Twice-yearly vaccinations successful in preventing HIV infection in women, trial data shows – LocalNews8.com

By Jacqueline Howard, CNN

(CNN) — Two injections per year of a drug currently used to treat HIV infections have been shown to be dramatically effective in preventing infection in a study among young women and adolescent girls in Africa.

The twice-yearly injection of the drug lenacapavir can provide complete protection against HIV infection, according to data from a phase 3 study released by pharmaceutical company Gilead and published Wednesday in the New England Journal of Medicine.

For years, most people have taken preventive measures known as PrEP, such as the daily pill Truvada, to prevent infection with the human immunodeficiency virus, or HIV.

More recently, some people have been given regular injections of the drug Apretude – two injections one month apart and then every two months – to reduce their risk of HIV.

The twice-yearly injections of lenacapavir could be an additional option to prevent HIV infections.

Of the more than 5,000 HIV-negative women and adolescent girls who participated in the study in Africa, none of the participants who received lenacapavir twice a year developed HIV infection during the study. These results were also presented at the International AIDS Conference in Munich.

“These great results show that twice-yearly lenacapavir for PrEP, if approved, could be a highly effective, tolerable, and discreet option that could potentially improve PrEP uptake and persistence, and help us reduce HIV among cisgender women globally,” said Linda-Gail Bekker, director of the Desmond Tutu HIV Centre at the University of Cape Town in South Africa and past president of the International AIDS Society, in a press release.

The study, called the PURPOSE 1 trial, involved adolescent girls and young women in South Africa and Uganda who were randomly assigned to receive either lenacapavir injections every 26 weeks or daily HIV medication – emtricitabine–tenofovir alafenamide or emtricitabine–tenofovir disoproxil fumarate – in pill form. It was a double-blind study, and participants did not know which group they were in.

Many women and girls who received lenacapavir, about 69%, had injection site reactions, compared with 35% in the placebo group. However, no safety concerns were found, the researchers said.

Among the women and girls, the researchers assessed how many HIV infections occurred over 26 weeks, and a total of 55 infections were observed: zero in the lenacapavir group, 39 in the daily emtricitabine-tenofovir alafenamide group, and 16 in the daily emtricitabine-tenofovir disoproxil fumarate group.

‘A major advancement for the field’

The finding that lenacapavir is 100% effective for HIV prevention in women “is an important advancement for the field, and I think the field will welcome it as an additional prevention option,” said Dr. Dan Barouch, director of the Center for Virology and Vaccine Research at Beth Israel Deaconess Medical Center.

“But I do think it’s important to realize that these data are only about prevention in young women. There’s another ongoing study that’s not finished yet in men,” he said. “So we’re waiting for more data to learn about the preventive effectiveness in men as well.”

There are multiple clinical trials underway with lenacapavir. The latest Phase 3 findings are part of Gilead’s PURPOSE program, which consists of five HIV prevention trials around the world.

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

Barouch also wasn’t involved in the latest Phase 3 trial, nor in the recently launched U.S. trials, but he previously investigated lenacapavir as a drug to prevent simian human immunodeficiency virus infection in preclinical animal studies. Those studies, he said, ultimately predicted how the drug would later perform as an HIV prevention agent in humans.

People who already take daily PrEP pills or regular PrEP injections to prevent HIV may benefit from having lenacapavir as an additional option, Barouch said.

“This is a really good option that is very convenient because it can only be given once every six months,” he said. “I think for people who are at high risk, who are not already on PrEP, it is an option because it provides a more convenient option, if that was the reason they were not interested in PrEP in the first place.”

Lenacapavir is not approved for HIV prevention anywhere in the world, but since it is still being investigated as a pre-exposure prophylaxis agent to prevent HIV infection, many questions arise about its cost.

“We know the drug is effective in cisgender women and appears safe from all the data we have,” Zucker said in the email. “My biggest concern is implementation; these drugs are often expensive once approved, and that cost can limit access and increase disparities rather than reduce them.”

Lenacapavir is already approved by the U.S. Food and Drug Administration for the treatment of HIV infection in adults, in combination with other antiretroviral HIV medications. The manufacturer’s list price estimates the drug will cost more than $40,000 per year, or about $39,000 per year as the average wholesale price.

Separate research presented Tuesday at the AIDS conference in Munich found that producing a generic version of lenacapavir could cost less than $100 per person.

The team of researchers – from the UK, Germany and the US – predicted what the minimum price of lenacapavir could be, based on the drug’s current ingredients, production models and cost models. The researchers showed that lenacapavir could be mass-produced for up to $93 per person per year, potentially dropping to around $40 per person per year.

“While Gilead awaits additional Phase 3 clinical trial data and potential regulatory filings for HIV prevention, which occur twice a year, it is premature to price lenacapavir for PrEP (prevention). Our commitment is to price our medicines that reflect the value they deliver to people, patients, healthcare systems and society,” a Gilead spokesperson said in an emailed statement Tuesday.

“Given the company’s ongoing commitment to communities affected by HIV, we have developed a strategy to enable broad, sustainable access globally,” the statement said. “A key component of this strategy is to rapidly, sustainably and in sufficient quantities supply lenacapavir, if approved, to high-incidence, resource-limited countries, which are primarily low- and lower-middle income countries.”

In late May, hundreds of activists wrote a letter to Gilead CEO Daniel O’Day urging the company to ensure that people in low- and middle-income countries have the same access to lenacapavir as an HIV drug as people in high-income countries.

“By requiring just two injections per year, it could be a real game-changer for those most excluded from quality healthcare worldwide. We urge Gilead to ensure that people living with or at risk of HIV in the Global South have access to this breakthrough medicine at the same time as people in the Global North,” said the letter, issued by the People’s Medicines Alliance, a global coalition focused on improving access to medicine.

“We urge you to license Lenacapavir now, without delay, through the Medicines Patent Pool and to open the license to all low- and middle-income countries,” the letter reads. “With Lenacapavir approved for treatment in the U.S. and Europe and likely to be available for prevention soon, there is no reason to delay sharing this technology.”

The-CNN-Wire
™ & © 2024 Cable News Network, Inc., a Warner Bros. Discovery Company. All rights reserved.