Table 2 Summary results from mixed model analysis of primary and secondary outcomes (change from baseline in score) at 24 weeks and 48 weeks by treatment group
Primary and secondary outcomes | Outcomes | Visit (weeks) | Mixed model analysis | |||
|---|---|---|---|---|---|---|
Dolutegravir | Efavirenz | |||||
Difference from baseline (95% CI) | p-valuea | Difference from baseline (95% CI) | p-valueb | |||
Primary outcomes | Physical health summary | 24 | 10.40 (9.24, 11.55) | < 0.0001 | 10.24 (9.10, 11.38) | < 0.0001 |
48 | 14.32 (13.08, 15.57) | < 0.0001 | 13.90 (12.70, 15.11) | < 0.0001 | ||
Mental health summary | 24 | 9.23 (7.35, 11.10) | < 0.0001 | 7.54 (5.66, 9.42) | < 0.0001 | |
48 | 12.50 (10.49, 14.51) | < 0.0001 | 12.63 (10.63, 14.63) | < 0.0001 | ||
Secondary outcomes | Role function | 24 | 6.87 (6.14, 7.60) | < 0.0001 | 5.76 (5.04, 6.49) | < 0.0001 |
48 | 6.87 (6.48, 7.26) | < 0.0001 | 6.87 (6.49, 7.26) | < 0.0001 | ||
Physical function | 24 | 16.92 (15.67, 18.17) | < 0.0001 | 13.95 (12.72, 15.19) | < 0.0001 | |
48 | 18.22 (17.51, 18.93) | < 0.0001 | 18.18 (17.49, 18.88) | < 0.0001 | ||
Social function | 24 | 10.94 (10.15, 11.73) | < 0.0001 | 11.19 (10.41, 11.97) | < 0.0001 | |
48 | 12.53 (12.04, 13.02) | < 0.0001 | 12.28 (11.80, 12.76) | < 0.0001 | ||
Pain | 24 | 10.91 (8.87, 12.94) | < 0.0001 | 12.57 (10.54, 14.59) | < 0.0001 | |
48 | 15.42 (13.69, 17.14) | < 0.0001 | 13.71 (12.01, 15.41) | < 0.0001 | ||
General health | 24 | 1.63 (0.55, 2.72) | 0.0032 | 1.88 (0.80, 2.96) | 0.0007 | |
48 | 4.26 (3.36, 5.17) | < 0.0001 | 4.27 (3.38, 5.17) | < 0.0001 | ||
Health transition | 24 | 12.07 (8.30, 15.84) | < 0.0001 | 12.58 (8.81, 16.35) | < 0.0001 | |
48 | 11.95 (8.60, 15.30) | < 0.0001 | 9.79 (6.45, 13.12) | < 0.0001 | ||
Quality of life | 24 | 12.36 (9.28, 15.45) | < 0.0001 | 9.76 (6.65, 12.86) | < 0.0001 | |
48 | 14.89 (12.15, 17.63) | < 0.0001 | 13.59 (10.85, 16.33) | < 0.0001 | ||
Health distress | 24 | 15.10 (12.45, 17.75) | < 0.0001 | 11.99 (9.35, 14.63) | < 0.0001 | |
48 | 19.33 (17.10, 21.55) | < 0.0001 | 19.93 (17.74, 22.13) | < 0.0001 | ||
Cognitive function | 24 | 2.30 (0.31, 4.29) | 0.0236 | 4.97 (2.99, 6.95) | < 0.0001 | |
48 | 6.60 (4.88, 8.33) | < 0.0001 | 6.50 (4.79, 8.21) | < 0.0001 | ||
Energy | 24 | 15.49 (13.14, 17.85) | < 0.0001 | 15.86 (13.51, 18.20) | < 0.0001 | |
48 | 22.90 (20.90, 24.89) | < 0.0001 | 21.43 (19.46, 23.40) | < 0.0001 | ||
Mental health | 24 | 8.57 (6.44, 10.70) | < 0.0001 | 6.43 (4.32, 8.54) | < 0.0001 | |
48 | 11.49 (9.70, 13.29) | < 0.0001 | 12.26 (10.50, 14.03) | < 0.0001 | ||