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.”