Once daily integrase inhibitor (INSTI) with boosted darunavir is non-inferior to standard of care in virologically suppressed children – Week 48 results of the SMILE Penta-17 Trial
Authors: Compagnucci A, Chan M, Saïdi Y, Cressey T, Bamford A, Riault Y, Coelho A, Nolan A, Chalermpantmetagul S, Amuge P, Musiime V, Violari A, Cotton M, Kekitiinwa A, Kaudha E,Groenewald M, Liberty A, Kanjanavanit S, Volokha A, Bologna R, Pavia Ruz N, Prieto Tato L, Paioni P, Marques L, Reliquet V, Welch S, Ford D, Giaquinto C, Gibb D, Babiker A, Ramos Amador JT, The SMILE-PENTA17-ANRS 152 Trial Group
Published in: IAS 2021
Background and overall aim: Current antiretroviral therapy (ART) guidelines recommend triple-drug ART as treatment of choice in HIV-infected adolescents and children with NRTI as backbone. However, NRTIs can be a potent source of adverse effects which are usually dose-related and cumulative. To reduce cumulative NRTI exposure in children, alternative NRTI-sparing ART regimens with a high generic barrier to resistance are available and may be an attractive switching option for children. The overall aim of SMILE is to evaluate antiviral efficacy and safety of once daily INSTI+DRV/r compared to current SOC therapy in HIV-1 infected, virologically suppressed paediatric participants.
Hypothesis: Children with chronic HIV infection on ART with suppressed viral load will maintain similar levels of viral suppression with once daily INSTI + DRV/r compared to continued standard of care triple ART.