Efavirenz-based simplification after successful early lopinavir-boosted-ritonavir-based therapy in HIV-infected children in Burkina Faso and Côte d'Ivoire: The MONOD ANRS 12206 non-inferiority randomised trial

Désiré Lucien Dahourou, Madeleine Amorissani-Folquet, Karen Malateste, Clarisse Amani-Bosse, Malik Coulibaly, Carole Seguin-Devaux, Thomas Toni, Rasmata Ouédraogo, Stéphane Blanche, Caroline Yonaba, François Eboua, Philippe Lepage, Divine Avit, Sylvie Ouédraogo, Philippe Van de Perre, Sylvie N'Gbeche, Angèle Kalmogho, Roger Salamon, Nicolas Meda, Marguerite Timité-KonanValériane Leroy*, Lucien Dahourou Désiré Lucien Dahourou, Ouédraogo Colette Ouédraogo, Mamadou Sawadogo, Somé Wilfried Somé, Sondo Désiré Sondo, Elisabeth Thio, Mamadou Barry, William Hiembo, Kouéta Fla Kouéta, Adama Ouattara, Ouédraogo Moussa Ouédraogo, Ouédraogo Rasmata Ouédraogo, Ouédraogo Sylvie Ouédraogo, Bernadette Congo, Rose Barry, Diarra Yé, Malika Congo, Minéné Edouard Minéné, Marie Coulibaly, Pierre Innocent Guissou Angèle Kalmogho, Ludovic Kam, Ouédraogo Emile Ouédraogo, Sangaré Lassana Sangaré, Sylvestre Tiendrebeogo, Odette Ky-Zerbo, Xavier Anglaret, Amani-Bossé Clarisse Amani-Bossé, Carole Devaux, Jean Claude Schmit, on behalf of the MONOD Study Group

*Corresponding author for this work

Research output: Contribution to journalArticleResearchpeer-review

11 Citations (Scopus)

Abstract

Background: The 2016 World Health Organization guidelines recommend all children <3 years start antiretroviral therapy (ART) on protease inhibitor-based regimens. But lopinavir/ritonavir (LPV/r) syrup has many challenges in low-income countries, including limited availability, requires refrigeration, interactions with anti-tuberculous drugs, twice-daily dosing, poor palatability in young children, and higher cost than non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs. Successfully initiating LPV/r-based ART in HIV-infected children aged <2 years raises operational challenges that could be simplified by switching to a protease inhibitor-sparing therapy based on efavirenz (EFV), although, to date, EFV is not recommended in children <3 years. Methods: The MONOD ANRS 12026 study is a phase 3 non-inferiority open-label randomised clinical trial conducted in Abidjan, CÔte d'Ivoire, and Ouagadougou, Burkina Faso (ClinicalTrial.gov registry: NCT01127204). HIV-1-infected children who were tuberculosis-free and treated before the age of 2 years with 1215 months of suppressive twice-daily LPV/r-based ART (HIV-1 RNA viral load (VL) <500 copies/mL, confirmed) were randomised to two arms: once-daily combination of abacavir (ABC) + lamivudine (3TC) + EFV (referred to as EFV) versus continuation of the twice-daily combination zidovudine (ZDV) or ABC + 3TC + LPV/r (referred to as LPV). The primary endpoint was the difference in the proportion of children with virological suppression by 12 months post-randomisation between arms (14% non-inferiority bound, Chi-squared test).

Original languageEnglish
Article number85
JournalBMC Medicine
Volume15
Issue number1
DOIs
Publication statusPublished - 24 Apr 2017

Keywords

  • Africa
  • Early antiretroviral treatment
  • Efavirenz
  • HIV
  • Infants
  • Lopinavir
  • Protease inhibitors
  • Randomised clinical trial
  • Treatment simplification
  • Virological outcomes

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