Adolescents have poorer treatment outcomes including higher loss to follow-up, lower treatment adherence, poorer virological suppression and higher mortality than older people living with HIV. Some of the adherence challenges in adolescents revolve around fear of disclosure associated with carrying/taking medication, HIV-stigma, and the burden of secrecy; this may be particularly difficult at weekends which are times for socialising with friends. Unstable lives, non-conducive to daily medication adherence, and relative lack of power in treatment decision-making also contribute to difficulties with daily-dosing, and may affect virological suppression.
The overarching objective of this trial was to evaluate an innovative and contemporary ART strategy in HIV-infected adolescents to provide choice for young people facing life-long treatment.
The BREATHER PLUS trial evaluated the virological efficacy, safety, acceptability and Quality of Life of DTG-based Short-cycle Therapy (SCT) with weekends off compared with Continuous Therapy (CT) with a DTG-based ART regimen, to optimise treatment for HIV-infected adolescents in sub-Saharan Africa. The backbone drugs will consist of tenofovir either as the TAF or TDF formulations partnered with either 3TC or FTC.
Expected impact: Evidence on efficacy, safety and acceptability of a novel treatment approach (weekends-off) in HIV-infected adolescents in sub-Saharan Africa.
Results: At week 96, a higher rate of viral failure occurred in 10% of the SCT (n=23) vs 5% in the CT arm (n=11); diff 5.1% (99%CI: –0.9 to +11.5). The showed that SCT was not non-inferior. The difference was also 5.1% (95%CI: +0.05 to +9.9), which showed that SCT was actually inferior to CT (p=0.034).
Reduced dosing (SCT) with TLD can not be recommended for adolescents when viral load is only monitored every 6-12 months. Therefore, daily TLD (CT) should continue to be recommended in adolescents living with HIV.
