US: FDA approves powerful HIV prevention drug: What to know about Yeztugo($14,109 EACH INJECTION)

 The Food and Drug Administration has approved a highly effective new HIV-prevention medication, Gilead Sciences reported Wednesday. In clinical trials, the drug nearly eliminated the spread among people given an injection every six months.

The extremely successful medication, known as Yeztugo, has sparked fervent anticipation among HIV prevention campaigners. It is hoped that the drug would hasten the obstinately sluggish drop in HIV transmission in the US.

According to Mitchell Warren, executive director of the nonprofit organization AVAC, which advocates for HIV prevention, "this is the single best opportunity in 44 years of HIV prevention."

According to experts, Yeztugo (generic name lenacapavir), which is administered by medical professionals in clinics, is far more effective than the current oral HIV-prevention medications since it seems to solve the difficulties that high-risk individuals have adhering to a daily pill regimen.

Daniel O'Day, the chairman and CEO of Gilead, implied in a statement on Wednesday that the medication would "finally put an end to the HIV epidemic."

It was authorized following remarkable outcomes from Gilead's extensive clinical trials. Participants at risk for HIV were randomized to either daily Truvada, a pill form of pre-exposure prophylaxis, or PrEP, or lenacapavir injections every six months. The HIV rate among gay and bisexual men and transgender individuals was 89% lower in the Yeztugo group than in the Truvada group, and 96% lower than what Gilead calculated would have been predicted in the absence of PrEP.

In a similar trial among cisgender women in sub-Saharan Africa, no one who received Yeztugo contracted HIV.

The shot is the first in a new class of antiretrovirals that block HIV from infecting and making new copies of itself inside the immune cells it targets. Lenacapavir was first approved in 2022, under the brand name Sunleca, for use with other medications to treat highly drug-resistant strains of the virus.

Every type of PrEP functions similarly: It is very successful at stopping the virus from spreading and creating a lifelong infection if there is an adequate amount of the medication in the body at the time of HIV exposure. Lenacapavir only requires injections twice a year due to its lengthy half-life.

However, experts caution that the political environment surrounding Yeztugo's use as PrEP against HIV could impede efforts to stop the virus's spread. The area of HIV prevention has been significantly impacted by the Trump administration's recent widespread cancellations of research funding and its drastic staffing reductions at the Centers for Disease Control and Prevention. HIV specialists worry that Yeztugo may not reach his full potential.

The vaccine is the first of a new family of antiretrovirals that prevent HIV from infecting and replicating within the immune cells it targets. The Gilead Sciences

The expense of Yeztugo, which is $14,109 each injection or $2,352 every month, may be an additional obstacle.

In the short run, health insurance may refuse to pay for the injections in favor of other PrEP options, such as the less expensive generic version of Truvada pills, which can cost as low as $30 a month. Or, according to Elizabeth Kaplan, director of health care access at Harvard Law School's Health Law and Policy Clinic, insurers may increase lenacapavir copays.

Within two days of Yeztugo's approval, consumers should be able to ask medical professionals for the medication, according to a Gilead representative. Nevertheless, aside from the issue of insurance coverage, it may take up to two months before clients receive their first shots.

However, PrEP use among men of color has remained disproportionately low, given the significantly higher HIV rate among Black and Latino homosexual men as compared to their white counterparts. Although the HIV prevalence among Black and Latino gay and bisexual men has remained at notably high levels, experts believe PrEP has probably accelerated the significant drop in HIV among white gay and bisexual men. Furthermore, Black homosexual men are less likely to follow their doctor's instructions when administered PrEP.

Both Truvada and Descovy reduce HIV risk by at least 99% when taken regularly. However, irregular use reduces PrEP's efficacy.