Efficacy and toxicity of antiretroviral therapy using 4 or more agents: application of a strategy for antiretroviral management in human immunodeficiency virus-infected children.

OBJECTIVE: To characterize the long-term tolerance and virologic efficacy of combination antiretroviral therapy consisting of 4 or more agents in a clinical setting.
METHODS: An observational review of 36 children infected with human immunodeficiency virus 1 (HIV-1) treated with 4 or 5 antiretroviral agents in 2 university hospital clinics between April 1, 1996, and October 31, 2000. Highly active antiretroviral therapy regimens were chosen with regard to the child's past antiretroviral exposure or results of genotypic resistance data. Plasma HIV-1 RNA levels were monitored weekly to monthly after initiation of highly active antiretroviral therapy, and adherence efforts were actively supported and monitored. MAIN OUTCOME MEASURE: Number of children with undetectable plasma HIV-1 RNA levels at longest follow-up.
RESULTS: Four- or 5-drug highly active antiretroviral therapy reduced plasma HIV-1 RNA levels to less than 50 copies/mL in 32 (89%) of 36 children. After a median of 28.7 months of observation, 28 children (78%) remained at this level of suppression. Adverse reactions were limited to mild neutropenia and mild transient or persistent elevations in alanine aminotransferase levels in 11% of children.
CONCLUSIONS: Treatment with 4 or 5 antiretroviral agents was well tolerated in HIV-1-infected children and resulted in a high degree of viral suppression, even in children with previous antiretroviral drug experience.