A brand new drug might be more effective at preventing HIV than current methods.
Many people take daily oral antiretroviral medication—known as PrEP (pre-exposure prophylaxis)—to protect themselves from catching HIV, but according to a new paper in the New England Journal of Medicine, a twice-yearly injection is "significantly more effective than the daily oral PrEP."
This drug, Lenacapavir, resulted in a 96 percent reduced risk of infection overall if taken once every 6 months, according to a recent Gilead-funded clinical trial led by physicians at Emory University and Grady Health System.
"Lenacapvir, which is injected under the skin every 6 months, provided 96 percent protection from acquiring new HIV infection," study lead author Colleen Kelley, a professor in the School of Medicine at Emory University and co-director of the Emory Center for AIDS Research, told Newsweek.
"Once FDA approved, this will be an incredible new option for people to use as HIV pre-exposure prophylaxis (HIV PrEP) as it is much easier to take than currently available HIV PrEP options, which include daily oral pills and injections every two months.
"In the trial, Lenacapavir was 89 percent better than oral PrEP. The nuance here is adherence. If people take oral PrEP every day, it is also highly effective. But many people, including those in the trial, are not able to take it every day, and the efficacy drops off. Getting injections means you don't have to take a pill every day," she said.
PrEP works by preventing HIV from establishing an infection in your body if you're exposed to the virus. HIV infects the body by attacking CD4 cells (a type of immune cell), inserting its genetic material, and replicating itself. PrEP medications contain antiretroviral drugs that interfere with this process.
Two oral PrEP medications have been approved by the U.S. Food and Drug Administration (FDA)—Truvada and Descovy—and one injection drug called Apretude that must be taken once every two months.
"PrEP reduces the risk of getting HIV from sex by about 99 percent when taken as prescribed. Although there is less information about how effective PrEP pills are among people who inject drugs, we know that PrEP pills reduce the risk of getting HIV by at least 74 percent when taken as prescribed," the CDC says.
If not taken as prescribed, these drugs are less effective at protecting against HIV.
"All HIV PrEP are medications that work against the virus, called antiretrovirals. PrEP is the concept of taking these antiretroviral medications before possible HIV exposure during sexual intercourse to prevent infection," Kelley said.
"This is similar to malaria prophylaxis for travelers—you take medications that are active against malaria when you travel to prevent getting malaria. Another good corollary is contraceptives for prevention of pregnancy.
This new drug, Lenacapvir, was seen to be more effective than oral Truvada PrEP overall because it doesn't require the regimented consistency of taking the medication every day.
According to the paper, in the Phase III clinical trial comparing the effectiveness of Truvada and Lenacapavir, two out of 2,179 people in the the Lenacapavir group acquired HIV. Nine out of 1,086 people in the Truvada group were infected.
"Oral PrEP requires that people adhere to the medication over a long period of time. We have seen in countless studies that adherence to oral PrEP decreases over time, and some people have difficulties taking oral PrEP every day due to their life circumstances," Kelley said.
"Unfortunately, the populations that have challenges taking daily oral PrEP over the long term are the same populations affected by health disparities and who experience increased rates of new HIV diagnoses."
Over half of new HIV infections in the United States in 2022 were in cisgender gay men, 70 percent of whom were Black or Hispanic, the paper said.
"We are not reaching everyone we need to reach with our current HIV prevention interventions, such as those who are disproportionately impacted by HIV and health care disparities," Kelley said in a statement. "For people that are unable to take the daily oral pills, the injectable agents can really give incredible efficacy and be a game changer in helping them stay HIV negative."
"This is a considerable and profound advancement in medicine," she said.
The Phase III trial has now been submitted to the FDA, and the researchers hope the drug may be approved for use as soon as 2025.
"The results of this study add to the armamentarium of novel tools for HIV prevention. Long acting antiretrovirals offer new hope for those who are not able to take oral medications," Carlos del Rio, chair of the Department of Medicine at Emory University School of Medicine and co-director of the Emory Center for AIDS Research, said in the statement.
"The challenge is now to roll out and make these tools available and accessible in an equitable way— only then we will see new HIV infections dramatically decreased locally and globally."
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References
Kelley, C. et al. Twice-Yearly Lenacapavir for HIV Prevention in Men and Gender-Diverse Persons. New England Journal of Medicine. Nov. 27, 2024. 10.1056/NEJMoa2411858
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