Table 1.
Biomarker | Baseline, Median (IQR) | Week 8,a Median (IQR) | Week 16,b Median (IQR) | Week 8 vs Baseline | Week 16 vs Week 8 | ||
---|---|---|---|---|---|---|---|
Median Change (IQR) | P value | Median Change (IQR) | P value | ||||
Microbial translocation | |||||||
LPS level, pg/mL | 25.2 (21.3–29.8) | 25.3 (22.3–32.9) | 26.4 (21.4–32.0) | +0.2 (−4.1 to 5.8) | .87 | −2.4 (−8.0 to 2.7) | .30 |
sCD14 level, μg/mL | 1.81 (1.57–2.00) | 1.73 (1.53–2.05) | 1.78 (1.61–1.98) | −0.02 (−0.18 to 0.06) | .62 | +0.06 (−0.03 to 0.24) | .23 |
LBP level, μg/mL | 13.5 (12.0–17.4) | 14.1 (11.3–17.8) | … | +0.5 (−1.6 to 2.5) | .24 | … | |
EndoCAb level, GMU/mL | 134.9 (62.9–250.0) | 117.0 (61.2–212.7) | … | −5.8 (−21.8 to 12.9) | .13 | … | |
T-cell activation | |||||||
CD38+HLA-DR+ CD4 T cells, % | 10.3 (7.0–13.0) | 11.2 (6.8–13.4) | 10.2 (6.9–13.9) | +0.1 (−0.7 to 2.6) | 1.00 | +0.5 (−0.8 to 1.6) | .20 |
CD38+HLA-DR+ CD8 T cells, % | 36.0 (25.6–51.4) | 36.1 (24.0–53.6) | 34.3 (24.2–51.8) | −0.5 (−1.8 to 2.0) | .73 | −0.2 (−1.9 to 6.0) | 1.00 |
Ki67+ CD4 T cells, % | 3.45 (2.75–4.78) | 3.30 (2.45–5.00) | 3.90 (3.00–4.90) | +0.03 (−0.58 to 0.40) | 1.00 | +0.20 (−0.30 to 0.80) | .14 |
Ki67+ CD8 T cells, % | 4.18 (2.98–5.68) | 4.60 (2.55–5.50) | 5.00 (3.20–5.70) | +0.10 (−0.43 to 0.78) | 1.00 | 0.30 (−0.50 to 0.90) | .44 |
Inflammation and cardiovascular disease | |||||||
IL-6 level, pg/mL | 1.65 (1.23–2.20) | 1.71 (1.27–2.31) | 1.68 (1.20–3.08) | −0.02 (−0.58 to 0.63) | .87 | 0.19 (−0.43 to 1.07) | .39 |
CRP level, ng/mL | 1768 (883–4029) | 2199 (708–4249) | 2353 (834–4077) | +46 (−653 to 1540) | .62 | −34 (−493 to 527) | .39 |
IL-1β level, pg/mL | 0.23 (0.14–0.32) | 0.26 (0.12–0.35) | 0.24 (0.08–0.33) | +0.03 (−0.09 to 0.10) | .38 | −0.01 (−0.07 to 0.06) | .70 |
IP-10 level, pg/mL | 278 (198–463) | 287 (168–412) | 343 (201–4356) | −16 (−60 to 24) | .24 | +19 (−10 to 83) | .06 |
sCD163 level, ng/mL | 1006 (690–1352) | 968 (735–1236) | 991 (638–1398) | +8 (−117 to 98) | .87 | +29 (−72 to 119) | .86 |
Fetuin A level, mg/mL | 0.88 (0.46–1.34) | 0.55 (0.22–0.98) | 0.66 (0.30–1.16) | −0.34 (−0.70 to 0.22) | .41 | +0.05 (−0.23 to 0.70) | .61 |
Coagulation | |||||||
D-dimer level, ng/mL | 184 (122–313) | 201 (143–335) | 199 (113–277) | +20 (−16 to 75) | .03 | −17 (−66 to 26) | .39 |
sTF level, pg/mL | 41.8 (36.0–50.0) | 37.7 (35.3–43.3) | 43.6 (37.3–49.4) | −2.0 (−6.7 to 0.1) | .001 | +3.8 (0.0 to 8.0) | .002 |
Metabolic index | |||||||
Total cholesterol level, mg/dL | 172 (154–198) | 155 (141–191) | 169 (154–200) | −13 (−29 to 6) | .18 | +9 (−4 to 25) | .01 |
HDL cholesterol level, mg/dL | 42 (35–53) | 42 (35–51) | 41 (36–54) | +1 (−6 to 3) | .61 | +1 (−3 to 6) | .59 |
Non-HDL cholesterol level, mg/dL | 127 (105–158) | 117 (92–140) | 125 (110–140) | −12 (−25 to 2) | .02 | +4 (−2 to 24) | .04 |
Triglycerides level, mg/dL | 121 (93–178) | 123 (101–193) | 130 (74–154) | −4 (−13 to 41) | .50 | −3 (−56 to 7) | .16 |
LDL cholesterol level, mg/dL | 101 (83–122) | 81 (68–101) | 94 (85–116) | −18 (−32 to 2) | .009 | +14 (−1 to 33) | .01 |
oxLDL cholesterol level, U/L | 64.4 (60.6–81.7) | 58.2 (48.3–72.3) | 64.2 (54.8–77.8) | −7.3 (−16.8 to 1.7) | .01 | +5.3 (−5.1 to 16.2) | .06 |
Glucose level, mg/dL | 88 (80–93) | 88 (76–95) | 89 (80–99) | −2 (−12 to 2) | .24 | +2 (−3 to 12) | .22 |
HIV disease parameter | |||||||
HIV-1 RNA load, log10 copies/mL | 3.58 (2.95–4.02) | 3.44 (2.96–4.04) | 3.73 (3.12–4.24) | −0.02 (−0.12 to 0.10) | .38 | 0.16 (−0.11 to 0.31) | .01 |
CD4 T-cell count, cells/mm3 | 585 (494–716) | 630 (505–738) | 573 (477–701) | −14 (−70 to 45) | .29 | −1 (−93 to 69) | .61 |
P values of <.05 are considered statistically significant.
Abbreviations: CRP, C-reactive protein; EndoCAb, endotoxin core antibody; GMU, immunoglobulin G median units; HDL, high-density lipoprotein; IL-1β, interleukin 1β; IL-6, interleukin 6; IP-10, interferon γ–inducible protein 10; IQR, interquartile range; LBP, lipopolysaccharide-binding protein; LDL, low-density lipoprotein; LPS, lipopolysaccharide; oxLDL, oxidized low-density lipoprotein; sCD14, soluble CD14; sCD163, soluble CD163; sTF, soluble tissue factor.
a During sevelamer treatment.
b Eight weeks after cessation of sevelamer treatment.