FDA approves a two -year shot to prevent HIV

On June 18, the US Food and Drug Administration (FDA) approved the first medicine to prevent HIV that only needs to be taken twice a year. People who run a high risk of HIV can now take the injection – Lenacapavir defects and sold as Yeztugo – only once every six months.

The approval is a milestone in the fight against HIV and could transform the epidemic. Although anti-HIV medicine treatments have helped millions of people to suppress the virus into non-detectable levels, so that they do not spread it to others and have also allowed people who are HIV-negative to retain their status when they are used to prevent infection-a regime of daily pills, and therefore effectiveness should.

In two studies, Gilead scientists, who developed Lenacapavir, showed that the drug was 96% effective in protecting Cisgender women against HIV positive compared to daily oral pills (Prep, shortly before prophylaxis before exposure). For men who have sex with men and gender people, the medicine was 100% effective.

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“Lenacapavir who is used for prevention in itself is a huge breakthrough,” says Dr. David Ho, professor of microbiology, immunology and medicine at Columbia University, who pioneered that anti-HIV drugs combining anti-HIV drugs to suppress the virus and the ability to mutate to become resistant to treatment. “The potential is great at limiting the epidemic.”

But interest groups and worldwide aid organizations express their concern about whether that will potentially be fully realized, given that recent cutbacks in HIV treatment and prevention programs all over the world supported by the US.

From treatment to prevention

Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral medicines. While they developed that treatment, the Gilead scientists noticed that Lenacapavir had two important properties that could make it potentially useful to prevent HIV: the ability to stay longer in the body than other antiviral medicines, and their power to interfere different steps in the process in the process that the virus uses to make copies.

“We have observed a fantastic effect after a single injection,” says Tomas Cihlar, senior vice president of Virology at Gilead. “In short, the protected non-human primates against acquiring HIV. Then we realized that we really had to get the full speed and full force behind the idea.”

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But because people who use a drug to prevent infections are -negative, “The bar for safety for people who don’t have the disease is quite high,” says Jared Baeten, vice -president of HIV development at Gilead. “Nevertheless, based on all pharmacology, science and antiviral activity and safety in the HIV treatment, we made the decision to bring Lenacapavir to prevention towards the end of 2020,” he says.

Although it is the same medicine, when doctors use Lenacapavir to treat HIV, they often combine it with other drugs to limit HIV’s potential for developing resistance. But to prevent disease in people who are HIV -Lenacapavir can only be used because there is no active reproducing virus population in the body.

How Lenacapavir HIV could destroy vaccine efforts

Lenacapavir is not a HIV vaccine, but its effect in preventing infection is comparable to one. Vaccins call in the immune system and train to recognize and target pathogens such as viruses, so the body becomes a factory for generating the right defenses to combat infections. Lenacapavir’s ability to ward off infections comes from having circulating levels of the drug in the body to combat any virus that can come in.

Whether it is about the immune system or the medicine, the effect is very on each other – which is enormous progress. In the more than 40 years since HIV was discovered, scientists have not been able to develop a vaccine against it. “Until now, the candidate vaccines do not show this kind of promise for preventing HIV infection,” says Ho. “We are nowhere close to an effective vaccine.”

Approved with Lenacapavir to prevent HIV, the bar is even higher for developing a vaccine. It can be ethically difficult to ask people to take a placebo to determine the effects of a vaccine, because both oral prep and now Lenacapavir and Prep are so effective in protecting HIV infection. Removing those in a vaccine test to take Lenacapavir by assigning them to receive a placebo would be problematic. “This can require a bit of the wind from the sails of vaccine research, because something is so effective in preventing HIV infection,” says Ho.

The future of HIV treatment and prevention

The long-acting nature of Lenacapavir represents a new direction for anti-HIV drugs that can make the prevention of infections of sustainable and more accessible to more people, says Hui Yang, head of the worldwide fund’s delivery operations to combat HIV, TB and Malaria. “We have learned from decades of experience that in prevention programs of therapy compliance is a big problem. And that is an aspect that we hope to tackle with the introduction of Lenacapavir for Prep.” The aim of the global fund is to get two million more people in prevention programs over the next three years, and Lenacapavir can accelerate that target.

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But the shot must still be managed by a care provider and people have to test negative on HIV before they receive every shot. These are obstacles for many of the most vulnerable populations in countries with low and middle income, many of whom are young adults. To further increase access, Yang says, a form of Lenacapavir would be that people could inject themselves twice a year even more suitable for such institutions. “It can be something like an insulin injection that people can do themselves,” she says.

Gilead is working on a one -off version of Lenacapavir that would reduce the need for multiple clinic visits.

The non -realized potential of Lenacapavir

Although the advance is scientifically exciting, the drug can take years or even decades to considerably curb the global HIV epidemic. “We have just built the best aircraft in the world, but unfortunately all the runways have torn,” says Kevin Frost, CEO of Amfar, the Foundation for AIDS Research. “Lenacapavir comes at the worst moment in the last 30 years of the AIDS epidemic. We see ourselves time to travel back tens of years because of the dismantling of the infrastructure about the treatment and prevention of HIV.” Cutbacks on USAID, Pepfar and the National Institutes of Health “Mean Lenacapavir will never have a shot from the gate. The architecture that Lenacapavir could deliver on a global scale to be transforming is being dismantled.”