Table 2. Efficacy End Points for the Comparison of Dolutegravir-based ART with Standard Care.*.
| End Point | Total Population | ODYSSEY A | ODYSSEY B | ||||||
|---|---|---|---|---|---|---|---|---|---|
| Dolutegravir (N = 350) |
Standard Care (N=357) |
Treatment Effect (95% Cl) |
Dolutegravir (N = I54) |
Standard Care (N = I57) |
Treatment Effect (95% Cl) |
Dolutegravir (N = I96) |
Standard Care (N = 200) |
Treatment Effect (95% Cl) |
|
| Primary end point | |||||||||
| Treatment failure by % wk — no. (%) |
47 (13) | 75 (21) | 15 (10) | 34 (22) | 32 (16) | 41 (20) | |||
| Primary end-point components — no. (%) | |||||||||
| Insufficient virologic response at 24 wk |
0 | 3(1) | 0 | 2(1) | 0 | 1(1) | |||
| Confirmed viral load ≥400 copies/ml at >36 wk |
40 (11) | 64 (18) | 10 (6) | 26 (17) | 30 (15) | 38 (19) | |||
| Severe WHO stage 3 event | 0 | l (<l) | 0 | 0 | 0 | 1 (1) | |||
| WHO stage 4 event | 7 (2) | 5 (1) | 5 (3) | 5 (3) | 2 (1) | 0 | |||
| Death | 0 | 2 (1) | 0 | 1 (1) | 0 | 1 (1) | |||
| Estimated probability of treat- ment failure (95% Cl) |
0.14 (0.10 to 0.17) |
0.22 (0.18 to 0.26) |
-0.08 (-0.14 to-0.03) † |
0.10 (0.05 to 0.15) |
0.22 (0.16 to 0.30) |
-0.12 (-0.21 to -0.04) |
0.16 (0.12 to 0.22) |
0.21 (0.15 to 0.27) |
-0.05 (-0.12 to 0.03) |
| P value | 0.004 | 0.003 | 0.22 | ||||||
| Secondary end points | |||||||||
| Viral load at 96 wk | |||||||||
| <50 copies/ml | |||||||||
| No. of participants | 270 | 252 | 117 | 113 | 153 | 139 | |||
| Percent of participants (95% Cl) |
81 (76 to 84) |
76 (71 to 80) |
5 (-1 to 11) |
80 (73 to 86) |
81 (73 to 86) |
-1 (-10 to 8) |
81 (75 to 86) |
72 (66 to 78) |
9 (0.4 to 17) |
| <400 copies/ml | |||||||||
| No. of participants | 299 | 285 | 129 | 124 | 170 | 161 | |||
| Percent of participants (95% Cl) |
89 (85 to 92) |
86 (81 to 89) |
3 (-2 to 8) |
88 (82 to 93) |
89 (82 to 93) |
0 (-8 to 7) |
89 (84 to 93) |
83 (77 to 88) |
6 (-1 to 12) |
| Mean change in CD4 count from baseline to 96 wk — cells/mm3 |
265±17 | 230±17 | 35 (-12 to 82) |
311±23 | 267±24 | 44 (-21 to 109) |
228±24 | 202±24 | 27 (-39 to 93) |
Plus-minus values are means +SE within the treatment groups. The probability of having virologic or clinical treatment failure by 96 weeks (primary end point) was adjusted for all stratification factors (Section S3.2). Proportions of participants who had other end-point events at or by 96 weeks were unadjusted. The mean change in the CD4 count from baseline to 96 weeks was calculated with the use of normal regression with adjustment for baseline measure; estimates are presented for the mean change from a baseline CD4 count of 521.8 cells per cubic millimeter in the total population, 487.4 cells per cubic millimeter in the ODYSSEY A cohort, and 548.8 cells per cubic millimeter in the ODYSSEY B cohort. Comparisons of treatment groups are adjusted for all stratification factors and are presented for the dolutegravir group as compared with the standard-care group. The between-group differences in the percentages of participants with a viral load of less than 50 copies per milliliter and of less than 400 copies per milliliter at 96 weeks are the marginal risk differences from the logistic regression model and are presented in percentage points. The between-group difference in the mean change from baseline was calculated with the use of normal regression with adjustment for baseline measure and stratification factors. ART denotes antiretroviral therapy.
P = 0.16 for the interaction between trial group (dolutegravir or standard care) and trial cohort (ODYSSEY A or B) for the primary end point.