Injectable HIV therapy every 8 weeks beat daily pills in African adolescents

A long-acting injectable given every eight weeks kept more African adolescents virally suppressed than daily tablets, in a trial that is among the first to test the approach in this age group. The result, from the LATA trial published in The Lancet on September 17, was a superiority finding, not merely non-inferiority [s1].

What the trial did

LATA was a randomised, open-label, multicentre, 96-week non-inferiority trial that recruited adolescents living with HIV aged from 12 years to younger than 20 years from five clinics in Kenya, South Africa, Uganda, and Zimbabwe [s1]. To enrol, participants had to have had virological suppression — an HIV-1 viral load below 50 copies per mL — for more than 12 months, with no previous treatment failure [s1].

Participants were randomly assigned 1:1 to one of two arms. The injectable group received cabotegravir 600 mg and rilpivirine 900 mg by intramuscular injection at weeks 4, 8, and 16, and every 8 weeks thereafter [s1]. The control group took a daily oral fixed-dose combination of dolutegravir 50 mg, lamivudine 300 mg, and tenofovir disoproxil fumarate 300 mg [s1].

Between June 22, 2023, and April 15, 2024, 476 of 560 screened adolescents were enrolled and randomly assigned — 235 to the injectable group and 241 to the control group [s1]. Of the 476, some 466 (98%) had acquired HIV vertically; 200 (42%) were recruited in Uganda, 128 (27%) in Zimbabwe, 77 (16%) in Kenya, and 71 (15%) in South Africa [s1]. Median age was 16.5 years, 256 (54%) were female, and the median duration of previous antiretroviral therapy was 11.7 years [s1]. Median follow-up ran to 120 weeks [s1].

The result

Two participants in the injectable group had a confirmed viral load of 50 copies per mL or higher by week 96 — a Kaplan-Meier estimated proportion of 0.9% (95% CI 0.0 to 2.2) [s1]. In the control group, 15 participants reached that threshold, an estimated 6.4% (3.7 to 9.8) [s1]. The estimated difference was -5.5% (99% CI -10.3 to -1.5), which met the pre-specified non-inferiority criterion and then demonstrated superiority over daily tablets (p=0.0013) [s1].

That is the headline: among adolescents who were already suppressed, the injectable was not just as good as continuing pills — it was better at keeping them suppressed over nearly two years.

Safety

By the end of follow-up, seven participants had permanently discontinued the injectable, for reasons including one confirmed viral load of 200 copies per mL or higher, two injectable-related adverse events, one incident tuberculosis, two planning pregnancy, and one participant's own choice [s1].

There were 14 serious adverse events, in 14 participants, in the injectable group — including one homicide — compared with 18 events, in 12 participants, in the control group, one of them a death from metastatic osteosarcoma (hazard ratio 1.16, 95% CI 0.54 to 2.51; p=0.71) [s1]. The only treatment-related serious adverse event was a hypersensitivity reaction [s1]. Grade 3 or higher events numbered 31 in the injectable group and 34 in the control group, and included four injection-site reactions in the injectable arm; otherwise the profiles were similar between groups [s1].

Why adolescents

The rationale is that adolescents living with HIV have poorer treatment outcomes than other age groups, and an injectable removes the daily task of taking a pill [s1]. That matters most where the burden is heaviest. WHO estimates that there were about 41.0 million people living with HIV at the end of 2025, 64% of them in the WHO African Region [s2]. In 2025, an estimated 570,000 people died from HIV-related causes and an estimated 1.2 million people acquired HIV [s2].

What it does and does not show

LATA tested a switch in adolescents who were already stably suppressed, not initiation in people with uncontrolled virus, so the finding speaks to maintenance rather than starting therapy [s1]. The trial was open-label — participants and clinical staff knew the allocation, though laboratory staff measuring viral loads were masked [s1]. And an every-eight-weeks injection schedule requires participants to reach a clinic on time, a demand that is not trivial in the settings studied.

The investigators conclude that in adolescents with virological suppression, injectable cabotegravir-rilpivirine was superior to daily tablets for maintaining suppression, with no new safety concerns, and that it should be considered a maintenance option for this population [s1]. The trial was funded by the European and Developing Countries Clinical Trials Partnership, Janssen, and the UK Medical Research Council, and is registered as NCT05154747 [s1].

What to watch

Whether ministries of health and global programmes can supply and administer an injectable on schedule at the scale the epidemic demands, and whether the maintenance benefit seen here holds in routine care outside a trial.

This article is informational and is not medical advice.