title: 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.
abstract: 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.
authors.affiliation: Department of Pediatrics, Teaching Hospital Center Sourô Sanou, Bobo-Dioulasso, Burkina Faso.
authors.forename: Makoura
authors.initials: M
authors.lastname: Barro
authors.forename: Jérôme
authors.initials: J
authors.lastname: Some
authors.forename: Vincent
authors.initials: V
authors.lastname: Foulongne
authors.forename: Yaya
authors.initials: Y
authors.lastname: Diasso
authors.forename: Emmanuelle
authors.initials: E
authors.lastname: Zouré
authors.forename: Hervé
authors.initials: H
authors.lastname: Hien
authors.forename: Rouet
authors.initials: R
authors.lastname: François
authors.forename: Segondy
authors.initials: S
authors.lastname: Michel
authors.forename: Aly
authors.initials: A
authors.lastname: Drabo
authors.forename: Hassane
authors.initials: H
authors.lastname: Tamboura
authors.forename: Adama
authors.initials: A
authors.lastname: Ouiminga
authors.forename: Serge
authors.initials: S
authors.lastname: Diagbouga
authors.forename: Alain
authors.initials: A
authors.lastname: Hien
authors.forename: Souleymane
authors.initials: S
authors.lastname: Yaméogo
authors.forename: Philippe
authors.initials: P
authors.lastname: Van De Perre
authors.forename: Boubacar
authors.initials: B
authors.lastname: Nacro
authors.forename: Philippe
authors.initials: P
authors.lastname: Msellati
mesh_terms: D000480:Alkynes; D048588:Benzoxazines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D018791:CD4 Lymphocyte Count; D002648:Child; D003521:Cyclopropanes; D016049:Didanosine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D015658:HIV Infections / Q000188:drug therapy* / Q000276:immunology / Q000821:virology; D006801:Humans; D019259:Lamivudine / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D008297:Male; D010349:Patient Compliance; D018894:Reverse Transcriptase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D019562:Viral Load
chemical_list: D000480:Alkynes; D048588:Benzoxazines; D003521:Cyclopropanes; D018894:Reverse Transcriptase Inhibitors; D019259:Lamivudine; C098320:efavirenz; D016049:Didanosine