Comparison of levels of antiretroviral drugs with efficacy in children with HIV infection.

OBJECTIVE: To determine the prevalence of low and high antiretroviral (ARV) plasma levels and to analyze correlation between ARV concentrations and the appearance of therapeutic failure and toxicity.
METHODS: The authors present here a study evaluating antiretroviral plasma concentrations in HIV infected children on nonnucleoside reverse transcriptase inhibitors and protease inhibitors based therapy. The authors carried out a multicentre, cross-sectional study, including HIV-infected children from five large Hospitals in Madrid, Spain. Clinical, haematological, biochemical and immuno-virological parameters were assessed. Antiretroviral plasma trough levels were performed using a validated high performance liquid chromatography method.
RESULTS: Between April 2006 and April 2008, 129 children were enrolled in the present study, with median treatment duration of 39.2 months. 25.5% of the non-nucleoside reverse transcriptase inhibitors levels were low and 17.6%, high. 27.9% percent of the protease inhibitors levels were low and 12.5%, high. A correlation was found among adequate or high levels of antiretrovirals and normal CD4 percentage and low viral load. Lopinavir/ritonavir plasma levels were correlated with an increase in lipodystrophy. Patients with Tanner stage 1 presented the lowest ARV plasma levels. Full adherence was reported for all the participants by a questionnaire.
CONCLUSION: Many HIV-infected children show ARV plasma levels out of the therapeutic range which demands a child-adjusted approach. However, larger studies are urgently needed in pediatric populations to define optimal reference values.