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• Posted November 28, 2024

Twice-Yearly Injection 96% Effective in Preventing HIV Infection

People whose partners have HIV must remember to take antiretroviral pills every single day or risk infection themselves.

But researchers have come up with a way to avoid that daily hassle – an injectable drug that patients would only have to receive twice a year.

What’s more, the new drug works even better than the currently available pills, clinical trial results show.

A twice-yearly injection of Sunlenca (lenacapavir) reduces the risk of HIV infection by 96%, which is significantly more effective than oral pre-exposure prophylaxis (PrEP) using pills like Truvada, researchers report in the New England Journal of Medicine.

“Seeing these high levels of efficacy – at almost 100% -- in an injectable that people only have to take every six months is incredible,” lead researcher Dr. Colleen Kelley, a professor of medicine at Emory University, said in a news release.

“This is a considerable and profound advancement in medicine, especially for people whose circumstances don’t allow them to take a daily oral medication, and for those among populations disproportionately impacted by HIV,”  she added.

In the new clinical trial, 99% of the patients receiving Sunlenca did not become infected with HIV, results show.

There were only two infections among 2,179 people taking Sunlenca, compared with nine infections among the 1,086 people randomly assigned to take Truvada.

Results also showed it was easier for people to stick with the twice-yearly injections than to take a daily pill. Truvada’s effectiveness becomes greatly compromised if it’s taken inconsistently, researchers noted.

“What we see over time is that about half of people who start taking daily oral PrEP stop within a year due to various factors,” Kelley said. “Having an effective injectable that is only needed twice annually is very significant for people who have trouble accessing healthcare or staying adherent to daily, oral pills.”

People at risk of HIV also tend to be people who have limited access to the pills, or may have trouble taking their meds consistently, researchers 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. “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.”

The U.S. Food and Drug Administration approved the drug, marketed as Sunlenca, in December 2022 as a treatment for people with HIV, to help control their infection.

These results show that it also could be used by people without HIV to prevent infection, researchers said. The trial data have been submitted to the FDA, and Kelley is hopeful the drug will be approved for this use by 2025.

“Long acting antiretrovirals offer new hope for those who are not able to take oral medications,” Dr. Carlos del Rio, chair of medicine at Emory University, said in a news release. “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.”

More information

The U.S. Centers for Disease Control and Prevention has more about pre-exposure prophylaxis.

SOURCE: Emory University, news release, Nov. 27, 2024