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Two vaccines a year, the drug currently used to treat HIV infection, have been remarkably effective in preventing infection. A study of young women and adolescent girls in Africa.
A twice-yearly injection of the drug lencapavir can provide total protection against HIV infections, showing 100% effectiveness in phase 3 trial data released by drugmaker Gilead on Wednesday. New England Journal of Medicine.
For years, most people have taken prevention tools known as PREP, such as a daily pill called Truvada, to prevent human immunodeficiency virus, or HIV, infection.
Recently, some people have accepted the norm Apretude of drug injections – Two vaccinations are given one month apart and then every two months – to reduce their exposure to HIV.
The twice-yearly injection of lencapavir may add another option to the toolbox to prevent HIV infection.
Among the more than 5,000 HIV-negative women and adolescent girls who took part in the trial in Africa, none of the participants who took lencapavir twice a year became infected with HIV. International AIDS Conference in Munich.
“These stellar results show that twice-yearly lenacapavir for PrEP, if approved, offers a highly effective, tolerable and discreet option that can improve PrEP uptake and persistence, helping us to reduce HIV in cisgender women globally,” said Linda-Gail Baker. Director of the Desmond Tutu HIV Center at the University of Cape Town in South Africa and President of the International AIDS Society He said in a news release..
The study, called the PURPOSE 1 trial, randomly assigned adolescent girls and young women in South Africa and Uganda to receive lencapavir injections every 26 weeks or to receive daily HIV drugs – emtricitabine–tenofovir alafenamide or emtricitabine–tenofovir disoproxil fumarate – in pill form. It was a double-blind study, and the participants did not know which group they were in.
More women and girls who received lenacapavir experienced a reaction at the injection site, 69% compared with 35% in the placebo injection group, but no safety concerns were found, the researchers said.
Among women and girls, the researchers evaluated how many HIV infections occurred during the 26 weeks and a total of 55 infections were observed: zero in the lencapavir group, 39 in the daily emtricitabine-tenofovir alafenamide group and 16 in the daily emtricitabine-tenofovir disoproxil fumarate group.
Finding 100% effectiveness of lenacapavir in women to prevent HIV “is an important development for the field, and I think the field will welcome it as an additional prevention option,” said Dr. Dan Baroch, director of the Virology Center. and a vaccine study at Beth Israel Deacon Medical Center.
“But I think it's important to note that these data are only about prevention in young women. “There's another study in men that's still ongoing, that hasn't been read yet,” he said. “So we're waiting for more data to learn about the effectiveness of prevention in men.”
Several clinical trials involving lencapavir are ongoing. The latest Phase 3 findings are part of Gilead's Purpose program, which includes five HIV prevention trials around the world.
Gilead said in a news release Wednesday that it expects results later this year in In the year In early 2025, another important trial from the program, Objective 2, is evaluating twice-yearly lenacapavir for the prevention of HIV infection among men, transgender women, and transgender people in Argentina, Brazil, Mexico, Peru, South Africa, Thailand, and the United States. States that have sex with partners are assigned male at birth.
“The regulatory record for lenacapavir for PrEP includes both Objective 1 and Objective 2 results, and if positive, lenacapavir for PrEP could be approved for many populations and communities in need of additional HIV prevention options,” the company said. Referring to the approval of lencapavir as an HIV prevention tool.
“We look forward to the results of other studies, including men who have sex with men and men who are at risk for HIV,” said Dr. Jason Zucker, assistant professor of medicine at Columbia University Irving Medical Center. He did not participate in the experiment, he is in the email.
Baruch is not involved in either the latest Phase 3 trial or the newly launched US trials, but has previously studied lencapavir as a drug to prevent simian-human immunodeficiency virus infections. Preclinical animal studiesFinally, he said, he predicted how the drug would become an anti-HIV tool in humans.
People who are already taking the daily PrEP pill or regular PrEP injection to prevent HIV may get lencapavir as an alternative, Baroch said.
“This is a very convenient option because it can only be given once every six months,” he said. “I think it's an option for high-risk people who aren't on PrEP yet because it's an option if they weren't interested in PrEP before.”
In the Phase 3 trial, researchers reported that the adherence to daily PrEP pills was low and some people only took them twice a week when they should have been taken every day.
Lenacapavir is not approved anywhere in the world to prevent HIV, but as it continues to be studied as a pre-exposure prophylaxis drug to prevent HIV infection, questions about cost abound.
“We know the drug is effective in cisgender women and is safe based on all the data we have,” Zucker said in an email. “My primary concern is around implementation. These drugs are often expensive once approved, and those costs can limit access and exacerbate rather than alleviate disparities.
Lenacapavir is already Approved by the US Food and Drug Administration The treatment of HIV infection in adults is in combination with other anti-HIV drugs and it is estimated. It costs more than 40,000 dollars per year as a manufacturer's list price, or about $39,000 per year, as an average wholesale price.
Different A study conducted at the AIDS conference on Tuesday It suggests that manufacturing a generic version of linacapavir in Munich could cost less than $100 per person.
A team of researchers – from the United Kingdom, Germany and the United States – predicted what the minimum cost of lencapavir would be based on the drug's current ingredients, production models and cost models. The researchers found that lenacapavir could be mass-produced for up to $93 per person per year, which could come down to $40 per person.
“While Gilead awaits additional Phase 3 clinical trial data and regulatory filings for twice-yearly HIV prevention, it is too early to comment on the PrEP value of linacapavir. Our commitment is to price our medicines to reflect the value they provide to people, patients, healthcare systems and society,” a Gilead spokeswoman said in an emailed statement Tuesday.
“Given the company's ongoing commitment to HIV-affected communities, we were. Develop a strategy “To enable broad and sustainable access globally,” the statement said in part. “A key component of this strategy is to deliver lenacapavir rapidly, sustainably and in sufficient quantities, once approved, to high-risk, resource-constrained, primarily low- and lower-middle-income countries.”
At the end of May, Hundreds of activists wrote a letter to Gilead CEO Daniel O'Day The company urged people in low- and middle-income countries to have the same access to the HIV drug lencapavir as in high-income countries.
“Requiring only two injections a year, it could be a real game changer for people most excluded from high-quality health care around the world. We urge Gilead to ensure that people living with or at risk of HIV in the Global South have access to this important drug while people in the Global North can.” Released by the combination of folk medicineA global consortium focused on improving access to medicines.
The letter read in part: “We request that you license lencapavir now in the drug patent pool and that the license be open to all low- and middle-income countries.” “Lenacapavir is approved for treatment in the US and Europe and will soon be available for prevention, so there is no reason to delay the sharing of this technology.”