FDA approves twice-a-year injection for HIV prevention

A drug currently used to treat certain HIV infections has also, on Wednesday, received approval from the US Food and Drug Administration to be used to prevent HIV.
Gilead Sciences, maker of the drug, announced that a twice-a-year injection of lenacapavir has been approved in the United States for HIV prevention under the brand name Yeztugo. In clinical trials, the drug was found to dramatically reduce the risk of infection and provide near-total protection against HIV, significantly more than the primary options available for pre-exposure prophylaxis or PrEP.
Therapies called PrEP have been used to prevent HIV infections for years. In the United States, this may involve taking pills, such as a daily medication called Truvada, or getting shots, such as injections every two months of the medication Apretude. But a twice-yearly shot of lenacapavir has now become another option in the prevention toolbox – making it the first and only such shot for HIV prevention.
With any PrEP drug, 'by having that medicine in your bloodstream or in your body, if you encounter HIV, it blocks it from taking hold. It arrests infection from taking hold,' said Dr. Jared Baeten, senior vice president of clinical development and the virology therapeutic area head at Gilead Sciences.
The human immunodeficiency virus or HIV, spread primarily through unprotected sex or sharing needles, attacks the body's immune system, and without treatment, it can lead to acquired immunodeficiency syndrome or AIDS. Although rates of new HIV infections have fallen in the US, about 1.2 million people are estimated to have HIV, and about 13% of them may not know it.
A study called the PURPOSE 2 trial found that just two shots a year of lenacapavir can reduce the risk of HIV infection by 96%, proving it to offer near-total protection against HIV. Another study, the PURPOSE 1 trial, found that lenacapavir demonstrated 100% efficacy for HIV prevention in women.
'Lenacapavir is a unique option for people for HIV prevention because it's an injection given just twice a year. So people can get it privately, discreetly, and then set it and forget it and not have to think about it until six months later,' Baeten said. 'For many people, that might be the empowered, private option that might make HIV prevention workable in their lives.'
There continues to be a lot of stigma, fear and misinformation around HIV, said Ian Haddock, who participated in the PURPOSE 2 trial for lenacapavir.
When Haddock was a teenager living in rural Texas, he recalled, he faced some of that stigma.
'The first thing that was said when my family found out that I was queer was, 'You're going to get AIDS,' ' said Haddock, who does not live with HIV. 'So that's the first thing I heard.'
Now, at 37, Haddock knows that HIV does not discriminate. He works to break such misguided stereotypes about the LGBTQ+ community as the founder of a nonprofit called the Normal Anomaly Initiative, and he said he is proud to have participated in the clinical trial.
'It feels like a full-circle moment,' he said.
Haddock said he started to take daily PrEP pills in 2015 to help reduce his risk of HIV, but sometimes they would give him an upset stomach or he would forget to take them.
In January 2024, when he learned about the lenacapavir clinical trial, he quickly enrolled. He had no side effects during the trial other than irritation at the injection site, he said.
Even though the trial has concluded, Haddock said, he plans to continue receiving lenacapavir injections twice a year, and he hopes the FDA approval will help raise awareness of HIV prevention tools.
In 2012, the FDA approved Truvada, also made by Gilead Sciences, making it the first PrEP medication for HIV prevention in uninfected adults in the United States – but 'even though PrEP has been around since 2012, people don't really know what it is, and they often kind of conflate it to having HIV or being extremely promiscuous,' Haddock said.
'So this just opens up a completely new opportunity,' he said of lenacapavir.
Last year, Gilead Sciences released data from the PURPOSE 2 trial that showed 99.9% of the participants who received an injection of lenacapavir twice a year for HIV prevention did not become infected.
There were only two cases among 2,180 people, effectively proving 89% more effective than the PrEP pill Truvada. The trial was unblinded early because it met its key endpoints, allowing lenacapavir to be offered to all participants, and the drug was found to be well-tolerated.
'The most common side effects, as you might expect, are injection-site reactions,' Baeten said, such as rash or discomfort.
The PURPOSE 2 trial included cisgender men, transgender men, transgender women and nonbinary people 16 or older who had sex with partners assigned male at birth. Some of the study participants became pregnant during the trial and continued to receive lenacapavir during pregnancy without complications, Baeten said.
'This is a milestone moment in the decades-long fight against HIV. With twice-yearly administration and remarkable efficacy, lenacapavir will help us prevent HIV on a scale never seen before,' Daniel O'Day, chairman and chief executive officer at Gilead Sciences, said in an emailed statement.
'After 17 years of research and pioneering clinical trials, Gilead scientists have delivered the next frontier in HIV innovation: a prevention medicine with remarkable efficacy that only needs to be delivered twice a year,' O'Day said. 'It's a true scientific breakthrough that could help millions of people around the world.'
Now that lenacapavir has been approved for prevention, people should be able to visit their providers and ask about the drug within two days, Gilead Sciences said in an email. The company added that it could take up to two months for someone to receive their first injections, based on coverage decisions.
The list price for lenacapavir, when used for HIV prevention, will be announced soon, Baeten said. The list price is expected to be different from when lenacapavir is used for the treatment of multidrug-resistant HIV, in which other HIV medications have not worked and the patient meets certain other requirements for lenacapavir treatment.
One study published in November in the Journal of Antimicrobial Chemotherapy found that for treatment, lenacapavir costs up to nearly $45,000 per person per year without insurance, as an average wholesale list price – but it could be mass-produced for less than $100 per person per year.
The team of researchers behind the study projected a possible minimum price based on the drug's current ingredients, production models and cost models. They demonstrated that lenacapavir could be mass-produced for up to $93 per person per year, potentially falling to about $40 per person per year 'if voluntary licences are in place and competition between generic suppliers substantially improves.'
'Voluntary licensing and multiple suppliers are required to achieve these low prices,' the researchers wrote in the study abstract. 'This mechanism is already in place for other antiretrovirals.'
Lenacapavir is the latest HIV prevention shot to receive FDA approval. Apretude, made by GSK's ViiV Healthcare, was the first injectable pre-exposure prophylaxis medication to receive approval in the US in 2021.
The hope is that PrEP tools could lead to a total halt to new HIV infections in future generations, Baeten said.
'Every one of us would like nothing more than to end this epidemic, and that's what really solid prevention can do for us – that coupled with testing and treatment,' he said.
'I want this next generation to think about HIV as something that they can end in their lifetime, end in their generation. And I want their next generation to be one where they've never had to think about HIV at all,' he said. 'We've got this amazing opportune moment right now as a world to think about where we can be in the future. We can be a world without HIV.'
The new FDA approval comes as the Trump administration has cut back funding for HIV-related research grants, HIV prevention and surveillance programs through the US Centers for Disease Control and Prevention, and sharply curtailed global HIV efforts.
The administration's 2026 budget proposal includes the elimination of funding for HIV programs, totaling more than $1.5 billion, according to the HIV+Hepatitis Policy Institute.
With the approval of lenacapavir for PrEP, 'now is not the time to pull the rug out from under HIV prevention,' Carl Schmid, executive director of the HIV+Hepatitis Policy Institute, said in an email.
'The obliteration of CDC HIV prevention and surveillance programs is an absurd proposal that will just increase HIV infections and health costs down the road,' he said. 'We urgently call on Congress to reject these cuts in order to ensure that states and community-based organizations have the resources to prevent HIV, which is still a serious infectious disease and results in about 32,000 new cases each year.'

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