Bulletin of the World Health Organization

Pharmacology and immuno-virologic efficacy of once-a-day HAART in African HIV-infected children: ANRS 12103 phase II trial

Boubacar Nacro, Emmanuelle Zoure, Hervé Hien, Hassane Tamboura, François Rouet, Adama Ouiminga, Ali Drabo, Souleymane Yameogo, Alain Hien, Hélène Peyriere, Olivier Mathieu, Deborah Hirt, Jean-Marc Treluyer, Joëlle Nicolas, Vincent Foulongne, Michel Segondy, Philippe van de Perre, Serge Diagbouga & Philippe Msellati

Volume 89, Number 6, June 2011, 451-458

Table 2. Median plasma concentrations of didanosine (DDI), lamivudine (3TC) and efavirenz (EFV) and proposed doses to reach effective target concentrations, ANRS 12103 trial, Bobo-Dioulasso, Burkina Faso, 2006–2007

Drug Cmin (mg/l) Median (IQR) Cmax (mg/l) Median (IQR) AUC0→24 (mg/l.h) Median (IQR) Target (mg/l) Recommended dose Proposed dose to reach target interval
DDI < 0.01 0.35 (0.23–0.67) 0.61 (0.35–1.70) This study AUC = 0.60 240 mg/m2 360 mg/m2
EFV 1.64 (1.08–2.56) 3.71 (2.88–5.22) 65.2 (48.1–91.9) This study: 1.1 < Cmin 13–15 kg: 200 mg 2–6 y: 25 mg/kg
Literature: Cmin < 4 15–20 kg: 250 mg 6–10 y: 15 mg/kg
20–25 kg: 300 mg 10–15 y: 10 mg/kg
25–32.5 kg: 350 mg
3TC 0.04 (0.01–0.14) 1.7 (1.34–2.01) 7.8 (4.72–14.27) Literature: AUCadult around 8.9 8 mg/kg < 17 kg: 10 mg/kg > 17 kg: 8 mg/kg

AUC, area under the curve; Cmax, maximal concentration; Cmin, minimal concentration; IQR, interquartile range; y, year.