LATITUDE PHASE III INTERIM TRIAL DATA INDICATES ViiV HEALTHCARE’S LONG-ACTING INJECTABLE HIV TREATMENT CABENUVA (CABOTEGRAVIR + RILPIVIRINE) HAS SUPERIOR EFFICACY COMPARED TO DAILY THERAPY IN INDIVIDUALS LIVING WITH HIV WHO HAVE ADHERENCE CHALLENGES

“The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals who have difficulty taking pills for HIV every day is a remarkable outcome,” said Kimberly Smith, MD, MPH, Head of R&D at ViiV Healthcare. “There are many reasons why people may find it challenging to stay on daily oral treatment and the LATITUDE study shows cabotegravir and rilpivirine injectable treatment can help them keep their virus suppressed, which benefits their overall health. Optimising therapy for all people living with HIV, including those with adherence challenges, is critical to the effort to end the HIV epidemic.”

The LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study is ongoing across 31 sites in the U.S. including Puerto Rico, implemented through Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG), a global NIH-funded clinical trials network focused on HIV and other infectious diseases. Participants with challenges taking daily oral ART as prescribed and evidence of viremia were screened to ensure the HIV in their blood was not resistant to the study drugs and that they met other health and safety criteria. Once enrolled, they 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. They were then randomised to receive long-acting injectable ART (cabotegravir + rilpivirine) every four weeks or to continue taking daily oral ART.

Last week, the DSMB performed a planned interim review. They 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.

There are many factors that can influence a person’s ability to take medicine every day, including access to health care or health insurance, affordability, unstable housing, stigma and fear of having their HIV status disclosed. Lack of consistent adherence is a common reason why some people living with HIV have difficulty maintaining undetectable viral loads.

LATITUDE is sponsored and funded by the National Institute of Allergy and Infectious Diseases (NIAID), 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.

About ACTG

ACTG is the world’s largest and longest running clinical trials network focused on HIV and other infectious diseases and the people living with them. It is funded by NIAID and collaborating NIH Institutes. Founded in 1987, ACTG conducts research to improve the management of HIV and its comorbidities; develop a cure for HIV; and innovate treatments for tuberculosis, hepatitis B, and emerging infectious diseases. It comprises thousands of dedicated researchers, staff, and community members who are pursuing research into novel treatments and cures for infectious diseases at hundreds of locations across four continents, with the ultimate goal of advancing science that meaningfully impacts the lives of the people we serve.