The drugs currently being used to treat certain HIV infections also appeared on Wednesday. Approved by the US Food and Drug Administration, which is used to prevent HIV.
Drug maker Gilead Science has announced that two annual infusions of Lenacapavil have been approved in the US for HIV prevention under the brand name Yeztugo. Clinical trials have found that the drug dramatically reduces the risk of infection and provides near-full protection against HIV.
A treatment called PREP has been used to prevent HIV infection for years. In the United States, this includes taking tablets such as a daily drug called trovada, or injections of the drug every two months. However, the two annual shots of the Renacapaville have become another option in the prevention toolbox. This is the first and only shot for HIV prevention.
“Yeztugo could be a transformative preparation option we’ve been waiting for. It offers the possibility of increasing the uptake and sustainability of Prep and adding powerful new tools in missions to end the HIV epidemic.” “Two times the annual injections can address important barriers such as more frequent prep dosing regimens, especially adherence and stigma that allow for daily oral preparation. Research also knows many people who prefer preparation needs or take it frequently.”
With any drug, “If you encounter HIV by having that drug in your bloodstream or in your body, it prevents it from colonizing. It prevents it from colonizing,” said Dr. Jared Baeten, Senior Vice President of Clinical Development at Gilead Sciences.
Human immunodeficiency virus or HIV spreads primarily through unprotected gender and needle sharing, attacking the body’s immune system, and without treatment, can lead to the acquired nature of immunodeficiency syndrome or AIDS. New HIV infection rates are falling in the US, but it is estimated that around 1.2 million people have HIV, with about 13% of people who may not know that.
A study called the Objective 2 trial found that only two shots of renacapavir annually could reduce the risk of HIV infection by 96%, providing almost complete protection against HIV. Another study, the Objective 1 trial, found that renacapavir was 100% effective in preventing HIV in women.
“Lenacapavil is a unique option for people for HIV prevention. It’s only injected twice a year, so people can personally, carefully get it, set it up and forget about it and don’t have to think about it until six months later,” Beten said. “For many people, it could be an authorized, private option that could make HIV prevention viable in their lives.”
Ian Haddock, who took part in the Lenacapavir’s objective 2 exam, said there is a lot of stigma, fear and misinformation around HIV.
He recalls that when Haddock was a teenager living in rural Texas, he faced some of the stigmas.
“The first thing my family said when they found out I was strange was, ‘You’re going to get AIDS,” said Haddock, who doesn’t live with HIV. “That was the first thing I heard.”
Currently, he is 37 years old, and Haddock knows that HIV does not discriminate. He said he was proud to work to break such misguided stereotypes about the LGBTQ+ community as the founder of a nonprofit called the usual abnormality initiative and took part in clinical trials.
“It feels like a full-sake moment,” he said.
Haddock said he started taking daily prep medications in 2015 to reduce the risk of HIV, but sometimes he forgets to either disgust or take away his stomach.
In January 2024, when he learned about the Renacapavir clinical trial, he quickly enrolled. He had no side effects during the test other than stimulation at the injection site, he said.
Haddock said he plans to continue receiving renacapavir injections twice a year despite the trial being over, and hopes that FDA approval will help raise awareness of HIV prevention tools.
In 2012, the FDA approved Truvada, created by Gilead Sciences, making it the first prep for HIV prevention in uninfected adults in the US, but “Since 2012 Prep really doesn’t know what it is, but it often blends with having HIV or being very rough,” Haddock said.
“So this just opens up a whole new opportunity,” he said of the Renacapaville.
Last year, Gilead Sciences released data from the Objective 2 trial, which showed that 99.9% of participants who received a lenacapavir injection twice a year to prevent HIV, were not infected.
There were only two cases out of 2,180, but in effect, 89% have been proven to be more effective than the PREP Pill Truvada. The trial was not early and blurred as it could meet key endpoints and provide Renacapavil to all participants.
“As you can imagine, the most common side effect is the reaction at the site of the injection,” Beten said, including rash and discomfort.
In the objective 2 exam, cisgender men, transgender men, transgender women, and non-binary people age 16 and older had sex with partners who had assigned a man 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 battle with HIV. With its management twice a year and outstanding effectiveness, Renacapaville will help prevent HIV on a scale that we have never seen before.”
“After 17 years of research and pioneering clinical trials, Gilead scientists have provided the next frontier for HIV innovation: preventive medicine with remarkable efficacy that only needs to be provided twice a year,” O’Day said. “This is a true scientific breakthrough that can help millions of people around the world.”
Now that Renacapavir has been approved for prevention, people should be able to visit providers and inquire about the medication within two days, Gilead Science said in an email. The company added that it could take up to two months for someone to receive their first injection, based on coverage decisions.
Lenacapavir’s regular prices will be announced soon if they are used to prevent HIV, Baeten said. The list price is expected to be different from when lenacapavir is used to treat multidrug resistant HIV. In this case, other HIV drugs are not working and the patient meets certain other requirements for renacapavir treatment.
In one study published in the Journal of Antibacterial Chemotherapy in November, for treatment, Lenacapavil costs up to $45,000 per person per year, with an average wholesale price price, without insurance, but could be mass-produced for less than $100 a year.
The team of researchers behind this study predicted the lowest possible prices based on the current ingredients, production models and cost models of the drug. They demonstrated that the Renacapavil could be mass-produced at up to $93 per person per year, and that “with voluntary licenses, if competition between generic suppliers is significantly improved, could reach around $40 a year.
“To achieve these low prices, you need voluntary licenses and multiple suppliers,” the researcher wrote in the research summary. “This mechanism is already in place for other antiretroviral agents.”
The Renacapaville is the latest HIV prevention shot for FDA approval. Created by GSK’s VIIV Healthcare, Apretude was the first injectable pre-exposure prophylactic approved in the US in 2021.
The hope is that the preparation tool could lead to a complete halt of new HIV infections in future generations, Baeten said.
“We all want nothing but end this epidemic, and that’s what, coupled with testing and treatment, can be really solid prevention,” he said.
“I want this next generation to think of HIV as something that can end for a lifetime and end in a generation. And I want to be a place where their next generation doesn’t have to think about HIV at all,” he said. “We have this incredible convenient moment right now as a world where we can be in the future. We can become a world without HIV.”
The new FDA approval comes as the Trump administration cut funding for HIV prevention and surveillance programs through HIV-related research grants, the U.S. Centers for Disease Control and Prevention, significantly reducing global HIV efforts.
According to the HIV+Hepatitis Policy Institute, the administration’s 2026 budget proposal includes elimination of funding for the HIV program, totaling over $1.5 billion.
Carl Schmid, executive director of the Institute for HIV+ Hepatitis Policy, emailed with the approval of PREP’s Lenacapaville, “Now is not the time to pull rugs out from under HIV prevention.”
“The erasure of the CDC HIV prevention and surveillance program is an absurd proposal to increase HIV infection and health costs in the future,” he said. “We urgently call on Congress to refuse these cuts to ensure state and community-based organizations have the resources to prevent HIV. This remains a serious infection, bringing about 32,000 new cases each year.”
