- Design
- Randomised, open-label, multicentre non-inferiority trial, 96 weeks
- Population
- 476 virologically suppressed adolescents aged 12–19 with HIV in Kenya, South Africa, Uganda and Zimbabwe
- Primary outcome
- Confirmed viral load ≥50 copies/mL by week 96
- Effect
- 0.9% vs 6.4%; difference −5.5% (99% CI −10.3 to −1.5); superior, p=0.0013
LATA randomised 476 adolescents aged 12 to 19 with HIV, suppressed for over a year, at five clinics in Kenya, South Africa, Uganda and Zimbabwe. Almost all had acquired HIV at birth and had been on treatment for a median of nearly 12 years. Half switched to intramuscular cabotegravir-rilpivirine every eight weeks; half stayed on daily oral dolutegravir, lamivudine and tenofovir.
By week 96, confirmed viral rebound occurred in 0.9% of the injection group against 6.4% on tablets, a difference of 5.5 percentage points. The injections met non-inferiority and then superiority. Serious and grade 3 or higher adverse events were similar; one serious hypersensitivity reaction led to stopping.
Adolescence is when adherence to daily pills most often fails, and this trial suggests removing the daily pill helps. It was open-label, and the control group's 6.4% rebound reflects real-world adherence rather than drug failure. Long-acting cabotegravir-rilpivirine needs eight-weekly clinic visits and cold-chain supply, and its availability in Indian public programmes is limited.
- Long-acting cabotegravir-rilpivirine is an option for suppressed adolescents struggling with daily tablets where it is available.
- Eligibility here required suppression for over a year and no previous treatment failure.
- Missed injection visits are the main risk of the long-acting route; the clinic needs a recall system before switching anyone.
- Watch for hypersensitivity after early injections; one serious reaction occurred.
- Adolescents planning pregnancy stopped injections in this trial; discuss plans before switching.
Why it matters
It suggests the adolescent adherence gap is better solved by removing the daily pill than by more counselling.
The statistics, in plain English
The difference of −5.5 percentage points has a 99% confidence interval of −10.3 to −1.5. The whole interval favours the injections, so the advantage is unlikely to be chance. The trial used a stricter 99% interval because the margin depended on the control group's event rate.
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