | 24 | 89, 1.46 (13.04) | 90, 2.67 (12.18) | − 0.25 (− 1.77, 1.28) | 0.7521 | |
48 | 312, 3.46 (10.83) | 324, 5.00 (10.76) | − 0.01 (− 1.28, 1.26) | 0.9900 | ||
Health transition | 24 | 88, 9.94 (25.30) | 88, 15.06 (27.48) | − 0.51 (− 5.86, 4.83) | 0.8512 | |
48 | 308, 9.09 (29.90) | 316, 12.97 (31.08) | 2.16 (− 2.58, 6.90) | 0.3707 | ||
Quality of life | 24 | 89, 13.48 (24.73) | 88, 9.09 (24.32) | 2.61 (− 1.77, 6.99) | 0.2428 | |
48 | 312, 15.71 (22.00) | 316, 12.66 (19.05) | 1.30 (− 2.58, 5.18) | 0.5096 | ||
Health distress | 24 | 88, 17.61 (30.90) | 88, 10.45 (26.19) | 3.11 (− 0.64, 6.86) | 0.1035 | |
48 | 304, 21.51 (30.10) | 315, 17.84 (22.72) | − 0.61 (− 3.74, 2.52) | 0.7028 | ||
Cognitive function | 24 | 89, 2.58 (18.92) | 90, 4.22 (17.17) | − 2.67 (− 5.48, 0.14) | 0.0621 | |
48 | 312, 6.79 (16.53) | 320, 5.94 (17.65) | 0.10 (− 2.33, 2.53) | 0.9354 | ||
Energy | 24 | 88, 17.27 (21.53) | 89, 14.44 (21.60) | − 0.36 (− 3.68, 2.96) | 0.8309 | |
48 | 307, 24.59 (18.96) | 320, 19.81 (20.76) | 1.46 (− 1.34, 4.27) | 0.3062 | ||
Mental health | 24 | 88, 9.73 (19.17) | 90, 5.96 (19.61) | 2.14 (− 0.86, 5.14) | 0.1622 | |
48 | 307, 12.40 (19.68) | 324, 11.21 (18.05) | − 0.77 (− 3.29, 1.74) | 0.5472 | ||