Trial shows that shot taken twice a year very effective at preventing HIV in women

A shot taken twice a year has shown to be extremely effective at preventing HIV infections in women and girls.

The drug Lenacapavir, if injected two times a year, can provide total protection against HIV infections. The trial, which took place in Africa, showed 100% efficacy in Phase 3 trial data, according to data published Wednesday in the New England Journal of Medicine.

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Pre-exposure prophylaxis has been available for over a decade in the form of Truvada, a pill taken daily. However, the findings of this study suggest that shots could be another effective option for preventing HIV transmission.

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Over 5,000 women and adolescent girls who were HIV-negative participated in the trial in Africa. During the course of the study, none of the participants who received twice-yearly Lenacapavir acquired HIV.

Linda-Gail Bekker, director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa and former President of the International AIDS Society, celebrated the good news in a news release.

“These stellar results show that twice-yearly Lenacapavir for PrEP, if approved, could offer a highly effective, tolerable, and discreet choice that could potentially improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” she said.

The study, called the PURPOSE 1 trial, was a double-blind study. Women in South Africa and Uganda were randomly assigned to either receive Lenacapavir injections every 26 weeks or daily HIV medications—either emtricitabine-tenofovir alafenamide or emtricitabine-tenofovir disoproxil fumarate—in pill form.

Researchers observed a total of 55 infections throughout the study. None took place in the lenacapavir group, 39 in the daily emtricitabine-tenofovir alafenamide group and 16 in the daily emtricitabine-tenofovir disoproxil fumarate group.

Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center, called the results “an important advance for the field, and I think that the field will welcome it as an additional prevention option.”

He also noted that “it’s important to realize that these data are only in prevention in young women. There is another study that’s still ongoing, that hasn’t been read out yet, in men,” he said. “So, we await more data to learn about the prevention efficacy in men as well.”

There are multiple clinical trials of Lenacapavir happening. Gilead, the drug maker, said that it expects results later this year and in early 2025 from the program’s other pivotal trial, PURPOSE 2, which is assessing twice-yearly Lenacapavir. This study looks at HIV infections among a more diverse gender group. It studies the drug’s efficacy in preventing infections among men, transgender women, and gender nonbinary people in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States who have sex with partners assigned male at birth.

“We are eagerly awaiting the results of the other studies, which enrolled other populations, including men who have sex with men and are disproportionately vulnerable to HIV,” Dr. Jason Zucker, assistant professor of medicine at Columbia University Irving Medical Center, who was not involved in the trial, said in an email to CNN.

Zucker also expressed worries. “We know that the drug is efficacious in cisgender women and appears safe with all the data we have,” Zucker said in the email. “My primary worry is around implementation; these drugs are often expensive after approval and those costs can serve to limit access and exacerbate disparities instead of alleviate them.”

A letter released by the People’s Medicines Alliance expressed these same concerns, acknowledging that two injections per year for total HIV prevention “could be a real game-changer worldwide for the people most excluded from high-quality healthcare.”

They urged the drug manufacturer to “ensure that people in the Global South living with or at risk of HIV can access this groundbreaking medicine at the same time as people in the Global North can… We request that you license Lenacapavir now, without delay, through the Medicines Patent Pool and make the license open to all low- and middle-income countries.”

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