February 5, 2001
Results from PACTG 382 was presented by Courtney Fletcher. In that study, HIV-infected children who were NNRTI- and PI-naive were started on efavirenz and nelfinavir and one new NRTI. The primary results were published in the New England Journal of Medicine in 1999. This analysis involved the pharmacology focus whereby 50 study subjects had intensive pharmacokinetic (pK) studies performed at weeks two and six. The study was set up so that the pK results would be available quickly so that the area under the curve could be measured and doses adjusted after the week two results were available in order to hit a target level. Those data resulted in a change in the efavirenz doses in 50% of the children (usually increased) and an increase in 20% of the nelfinavir doses. Analysis of the virologic response demonstrated that children with higher AUCs for efavirenz and nelfinavir at week two had a more rapid decrease in plasma RNA levels. Those results seem to support efforts to optimize dosing of anti-HIV drugs soon after initiating therapy.
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