AIDS 2024: “Miracle” long-acting injectable provides 100% protection against HIV, researchers find
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Lenacapavir, a long-acting injectable pre-exposure prophylaxis taken once every six months, demonstrated 100% protection against HIV infections among cisgender women enrolled in the PURPOSE 1 clinical trial conducted in South Africa and Uganda, researchers presented at AIDS 2024, the 25th International AIDS Conference. The remarkable results are potentially revolutionary in the fight against HIV, researchers said, but only if the product becomes affordable and accessible to those who need it the most.
The PURPOSE 1 trial aimed to evaluate the efficacy of long-acting lenacapavir and the daily pill emtricitabine and tenofovir alafenamide, or Descovy, for preventing HIV acquisition compared to the standard daily oral PrEP medication currently used by over a million people globally — emtricitabine and tenofovir disoproxil fumarate — also known as Truvada. The Gilead-sponsored, double-blind randomized control trial enrolled 5,345 cisgender adolescent girls and young women aged 16 to 24, of whom 2,134 were enrolled in the lenacapavir arm, 2,136 in the Descovy arm and the rest in the Truvada control arm.
Since the trial began in April 2021, not a single participant enrolled in the lenacapavir arm has acquired HIV, compared to 39 in the Descovy arm and 16 in the Truvada arm, which is consistent with infection rates in other oral PrEP clinical trials, said Linda Gail-Bekker, MBChB, PhD, of the Desmond Tutu HIV Centre. Researchers did not see any statistical difference between Descovy and Truvada in preventing HIV acquisition.
The results were so remarkable that the study’s Data Monitoring Committee, tasked with assessing the progress of the trial, recommended the trial be immediately halted and that all participants be offered lenacapavir, Dr. Gail-Bekker said. Since then, hundreds of trial participants have opted to initiate lenacapavir, highlighting the desire for a long-acting injectable PrEP option compared to daily oral PrEP.
Adherence in the lenacapavir arm was better than the daily oral PrEP arms as well, Dr. Gail-Bekker said, with over 90% of participants returning for their second and third shots on time, 26 weeks and 56 weeks after initiation. Adherence to both forms of daily oral PrEP was low and declined over time, with nearly 70% of participants in the Descovy arm reported to have low adherence after 26 weeks and nearly 90% in the Truvada arm. These results are consistent with other reports of low adherence to daily oral PrEP, especially among young women. Descovy and Truvada adherence was measured through detection of tenofovir diphosphate in blood samples, researchers said.
Game-changing results in the fight against HIV globally
“These results represent a game changer in the HIV response globally, especially in low- and middle-income countries with high incidence in vulnerable groups,” said Beatriz Grinsztejn, MD, PhD, president-elect of the International AIDS Society. This is particularly true for adolescent girls and young women, who are one of the most vulnerable groups in Sub-Saharan Africa, researchers said.
In Sub-Saharan Africa, three out of every four new infections are among adolescent girls and young women, said Winnie Byanyima, executive director of UNAIDS. “This is a product that is completely in their hands,” she added. “They don’t have to negotiate safe sex with a man, over the issue of HIV, anymore,” she said.
“It’s a feminist product. For girls in Africa, this is magical,” said Byanyima, who called lenacapavir a “miracle tool.”
Yvette Raphael, executive director of the Advocacy for Prevention of HIV & AIDS organization in South Africa, and a woman with HIV, agreed. “For the women of Africa, we want our children to stay HIV free,” she said. “My 24-year-old daughter is here at the conference, and in two years time at the next AIDS conference, I want her to have this product.”
“I did not go onto PMTCT for my daughter to get HIV now,” Raphael added, referencing HIV services among pregnant people to prevent the transmission of HIV to their children.
But adolescent girls, young women and other vulnerable groups won’t be able to access the game-changing product unless prices come down, Byanyima said. Currently, long-acting injectables cost upwards of $40,000 per patient, per year. Only a few thousand clients have been able to access long-acting cabotegravir in Sub-Saharan Africa and only through demonstration projects, compared to over 11,000 users in the U.S. Daily oral PrEP, by comparison, costs only $40 per year per patient in South Africa.
Calls for lower pricing to ensure access
Byanyima called on lenacapavir’s manufacturer, Gilead, to ensure lower prices for the drug as quickly as possible, including licensing lenacapavir with the United Nations-backed Medicines Patent Pool to allow for generic manufacturing at a fraction of current costs. She added that Gilead needs to take steps to ensure affordability and accessibility for middle-income as well as low-income countries, where 37% of people with HIV are located and are often the poorest individuals within more affluent societies.
“This is not a Gucci handbag for rich people,” Byanyima said. “This is a product for people who live on the margins, in the favelas of Brazil, and other poor people on the margins in middle-income countries like Jamaica and Indonesia,” she said, adding that failing to make lenacapavir available in middle-income countries will leave millions of people behind.
Jared Baeten, MD, PhD, with Gilead said the company is “working to set up voluntary licensing with generic manufacturers and examining which manufacturers across regions can be fast acting and manufacture to scale.”
There must be competition among generic producers to drive down the price, Byanyima said. “We don’t want Gilead to choose a handful of generic producers who will then create a cartel and get together and hike the price,” she said, adding that it’s easy for a small number of companies to get together and agree to keep the price high.
Researchers at the conference argued that the price of lenacapavir could come down to just $40 per person per year and still allow for a 30% profit, assuming that 10 million people use it annually.
Byanyima also called on Gilead to consider African manufacturers, citing the speed and efficiency with which South African generic manufacturers produced COVID-19 vaccines. “At the very least, have the places where the trials were run have access,” she said. “Scale up for originators should come sooner.”
Looking ahead
PURPOSE 1 is just one of several clinical trials looking at the efficacy of lenacapavir among high-risk populations, researchers said. By the end of the year, results for the PURPOSE 2 study, which is looking at HIV prevention among cisgender men who have sex with men, transgender men, transgender women and nonbinary individuals, are expected to be released. PURPOSE 2 is currently underway in the U.S., South Africa, Peru, Brazil, Argentina, Mexico and Thailand.
Photo: Researcher Linda Gail-Bekker, MBChB, PhD, speaks during a media rountable at the AIDS 2024 conference in Munich, Germany.
