Background
HIV-infected children receiving antiretroviral therapy (ART) have increased prevalence of hyperlipidemia and risk factors for cardiovascular disease. No studies have investigated the efficacy and safety of statins in this population.
Methods
HIV-infected youth aged 10 - < 24 years on stable ART with low-density lipoprotein-cholesterol (LDL-C) ≥130 mg/dL for ≥ 6 months initiated atorvastatin 10mg once daily. Atorvastatin was increased to 20mg if LDL-C efficacy criteria (LDL-C < 110 mg/dL or decreased ≥30% from baseline) were not met at week 4. Primary outcomes were safety and efficacy.
Results
Twenty-eight youth initiated atorvastatin; 7 were 10 - 15 years and 21 were 15 - 24 years. Mean baseline LDL-C was 161mg/dL (sd 19mg/dL). Efficacy criteria were met at week 4 by 17/27(63%). Atorvastatin was increased to 20mg in 10 participants. Mean LDL-C decreased from baseline by 30% (90% CI: 26%, 35%) at week 4, 28% (90% CI: 23%, 33%) at week 24, and 26% (90% CI: 20%, 33%) at week 48. LDL-C was less than 110 mg/dL in 44% at week 4, 42% at week 12, and 46% at weeks 24 and 48.Total cholesterol (TC), non-high-density lipoprotein (non-HDL)-C and apolipoprotein B (ApoB) decreased significantly, but IL-6 and high-sensitivity C-reactive protein did not. Two participants in the younger age group discontinued study for toxicities possibly related to atorvastatin.
Conclusions
Atorvastatin lowered TC, LDL-C, non-HDL-C and ApoB in HIV-infected youth with ART-associated hyperlipidemia. Atorvastatin could be considered for HIV-infected children with hyperlipidemia, but safety monitoring is important particularly in younger children.