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Short-Term Virological Efficacy, Immune Reconstitution, Tolerance, and Adherence of Once-Daily Dosing of Didanosine, Lamivudine, and Efavirenz in HIV-1–Infected African Children: ANRS 12103 Burkiname

2011; Lippincott Williams & Wilkins; Volume: 57; Issue: Supplement 1 Linguagem: Inglês

10.1097/qai.0b013e31821fd64f

1944-7884

Makoura Barro, Jérôme W. Somé, Vincent Foulongne, Yaya Diasso, Emmanuelle Zouré, Hervé Hien, François Rouet, Segondy Michel, Aly Drabo, Hassane Tamboura, Adama Ouiminga, Serge Diagbouga, Alain Hien, Souleymane Yaméogo, Philippe Van de Perre, Boubacar Nacro, Philippe Msellati,

HIV Research and Treatment

Access to antiretroviral therapy (ART) and routine laboratory monitoring are limited for HIV-1-infected children from sub-Saharan Africa. This trial conducted in Bobo-Dioulasso, Burkina Faso, aimed to describe the biological efficacy, tolerance, and adherence of the combination of didanosine, lamivudine, efavirenz in once-daily administration among eligible HIV-1-infected children. From February 2006 to November 2007, 51 HIV-1-infected children aged from 30 months to 15 years and eligible for ART were enrolled in a phase II open clinical trial with follow-up visits every 3 months. HIV-1 genotype testing was performed in children with plasma viral load (PVL) >1000 copies per milliliter after ART initiation. Children were followed for a median of 13.4 months [interquartile range (IQR) 12.8-14.2]. At enrollment, median CD4 count was 8% (IQR = 4.5-12). PVL was 341,032 (IQR = 127,838-761,539) copies per milliliter. At 12 months, median CD4 increased significantly by +15% (P < 10(-3)), and median PVL decreases significantly by -290,500 copies per milliliter (P < 10(-4)). Hemoglobin and platelets counts increased significantly by +1.05 g/dL (P < 10(-5)) and 108,500 cells per milliliter (P < 10(-3)), respectively. Based on pill count, mean yearly adherence was 97.3%, and 48% of the children had an adherence rate ≥ 95% at the four quarterly visits. Adherence was better for girls than for boys independently of other sociodemographic variables or markers of HIV disease progression. Drug-resistant mutations were found in 11 children (21.6%). This once-daily drug combination is associated with excellent virological efficacy, immune reconstitution, and good adherence. However, the high prevalence of drug resistance mutations is a matter of concern.