Table 3.
Summary results for drug conservation vs. viral suppression at month 2 compared with baseline from fitting an analysis of covariance.
| DC arm (N = 200) Mean loge change (SD) |
VS arm (N = 200) Mean loge change (SD) |
Difference in mean loge change DC/VSa (95% CI) | P-value | |
|---|---|---|---|---|
| (a) Overall results | ||||
| Cytokines | ||||
| IL-1β | –0.02 (1.25) | –0.16 (1.16) | 0.04 (–0.17, 0.25) | 0.708 |
| IL-2 | –0.16 (1.59) | –0.16 (1.34) | –0.16 (–0.41, 0.09) | 0.206 |
| IL6-M | 0.21 (1.26) | –0.05 (0.97) | 0.20 (0.00, 0.41) | 0.049 |
| IL6-E (month 1) | 0.43 (0.76) | 0.06 (0.78) | 0.26 (0.06, 0.46) | 0.010 |
| IL-7 | –0.05 (1.02) | –0.10 (0.90) | –0.07 (–0.22, 0.09) | 0.400 |
| IL-8 | 0.08 (0.77) | –0.03 (0.69) | 0.09 (–0.04, 0.21) | 0.168 |
| IL-12 p70 | –0.29 (1.82) | –0.16 (1.49) | –0.34 (–0.63, –0.05) | 0.022 |
| IL-17 | –0.41 (1.43) | –0.02 (1.03) | –0.44 (–0.65, –0.23) | <0.001 |
| TNFα | 0.35 (0.70) | –0.08 (0.62) | 0.34 (0.24, 0.45) | <0.001 |
| IFNγ | –0.17 (1.63) | –0.25 (1.46) | –0.03 (–0.29, 0.24) | 0.854 |
| GM-CSF | –0.30 (1.76) | 0.05 (1.43) | –0.40 (–0.68, –0.12) | 0.006 |
| IL-4 | –0.20 (2.51) | –0.28 (1.89) | –0.06 (–0.45, 0.34) | 0.785 |
| IL-5 | –0.13 (1.45) | –0.11 (1.16) | –0.13 (–0.36, 0.10) | 0.270 |
| IL-10 | 0.34 (1.08) | –0.13 (0.88) | 0.33 (0.18, 0.49) | <0.001 |
| IL-13 | –0.26 (2.48) | –0.19 (2.08) | –0.11 (–0.54, 0.31) | 0.599 |
| CXCL10 | 0.62 (0.87) | –0.04 (0.65) | 0.66 (0.53, 0.79) | <0.001 |
| DC vs. VS; adjusted differencesb (95% CI) |
||||||
|---|---|---|---|---|---|---|
| Biomarker |
||||||
| IL6-M | IL-12 | IL-17 | TNFα | IL-10 | CXCL10 | |
| (b) Biomarkers levels according to baseline subgroups | ||||||
| Characteristics | ||||||
| Sex | ||||||
| Male | 0.18 (–0.06, 0.42) | –0.35 (–0.68, –0.01) | –0.52 (–0.76, –0.27) | 0.36 (0.24, 0.49) | 0.31 (0.13, 0.49) | 0.61 (0.46, 0.76) |
| Female | 0.27 (–0.13, 0.67) | –0.31 (–0.88, 0.25) | –0.24 (–0.66, 0.17) | 0.29 (0.08, 0.50) | 0.40 (0.09, 0.70) | 0.80 (0.54, 1.06) |
| Interaction test P-value | 0.71 | 0.92 | 0.26 | 0.54 | 0.63 | 0.21 |
| Age, years | ||||||
| <45 | 0.31 (0.01, 0.60) | –0.37 (–0.79, 0.05) | –0.43 (–0.73, –0.12) | 0.40 (0.25, 0.55) | 0.43 (0.20, 0.65) | 0.71 (0.52, 0.90) |
| >45 | 0.12 (–0.17, 0.40) | –0.29 (–0.70, 0.11) | –0.47 (–0.77, –0.18) | 0.32 (0.17, 0.46) | 0.27 (0.05, 0.48) | 0.63 (0.44, 0.81) |
| Interaction test P-value | 0.36 | 0.79 | 0.83 | 0.43 | 0.31 | 0.56 |
| Ethnicity | ||||||
| Black | 0.11 (–0.21, 0.42) | –0.33 (–0.78, 0.12) | –0.64 (–0.97, –0.31) | 0.37 (0.21, 0.54) | 0.31 (0.07, 0.55) | 0.63 (0.42, 0.83) |
| White/other | 0.27 (0.01, 0.54) | –0.35 (–0.73, 0.03) | –0.30 (–0.58, –0.02) | 0.32 (0.19, 0.46) | 0.35 (0.15, 0.55) | 0.68 (0.51, 0.86) |
| Interaction test P-value | 0.43 | 0.95 | 0.12 | 0.66 | 0.81 | 0.69 |
| Class of third drugc | ||||||
| PI based | 0.12 (–0.18, 0.42) | –0.58 (–1.00, –0.17) | –0.38 (–0.69, –0.07) | 0.29 (0.13, 0.45) | 0.42 (0.18, 0.65) | 0.69 (0.48, 0.89) |
| NNRTI based | 0.32 (0.02, 0.62) | 0.10 (–0.32, 0.52) | –0.49 (–0.80, –0.18) | 0.38 (0.22, 0.54) | 0.31 (0.07, 0.54) | 0.67 (0.46, 0.88) |
| Interaction test P-value | 0.35 | 0.02 | 0.64 | 0.43 | 0.52 | 0.90 |
| Co-infected | ||||||
| No | 0.21 (–0.02, 0.43) | –0.27 (–0.59, 0.04) | –0.44 (–0.68, –0.21) | 0.36 (0.24, 0.48) | 0.38 (0.20, 0.55) | 0.75 (0.60, 0.89) |
| Yes | 0.14 (–0.35, 0.63) | –0.73 (–1.43, –0.03) | –0.39 (–0.90, 0.13) | 0.24 (–0.02, 0.50) | 0.08 (–0.29, 0.46) | 0.20 (–0.12, 0.52) |
| Interaction test P-value | 0.81 | 0.25 | 0.84 | 0.40 | 0.17 | 0.002 |
CI, confidence interval; DC, drug conservation; GM-CSF, granulocyte macrophage colony-stimulating factor; IFN, interferon; IL, interleukin; NNRTI, nonnucleoside reverse transcriptase inhibitor; PI, protease inhibitor; TNF, tumor necrosis factor; VS, viral suppression.
a
Model includes baseline level of marker (natural logarithmic scale).
b
Adjusted for baseline using analysis of covariance.
c
Thirty-three patients receiving both/neither NNRTI and PI were excluded.