Study results indicates that the injectable antiretroviral therapy can benefit patients who are historically underserved and may face treatment barriers, including those with mental illness.
A long-acting antiretroviral treatment (LA-ART) given every 4 to 8 weeks, and delivered with comprehensive support services, suppressed HIV in individuals who were not virologically suppressed, according to the results of a study in San Francisco, California, funded by the National Institutes of Health.
The study results indicated that long-acting injectable ART can benefit individuals who are historically underserved and may face treatment barriers.
“ART has been a medical gamechanger for saving lives as treatment and as a potent prevention tool with Undetectable=Untransmittable, or U=U. Yet, we have substantial gaps that remain for [individuals] who face co-occurring health, housing, and other socio-economic challenges,” Carl Dieffenbach, PhD, director of the National Institute of Allergy and Infectious Diseases Division of AIDS, said in a statement.
“Making progress against the HIV pandemic necessitates that societies prioritize reaching those who have historically been left behind, yet stand to benefit the most from making newer, easier formulations of ART available,” he said.
Investigators included 133 participants with HIV and focused on reaching those who have historically had less access to ART, including individuals experiencing housing insecurity, mental illness, and substance use disorder.
Barriers can also include food insecurity, involvement with the legal system, and transportation challenges. LA-ART medication could help close these barriers to care. However, the only combination regimen approved by the FDA includes cabotegravir and rilpivirine, which is approved only for individuals who are on oral ART and have already achieved viral suppression.
The individuals in the study did not have to be on a daily oral ART or viral suppression to be eligible and start treatment with long-acting injectables. The individuals identified as 88% cisgender men, 68% as non-white, 58% with unstable housing, 38% with mental illness, 33% with substance abuse, and 8% reported experiencing homelessness.
Between June 2021 and November 2022, 133 individuals with HIV started on LA-ART, including 57 with unsuppressed or untreated HIV and 76 who were virologically suppressed on an oral ART.
Investigators performed biweekly reviews of each individual’s health status, and pharmacy professionals conducted regular outreach to remind them of their injection appointments.
Among the individuals who began the treatment with virological suppression, 100% remained suppressed over the follow-up period. Among those who did not begin the study with virological suppression, 97% had achieved virological suppression at a median of 33 days.
Just 2 individuals in the study did not achieve or maintain viral suppression, which was in line with findings from previous clinical trials that studied LA-ART in individuals with HIV who had achieved viral suppression on daily oral ART.
“Our patient population does not look like the patient population that got enrolled in the clinical trials to determine the approval criteria for long-acting ART,” Monica Gandhi, MD, MPH, professor of medicine and associate division chief at the University of California San Francisco, said in the statement.
“It is the role of [investigators] to help address disparities through intentionally and proactively including diverse groups in our studies, and for this population to have the same successful outcomes as those in the other clinical trials was very important and exciting. We want to have the ability to offer these drugs to patients who stand to benefit the most, including those who face challenges adhering to daily treatment,” Gandhi said.
Further clinical trial data on the effectiveness of LA-ART in achieving and sustaining virologic suppression among individuals who face treatment barriers are needed, investigators said.
Findings were presented at the Conference of Retroviruses and Opportunistic Infections.
Long-acting antiretroviral therapy suppresses HIV among people with unstable housing, mental illnesses, 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-housing-mental-illnesses-substance-use-disorder