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Body Composition and Metabolic Changes in Antiretroviral-Naïve HIV-Infected Patients Randomized to Didanosine and Stavudine (ddI+d4T) vs. Abacavir and Lamivudine (ABC+3TC).

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Body Composition and Metabolic Changes in Antiretroviral-Naïve HIV-Infected Patients Randomized to Didanosine and Stavudine (ddI+d4T) vs. Abacavir and Lamivudine (ABC+3TC)

J. Shlay, F. Visnegarwala, G. Bartsch, J. Wang, G. Peng,W. El-Sadr, C. Gibert, D. Kotler, C. Grunfeld, S. Raghavanfor the Terry Beirn Community Programs for Clinical Research on AIDS (CPCRA)

XV International AIDS Conference

Abstract # ThOrB1360

objectives
Objectives
  • To compare the rates of change in body composition and various metabolic parameters in antiretroviral naïve patients randomized to ddI+d4T vs. ABC+3TC containing regimens in the presence of highly active antiretroviral therapy
background
Background
  • Lipodystrophy has been associated with the use of thymidine analogue nucleoside reverse transcriptase inhibitors, particularly d4T
  • Few prospective studies have compared body composition changes in thymidine analogue-sparing regimens to thymidine analogue-containing regimens
slide4

Patient meets eligibility requirements

Randomized to 3 strategy arms (1:1:1)

N=1,397

(422 inMetabolic Substudy)

PI + NRTI

N=470

NNRTI + NRTIN=463

PI + NNRTI + NRTI

N=464

Allowed additional randomization to NRTI Substudy (1:1)

N=182

ddI+d4T

N = 89

(46 in Metabolic Substudy)

ABC+3TC

N = 93

(50 in Metabolic Substudy)

C•P•C•R•A

methods
Methods
  • At baseline and every 4 months, the following measurements were obtained:
    • Anthropometric measurements:
      • centralized and standardized training; re-certification annually
      • height, weight, body mass index (BMI),
      • body circumferences: arm, waist, hip, thigh
      • skinfolds: triceps, suprascapular, subscapular, abdomen, thigh
    • body cell mass (BCM), total body fat (TBF) using BIA
    • Metabolic parameters: triglycerides, total cholesterol, HDL, LDL, VLDL, glucose, insulin (all also done at 1 month)
baseline characteristics 1
Baseline Characteristics - 1

ddI+d4T*

N = 46

ABC+3TC*

N = 50

Age (yrs) 38 35

Female (%) 30 26

Race (%)Non-white 76 76

Mean CD4 cells/mm3 268 234

Mean logRNA copies/ml 4.85 5.03

Initial PI (%) 70 70

* No significant differences between treatment arms

baseline characteristics 2
Baseline Characteristics - 2

ddI+d4T*

N = 46

ABC+3TC*

N = 50

Body compositionBMI (kg/m2) 25.0 24.7

BCM (kg) 26.5 26.6

TBF (kg) 17.4 16.6

Circumferences (cm)Waist 86.1 85.1Hip 99.6 97.6

Skinfold fat area (cm2)Mid-arm 20.7 21.6Waist 77.4 74.7

* No significant differences between treatment arms

baseline characteristics 3
Baseline Characteristics - 3

ddI+d4T*

N = 46

ABC+3TC*

N = 50

Triglycerides (mg/dL) 129.3 124.6

Total cholesterol (mg/dL) 177.3 161.4HDL cholesterol (mg/dL) 41.3 36.7LDL cholesterol (mg/dL) 111.8 99.8

Glucose (mg/dL) 82.4 83.0

Insulin (µ/mL) 9.4 11.6

Insulin resistance (HOMA)†: 2.1 2.5

* No significant differences between treatment arms

† Insulin resistance = (0.0555 x glucose x insulin / 22.5)

rates of change of body mass index

Change(kg/m2/month)

SE

P-value

ddI+d4T -0.02 0.02 0.01

ABC+3TC 0.04 0.02

C•P•C•R•A

Rates of Change of Body Mass Index

Body Mass Index (kg/m2)

-2 -1 0 1 2 3 4

Mean Change from Baseline

0 4 8 12 16 20 24 28 32

No. of Patients

Months

46 45 41 44 26 35 36 31 20

50 49 47 45 27 39 39 34 22

ddI+d4T

ABC+3TC

rates of change of body composition

0 4 8 12 16 20 24 28 32

Months

Change(kg/month)

SE

P-value

ddI+d4T 0.02 0.01 0.30

ABC+3TC 0.04 0.01

C•P•C•R•A

* As measured by BIA

Rates of Change of Body Composition

Body Cell Mass* (kg)

