Published online February 16, 2007
PEDIATRICS Vol. 119 No. 3 March 2007, pp. e705-e715 (doi:10.1542/peds.2006-1367)
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ARTICLE

Once-Daily Highly Active Antiretroviral Therapy for HIV-Infected Children: Safety and Efficacy of an Efavirenz-Containing Regimen

Henriëtte J. Scherpbier, MD, PhDa, Vincent Bekker, MD, PhDa, Dasja Pajkrt, MD, PhDa, Suzanne Jurriaans, PhDb, Joep M. A. Lange, MD, PhDc,d,e and Taco W. Kuijpers, MD, PhDa

a Emma Children's Hospital
b Department of Human Retrovirology
c Center for Poverty-Related Communicable Diseases
d Department of Internal Medicine, Academic Medical Center, Amsterdam, Netherlands
e International Antiviral Therapy Evaluation Center, Amsterdam, Netherlands

OBJECTIVE. To improve adherence and virologic suppression, we assessed the feasibility and effectiveness of a once-daily regimen of efavirenz with 3 nucleoside reverse transcriptase inhibitors as first-line or second-line highly active antiretroviral therapy in a cohort of HIV-1–infected children.

METHODS. HIV-1–infected children naive to efavirenz were treated with a combination of efavirenz, abacavir, didanosine, and lamivudine in an observational, prospective, single-center study. Virologic failure-free survival was assessed with Kaplan-Meier analysis. The CD4+ T-cell increase was estimated by using a generalized linear model incorporating repeated measurements.

RESULTS. Thirty-six children received the study medication for a median of 69 weeks. Virologic failure-free survival rates were 76% and 67% after 48 weeks and 96 weeks, respectively. No significant difference was found in efficacy between first-line and second-line highly active antiretroviral therapy. All children receiving highly active antiretroviral therapy showed a sustained CD4+ T-cell increase, irrespective of virologic suppression. Growth rates improved with highly active antiretroviral therapy. Study medication administration was stopped for 14 children, mostly because of nonadherence (4 cases) or virologic rebound (5 cases) and because of adverse events (unrelated death and grade 2 liver toxicity) in 2 cases. Lipid abnormalities and abacavir-related hypersensitivity were not observed.

CONCLUSIONS. For the first time, once-daily highly active antiretroviral therapy is demonstrated to be a safe, convenient, and potent antiretroviral regimen for HIV-1–infected children.

Key Words: pediatric HIV • once-daily highly active antiretroviral therapy • efficacy • efavirenz • growth

Abbreviations: ART—antiretroviral therapy • HAART—highly active antiretroviral therapy • IQR—interquartile range • LLQ—lower limit of quantification • NNRTI—nonnucleoside reverse transcriptase inhibitor • NRTI—nucleoside reverse transcriptase inhibitor • PI—protease inhibitor • pVL—plasma viral load • RT—reverse transcriptase

Accepted Sep 15, 2006.




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