A version of this article was originally published in Pharmacy Times. This version has been slightly edited.
Long-acting antiretroviral treatment (LA-ART) given every 4 to 8 weeks and delivered with comprehensive maintenance services suppresses HIV in individuals who were not virologically suppressed, according to the results of a San Francisco, California, study funded by the National Institutes of Health in healthcare.
Study results suggest that long-acting injectable ART may benefit individuals who have been historically underserved and may face barriers to treatment.
“ART is changing the medical game to save lives as a treatment and as a powerful prevention tool with Undetectable=Untransmittable or U=U. Yet we have significant gaps that remain [individuals] who face accompanying health, housing and other socioeconomic challenges,” Dr. Carl Diefenbach, director of the AIDS Division of the National Institute of Allergy and Infectious Diseases, said in a statement.
“Making progress against the HIV pandemic requires societies to prioritize reaching those who have historically been left behind, yet who could benefit most from the provision of newer, easier formulations of ART,” said he.
Researchers enrolled 133 participants with HIV and focused on reaching those who historically had less access to ART, including individuals experiencing housing insecurity, mental illness, and substance use disorders.
Barriers can also include food insecurity, involvement in the legal system, and transportation challenges. LA-ART can help overcome these barriers to care. However, the only FDA-approved combination regimen includes cabotegravir and rilpivirine, which is only approved for individuals who are on oral ART and have already achieved viral suppression.
Subjects in the study did not have to be on daily oral ART or viral suppression to be eligible and start treatment with long-acting injectables. Individuals identified as 88% cisgender male, 68% as nonwhite, 58% with housing instability, 38% with mental illness, 33% with substance abuse, and 8% reported experiencing homelessness.
Between June 2021 and November 2022, 133 individuals with HIV initiated LA-ART, including 57 with unsuppressed or untreated HIV and 76 who were virologically suppressed on oral ART.
The researchers performed biweekly health checks on each individual, and the pharmaceutical professionals held regular meetings to remind them of their injection appointments.
Among individuals who started treatment with virologic suppression, 100% remained suppressed during the follow-up period. Among those who did not enter the study with virologic suppression, 97% achieved virologic suppression at a median of 33 days.
Only 2 individuals in the study did not achieve or maintain viral suppression, which is consistent with findings from previous clinical trials that studied LA-ART in individuals with HIV who achieved viral suppression with daily oral ART.
“Our patient population does not resemble the patient population that was included in the clinical trials to determine the approval criteria for long-acting ART,” Monica Gandy, MD, MPH, professor of medicine and associate department head at UC San Francisco , the statement said.
“That’s the role of [investigators] to help address the disparities by intentionally and proactively including different groups in our studies and for this population to have the same successful outcomes as those in other clinical trials was very important and exciting. We want to have the ability to offer these drugs to patients who can benefit the most, including those who face challenges adhering to daily treatment,” Gandhi said.
Additional clinical trial data are needed on the effectiveness of LA-ART in achieving and maintaining virological suppression among individuals who face barriers to treatment, the researchers said.
The findings were presented at the Conference on Retroviruses and Opportunistic Infections.
Long-acting antiretroviral therapy suppresses HIV among people with unstable housing, mental illness, and substance use disorder. National Institutes of Health. News release. February 21, 2023. Accessed February 24, 2023. https://www.nimh.nih.gov/news/science-news/2023/long-acting-antiretroviral-therapy-suppresses-hiv-among-people-with- unstable – residential-mental-substance-use-disorders