Injectable cabotegravir-rilpivirine kept more adolescents virally suppressed than daily oral therapy

Design

Randomised, open-label, multicentre non-inferiority trial, 96 weeks

Population

476 virally 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

LATA was an open-label randomised trial at five clinics in Kenya, South Africa, Uganda and Zimbabwe. It enrolled 476 adolescents aged 12 to 19, almost all infected at birth and on treatment for a median of nearly 12 years, who had been virally suppressed for over a year with no previous treatment failure. They either switched to intramuscular cabotegravir-rilpivirine every 8 weeks after loading doses, or stayed on daily dolutegravir-lamivudine-tenofovir.

By week 96, confirmed viral rebound to 50 copies/mL or more had occurred in 2 of 235 on injections (0.9%) and 15 of 241 on pills (6.4%), a difference of −5.5 percentage points (99% CI −10.3 to −1.5). That met non-inferiority and then superiority. Serious adverse events and grade 3 or higher events were similar between groups. Seven stopped injections, two for drug reactions including one serious hypersensitivity reaction.

Adolescence is when adherence to daily therapy fails most often, and this trial suggests removing the daily pill removes much of that failure. It was run in suppressed, adherent adolescents, so it does not show that injections rescue someone who is already failing. Availability and cost of long-acting cabotegravir-rilpivirine vary widely between countries, and its regulatory status in India is not established here.

• Long-acting injectable therapy is an option to discuss with suppressed adolescents who find daily pills hard.
• The trial enrolled only those suppressed for over 12 months with no previous treatment failure.
• Injections every 8 weeks depend on clinic attendance: a missed visit matters more than a missed pill.
• Watch for hypersensitivity and injection-site reactions, the main treatment-related harms seen.
• Screen for tuberculosis and pregnancy plans, both reasons participants stopped injections.

Why it matters

For the age group most likely to fail daily therapy, the delivery method may matter as much as the drugs.

Don't overread it

This applies to adolescents already suppressed; it says nothing about switching someone with a detectable viral load.

The statistics, in plain English

The difference of 5.5 points comes with a 99% confidence interval, deliberately stricter than usual, which still excludes no difference. Rebound was rare in both arms, so the absolute gain is about 1 adolescent in 18 kept suppressed over two years.

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