New Hope in HIV Prevention as U.S. FDA Approves First Twice-Yearly PrEP Injection Yeztugo (Lenacapavir)
Nikhil Prasad Fact checked by:Thailand Medical News Team Jun 19, 2025 6 hours, 22 minutes ago
Pharma News: In a monumental step forward in the fight against HIV, the United States Food and Drug Administration (FDA) has officially approved a groundbreaking new HIV prevention treatment—Yeztugo, a long-acting injectable medication developed by Gilead Sciences. This drug, also known by its scientific name lenacapavir, is designed to be administered just twice a year, offering a much-needed and more convenient alternative to traditional daily HIV prevention pills. Yeztugo is a revolutionary drug that could transform global HIV prevention efforts.
New Hope in HIV Prevention as U.S. FDA Approves First Twice-Yearly PrEP Injection Yeztugo (Lenacapavir)
The U.S. FDA’s green light came a day earlier than anticipated, ahead of the scheduled June 19 decision date. Yeztugo is now the first and only twice-yearly pre-exposure prophylaxis (PrEP) treatment available in the United States for individuals at risk of sexually acquiring HIV. The timing of this approval is also symbolic, occurring nearly 13 years after the launch of the world’s first daily PrEP pill—Truvada, which was also developed by Gilead Sciences.
This
Pharma News report aims to break down this complex development in simple terms so that everyone, regardless of their medical background, can understand how it affects the future of public health and HIV prevention.
A Historic Breakthrough in HIV Medicine
Gilead’s Chief Executive Officer Daniel O’Day described the U.S. FDA approval of Yeztugo as a historic day in the decades-long battle against HIV. He called Yeztugo “one of the most important scientific breakthroughs of our time,” highlighting how the drug could help achieve the long-standing goal of ending the HIV epidemic.
The medication works by inhibiting a vital part of the HIV virus’s structure called the capsid. Unlike other antivirals that target only one stage of the virus’s life cycle, lenacapavir works across multiple stages, making it more effective and harder for the virus to become resistant to it. It is administered as an injection once every six months—offering users a convenient “get it and forget it” option, especially helpful for those who struggle with the routine of taking a pill every day.
Outstanding Efficacy in Global Trials
The U.S. FDA’s approval of Yeztugo was based on two large-scale clinical studies, known as PURPOSE 1 and PURPOSE 2. These trials are considered the most comprehensive and diverse HIV prevention studies ever conducted.
In PURPOSE 1, which was conducted among cisgender women in South Africa and Uganda, the results were astounding: zero cases of HIV infection were reported among those who received the Yeztugo injection. That means a 100% effectiveness rate.
In the broader PURPOSE 2 trial, which included gay and bisexual men, transgender people, and nonbinary individuals across multiple countries, only two particip
ants out of more than 2,000 contracted HIV while on Yeztugo—leading to a 99.9% effectiveness rate. Gilead reported that Yeztugo was 89% more effective in preventing HIV infections compared to its own once-daily Truvada pill.
These studies also revealed that one of the main challenges with daily PrEP pills is adherence. Many people simply forget to take their medication regularly, which greatly reduces its effectiveness. A twice-a-year injection eliminates that problem almost entirely.
Expanding Global Access and Affordability
Gilead is not just focusing on the United States. The company has already entered agreements with six generic drug manufacturers to supply royalty-free, low-cost versions of Yeztugo to 120 countries that are struggling with high rates of HIV. These nations often lack the healthcare infrastructure to support daily medication regimens, making the long-acting injection particularly valuable.
To fast-track global approvals, Gilead is also collaborating with the European Medicines Agency under its EU-M4all program, which allows other regulatory agencies around the world to use Europe’s drug reviews to accelerate their own assessments. Applications are already underway in countries like Australia, Brazil, Canada, and South Africa, with more to follow.
Jared Baeten, Gilead’s Senior Vice President and head of virology, stressed that the goal is not just about approval but about global impact. He explained that the company is pushing on all fronts to ensure Yeztugo becomes accessible to those who need it most.
