Background
Adolescents and young adults living with HIV (YLHIV) are a population who face antiretroviral therapy (ART) adherence challenges. Long-acting injectable (LAI) formulations have the potential to address some of these challenges, including pill fatigue, stigma and disclosure. We conducted a study to determine the acceptability and feasibility of delivering LAI ART to YLHIV in a community setting in Cape Town, South Africa.
Methods
We enrolled YLHIV, on or starting first-line ART, aged 12-24 years in 3 cohorts: 1) those who are virally suppressed (<50 copies/mL) and adherent to ART; 2) those who are virally unsuppressed or have evidence of recent adherence challenges, and 3) those who are ART naïve. We allowed for up to 24 weeks of screening during which viral suppression (<50 c/mL) could be achieved on first-line oral ART. When virally suppressed, YLHIV were offered a switch to cabotegravir and rilpivirine LAI administered every 8-weeks, with an optional oral lead-in. Viral load was measured at Week 24 and Week 48 after switching. Qualitative assessments were made through serial individual interviews.
Results
We enrolled 179 YLHIV across the 3 cohorts. 134 were switched to LAI (59 in cohort 1 who were virally suppressed at baseline and 75 in cohorts 2 & 3 who achieved viral suppression during screening). The median age was 20 years (IQR 18-22) and 85 (63.4%) identified as female. As of 31 August 2024, 70 participants were expected to have reached Week 48. Sixty-eight of the 70 (97%) attended the Week 48 visit, with one lost to follow-up and one participant transferring out of the study area. Three (4%) participants had a viral load >50 c/mL at Week 48 (60, 251, and 254 c/mL). All re-supressed within 4 weeks, prior to their next injections. There have been no drug-related severe or serious adverse events to date. Qualitative assessments have confirmed this regimen is highly acceptable to YLHIV.
Conclusions
High retention and high viral suppression rates at Week 48 have been demonstrated in this community-based cohort of YLHIV in Cape Town, South Africa. Long-acting cabotegravir and rilpirivine LAI are an effective, acceptable and feasible treatment option and should be considered as a priority in national ART programs for adolescents and young adults living with HIV.
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