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Weekends off efavirenz-based antiretroviral therapy (ART) in children and adolescents non-inferior to continuous therapy
BREATHER (BREaks in Adolescent and child Therapy using Efavirenz and two nRTIs) was an open-label, randomised, non-inferiority trial previously showing short-cycle therapy (SCT, 5 days on, 2 days off) was non-inferior at maintaining viral suppression with similar safety and resistance profiles, compared with continuous therapy (CT) at 48 weeks; Turkova et al 1 report the results from the extended additional 96 weeks of follow-up. Participants were eligible if 8–24 years old, virologically suppressed for at least a year on first-line efavirenz-based antiretroviral therapy (ART). The primary outcome was the proportion who had viral rebound by week 48, with secondary endpoints for the extended follow-up being viral rebound at any stage, viral suppression at 96 and 144 weeks, and adverse events. Ninety-nine participants were assigned to SCT and 100 to CT; 97 per arm consented to the extended follow-up. The median age was 14 years, 53% were male, 90% were vertically infected, and the median CD4 was 735x10^6/L. Sixteen from each arm had viral load >50 copies/mL by …
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