A new clinical trial has found that monthly injectable HIV treatment works better than daily pills for people living with HIV who have difficulty consistently taking oral medication.
The study, published in the New England Journal of Medicine, tested a long-acting injectable regimen in people whose HIV was not well controlled due to challenges sticking to daily treatment. The trial, known as LATITUDE, provides some of the strongest evidence to date that monthly injections can improve outcomes in this high-risk group.
“For some people living with HIV, taking a pill every single day is a major challenge,” said Kristina Brooks, PharmD, University of Colorado Anschutz Skaggs School of Pharmacy assistant professor and study co-author. “This trial shows that a monthly injectable option can significantly reduce the risk of treatment failure for those who need a different approach.”
Why This Matters
HIV treatment requires consistent daily medication to keep the virus suppressed. Missing doses can allow the virus to rebound, increase the risk of drug resistance and raise the chance of transmitting HIV to others. Many people face barriers to daily adherence, including unstable housing, stigma, mental health challenges, substance use and difficulty accessing care.
Long-acting injectable therapies offer an alternative: instead of taking pills every day, patients receive a shot once a month in a healthcare setting. Researchers considered concerns over whether people who struggled with daily oral pills would show up to the clinic consistently to receive injections.
How the Study Worked
The LATITUDE study was the first randomized study to look at whether long-acting injectables could help people with HIV and adherence challenges achieve virologic suppression. This study was conducted through the Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections (ACTG) Network, which is an international clinical trials network funded by the NIH that focuses on HIV and other related infectious diseases.
“This study specifically focused on individuals who have historically been underrepresented in clinical trials and who face the greatest barriers to consistent care,” said Brooks. “These are the people who are in need of different HIV treatment strategies and may benefit from long-acting therapy options.”
Researchers enrolled 453 adults living with HIV who were not consistently taking their medication. In step one of the study, participants took daily oral pills and received adherence support along with economic incentives to help support achieving or maintaining suppressed HIV viral loads. In step two, 306 participants were randomly assigned to either continue standard daily oral HIV treatment, or switch to monthly injections of long-acting cabotegravir plus rilpivirine.
The median age was 40 years. Nearly two-thirds were Black, almost one-third were assigned female sex at birth and many reported various barriers to adherence such as mental health conditions, alcohol or substance use, unstable housing and other factors. These are populations that often disproportionately experience barriers to HIV care.
Better Treatment Outcomes with Monthly Injections
After about 48 weeks of follow-up, the injectable treatment clearly outperformed daily pills:
- Treatment failure occurred in 22.8% of participants receiving monthly injections
- Treatment failure occurred in 41.2% of those continuing daily oral therapy
Participants receiving injections were significantly less likely to experience virologic failure or discontinue treatment. Because the injectable therapy showed clear advantages in key outcomes, an independent data safety and monitoring board stopped randomization early to allow broader access to the more effective option.
Side effects were similar between the two groups and serious safety concerns were not increased with injections. Of those who failed therapy, only a small number of participants in either group developed drug-resistant virus.
The findings from this study suggest that monthly long-acting injectable HIV treatment can be a powerful tool for people who struggle to take daily medication consistently. By reducing the burden of daily pills, this approach may help more individuals maintain viral suppression, which protects their health and prevents HIV transmission.
Additionally, researchers say expanding access to long-acting injectable therapy could help reduce health disparities and improve outcomes in communities that face the greatest challenges with adherence.
The LATITUDE study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health, through the ACTG (award numbers, UM1 AI068634, UM1 AI068636, and UM1 AI106701), with additional support from the National Institute of Mental Health, the National Institute on Drug Abuse, and the Eunice Kennedy Shriver National Institute of Child Health and Human Development. Study medication was provided by ViiV Healthcare and Johnson & Johnson. This content does not necessarily represent the official views of the NIH.
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