What to know about Yeztugo

Food and Drug Administration approved a new very effective HIV prevention drug, Gilead Sciences reported on Wednesday. In clinical trials, the drug has almost eliminated the spread of HIV in people with injection every six months.

Called Yeztugo, the very effective medication has inspired a feverish anticipation among HIV prevention defenders. Hope is that the drug could accelerate the stubbornly slow drop in HIV transmission to the United States.

“This is the best opportunity in 44 years of HIV prevention,” said Mitchell Warren, executive director of the AVAC HIV non -profit group.

Yeztugo (generic name Lenacapavir), which is given by health workers in clinics, is much more effective than existing HIV prevention drugs, have declared experts, because it seems to take up challenges to stick to a daily pill scheme for people who run a high risk of HIV.

Gilead’s president-director Daniel O’Day suggested on Wednesday in a statement that drugs could “end the HIV epidemic once and for all”.

It was approved after amazing results in the great clinical trials of Gilead on the drug. The trials have randomly assigned people at risk of HIV to receive injections from Lénacapavir every six months or daily truvada, a form of pre-exhibition or preparation prophylaxis. Among the gay and bisexual men and transgender people, the Yeztugo group had an 89% lower HIV rate to a Truvada group and a 96% lower rate that Gilead estimated would have been expected in the absence of any preparation.

In a similar trial among cisgenres women in sub -Saharan Africa, a person who received Yeztugo contracted HIV.

The shooting is the first of a new class of antiretrovirals which prevent HIV from infecting and making new copies of itself inside the immune cells which it targets. Lenacapavir was approved for the first time in 2022, under the Sunleca brand, for use with other drugs to treat strains very resistant to virus medicines.

All forms of preparation work in the same way: if enough medication is present in the body when a person is exposed to HIV, it is very effective in preventing the virus from setting up and establishing a life infection. Lenacapavir is so long that it should be injected only twice a year.

However, the use of Yeztugo as preparation against HIV emerges in a political climate that experts warn could advance progress against the propagation of the virus. Recent recent cancellations of the Trump administration of research grants and its serious cuts in the staff of Centers for Disease Control and Prevention have considerably affected the field of HIV prevention in particular. HIV experts fear that the full potential of Yeztugo will remain unable to.

At $ 14,109 per injection, or $ 2,352 per month, Yeztugo’s cost could be another obstacle.

Health insurers, at least in the short term, could refuse to cover the plans in favor of other forms of preparation, including the cheaper generic version of Truvada pills, which do not cost as little as $ 30 per month. Or insurers could impose higher Copays for Lenacapavir, said Elizabeth Kaplan, director of access to health care at the Harvard Lad School law clinic.

A decision of the supreme courting court concerning a pillar of the affordable care law could also be an obstacle to insurance coverage for drugs that prevent HIV. ACA, or Obamacare, obliges to cover without cost for certain preventive interventions such as preparation.

A spokesperson for Gilead said that within two days of Yeztugo’s approval, people should be able to start asking the health care providers the drug. However, by putting aside the question of whether the insurance will cover the drug, it could take up to two months for people to really receive their first injections.

Mixed success for preparatory drugs

Ancient forms of preparation have had a mixed success.

Truvada, also produced by Gilead, was the first preproductive drug in 2012, followed by a similar oral medication of the company, Descovy, in 2019.

They have regularly gained popularity among gay and bisexual men who, according to the CDC, represent 7 cases out of 10 new cases of HIV and include the overwhelming share of preparation users.

However, given to what extent the HIV rate is high in black and Latinos gay men compared to their white peers, the use of preparation in men of color has remained disproportionate. Experts believe that preparation has most likely accelerated the considerable decline of HIV in gay and white bisexual men, but the HIV rate among black and Latin bisexual men has persisted at high rates. In addition, when prescribed preparation, black gay men are less likely to take the regime of pills as prescribed.

When taken daily, Truvada and Descovy each risk of HIV forced at least 99%. But the inconsistent use decreases the effectiveness of the preparation.

At the end of 2021, the abretude of VIIV Healthcare was approved as an injectable preparation given every two months.

Despite being much more effective than Truvada to reduce HIV in a population of gay and bisexual men and transgender women in a major clinical trial, the rating has gained little traction until recently. About 21,000 people take it, VIIV reported. It is possible that, in part, people have been alienated by the obligation to visit a clinic every two months for watering, instead of three months for a prescription for oral preparation.

Yeztugo has the potential, but will he deliver?

The injection twice a year offers an alternative to people who will not have or find it difficult to remember to take a pill every day, reducing the number of annual visits required from four to two.

According to CDC estimates, during the decade after the beginnings of the PREP, the annual rate of HIV transmission decreased by only 17%, going from 38,300 cases in 2012 to 31,800 cases in 2022. A large part of the drop occurred since 2018, the number of cases falling 12% during this four -year period.

In 2019, the Trump administration launched the end of the HIV epidemic, or EHE, on the initiative, which has since targeted nearly $ 3 billion new expenses to combat HIV, including promoting preparation, in 48 hot spots in particular. Target jurisdictions experienced a faster 21% drop in transmissions estimated by HIV from 2018 to 2022.

In a study published in October, CDC investigators indicated that the use of preparation had increased regularly since 2014 and that around 200,000 people received a form in a month of 2023.

But it is only a small fraction of the 1.5 million gay and bisexual men who are good preparation candidates, according to estimates in a new study of the CDC published in May.

The crucial question is whether a critical mass of people who otherwise would not have stuck to an oral preparation regime can systematically provide the Lenacapavir while they risk HIV.

Dre Susanne Doblecki-Lewis, head of the Division of Infectious Diseases at the Miami Miller University School of Medicine, is the main researcher of the site for the clinical trial of Lenacapavir in gay men and a separate trial in people who inject drugs. She said that Lenacapavir could alleviate the racial disparities linked to HIV, provided that it is made “easily and at low cost or at no cost for people who can benefit from them who are not guaranteed or under-assured”.

But, she said, “if there are obstacles, such as complicated previous authorizations or high copays that will prevent people from starting it easily, we could see the disparities get worse.”

Political challenges

The Trump administration’s budget demand in 2026 requires a reduction of $ 1.5 billion, or 35%, the reduction in inner HIV financing. This includes the closing the HIV prevention division of $ 794 million from the CDC, although some leftovers are apparently intended to be integrated into a new Federal Health Department, as well as $ 220 million maintained in EHE.

A large part of the HIV prevention budget and the CDC survival is divided into grants to health services and non -profit organizations for health and non -profit organizations. Serious federal budget cuts would most likely hinder the efforts of these entities to educate populations at risk and doctors on Lenacapavir and provide services to facilitate its use.

Another obstacle for prescribers is whether they can ensure that people at risk of HIV come back for the blows of Lanacapavir twice a year. Two recent studies, one published in May and another presented at a conference in March, revealed that less than half of the users of oral preparation remain there six months or more.