Table 3.
Median Changes From Baseline in Cellular Biomarkers and Median Log10 Change From Baseline in Soluble Biomarkers
| Biomarker | Week After Baseline | Treatment Arm | Subjects, No. | Median (IQR) Change From Baseline | 95% CI for Median Change | P Value |
|---|---|---|---|---|---|---|
| Cellular activation markers | ||||||
| HLA-DR+CD38+ CD8+ T cells, % | 2 | Rifaximin | 42 | 0.01 (−1.32 to 1.88) | −.63 to 1.12 | .34 |
| No study treatment | 22 | 0.30 (−0.25 to 1.98) | −.10 to 1.99 | |||
| 4 | Rifaximin | 43 | 0.00 (−1.70 to 1.00) | −.99 to 0.33 | .03 | |
| No study treatment | 22 | 0.64 (0.11–1.48) | .11 to 1.51 | |||
| 8 | Rifaximin | 41 | 0.01 (−1.84 to 0.89) | −1.11 to .50 | .72 | |
| No study treatment | 21 | −0.19 (−0.85 to 0.86) | −1.05 to 1.32 | |||
| Ki-67+ CD8+ T cells, % | 2 | Rifaximin | 42 | 0.00 (−0.26 to 0.26) | −.13 to .13 | .11 |
| No study treatment | 22 | 0.12 (−0.09 to 0.44) | .01 to .41 | |||
| 4 | Rifaximin | 43 | −0.12 (−0.27 to 0.12) | −.21 to .00 | .01 | |
| No study treatment | 22 | 0.12 (−0.07 to 0.27) | −.02 to .27 | |||
| 8 | Rifaximin | 41 | −0.07 (−0.18 to 0.11) | −.17 to .07 | .08 | |
| No study treatment | 21 | 0.12 (−0.04 to 0.23) | −.06 to .23 | |||
| Microbial translocation and monocyte activation markers | ||||||
| LPS, log10 pg/mL | 2 | Rifaximin | 43 | −0.01 (−0.09 to 0.02) | −.05 to .01 | .01 |
| No study treatment | 22 | 0.03 (−0.03 to 0.11) | −.01 to .15 | |||
| 4 | Rifaximin | 43 | 0.00 (−0.08 to 0.05) | −.04 to .02 | .44 | |
| No study treatment | 22 | −0.01 (−0.04 to 0.05) | −.02 to .05 | |||
| 8 | Rifaximin | 42 | −0.01 (−0.12 to 0.06) | −.06 to .03 | .22 | |
| No study treatment | 21 | 0.02 (−0.02 to 0.08) | −.03 to .08 | |||
| sCD14, log10 ng/mL | 2 | Rifaximin | 43 | −0.00 (−0.06 to 0.04) | −.04 to .02 | .03 |
| No study treatment | 22 | 0.05 (−0.02 to 0.13) | −.00 to .09 | |||
| 4 | Rifaximin | 43 | −0.03 (−0.07 to 0.06) | −.05 to .01 | .97 | |
| No study treatment | 22 | −0.03 (−0.05 to 0.01) | −.07 to .02 | |||
| 8 | Rifaximin | 42 | −0.04 (−0.09 to 0.03) | −.08 to −.01 | .049 | |
| No study treatment | 21 | 0.01 (−0.05 to 0.08) | −.03 to .07 | |||
| Soluble biomarkers | ||||||
| d-dimer, log10 ng/mL | 2 | Rifaximin | 42 | −0.03 (−0.09 to 0.09) | −.05 to .04 | .30 |
| No study treatment | 22 | 0.00 (−0.03 to 0.11) | −.02 to .08 | |||
| 4 | Rifaximin | 43 | −0.00 (−0.12 to 0.06) | −.07 to .03 | .33 | |
| No study treatment | 22 | −0.03 (−0.14 to 0.04) | −.11 to .01 | |||
| 8 | Rifaximin | 42 | −0.04 (−0.17 to 0.14) | −.09 to .04 | .23 | |
| No study treatment | 21 | 0.04 (−0.07 to 0.10) | −.04 to .14 | |||
| IL-6, log10 pg/mL | 2 | Rifaximin | 43 | 0.02 (−0.11 to 0.15) | −.07 to .07 | .94 |
| No study treatment | 22 | −0.05 (−0.11 to 0.20) | −.10 to .20 | |||
| 4 | Rifaximin | 43 | −0.03 (−0.14 to 0.08) | −.08 to .03 | .33 | |
| No study treatment | 22 | 0.05 (−0.13 to 0.12) | −.06 to .13 | |||
| 8 | Rifaximin | 42 | −0.05 (−0.18 to 0.07) | −.12 to .01 | .02 | |
| No study treatment | 21 | 0.05 (−0.08 to 0.18) | −.02 to .19 | |||
| CRP, log10 ng/mL | 2 | Rifaximin | 43 | 0.00 (−0.26 to 0.21) | −.14 to .08 | .14 |
| No study treatment | 22 | 0.04 (−0.09 to 0.32) | −.04 to .27 | |||
| 4 | Rifaximin | 43 | −0.08 (−0.29 to 0.15) | −.20 to .03 | .73 | |
| No study treatment | 22 | −0.09 (−0.21 to 0.16) | −.22 to .12 | |||
| 8 | Rifaximin | 42 | −0.04 (−0.26 to 0.13) | −.18 to .03 | .046 | |
| No study treatment | 21 | 0.09 (−0.02 to 0.28) | −.06 to .31 | |||
| sTNFR-II, log10 pg/mL | 2 | Rifaximin | 42 | −0.03 (−0.11 to 0.03) | −.08 to .01 | .04 |
| No study treatment | 22 | 0.04 (−0.06 to 0.17) | −.03 to .13 | |||
| 4 | Rifaximin | 42 | −0.04 (−0.17 to 0.09) | −.09 to .02 | .08 | |
| No study treatment | 22 | 0.07 (−0.05 to 0.13) | −.06 to .11 | |||
| 8 | Rifaximin | 42 | 0.04 (−0.07 to 0.12) | −.02 to .08 | .35 | |
| No study treatment | 21 | −0.01 (−0.15 to 0.10) | −.11 to .06 | |||
| sCD163, log10 ng/mL | 2 | Rifaximin | 43 | 0.01 (−0.04 to 0.05) | −.02 to .02 | .31 |
| No study treatment | 22 | 0.02 (−0.03 to 0.07) | −.01 to .06 | |||
| 4 | Rifaximin | 43 | 0.00 (−0.03 to 0.04) | −.02 to .02 | .30 | |
| No study treatment | 22 | 0.02 (−0.04 to 0.09) | −.01 to .07 | |||
| 8 | Rifaximin | 42 | 0.01 (−0.03 to 0.04) | −.02 to .03 | .48 | |
| No study treatment | 21 | 0.04 (−0.06 to 0.09) | −.02 to .08 | |||
Abbreviations: CI, confidence interval. CRP, C-reactive protein; HIV, human immunodeficiency virus; IL-6, interleukin 6; IQR, interquartile range; LPS, lipopolysaccharide; sCD14, soluble CD14; sCD163, soluble CD163; sTNFR-II, soluble tumor necrosis factor α receptor II.