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Session 100
Poster Abstracts Dyslipidemias and Body Fat Abnormalities: Incidence, Risk Factors, Response to Therapy Monday, 1:30 - 3:30 pm Poster Hall |
Background: Lipid abnormalities and body fat redistribution are common in HIV-infected patients receiving antiretroviral (ARV) therapy, and assessment of the effect of new ARV drugs on these safety issues is essential.
Methods: Prospective, double-blind, randomized, controlled trial comparing 200 mg emtricitabine (FTC) once daily to standard doses of stavudine (d4T) twice daily within a background of ddI-EC plus efavirenz given once daily in 571 ARV-naïve, HIV-infected patients (mean age 36 years, 85% male). The mean change from baseline at week 72 in body weight (BW), body mass index (BMI), abdominal girth (AG), waist circumference (WC), hip circumference (HC), waste/hip ratio % (WHR), chest circumference (CC), fasting triglycerides (TRI), HDL cholesterol (HDL), total cholesterol (CHOL), LDL cholesterol (LDL), and glucose (GLUC) was compared using a stratum-adjusted 95% confidence interval for the difference between treatment arms.
Results: The significant superiority of FTC over d4T, both on efficacy and safety criteria, as long as week 60, has already been reported for the comparative phase of this clinical trial. The mean change from baseline at week 72 for the parameters described above are as follows:
|
|
BW (kg) |
BMI (kg/m2) |
AG (cm) |
WC (cm) |
HC (cm) |
WHR (%) |
CC (cm) |
TRI (mg/dL) |
HDL (mg/dL) |
LDL (mg/dL) |
CHOL (mg/dL) |
Gluc (mg/dL) |
|
FTC |
+1.2 |
+0.4 |
+0.9 |
+0.7 |
+0.6 |
0 |
+0.8 |
+27.7 |
+13.5 |
+17.4 |
+37.2 |
+4.2 |
|
d4T |
-1.7 |
-0.6 |
-0.8 |
-1.0 |
-1.7 |
+0.9 |
-1.1 |
+97.8 |
+8.8 |
+15.3 |
+43.8 |
+2.7 |
|
Δ FTC -
d4T |
+3.0 |
+1.0 |
+2.1 |
+2.0 |
+2.3 |
-1.3 |
+1.7 |
-60.6 |
+5.1 |
+1.6 |
-7.3 |
+0.6 |
|
p |
<0.05 |
<0.05 |
<0.05 |
<0.05 |
<0.05 |
NS |
<0.05 |
<0.05 |
<0.05 |
NS |
NS |
NS |
All differences that were statistically significant were in favor of the FTC treatment arm.
Conclusions: As part of a triple combination regimen with ddI plus efavirenz when compared with d4T, FTC was associated with a significantly more favorable lipid and body habitus profile over 72 weeks of follow-up.
Keywords: FTC; d4T; Lipoatrophy
