Switch to injectable cabotegravir-rilpivirine given every 8 weeks in adolescents living with HIV with virological suppression in sub-Saharan Africa (LATA): a randomised, open-label, multicentre, 96-week non-inferiority trial.

In 30 seconds

LATA was a randomised, open-label, multicentre, 96-week non-inferiority trial comparing injections of cabotegravir-rilpivirine every 8 weeks with daily oral dolutegravir-lamivudine-tenofovir disoproxil fumarate in adolescents aged 12 to younger than 20 years with sustained viral suppression at clinics in four sub-Saharan African countries. Among 476 participants, confirmed viral load of 50 copies per mL or higher by week 96 occurred in an estimated 0·9% with injections versus 6·4% with oral therapy (estimated difference -5·5%, 99% CI -10·3 to -1·5). Injectable therapy met non-inferiority criteria and was superior to oral therapy.

Key findings

• By week 96, confirmed viral load of 50 copies per mL or higher was estimated in 0·9% of the injectable group versus 6·4% of the oral-therapy group.
• The estimated difference was -5·5% (99% CI -10·3 to -1·5); injectable therapy met non-inferiority criteria and demonstrated superiority (p=0·0013).
• Grade 3 or higher adverse events occurred in 27 participants receiving injections and 26 receiving oral therapy; adverse-event profiles were otherwise similar.

Why it matters

Daily oral treatment can be challenging for adolescents, a group identified as having poorer HIV treatment outcomes. This trial provides comparative evidence that an every-8-week injectable regimen can maintain viral suppression in adolescents already suppressed on ART, with similar overall adverse-event profiles to daily oral therapy. The findings are relevant to evaluating treatment options for this population in the settings studied.

What to keep in mind

The trial was open-label and enrolled adolescents with sustained viral suppression and no previous treatment failure; findings may not apply to adolescents with unsuppressed HIV or prior treatment failure.