'Paradigm-shifting' study confirms effectiveness of long-acting HIV treatment

UC was the leading enrolling site in the U.S., with 32 of the 453 participants taking part in the LATITUDE study, a Phase III randomized trial that tested the efficacy of monthly injectable antiretroviral therapies cabotegravir and rilpivirine instead of daily oral antiretroviral therapy (ART).

The findings indicate that both injectable drugs are superior in preventing regimen failure among people living with HIV who have struggled with medication adherence.

“The oral ART group was almost twice as likely to have regimen failure, at 41.2 percent, compared to the injectable group, which had a failure rate of 22.8 percent,” said Carl Fichtenbaum, MD, study author and endowed professor of internal medicine in the College of Medicine.

“This is a paradigm-shifting study,” he said. “It has impacted not only the direction of research but also treatment guidelines around the world.”

LATITUDE is the first study seeking to determine whether a long-acting approach could maintain viral suppression among people who have difficulty taking oral ART, as only an estimated 67% of Americans living with HIV maintain viral suppression with oral ART.

“A significant number of people with HIV struggle taking antiretroviral pills every day. As a result, they have uncontrolled HIV, which contributes to their decline in health and leads to further spread of HIV in the community,” said Fichtenbaum, a faculty member in the Division of Infectious Diseases in the Department of Internal Medicine. “Developing an intermittent treatment relieves the need for daily pills and, given that no medicine is needed at home, directly addresses the stigma that many people with HIV face.”

In infectious diseases such as HIV — in addition to impacting a patient’s personal health — reduced medication adherence results in ongoing transmission of the virus and can have a significant impact on public health.   

“This will likely lead to an increase in the number of people with well-controlled HIV in the community,” said Fichtenbaum.

Corresponding author Aadia Rana, MD, professor of medicine in the Division of Infectious Diseases at the University of Alabama at Birmingham Marnix E. Heersink School of Medicine, emphasized the importance of clinical trials including populations representative of the HIV epidemic.

“This study enrolled participants from 33 sites across the United States who face challenges with consistent engagement in care, including those with active substance use, mental health issues and unstable housing,” she said. “This is exactly the population we need to target when testing interventions to end the HIV epidemic.”

The study was led by ACTG, a global clinical trials network focused on HIV and other infectious diseases.

“LATITUDE is a groundbreaking study, and these results enable us to significantly expand the population of individuals who will benefit from this long-acting treatment option,” said ACTG Chair Joseph Eron, MD, professor of medicine at the University of North Carolina School of Medicine. 

LATITUDE was funded in part by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases. ViiV Healthcare and Johnson & Johnson provided medications for the study.

Featured image at top: iStock/SyhinStas.