Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial

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dc.contributor.authorAnna, Turkova
dc.contributor.authorEllen, White
dc.contributor.authorAdeodata, R. Kekitiinwa
dc.contributor.authorMumbiro, Vivian
dc.contributor.authorKaudha, Elizabeth
dc.contributor.authorAfaaf, Liberty
dc.contributor.authorAhimbisibwe, Grace Miriam
dc.contributor.authorMoloantoa, Tumelo
dc.contributor.authorUssanee, Srirompotong
dc.contributor.authorNozibusiso, Rejoice Mosia
dc.contributor.authorThanyawee, Puthanakit
dc.contributor.authorKobbe, Robin
dc.contributor.authorClàudia, Fortuny
dc.contributor.authorKataike, Hajira
dc.contributor.authorBbuye, Dickson
dc.contributor.authorSathaporn, Na-Rajsima
dc.contributor.authorAlexandra, Coelho
dc.contributor.authorLugemwa, Abbas
dc.contributor.authorBwakura-Dangarembizi, Mutsa F.
dc.contributor.authorNigel, Klein
dc.contributor.authorHilda, A. Mujuru
dc.contributor.authorKityo, Cissy
dc.contributor.authorMark, F. Cotton
dc.contributor.authorRashida, A. Ferrand
dc.contributor.authorCarlo, Giaquinto
dc.contributor.authorPablo, Rojo
dc.contributor.authorAvy, Violari
dc.contributor.authorDiana, M. Gibb
dc.contributor.authorDeborah, Ford
dc.date.accessioned2025-04-12T05:20:30Z
dc.date.available2025-04-12T05:20:30Z
dc.date.issued2023
dc.description.abstractCohort studies in adults with HIV showed that dolutegravir was associated with neuropsychiatric adverse events and sleep problems, yet data are scarce in children and adolescents. We aimed to evaluate neuropsychiatric manifestations in children and adolescents treated with dolutegravir-based treatment versus alternative antiretroviral therapy. Methods This is a secondary analysis of ODYSSEY, an open-label, multicentre, randomised, non-inferiority trial, in which adolescents and children initiating first-line or second-line antiretroviral therapy were randomly assigned 1:1 to dolutegravir-based treatment or standard-of-care treatment. We assessed neuropsychiatric adverse events (reported by clinicians) and responses to the mood and sleep questionnaires (reported by the participant or their carer) in both groups. We compared the proportions of patients with neuropsychiatric adverse events (neurological, psychiatric, and total), time to first neuropsychiatric adverse event, and participant-reported responses to questionnaires capturing issues with mood, suicidal thoughts, and sleep problems. Findings Between Sept 20, 2016, and June 22, 2018, 707 participants were enrolled, of whom 345 (49%) were female and 362 (51%) were male, and 623 (88%) were Black-African. Of 707 participants, 350 (50%) were randomly assigned to dolutegravir-based antiretroviral therapy and 357 (50%) to non-dolutegravir-based standard-of-care. 311 (44%) of 707 participants started first-line antiretroviral therapy (ODYSSEY-A; 145 [92%] of 157 participants had efavirenz-based therapy in the standard-of-care group), and 396 (56%) of 707 started second-line therapy (ODYSSEY-B; 195 [98%] of 200 had protease inhibitor-based therapy in the standard-of-care group). During follow-up (median 142 weeks, IQR 124–159), 23 participants had 31 neuropsychiatric adverse events (15 in the dolutegravir group and eight in the standard-of-care group; difference in proportion of participants with ≥1 event p=0·13). 11 participants had one or more neurological events (six and five; p=0·74) and 14 participants had one or more psychiatric events (ten and four; p=0·097). Among 14 participants with psychiatric events, eight participants in the dolutegravir group and four in standard-of-care group had suicidal ideation or behaviour. More participants in the dolutegravir group than the standard-of-care group reported symptoms of self-harm (eight vs one; p=0·025), life not worth living (17 vs five; p=0·0091), or suicidal thoughts (13 vs none; p=0·0006) at one or more follow-up visits. Most reports were transient. There were no differences by treatment group in low mood or feeling sad, problems concentrating, feeling worried or feeling angry or aggressive, sleep problems, or sleep quality.
dc.identifier.citationTurkova, A., White, E., Kekitiinwa, A. R., Mumbiro, V., Kaudha, E., Liberty, A., ... & Gondo, S. (2023). Neuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial. The Lancet Child & Adolescent Health, 7(10), 718-727. https://doi.org/10.1016/S2352-4642(23)00164-5
dc.identifier.urihttps://doi.org/10.1016/S2352-4642(23)00164-5
dc.identifier.urihttps://nru.uncst.go.ug/handle/123456789/10544
dc.language.isoen
dc.publisherThe Lancet Child & Adolescent Health
dc.titleNeuropsychiatric manifestations and sleep disturbances with dolutegravir-based antiretroviral therapy versus standard of care in children and adolescents: a secondary analysis of the ODYSSEY trial
dc.typeArticle
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