PREDICT was a 144-week randomised trial of immediate ART (at CD4 15-24%) versus deferred nevirapine-based ART (at CD4 <15%) conducted in ART-naive Thai and Cambodian children 1-12 years of age with baseline CD4 between 15-24%.1
Suparat Kanjanavanit showed findings from a substudy of PREDICT -- in which the children's fasting lipid profile was compared between arms -- in an oral presentation at IAC 2012.
The study included data from 263 children. Of these, 129 received immediate ART and 194 deferred starting ART. At the time of analysis, 60 children in the deferred arm had started ART and 143 had not started ART.
At baseline, the children's median (IQR) age was 6.5 (4.1-8.5) years, 58% were girls and 57% were Thai. Their median fasting time was 8 hours. There were no significant differences between study arms in clinical characteristics at week 0, see Table 1.
Abnormal lipid levels were defined as: total cholesterol > 200 mg/dL; LDL-cholesterol > 130 mg/dL; HDL-cholesterol ≤ 40 mg/dl and triglyceride > 130 mg/dL.
At week 144, 60 children in the deferred had started ART. At this time point the investigators found dyslipidemia to be significantly less in the immediate arm. They also found the immediate arm had significantly higher total cholesterol (TC), low-density lipoprotein (LDL), and high-density lipoprotein (HDL) but lower triglyceride and TC/HDL ratio than the deferred arm.
In multivariate analysis, the mean differences over 144 weeks between the immediate arm and the deferred arm without ART (n=73) were significant for all lipid parameters, see Table 2.
|Table 1: Clinical Characteristics at Week 0 and 144|
|Parameters||Week 0||Week 144||Immediate||Deferred|
|VL (log10 c/mL)||4.9||4.7||1.7||3.4*|
WAZ= weight for age z-score, HAZ = height for age z-score
|Table 2: Treatment Effects on Lipid Profiles|
|Lipid Profiles||Immediate (n=129) vs Deferred Not Started ART (n=143)||Immediate (n=129) vs Deferred Started ART (n=60)|
|Mean Difference (95% CI)||p||Mean Diff. (95% CI)||p|
|Total cholesterol||20.2 (15.9 to 24.5)||<0.001||3.2 (-2.1 to 8.6)||0.24|
|Triglyceride||-9.8 (-16.8 to -2.8)||0.006||-8.1 (-16.2 to 0.04)||0.05|
|LDL||9.1 (5.5 to 12.9)||<0.001||-0.7 (-4.0 to 5.5)||0.76|
|HDL||13 (10.8 to 15.3)||<0.001||4.9 (2.1 to 7.8)||0.001|
Dr Kanjanavanit noted that the overall rate of dyslipidemia was reduced from 64% to 37% in immediate treatment arm but increased to 78% in the deferred not starting ART arm.
He also noted that although this comparison was made in a substudy of a randomised trial, the small number of children and short duration of ART in the deferred arm are limitations to the findings.
He concluded, "After 3 years of follow-up, nevirapine-based initiation achieved favourable lipid profile in children with mild to moderate HIV-associated immune deficiency. Less dyslipidemia was found in treatment group compared to deferred group."
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