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Table 1

From: Metabolic: week 48 comparison of metabolic parameters and biomarkers in subjects receiving darunavir/ritonavir or atazanavir/ritonavir

Changes in metabolic and efficacy parameters from baseline to Week 48      
  DRV/r   ATV/r   Difference in mean change between arms, (95% CI)
  BL Change from BL at Week 48 BL Change from BL at Week 48  
Fasting lipid parametersa      
TG, mg/dL      
Mean (SD) 114 (57) 26 (69) 114 (84) 10 (74) 16.5 (—25.0, 58.0)
Median (IQR) 87 (77, 153) 11 (—15, 37) 90 (65, 119) 15 (—24, 54)  
TC, mg/dL      
Mean (SD) 142 (28) 22 (31) 165 (30) 12 (32) 10.5 (—7.7, 28.8)
Median (IQR) 136 (122, 159) 22 (10, 40) 163 (140, 183) 13 (—11, 29)  
LDL, mg/dL      
Mean (SD) 85 (22) 15 (26) 100 (24) 14 (27) 0.8 (—14.6, 16.3)
Median (IQR) 81 (71, 101) 17 (1, 30) 104 (79, 117) 8 (—7, 33)  
HDL, mg/dL      
Mean (SD) 38 (13) 6 (7) 45 (14) 4 (10) 2.3 (—2.8, 7.3)
Median (IQR) 37 (28, 44) 6 (2, 10) 44 (39, 49) 2 (—2, 11)  
TC/HDL ratio      
Mean (SD) 4.1 (1.14) 0.1 (1.06) 3.9 (1.02) —0.1 (0.75) 0.20 (—0.34, 0.75)
Median (IQR) 4.08 (3.41, 4.90) 0.05 (—0.62, 0.67) 3.87 (3.10, 4.24) —0.08 (—0.54, 0.26)  
Apo A1, mg/dL      
Mean (SD) 115 (26) 12 (16) 128 (22) 3 (19) 9.7 (—0.5, 19.8)
Median (IQR) 112 (96, 127) 11 (—1, 27) 127 (112, 132) 3 (—11, 19)  
Apo B, mg/dL      
Mean (SD) 74.5 (19) 4 (21) 81.7 (18.5) 2 (17) 2.0 (—9.3, 13.4)
Median (IQR) 72 (64, 84) 3 (—3, 15) 81 (66, 95) 4 (—10, 12)  
Apo B/A1 ratio      
Mean (SD) 0.68 (0.20) 0.68 (0.25) 0.65 (0.16) 0.66 (0.17) —0.02 (—0.125, 0.079)
Median (IQR) 0.67 (0.55, 0.82) 0.63 (0.51, 0.79) 0.64 (0.56, 0.73) 0.68 (0.54, 0.78)  
Fasting glucose, fasting insulin and HOMA-IR, b mean (SD)      
Glucose, mg/dL 89 (12) 3 (9) 90 (11) 6 (22) —3.6 (—12.8, 5.6)
Insulin, uIU/mL 6 (6) 1 (6) 9 (14) —3 (17) 3.8 (—3.0, 10.6)
HOMA-IR 1.62 (1.70) 0.04 (2.26) 2.94 (6.02) —1.24 (8.01) 1.27 (—2.66, 5.20)
Creatinine clearance, b mean (SD)      
Creatinine clearance, mL/min 107.6 (28.7) —0.00 (0.288) 110.9 (27.9) —0.03 (0.244) 0.03 (—0.12, 0.18)
Biomarkers, b mean (SD)      
IL-1 Beta, pg/mL 0.2 (0.3) 0.3 (1.4) 0.3 (0.3) —0.1 (0.3) 0.40 (—0.22, 1.04)
IL-6, pg/mL 1.9 (1.9) 0.2 (7.3) 1.0 (1.3) 0.3 (0.9) —0.08 (—3.24, 3.08)
hs-CRP, mg/L 3.1 (5.2) 1.2 (11.2) 2.2 (2.5) 0.6 (5.1) 0.65 (—4.55, 5.85)
TNF-alpha, pg/mL 4207 (1702) —1384 (1722) 2957 (727) —442 (722) —942.1 (—1735.3, —149.0)
LPS, pg/mL 85 (29) —18 (35) 87 (31) —17 (51) —1.4 (—25.6, 22.9)
D-dimer, ng/mL 373 (580) —192 (587) 189 (111) —24 (144) —168.0 (—432.2, 96.2)
Fibrinogen, g/L 3.3 (1.1) —0.3 (1.1) 3.2 (0.7) —0.3 (0.9) 0.02 (—0.60, 0.61)
Efficacy parameters, b mean (SD)      
Viral load, log10 copies/mL 5.0 (0.8) —3.3 (0.8) 4.6 (0.7) —2.9 (0.7) —0.4 (—0.8, 0.1)
CD4+ cell count, cells/mm3 268.3 (144.2) 217.4 (116.8) 326.7 (174.1) 205.3 (153.5) 12.1 (—61.8, 86.1)
  1. aLipid evaluable set; bITT-observed (sample size varies by time point and parameter);
  2. DRV/r, darunavir/ritonavir; ATV/r, atazanavir/ritonavir; BL, baseline; CI, confidence interval; TG, triglycerides;
  3. SD, standard deviation; IQR, interquartile range; TC, total cholesterol; LDL, low-density lipoprotein;
  4. HDL, high-density lipoprotein; Apo, apolipoprotein; HOMA-IR, homeostasis model assessment-estimated insulin resistance;
  5. IL, interleukin; hs-CRP, high-sensitivity c-reactive protein; TNF, tumor necrosis factor; LPS, lipopolysaccharide;
  6. ITT, intent-to-treat