ViiV Healthcare has announced promising interim data from the LATITUDE phase III trial, presented at the CROI 2024. The data indicate that Cabenuva (cabotegravir + rilpivirine), a long-acting injectable antiretroviral treatment (ART) for HIV, shows superior efficacy in maintaining viral load suppression compared to daily oral therapy, particularly benefiting individuals facing ART adherence challenges.
The US sees an estimated one-third of people living with HIV struggling to maintain viral suppression. The LATITUDE study demonstrates that long-acting injectable cabotegravir + rilpivirine can potentially improve health outcomes for this group by providing an alternative treatment option that simplifies adherence. Moreover, achieving undetectable viral loads can contribute to preventing virus transmission to sexual partners, adding to efforts in ending the HIV epidemic.
LATITUDE, a randomized, open-label study, involved participants who initially received comprehensive adherence support with guideline-recommended oral ART regimens to achieve viral suppression. Eligible participants who achieved suppression were then randomized to either continue with their oral standard of care (SOC) regimen or switch to LA-ART administered monthly. Despite not meeting the strict predefined stopping criterion for the interim analysis, the study’s outcomes favored LA-ART over SOC, with significant differences in key secondary endpoints of virologic failure and treatment-related failure.
Taking into account the totality of evidence, the study’s Data Safety Monitoring Board (DSMB) concluded that long-acting ART demonstrated superior efficacy over daily oral SOC. Consequently, the DSMB recommended that all eligible participants be offered the long-acting injectable option. The safety profiles were similar across the two arms, with a few serious injection site reactions reported in the LA-ART arm, and resistance-associated mutations were detected in a small number of virologic failures in each treatment arm.
This promising data underline the importance of providing diverse treatment options tailored to meet varying patient needs in HIV management.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
