PEDIATRICS Vol. 119 No. 3 March 2007, pp. e705-e715 (doi:10.1542/10.1542/peds.2006-1367)
ARTICLE |
Once-Daily Highly Active Antiretroviral Therapy for HIV-Infected Children: Safety and Efficacy of an Efavirenz-Containing Regimen
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.
![]()
CiteULike
Connotea
Del.icio.us
Digg
Facebook
Reddit
Technorati
Twitter What's this?
This article has been cited by other articles:
![]() |
U. Wintergerst, F. Hoffmann, A. Jansson, G. Notheis, K. Huss, M. Kurowski, and D. Burger Antiviral efficacy, tolerability and pharmacokinetics of efavirenz in an unselected cohort of HIV-infected children J. Antimicrob. Chemother., June 1, 2008; 61(6): 1336 - 1339. [Abstract] [Full Text] [PDF] |
||||





