Skip to main content

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
Back to article page

Journal of the International AIDS Society

ISSN: 1758-2652