The U.S. Food and Drug Administration (FDA) has approved the first-ever twice-yearly injectable medication to prevent HIV. Branded Yeztugo® (lenacapavir) and developed by Gilead Sciences, this drug offers individuals a new option—just two subcutaneous injections per year—to reduce their risk of HIV infection [1][2].

The injection contains the drug lenacapavir, a long-acting HIV medicine that’s been in development for years [5]. The FDA’s approval comes after results from major clinical trials showed the treatment was highly effective at preventing new infections. In studies involving more than 5,000 people at risk of HIV, the drug was found to be 99.9% effective, with only a handful of infections occurring among those who received the shot [3][4]. Researchers said the results were among the strongest ever seen for an HIV prevention method. 

“This is a breakthrough in HIV prevention,” said Merdad Parsey, Gilead’s Chief Medical Officer. “With just two injections a year, Yeztugo removes many of the barriers people face when trying to protect themselves from HIV.” 

Yeztugo is part of a new class of drugs called capsid inhibitors, which block the protein shell surrounding the virus’s genetic material [6]. By targeting a part of the virus different from that of existing drugs, lenacapavir can remain in the body for months, making it suitable for long-term prevention [7]. 

The approval marks a major shift in how HIV prevention is delivered. Until now, the most common option has been daily oral PrEP (pre-exposure prophylaxis) pills like Truvada and Descovy, which are highly effective but require consistent daily use. Health experts say the twice-yearly shot could be a game-changer, especially for people who struggle with taking daily medication due to stigma, unstable housing, mental health issues, or other barriers [3][4]. 

“The approval of lenacapavir is a much-needed boost for HIV prevention, given the strength of the science and the simultaneous disruption in HIV programs globally,” said Mitchell Warren, executive director of AVAC, a global HIV prevention advocacy group. “But U.S. FDA approval is just one in a series of steps needed to ensure that injectable lenacapavir can help reduce the 1.3 million new HIV infections that occur each year. Scientific progress only matters if innovation reaches people.” [13]

Access and Pricing Questions Remain 

While the approval has been widely welcomed, there are concerns about the drug’s affordability. In the U.S., Yeztugo is expected to carry a list price similar to other PrEP medications — roughly $28,000 a year — which could limit access for people without insurance. [14] 

Globally, Gilead has entered licensing agreements to allow generic manufacturers to produce the drug at lower cost in more than 120 low- and middle-income countries. However, advocates say that middle-income countries not covered by those licenses could be left behind. [15] 

An analysis by researchers at the University of Liverpool estimated that lenacapavir could be manufactured for as little as $25 per year [8] — fueling criticism of what some say is excessive pricing in high-income markets. 

A Shift in the HIV Landscape

Yeztugo is now the longest-acting PrEP option available, surpassing Apretude, which requires an injection every two months **[9]**. The FDA’s approval comes as global health leaders continue to push toward the goal of ending HIV as a public health threat by 2030. [1] 

Roughly 1.3 million people are newly infected with HIV each year, and while daily PrEP has helped reduce that number in some regions, uptake remains low in many communities — particularly among young people, Black and Latino men, and women in sub-Saharan Africa [10]. 

Experts say new options like Yeztugo could help close those gaps by offering a simpler, more discreet way to stay protected [3][4]. 

“This is a big step forward, especially for people who can’t or don’t want to take a pill every day,” said Dr. Boghuma Kabisen Titanji, an infectious disease specialist and HIV researcher. “But it’s not just about approval. It’s about making sure the people who need it most can get it.” [17]

What Comes Next

Gilead says it plans to begin rolling out Yeztugo in the U.S. later this year, with plans to expand internationally in 2026 [1]. Doctors and clinics are being trained to administer the injection, which is given just under the skin (subcutaneous) of the abdomen or thigh, every six months. [16] 

The company also said it is working with insurance providers and government programs to ensure the drug is covered, though it remains unclear how quickly it will be included in PrEP access programs like Ready, Set, PrEP in the U.S. [11]. 

As the landscape of HIV prevention continues to evolve, Yeztugo offers a promising new tool — one that, if made widely available, could help turn the tide in the decades-long fight against HIV [12]. 

“This is the most significant opportunity we’ve had in 44 years of HIV prevention,” said Mitchell Warren, executive director of the HIV advocacy organisation AVAC. [17]