People living with HIV are one step
closer to having a once-a-month treatment alternative to downing two or more pills
a day.

There is no cure for HIV, the virus that causes AIDS. But combination antiretroviral therapy, or ART, can effectively halt the replication of the virus, nearly eliminating it from the bloodstream and prolonging life expectancy (SN: 11/15/19). For the therapy to work, though, people must stick to a daily regimen of two or more pills, which experts say can be a challenge for many.

Now, the results of two phase III
clinical trials suggest that a monthly shot of
antiretroviral drugs
works just as well as daily pills, researchers
report March 4 in two studies in the New England Journal of Medicine. If
approved by regulators, the therapy could be a more convenient treatment for
the estimated 1.1 million people living with HIV in the United States.

“From a patient perspective, these
results are very positive,” says Elizabeth Tolley, an epidemiologist at FHI 360,
a public health nonprofit based in Durham, N.C. Stigma can make people
reluctant to keep HIV drugs around the house or to take them each day in front
of a loved one, she says. A monthly alternative could be a better option for
many.

The injectable ART is a long-acting
combination of HIV drugs cabotegravir and rilpivirine. One of the phase III clinical
trials — the gold standard for getting regulatory approval for a new drug — was
led by Chloe Orkin, an HIV researcher at Queen Mary University of London. She
enrolled 566 participants who had never tried ART, so they first took the pill
version, which included a combination of other HIV drugs, for 20 weeks to get
the virus under control. Then, the participants either transitioned to
once-a-month shots or continued using pills.

The other trial, led by Susan Swindells, an internist at the University of
Nebraska Medical Center in Omaha, enrolled 616 participants whose HIV
had been controlled by ART pills for at least six months.

In both trials, participants were
randomly assigned to get the monthly shot treatment or continue taking pills.
After 48 weeks, there was no significant difference in the viral load of
participants for each treatment, suggesting that monthly shots work just as
well as pills. Most patients did report some pain or swelling with the shot.

“There are pluses and minuses” to
each option, says Marc Siegel, an infectious disease physician at George
Washington University in Washington, D.C. A “patient won’t have to remember to
take a pill every day, though they will have to visit the doctor’s office once
a month.”

Monthly shots may be more feasible
for people who struggle with housing instability and don’t have a place to
store pills, Siegel says. “If we can figure out how to help these people get to
a clinic, we might be able to reach a group that’s been harder to treat.”