ViiV Healthcare’s Cabenuva for HIV highlights efficacy compared to daily oral therapy for people with adherence challenges
Posted on February 23, 2026
GSK has recently announced that ViiV Healthcares final data from the LATITUDE phase III trial, confirming its long-acting injectable treatment for HIV, Cabenuva, demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of antiretroviral treatment adherence challenges.
Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “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. This 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.”
Note that the LATITUDE is a phase III, randomised, open-label study which enrolled 453 participants who face challenges taking daily oral ART or who disengaged from HIV care. In the study, the median age was 40 years; 63% were Black/African American, 29% were female, 17% were Hispanic, and 14% reported either ongoing or prior injection drug use. Once enrolled, participants received adherence support including conditional economic incentives to achieve viral suppression while taking guideline-recommended daily oral ART.
The primary endpoint was a comparison of regimen failure between arms, defined as a combination of virologic failures and regimen discontinuation for any reason. The cumulative risk of regimen failure through 48 weeks of treatment was reduced by nearly half in the study: 22.8% for those who were switched to long-acting injectable cabotegravir + rilpivirine vs. 41.2% for people continuing on daily oral therapy.
| Endpoint | Cumulative probability, long-acting injectable cabotegravir + rilpivirine (n=152) | Cumulative probability, daily oral therapy (n=154) | Cumulative incidence difference (98.4% CI) |
|---|---|---|---|
| VF (events) | 6.8% (6) | 28.2% (34) | -21.4% (-33.5%, -9.3%) |
| Treatment-related failure* (events) | 8.9% (9) | 28.1% (34) | -19.2% (-31.6%, -6.9%) |
| Permanent discontinuation of treatment (events) | 19.8% (26) | 28.2% (37) | -8.4% (-21.3%, 4.5%) |
We can see that the rate of AEs was similar in both arms. The most common AE in the long-acting arm was injection site reactions, with two participants discontinuing due to an ISR. Two confirmed VF in each arm had new resistance associated mutations, including two new integrase inhibitor RAMs in both long-acting arm participants.
Related Topics and Keywords
cabenuva, Cabenuva (cabotegravir + rilpivirine), HIV, ViiV Healthcare
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