Tackling the Crisis at Home
Back in the United States, the HIV prevention landscape remains far from perfect. Although daily PrEP pills like Truvada have been available for over a decade, only about one in three people who are eligible actually take them. The reasons vary: social stigma, lack of awareness, and the difficulty of adhering to daily medication all play a role.
This is particularly true for marginalized populations—women, Black and Hispanic individuals, and those living in the southern U.S.—where access to healthcare is often more limited. In 2023 alone, more than 100 people were newly diagnosed with HIV in the U.S. every single day.
Dr. Carlos del Rio, a leading infectious disease expert from Emory University, believes Yeztugo could be the game-changer that finally helps reach those left behind by earlier prevention efforts. He noted that a twice-yearly injection is not only easier to adhere to, but it could also reduce stigma associated with daily PrEP use.
What Is Yeztugo and How Does It Work
Yeztugo’s active ingredient, lenacapavir, was first approved a few years ago for use in people with drug-resistant HIV. It was originally marketed under the brand name Sunlenca.
https://www.thailandmedical.news/news/hiv-news-u-s-fda-grants-gilead-sciences-approval-for-new-drug-sunlenca-lenacapavir-to-be-used-to-treat-treatment-resistant-hiv-
Now, with Yeztugo, it’s being repurposed for HIV prevention in those who are not yet infected but are at risk.
The medication works by disrupting the protective shell—or capsid—of the HIV virus, a crucial part of its ability to reproduce and spread in the body. Its multi-stage attack on the virus sets it apart from other treatments, which typically focus on just one point in the infection process.
And while no HIV prevention method is entirely without risks, Yeztugo has shown a strong safety profile. The most commonly reported side effects were mild and included injection site reactions, headaches, and nausea.
Access Programs and Cost Coverage
Gilead is rolling out Yeztugo with a focus on making it broadly available, regardless of a person’s insurance status. For those with commercial insurance, Gilead is offering co-pay savings programs that could bring the cost down to zero.
For uninsured individuals, the company’s Advancing Access program will provide the drug free of charge if they meet eligibility requirements. Gilead has also started working with insurers and public health systems to integrate Yeztugo into existing HIV prevention plans.
This approach is part of Gilead’s long-term vision to expand the current U.S. PrEP market from about 400,000 people to over one million by the mid-2030s. Analysts expect rapid uptake of the medication, especially among those who have been waiting for a more convenient prevention option.
A Market Shifting Moment
Until now, the longest-acting PrEP treatment available was GSK’s Apretude, approved in 2021 and administered every two months. With Yeztugo’s six-month schedule, Gilead has now set a new bar in the PrEP space.
Financial analysts are taking notice. Initial forecasts put lenacapavir’s peak annual sales between $4 and $5 billion. However, after seeing strong demand and trial results, some firms have raised their estimates to as high as $8 billion. Industry experts believe Gilead could soon dominate over 60% of the U.S. PrEP market.
The Bigger Picture and Next Steps
Despite this major leap forward, it is important to remember that Yeztugo is not a cure for HIV or AIDS. Prevention remains one of many strategies required to control the virus. However, by making HIV prevention more accessible, less burdensome, and more effective, Yeztugo could significantly reduce new infections around the world.
Gilead continues to explore future HIV treatments that combine lenacapavir with other agents or offer different dosing options to better serve diverse communities. Their ambition is to eventually build an arsenal of long-acting treatments that provide choice, flexibility, and hope to all people vulnerable to HIV.
Conclusion
The FDA’s approval of Yeztugo marks a turning point in global efforts to prevent HIV. For the first time, people at risk have access to a simple, twice-yearly injection that offers unmatched effectiveness and convenience. This innovation has the power to overcome the many barriers that have kept people from using daily PrEP pills—whether it be the hassle of daily medication, social stigma, or limited access to healthcare services. With global partnerships already in place, Gilead is not just changing the U.S. HIV prevention market—it is redefining what HIV prevention could look like worldwide. Although challenges remain in ensuring access, affordability, and education, Yeztugo has the potential to reach populations that have long been overlooked. It is a hopeful step forward in what has been a long and difficult fight. If deployed thoughtfully, Yeztugo may very well be the breakthrough that finally moves the world closer to ending the HIV epidemic for good.
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