February 7, 2001
In another take on the NNRTI-for-protease inhibitor substitution, this study took a first look at this strategy applied to a pediatric population. Children ages 1-18 were eligible if they were receiving protease inhibitor-based antiretroviral therapy for at least six months, had a viral load <400 x four months, and were NNRTI-naive.
A total of 15 patients were enrolled, with a mean age of around 10 years. Most had received extensive treatment with nucleoside analogues prior to starting the protease inhibitor-based therapy. Efavirenz was substituted for the PI in an open-label fashion.
At the end of a mean 32 weeks of follow-up (range 6-48 weeks), viral load remained <50 in all patients. There were no significant adverse events, and triglycerides, LDL cholesterol, and total cholesterol all decreased. No changes occurred in insulin levels or anthropometrics, except for a slight decrease in triceps skinfold thickness.
This study suggests that substituting efavirenz for the PI is virologically safe in children, and is overall well tolerated. The investigators also cite better adherence and quality of life for the children, although they do not present these data. The study is ongoing, with continued accrual and follow-up planned.
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