Background
ODIN was a Phase IIIb, randomised, open-label trial showing non-inferiority of DRV/r 800/100mg qd vs 600/100mg bid (+ ≥2 NRTIs) in treatment-experienced HIV-1-infected adults with no DRV resistance-associated mutations at screening. We evaluated the effect of demographic and baseline (BL) disease parameters on virological response (VR) of qd vs bid DRV/r at Week 48.
Methods
Week 48 VR (HIV-1 RNA <50 copies/mL; ITT-TLOVR) was analysed by subgroups including gender, age, race, HIV clade, BL HIV-1 RNA and CD4 count.
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Results
Week 48 VR was 72.1% for DRV/r qd vs 70.9% for bid (95% CI = -6.1 to 8.5%). Week 48 VR by gender, age, race, HIV clade, BL CD4 count and HIV-1 RNA is reported (Table 1).
Table 1
% patients with HIV-1 RNA <50 copies/mL at Week 48
DRV/r qd | DRV/r bid | ||||
|---|---|---|---|---|---|
Baseline factor
| N | % response | N | % response | Difference in response (95% CI) |
HIV-1 RNA (as stratified) (copies/mL) | |||||
≤50,000 | 222 | 78.4 | 224 | 76.8 | 1.6 (-6.2, 9.4) |
>50,000 | 72 | 52.8 | 72 | 52.8 | 0.0 (-16.4, 16.4) |
CD4 count (cells/mm
3
)
| |||||
<50 | 13 | 53.8 | 3 | 100 | -46.2 (-109.6, 17.3) |
50-<100 | 36 | 58.3 | 35 | 57.1 | 1.2 (-22.2, 24.6) |
100-<200 | 76 | 77.6 | 77 | 67.5 | 10.1 (-4.1, 24.3) |
200-<350 | 108 | 72.2 | 107 | 74.8 | -2.5 (-14.4, 9.3) |
≥350 | 61 | 77.0 | 74 | 74.3 | 2.7 (-12.0, 17.4) |
Gender
| |||||
Female | 115 | 69.6 | 98 | 69.4 | 0.2 (-12.3, 12.7) |
Male | 179 | 73.7 | 198 | 71.7 | 2.0 (-7.0, 11.1) |
Age (years)
| |||||
≤30 | 35 | 71.4 | 35 | 60.0 | 11.4 (-11.0, 33.9) |
30-≤45 | 180 | 75.6 | 169 | 72.8 | 2.8 (-6.4, 12) |
45-≤55 | 64 | 60.9 | 72 | 72.2 | -11.3 (-27.2, 4.6) |
55-≤65 | 14 | 78.6 | 18 | 66.7 | 11.9 (-20.6, 44.4) |
>65 | 1 | 100 | 2 | 100 | 0 (0, 0) |
Race
| |||||
Black | 83 | 62.7 | 72 | 65.3 | -2.6 (-17.9, 12.7) |
Caucasian | 102 | 71.6 | 110 | 69.1 | 2.5 (-9.9, 14.9) |
Hispanic | 47 | 72.3 | 59 | 67.8 | 4.5 (-13.2, 22.3) |
Asian | 48 | 89.6 | 41 | 87.8 | 1.8 (-11.6, 15.1) |
Other | 14 | 71.4 | 14 | 78.6 | -7.1 (-40.7, 26.4) |
Clade
| |||||
B | 179 | 70.4 | 199 | 64.3 | 6.4 (-3.4, 15.6) |
Non-B | 115 | 74.8 | 97 | 84.5 | -9.8 (-20.7,1.2) |
Conclusions
VR was comparable with DRV/r qd and bid regardless of subgroup analysed. As the trial was not powered for treatment comparisons in subgroups, and as numbers were small for some subgroups, these exploratory findings should be interpreted with caution.
This article is published under license to BioMed Central Ltd. This is an open access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.