ViiV Healthcare announces interim data of LATITUDE phase III trial

ViiV Healthcare announced data from a planned interim analysis of the LATITUDE phase III trial, indicating that their long-acting injectable antiretroviral treatment for HIV, Cabenuva, demonstrated superior efficacy in maintaining viral load suppression compared to daily oral therapy in individuals with a history of ART adherence challenges. The data were presented by the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections network at the Conference on Retroviruses and Opportunistic Infections, in Denver, Colorado. LATITUDE is a phase III, randomised, open-label study. Participants received comprehensive and incentivised adherence support while taking guideline-recommended, three-drug regimen oral ART, including dolutegravir and bictegravir-based regimens, to achieve viral suppression. Those who achieved viral suppression were eligible to randomise to staying on oral standard of care regimens or switch to long-acting injectable cabotegravir + rilpivirine dosed monthly. During the randomised phase of the study, 146 participants received monthly LA-ART and 148 continued on SOC. The primary endpoint was a comparison of regimen failure, defined as a combination of virologic failures and regimen discontinuations, between arms. 24.1% of participants on LA-ART experienced regimen failure compared to 38.5% on SOC. Although the primary endpoint did not meet the strict predefined stopping criterion for the interim analysis, key secondary endpoints of virologic failure favoured the LA-ART regimen. The study’s Data Safety Monitoring Board considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. The DSMB recommended that all eligible participants should be offered long-acting injectable cabotegravir + rilpivirine. The rate of adverse events was similar in both arms. Three participants in the LA-ART arm had serious injection site reactions and one participant discontinued due to an ISR. Two confirmed virologic failures in each arm had new resistance associated mutations, including at least two new integrase inhibitor RAMs in both LA-ART participants. The LATITUDE study is ongoing across 31 sites in the U.S. including Puerto Rico, implemented through ACTG. The median age of study participants was 40 years old; 40 percent of participants were male, 64 percent were Black/African American, 17 percent were Hispanic, 5 percent were transgender, and 14 percent currently or previously used injection drugs. The study is sponsored and funded by the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, and is being conducted by ACTG, with additional support from the National Institute of Mental Health, the National Institute on Drug Abuse, ViiV Healthcare and the Janssen Pharmaceutical Companies of Johnson & Johnson.