FDA Approves a Twice-Yearly Shot to Prevent HIV

On June 18 / people who are at risk of HIV can now take the injection – called and sold and sold in the name of Yeztugo – once every six months.

Approval is a milestone in the fight against HIV and can transform the epidemic. While anti-HIV drug treatments have helped millions of people suppress the virus to levels that cannot be discovered so that they do not spread to others-and thus allowed people who are negative in HIV to maintain their position when they are used to prevent infection-a system of daily grains means this compliance, and therefore effectiveness, often not as strong as it should.

In two studies, scientists at Gilead, which developed Lenacapavir, showed that the drug was 96 % effective in protecting CISGERDER women from becoming positive HIV compared to daily oral pills (called preparatory, short to prevent exposure). In men who have sex with men and people between the sexes, the drug was 100 % effective.

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Dr. David Ho, a professor of microbiology, immunity, and medicine at the University of Colombia, who was a leader in combining anti -HIV drugs to suppress the virus and its ability to shift to become treatment. “Its potential is great in reducing the epidemic.”

But the calling groups and global AIDS organizations raises concerns about whether these capabilities will be fully achieved, given the recent discounts of the United States for the treatment and prevention of HIV around the world.

From treatment to prevention

It was Lenacapavir It was approved by the FDA in 2022 to treat people with HIV The virus has become anti -viral drug. Since they were developing this treatment, Gilead scientists have noticed that Lenacapavir had two important properties that could make it useful in preventing HIV as well: its ability to stay in the body for a longer period of antiviral drugs, and its strength to interfere with several steps in the process that the virus uses to create copies of itself.

“We have noticed a great impact after one injection,” says Thomas Sellar, Senior Vice President of Virus at Gilead. “Basically, it protects the non -human majority from obtaining HIV. When we realized that we really need to have full speed and full power behind the idea of ​​prevention.”

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But because people who take a drug to prevent HIV prevention are negative, “the safety tape for people who do not suffer from the disease is very high,” says Jarid Bitten, Vice President of HIA Development in Gilead. “However, based on all pharmacy and science, anti -viral and safety activity in the field of HIV treatment showed, by the end of 2020, we made a decision to transfer Lenacapavir to prevention,” he says.

While it is the same drug, when doctors use Lenacapavir to treat HIV, they often collect it with other drugs to reduce HIV capabilities to develop resistance. But to prevent diseases in people with HIV, LenacAPAVIR can be used alone, as there is already a group of viruses in the body.

How can the Lenakapafer cancel HIV efforts

Lenacapavir is not a HIV vaccine, but its effect on preventing infection is similar to one. Recruitment of vaccines and training the immune system to identify and target pathogens such as viruses, and thus the body becomes a factory to generate appropriate defenses to combat infections. Lenacapavir is to repel infection from the presence of levels of the drug in the body to fight any virus that may enter.

Whether it is the immune system or the drug, the effect is very similar – and it is great progress. In more than 40 years since the discovery of HIV, scientists have not been able to develop a vaccine against it. “So far, the candidate vaccines do not appear this type of promise to prevent HIV infection,” he says. “We are anywhere close to an effective vaccine.”

With the approval of LenacAPAVIR to prevent HIV, the vaccine development bar is higher. It may be morally difficult to justify the demand for people to take fake cards to prove the effects of the vaccine, because both preparatory orally and now leanaciapavir as a very effective work in protecting against HIV infection. Depriving those in a vaccine experience of taking LenacAPavir by appointing them to an imaginary reception will be a problem. “This may take a little wind from the sails of vaccine research, because there is a very effective thing to prevent HIV infection,” he says.

The future of HIV treatment and prevention

Hui Yang, head of supply operations at the Global Fund for fighting HIV, tuberculosis and malaria. “We have learned decades ago that continued for decades that in prevention programs, commitment is a major issue. This is aspect that we hope we deal with with the introduction of Lenacapavir for Prep.” The goal of the global fund is to obtain two million people in the prevention program over the next three years, and Lenacapavir can accelerate this goal.

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But the snapshot should still be given by the healthcare provider, and people need a negative HIV test before receiving each shot. These are the obstacles to many of the most vulnerable population in low -income countries, and many of them are young. Yang says, to increase access, Yang says, the shape of Lenacapavir can pump themselves as twice a year that will be more suitable for such settings. “It can become like insulin injection that people can do themselves,” she says.

Gilead works on a copy once a year of Lenacapavir that will reduce the need for multiple clinic visits.

The unrealized capabilities of the nakapavir

Although progress is scientifically exciting, the drug may take years or even contracts to significantly reduce the global HIV. “We have just built the best plane in the world, but unfortunately, we torn all the corridors,” says Kevin Frost, CEO of AIDS, AIDS Research Corporation. “Lenacapavir comes in the worst moment in the last thirty years of the AIDS epidemic. We see ourselves traveling to contracts due to the dismantling and prevention of infrastructure about HIV treatment.” Discounts to the United States Agency for International Developmentand PepfarAnd the National Health Institutes “means that Lenacapavir will not have a shot from the gate. The same architecture is dismantled that can provide LenacAPavir on a global scale to be transformative.”