LAI CAB/RPV may be an alternative to daily oral ART in virally suppressed adolescents with HIV.The week-96 LATA trial results demonstrate the superiority of long-acting injectable (LAI) cabotegravir/rilpivirine (CAB/RPV) to tenofovir/lamivudine/dolutegravir (TLD) for maintaining virologic suppression in adolescents with HIV in sub-Saharan Africa.
In the intent-to-treat analysis, two participants in the LAI group had confirmed viral rebound (CVR; two consecutive HIV-1 RNA ≥50 copies[c]/mL) compared with 15 in the control group (0.9 percent vs 6.4 percent). LAI was superior to control (p=0.001) and was noninferior using a noninferiority margin of 8.9 percent.
In the per-protocol analysis, only one (0.5 percent) LAI recipient had CVR compared with 13 (5.8 percent) in the control group. “This confirmed the superiority of LAI to control (p=0.001),” said Dr Mutsa Bwakura Dangarembizi from the University of Zimbabwe Clinical Research Centre, Harare, Zimbabwe, at AIDS 2026.
Looking at the FDA snapshot, only one LAI recipient had HIV-1 RNA ≥50 c/mL compared with eight in the control group (adjusted difference, –2.8 percent; p=0.018), confirming the primary outcome, Dangarembizi noted.
The LAI group had fewer participants with confirmed HIV-1 RNA ≥200 c/mL than the control group (0.9 percent vs 2.5 percent; p=0.183), but both groups had similar proportions of participants with confirmed HIV-1 RNA ≥1,000 c/mL (0.9 percent vs 0.8 percent; p=0.979). [AIDS 2026, abstract OAX1105LB]
Safety, preference
The LAI and control groups had similar incidences of WHO 3/4 or death (3 percent vs 2 percent), serious adverse events (AEs; 14 percent vs 12 percent), and grade ≥3 AEs (27 percent vs 26 percent).
In the LAI group, four participants permanently discontinued treatment due to CVR, drug eruption, hypersensitivity, and tuberculosis; two did so because they were planning pregnancies; and one did so by choice. None discontinued in the control group.
Ninety-one percent of participants in the LAI group reported injection site reactions, but these were mainly mild and pain-related, and none led to LAI discontinuation, Dangarembizi said.
Moreover, pregnancies were reported, with more live births in the LAI group than in the control group (n=8 vs 4). Again, Dangarembizi noted no safety concerns. “Of the 18 participants in the LAI group who fell pregnant, 12 preferred to continue [treatment].” Also, all live-born infants tested negative for HIV.
In terms of acceptability, almost all participants reported that taking HIV medication was not a burden and did not interfere with their normal lives, Dangarembizi added. Among those on LAI, 94 percent noted that injectable HIV medications were ‘a lot easier’ to receive than those administered daily.
LAI may reduce daily oral ART burden
According to Dangarembizi, adolescents with HIV have poorer treatment outcomes than adults. Of note, the only LAI CAB/RPV study in adolescents was a single-arm trial. [Lancet HIV 2026;13:e85-e94]
The study included 476 adolescents with HIV (median age 16.5 years, 54 percent female) who had a viral load <50 c/mL for ≥12 months on antiretroviral therapy (ART) and no history of treatment failure. They were randomized to LAI CAB/RPV Q8W (n=235) or daily oral TLD (n=241). Forty percent of LAI recipients chose to receive the oral CAB/RPV lead-in. Ninety-eight percent of the participants vertically acquired HIV, and a majority (42 percent) were from Uganda.
“Using the primary outcome of confirmed HIV-1 RNA ≥50 c/mL and FDA snapshot HIV-1 RNA ≥50 c/mL, Q8W LAI CAB/RPV was superior to TLD over 96 weeks. The LAI was well tolerated, with no new safety concerns, and was strongly preferred by adolescents,” Dangarembizi said.
“The results support WHO guidelines recommending LAI CAB/RPV as an alternative for virally suppressed adolescents with HIV to reduce the burden of daily oral ART,” she concluded.