FDA Approves a Twice-Yearly Shot to Prevent HIV

On June 18, the Food and Drug Administration of the United States (FDA) approved the first medication to prevent HIV, which should only be taken twice a year. People who are at high risk of HIV can now have the injection – called Lenacapavir and sold like Yeztugo – once every six months.

Approval is an important step in the fight against HIV and could transform the epidemic. Although anti -HIV treatment has helped millions of people to remove the virus at undetectable levels so that they do not distribute it to others – and also allowed HIV positive people to maintain their status when used to prevent infection – a daily pill diet means that compliance, and therefore efficiency, is often not as strong as it should.

In two studies, Gilead scientists, who have developed Lenacapavir, have shown that the drug was 96% effective to protect cisgenres women from becoming HIV positive compared to daily oral pills (called preparation, abbreviation of pre-exhibition prophylaxis). In men who have sex with men and sex, drugs were 100%effective.

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“The Lenacapavir used by itself for prevention is a huge breakthrough,” said Dr. David Ho, professor of microbiology, immunology and medicine at Columbia University who was the anti-HIV combination pioneer to remove the virus and his ability to mutate to become treatment resistant. “Its potential is excellent for reducing the epidemic.”

But defense groups and global AIDS organizations raise concerns as to whether this potential will be fully carried out, given the recent reductions in the United States supported by the treatment and prevention of HIV worldwide.

From prevention to

Lenacapavir was approved by the FDA in 2022 to treat people with HIV whose virus has become resistant to other antiviral drugs. While developing this treatment, Gilead scientists noticed that Lenacapavir had two important properties that could potentially make it useful to also prevent HIV: its ability to stay in the body for a longer period than other antiviral drugs, and its power to intervene with several stages of the process that the virus uses to make copies of itself.

“We observed a fantastic effect after a single injection,” explains Tomas Cihlar, vice-president of virology at Gilead. “Basically, he protected the non-human primates from the acquisition of HIV. It was then that we realized that we really needed to get a speed and full strength behind the idea of ​​prevention.”

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But because people who take medication to prevent infection are seroped, “the bar for the safety of people who do not have the disease is high enough,” said Jared Baeten, Vice-President of HIV development at Gilead. “However, on the basis of all pharmacology, science and has demonstrated an antiviral activity and security in the sphere of treatment for HIV, at the end of 2020, we made the decision to move the Lénacapavir in prevention,” he said.

Although it is the same drug, when doctors use Lenacapavir to treat HIV, they often combine it with other drugs to limit the potential of HIV to develop resistance. But to prevent diseases in seronic people, Lenacapavir can be used alone, because there is not already an active reproductive virus population in the body.

How the Lenacapavir could cancel the efforts of the HIV vaccine

Lénacapavir is not a HIV vaccine, but its effect in prevention of infection is similar to one. Vaccines enlist and form the immune system to recognize and target pathogens and viruses, so the body becomes a factory to generate the appropriate defenses to fight infections. Lenacapavir’s ability to repel the infection comes from the dissemination of drug levels circulating in the body to fight any virus that could enter.

Whether it is the immune system or the drug, the effect is very similar – which is a huge advance. During the over 40s that followed HIV, scientists have not been able to develop a vaccine against him. “Until now, candidate vaccines do not show this kind of promise to prevent HIV infection,” said Ho. “We are far from an effective vaccine.”

With the approved Lenacapavir to prevent HIV, the bar to develop a vaccine becomes even higher. It could be ethically difficult to justify asking people to take a placebo to establish the effects of a vaccine, because oral preparation and now the Lenacapavir as preparation are so effective to protect against HIV infection. Depriving those who in a vaccination trial to take Lénacapavir by assigning them to receive a placebo would be problematic. “It could withs a little wind from the search sails on vaccines, because there is something so effective in preventing HIV infection,” said HO.

The future of HIV treatment and prevention

The prolonged action nature of Lénacapavir represents a new direction for anti-HIV drugs which could make prevention of infections more tenable and accessible to more people, explains Hui Yang, responsible for supply operations for the Global Fund to combat HIV, TB and malaria. “We have learned from the experience of decades that in prevention programs, membership is a big problem. And this is an aspect that we hope to approach with the introduction of Lenacapavir for the preparation. ” The goal of the World Fund is to obtain two million more people in prevention programs over the next three years, and Lenacapavir could accelerate the achievement of this objective.

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But the blow must always be administered by a health care provider, and people must test negative for HIV before receiving each shot. These are obstacles for many of the most vulnerable populations in low and intermediate income countries, many of whom are young adults. To further increase access, says Yang, a form of Lenacapavir that people could inject twice a year would be even more suitable for such contexts. “It could become something like an insulin injection that people can do themselves,” she said.

Gilead works on a version once a year of Lenacapavir which would reduce the need for several clinical visits.

The unrealized potential of Lenacapavir

Although the advance is scientifically exciting, the drug can take years, even decades, to considerably slow down the world HIV epidemic. “We have just built the best plane in the world, but unfortunately, has torn all the tracks,” explains Kevin Frost, CEO of Amfar, Foundation for Aids Research. “Lenacapavir arrives at the worst moment of the last 30 years of the AIDS epidemic. We see ourselves of time returning from decades due to the dismantling of infrastructure around the treatment and prevention of HIV. ” Cups at USAID, PEPFAR and National Institutes of Health “Mean Lenacapavir will never be lucky that comes out of the door. The very architecture that could deliver from Lénacapavir worldwide to be transformer is being dismantled.”