Total Body Fat* (kg)

Mean Change from Baseline

Mean Change from Baseline

-5 0 5 10

-2 0 2 4

0 4 8 12 16 20 24 28 32

Months

Change(kg/month)

SE

P-value

ddI+d4T -0.08 0.04 <0.01

ABC+3TC 0.08 0.04

rates of change of circumferences

C•P•C•R•A

Rates of Change of Circumferences

Waist (cm)

Hip (cm)

0 5 10

-15 -10 -5 0 5 10 15

Mean Change from Baseline

Mean Change from Baseline

0 4 8 12 16 20 24 28 32

0 4 8 12 16 20 24 28 32

Months

Months

Change(cm/month)

SE

P-value

Change(cm/month)

SE

P-value

ddI+d4T -0.02 0.05 0.14

ABC+3TC 0.07 0.04

ddI+d4T -0.18 0.06 <0.01

ABC+3TC 0.10 0.06

rates of change of skinfold fat areas

C•P•C•R•A

Rates of Change of Skinfold Fat Areas

Mid

-

arm

(cm2)

Waist (cm2)

-5 0 5 10

-40 -20 0 20 40 60 80

Mean Change from Baseline

Mean Change from Baseline

0 4 8 12 16 20 24 28 32

0 4 8 12 16 20 24 28 32

Months

Months

Change(cm2/month)

SE

P-value

Change(cm2/month)

SE

P-value

ddI+d4T -0.21 0.06 <0.01

ABC+3TC 0.05 0.06

ddI+d4T -0.62 0.29 <0.01

ABC+3TC 0.62 0.27

rates of change of fat free areas

C•P•C•R•A

Rates of Change of Fat Free Areas

Mid

-

arm

(cm2)

Waist (cm2)

0 50 100

-5 0 5 10 15

Mean Change from Baseline

Mean Change from Baseline

0 4 8 12 16 20 24 28 32

0 4 8 12 16 20 24 28 32

Months

Months

Change(cm2/month)

SE

P-value

Change(cm2/month)

SE

P-value

ddI+d4T 0.01 0.06 0.81

ABC+3TC 0.03 0.06

ddI+d4T 0.32 0.56 0.91

ABC+3TC 0.41 0.53

rates of change of metabolic parameters

C•P•C•R•A

Rates of Change of Metabolic Parameters

LDL Cholesterol* (mg/dL)

HDL Cholesterol (mg/dL)

-5 0 5 10 15 20

Mean Change from Baseline

Mean Change from Baseline

-20 0 20 40

0 4 8 12 16 20 24 28 32

0 4 8 12 16 20 24 28 32

Months

Months

Change(mg/dL/month)

SE

P-value

Change(mg/dL/month)

SE

P-value

ddI+d4T -0.66 0.16 0.08

ABC+3TC -0.26 0.16

ddI+d4T --0.11 0.08 0.03

ABC+3TC 0.13 0.08

* If triglycerides ≥400, direct LDL, otherwise calculated LDL

rates of change of metabolic parameters1

C•P•C•R•A

Rates of Change of Metabolic Parameters

Insulin (µ/mL)

Triglycerides (mg/dL)

Mean Change from Baseline

Mean Change from Baseline

--50 0 50 100 150

-10 0 10 20

0 4 8 12 16 20 24 28 32

0 4 8 12 16 20 24 28 32

Months

Months

Change(mg/dL/month)

SE

P-value

Change(µ/month)

SE

P-value

ddI+d4T 2.14 0.87 0.08

ABC+3TC 0.07 0.83

ddI+d4T 0.12 0.09 0.57

ABC+3TC 0.05 0.09

conclusions i
Conclusions - I
  • After initiation of HAART, an initial increase was seen in all body composition parameters (i.e., BMI, BCM, total and subcutaneous fat), regardless of the treatment arms
  • Progressive loss of total and regional fat was observed in the ddI+d4T arm compared to the ABC+3TC arm after the initial period, indicating a differential treatment effect
  • Significant early and sustained increases in insulin and insulin resistance was seen in the ddI+d4T arm compared to ABC+3TC, despite a similar proportion of PI use for each arm
conclusions ii
Conclusions - II
  • The differential effects on lipid metabolism and insulin by treatment assignment necessitate close clinical monitoring and ongoing longitudinal assessment
  • Our study, using anthropometric measurements, yielded data consistent with the other studies that have utilized DEXA scans, supporting the use of these simple measures