The FDA approves Yeztugo (Lenacapavir), twice a year for HIV prevention

ahsan65@gmail.comJune 20, 2025

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The FDA approves Yeztugo (Lenacapavir), twice a year for HIV prevention

Persons risked contracting HIV by sexual contact have a new revolutionary option to protect themselves: Food and Drug Administration (FDA) approved Yeztugo (Lenacapavir), the first and first prevention drug of HIV injectable for adults and adolescents who weigh at least 77 pounds. Studies have shown that the new drug was effective by more than 99.9% to prevent HIV.

Yeztugo offers an alternative to the current therapeutic patterns available for PREP (pre-exhibition prophylaxis) that people use to prevent HIV, in the form of daily pills or injections of every month.

The formulation of twice a year and the approval are both “really, really exciting”, says

Matthew Hamill, MBCHB, PHD, associate professor of medicine and infectious diseases at Johns Hopkins Medicine in Baltimore.

“I speak not only for myself, but also for many of my colleagues in the field. And many of my patients asked me: “When can I get the injection twice a year? This approval changes completely, ”explains Dr. Hamill, who was not involved in the development of Yeztugo.

The most effective HIV prevention drug to date

The approval of Yeztugo was based on the data of two pivotal trials of phase 3, objective 1 and objective 2.

In PUT 1 trial, which included more than 5,000 cisgenres women in sub -Saharan Africa, no participant who received the HIV acquired from Yeztugo – an impressive reduction of 100%.

Similarly, in trial 2 of more than 3,000 men who have sex with men and sex individuals, only two cases of HIV have occurred in Yeztugo beneficiaries, resulting in a protection rate of 99.9%.

“I think there is no doubt that it is the most effective medication we have to date,” said Hamill.

In clinical trials, Yeztugo was sure and had no significant side effects

The drug received a priority review and obtained the designation of revolutionary therapy by the FDA in 2024, which helps to accelerate the development of drugs which show substantial improvements in relation to existing treatments.

Yeztugo was generally well tolerated in clinical trials. The most frequently reported side effects were light to moderate injection site reactions, including nodules (lumps) and localized pain.

Scientists have observed no significant or unexpected security problem.

A new option could particularly help people in color

The FDA approved the first HIV prevention drug, the daily Truvada (also developed by Gilead) in 2012. But the most recent data show that only about 1 people in 3 in the United States which could benefit from PREP have received HIV prevention treatment.

Research suggests that stigma around HIV, the low awareness of drug options and the daily load of pills continue to limit the use of preparation, especially in women, blacks and Latin American and people living in the southern United States.

This is why many people – experts and individuals at risk – hope that Yeztugo will address these obstacles.

This includes Ian L. Haddock, participating in the Yeztugo clinical trials. Haddock is the founder of the normal anomaly initiative, a non -profit organization focused on the empowerment of black queer communities in the south.

As a black gay man, Haddock includes many of the challenges of HIV prevention, including mistrust inherent in many black Americans towards the medical community due to previous damage.

In addition, many of the people who could benefit the most progress like PREP are not aware of these new opportunities, he said.

“I know that if the community can access this information, it will revolutionize the way people approach prevention,” says Haddock.

On a global scale, Yeztugo puts women in control

The results of the test in Cisgenres women are particularly notable because, historically, the trials in women in Africa have given disappointing results, explains Hamill. This was mainly motivated by poor membership of preventive drugs, caused by many complex reasons, he said.

Yeztugo removes these challenges, explains Hamill. “This takes away from hiding your pills from your partner, if you fear that your partner is abusive if he discovers that you use the preparation. This removes the stigma of the transport of drugs that people can be part of the treatment of HIV. ”

“I would compare this to the injectable contraceptives. Women control – no one needs to know, and it gives them more autonomy, ”he says.

Will people in the United States and in the world be able to get the new drug?

Yeztugo will cost $ 14,109 per injection, or $ 2,352 per month, per USA Today, This means that the cost could be an obstacle.

In the United States, Gilead’s access strategy is designed to allow wide availability for people with insurance coverage, explains a company spokesperson.

“It will be assessed in accordance with existing brand HIV prevention options, and we expect to see high levels of coverage for this,” they say.

For eligible people with commercial insurance, there is a copamentation savings program that could reduce the costs of the pocket as little as zero dollar, explains the spokesperson for Gilead, and non-insured people eligible could be able to get Yeztugo free of charge through the assistance program for Advance Access patients.

The question of whether people around the world will have access to Yeztugo is “the question of the million dollars,” says Hamill.

This drug has the potential to end the HIV epidemic in the world – but prices will be an important factor to make it a reality, he said.

Thanks to a variety of channels, in particular by providing drugs to certain high incidence countries without asking for a profit, the company aims to reach two million people worldwide in three years, said Gilead spokesperson.

ahsan65@gmail.comJune 20, 2025

0 0 4 minutes read