In a step described as "historic" by experts and activists, the United States Food and Drug Administration (FDA) approved on Wednesday the use of the first preventive injection against HIV, a treatment called lenacapavir, which requires only two applications per year.
Manufactured by the pharmaceutical company Gilead Sciences, the drug is now the most durable and effective option available for the prevention of the human immunodeficiency virus (HIV).
Marketed under the name Yeztugo, lenacapavir reduced the risk of infection by more than 99.9% in clinical trials with high-risk adults and adolescents, according to a report by Univisión.
"This is a historic day. Lenacapavir has the real potential to end the transmission of HIV," declared Daniel O’Day, CEO of Gilead.
Lenacapavir is administered via two subcutaneous injections per year in the abdomen, where the medication is deposited and released slowly into the body. This mechanism not only simplifies treatment but also provides an effective alternative for individuals who forget to take daily oral PrEP or who face stigma in doing so.
"It is the closest thing to an HIV vaccine that we have," noted Greg Millett, director of public policy at the amfAR.
"This could really change the game," he emphasized.
Although FDA approval marks the beginning of a global rollout of lenacapavir, it is still unclear how many people in the U.S. and abroad will be able to access the medication, primarily due to its high cost.
It is estimated that the starting price could be around $25,000 annually, a figure that could restrict its availability in low-income communities, both in the country and in other regions of the world where HIV continues to pose a serious threat.
Activists and organizations have called for the price to be drastically reduced to around 25 dollars a year in order to achieve global goals for eradicating the virus by 2030.
PrEP (pre-exposure prophylaxis) has been around for over a decade, but its effectiveness has been limited by the requirement to take it daily.
In contrast, the biannual protection offered by lenacapavir facilitates treatment adherence and breaks down social and logistical barriers that have hindered prevention in many populations.
According to the CDC, more than 30,000 new HIV infections are recorded each year in the United States and approximately 1.3 million worldwide. The emergence of a more accessible and long-lasting preventive method could represent a turning point in the fight against the disease.
With the approval now in effect, Gilead is preparing the commercial launch of Yeztugo in the U.S. market while advancing global agreements to expand access, particularly in developing countries.
Meanwhile, public health experts and advocates for universal access to treatment insist that the success of this tool will depend not only on its medical efficacy, but also on its affordability, availability, and equitable distribution.
Today's announcement marks a new era in HIV prevention, but it also raises a key question: who will be able to afford access to this advancement? they ask.
Frequently Asked Questions about the Preventive HIV Vaccine Approved in the U.S.
What is lenacapavir and how does it work?
Lenacapavir is a preventive treatment against HIV that is administered through two subcutaneous injections per year. This medication, marketed under the name Yeztugo, is deposited in the abdomen and is released slowly into the body, reducing the risk of infection by more than 99.9% according to clinical trials.
Why is the use of lenacapavir considered historic?
The approval of lenacapavir is considered historic because it represents a significant advancement in HIV prevention, offering a durable and effective option with just two applications per year. This simplifies treatment and can break down social and logistical barriers for individuals facing stigma when taking daily PrEP.
What are the barriers to accessing lenacapavir?
The high cost of lenacapavir, estimated at around $25,000 per year, could limit its availability in low-income communities. Activists and organizations are advocating for a drastic reduction in price to broaden access and achieve global HIV eradication goals.
How might Trump's drug pricing policy influence the accessibility of lenacapavir?
Trump's policies aim to lower drug prices in the U.S., which could enhance the accessibility of lenacapavir. However, the effective price reduction will depend on the implementation of these policies and negotiations with the pharmaceutical industry.
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