Landmark HIV Trial Breaks Treatment Access Barrier With Long-Acting Meds

    For the first time, clinical researchers have provided long-acting HIV treatment to people who had not previously completed a higher-barrier regimen of daily medication. Their approach yielded a success rate of nearly 100 percent, creating a blueprint of accessible HIV care for the people most vulnerable to it—particularly those without housing.

    HIV, the virus that can lead to AIDS, disproportionately impacts people who use drugs and other groups often targeted for state violence and disenfranchised from social supports, such as sex workers and LGBTQ communities. HIV isn’t curable, but it is manageable. Antiretroviral medications (ARV) can suppress the viral load of someone with HIV so that it becomes undetectable and, as a result, untransmissible to others.

    But ARV must be taken daily. One of the largest barriers to adhering to that kind of regimen is lack of stable housing, or housing at all.

    Long-acting antiretroviral therapies (LA-ART) formulate treatment as monthly injections rather than daily pills, similar to what Sublocade injections are to buprenorphine, or Vivitrol to naltrexone.

    LA-ART is medically safe whether or not patients have already suppressed their viral load. But the Food and Drug Administration has only approved LA-ART for patients who have already done so, excluding already-marginalized people who haven’t found ARV accessible.

    Past research has focused only on transitioning those people to LA-ART, since they also tend to be less likely to drop out from high-barrier clinical trials. A National Institutes of Health-funded LA-ART study has now changed this.

    “It was actually in this patient population that we deliberately wanted to try long-acting antiretroviral therapy on, with the hopes that this would be the trick,” coauthor Monica Gandhi told Filter.

    Gandhi is the medical director at San Francisco General Hospital’s Ward 86, one of the oldest and most established HIV clinics in the country. From June 2021 to November 2022, she and her coauthors enrolled 133 participants in a treatment regimen comprising intramuscular injections of two LA-ART (cabotegravir and rilpivirine) every four weeks. After two months, patients with suppressed viral loads could transition to maintenance injections every eight weeks.

    “For many in our clinic, it is impossible for them to take an oral pill every day because everything else gets in the way,” Gandhi said. “This could be the key to get them virologically suppressed.”

    While 76 participants had already suppressed their viral load with ARV, the other 57 had never accessed treatment. By the end of the study, 100 percent of patients in the former group had maintained virological suppression, and 98.5 percent of the latter group—all but two patients—had reached it. The findings were presented at the Conference on Retroviruses and Opportunistic Infections in late February.

    While most injections took place at the clinic, others were administered in SROs, and at least one in the parking lot of a Safeway.

    Isaac Jackson, founder of the San Francisco Drug Users Union and member of the city’s Community HIV Advisory Board, said that whether this success could be replicated outside of clinical trials would depend on how rigid the model of care would be. Anything requiring scheduled visits to a doctor’s office is likely a non-starter.

    “If you’re homeless I don’t think it’s that much of a difference [between treatment options if] they both mean you have to be on time,” Jackson told Filter.

    While it’s ideal to minimize interruptions to treatment, there is some leeway. In the case of the Ward 86 study, “on-time” injections were defined as every 28 days, plus or minus seven days.

    The study’s success rate is a testament to the medical efficacy of LA-ART, but also its adaptability to an outreach model. While Gandhi and her colleagues administered most injections at the clinic, others were administered in participants’ Single Room Occupancy housing units, and at least one in the parking lot of a Safeway. When one participant had to travel unexpectedly, rather than having to drop out from the trial they were given ART pills as a bridge until their next injection. They maintained virological suppression despite switching back and forth between the two types of medications.

    “It’d be nice if you could do both,” Jackson said. “When you come in to get your shot, maybe they give you pills too in case you can’t make the next visit. That’d be a nice backup.”

    Real-world success will depend on outreach resources like mobile vans, and especially on collaboration with peer workers.

    Though LA-ART has to be refrigerated, it can survive room temperature for up to six hours. This means providers have a viable window for connecting with unhoused patients, many of whom might spend most of their time at a few established locations within a given neighborhood. It also suggests that the success of real-world implementation will depend on access outreach resources like mobile vans, and especially on collaboration with peer workers to facilitate linkages to care.

    “I don’t know how scalable that’s going to be, but that is our next step,” Gandhi said. “We’re putting in funding requests, we’re trying to [bring on] a mobile nurse.”

    Gandhi and her colleagues will continue providing treatment to the patients from the study, as well as to new ones—Ward 86 has a current LA-ART waitlist of about 100 people. There’s also a plan to expand the research to other states. Replicating the success of the San Francisco project could provide the safety and efficacy evidence required to expand LA-ART access at the federal level. Gandhi hopes to begin in the next six months.

    “The best medication is a medication you can take,” Gandhi said. “Getting the medication into your system is imperative for efficacy, so it does imply that if they weren’t able to take [ARV] but are able to take the injectable, then that is better.”



    Image via National Institutes of Health

    • Brishti reports on health care, drug policy, mental health, policing, race, sexual violence and the intersections between them. She was a finalist for several prestigious national and provincial awards for her work as a Capital Daily staff reporter. Her freelance reporting has been published in publications such as VICE, the Tyee, the Narwhal, National Geographic and BBC Future. She’s based in Victoria, Canada.

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