Neuropsychiatric adverse effects of dolutegravir in children and adolescents
A secondary analysis of the ODYSSEY trial was published recently in The Lancet Child and Adolescent Health. The ODYSSEY trial was a randomised non-inferiority trial in which participants were randomly assigned to a dolutegravir-based regimen or standard-of-care. Neuropsychiatric events as reported by physicians as well as participant/carer responses to mood and sleep questionnaires were analysed. Neuropsychiatric manifestations were a rare occurrence (3%); less than a third of these resulted in medication changes. Numerically more participants experienced neuropsychiatric side-effects and suicidal thoughts in the dolutegravir arm, but these findings were not statistically significant. There was no difference between the two groups in terms of effects on sleep.