Final data published in the New England Journal of Medicine confirm that ViiV Healthcare’s long-acting injectable HIV treatment, Cabenuva (cabotegravir + rilpivirine), is superior to daily oral therapy for individuals with a history of challenges adhering to medication regimens.
The LATITUDE study, a phase III, randomised, open-label trial, enrolled 453 participants who reported difficulties taking daily oral antiretroviral therapy (ART) or had previously disengaged from HIV care. Participants had a median age of 40, with a diverse demographic breakdown: 63% were Black/African American, 29% were female, 17% were Hispanic, and 14% reported current or past injection drug leverage. Prior to randomisation, all participants received adherence support, including financial incentives tied to achieving viral suppression while on standard daily oral ART.
Researchers then randomised 306 participants who had achieved viral suppression to either receive long-acting injectable cabotegravir + rilpivirine every four weeks (152 participants) or continue with their existing daily oral ART regimen (154 participants). The primary measure of success was the rate of regimen failure, defined as a combination of virologic failure (VF) and permanent discontinuation of the assigned treatment for any reason.
Through 48 weeks of treatment, the cumulative risk of regimen failure was nearly halved in the group receiving the injectable therapy, at 22.8%, compared to 41.2% in those continuing daily oral ART (29 out of 152 versus 55 out of 154, respectively). Specifically, 19% (29/152) of participants on the injectable regimen experienced regimen failure, with 3% (5/152) experiencing virologic failure and 16% (24/152) discontinuing treatment. In contrast, 36% (55/154) of participants on daily oral therapy experienced regimen failure, with 21% (32/154) experiencing virologic failure and 15% (23/154) discontinuing treatment.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, stated, “The LATITUDE study adds to a robust body of evidence supporting the role of long-acting injectable cabotegravir + rilpivirine as a valuable treatment option for people living with HIV. What we have is the first randomised study confirming this regimen is superior to daily oral therapy in this population. As such, these findings have the potential to validate a long-acting approach for this additional group of patients and could make a significant difference to people living with HIV and our goal of ending the epidemic.”
The Data Safety Monitoring Board (DSMB) for the ACTG study initially recommended halting randomisation in February 2024, based on interim efficacy data, and offered all eligible participants the opportunity to transition to the long-acting injectable therapy. Full data from the study were published February 18, 2026.
