The FDA Just Approved a Long-Lasting Injection to Prevent HIV
Jun 20, 2025 7:30 AM Clinical trials have shown that six-monthly injections of lenacapavir are almost 100 percent protective against becoming infected with HIV. But big questions remain over the drug's affordability. Photograph: Konstantin Voronov/GETTY IMAGES
The US Food and Drug Administration has just approved lenacapavir, an injectable form of HIV prevention that is almost 100 percent effective and requires only two doses per year. Science magazine described the medicine the most important scientific advance of 2024.
In clinical trials, lenacapavir proved to be 99.9 percent effective in preventing HIV infection through sexual transmission in people weighing more than 35 kilograms. The drug, an antiretroviral, works not by stimulating an immune response, but by blocking HIV from reproducing during its early stages—specifically, by disrupting the function of the virus's capsid protein. This happens so long as the body receives injections every six months.
Lenacapavir has already been approved in some countries as a treatment for HIV in people with forms of the virus that are resistant to other treatments. However, prior to this week, its prophylactic use had not been approved anywhere, making the FDA's decision a significant new development in the fight against the HIV/AIDS epidemic.
The drug is not the first medicine that can be taken preemptively to protect against an HIV infection: pre-exposure prophylaxis (PrEP) pills were already available in many countries, including the United States. But these must be taken every day, and ensuring ongoing access to these medicines, and that people actually remember to take them, is a known challenge. It's hoped the long-lasting effects of lenacapavir will make it easier for people to stay protected against the virus.
According to its creator, Gilead Sciences, lenacapavir will be marketed under the trade name Yeztugo. The company has committed to manufacturing 10 million doses by 2026.
'This is a historic day in the decades-long fight against HIV. Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic,' Daniel O'Day, president and CEO of Gilead, said in a statement on Wednesday.
However, lenacapavir's price may be a barrier to access. Yeztugo will have an annual list price of $28,218 per person in the US. Winnie Byanyima, executive director of of the Joint United Nations Program on HIV/AIDS (UNAIDS), has also flagged in the past that the drug is unaffordable for many people in Africa, where the medicine has the potential to have the biggest impact. Roughly two-thirds of the people living with HIV worldwide live in sub-Saharan Africa.
Gilead said in a statement last year that it had been 'developing a strategy to enable broad, sustainable access globally' to lenacapavir, although the company has not yet provided detailed information on how it will do this. One option could be 'voluntary licensing,' where other companies are granted permission to produce and sell generic versions of a patented product exclusively to people in certain (often low-income) countries. Researchers at the University of Liverpool in the UK have calculated that a year's worth of lenacapavir could be made available for as little as $25.
This story originally appeared on WIRED en Español and has been translated from Spanish.
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
30 minutes ago
- Yahoo
AI is learning to lie, scheme, and threaten its creators
The world's most advanced AI models are exhibiting troubling new behaviors - lying, scheming, and even threatening their creators to achieve their goals. In one particularly jarring example, under threat of being unplugged, Anthropic's latest creation Claude 4 lashed back by blackmailing an engineer and threatened to reveal an extramarital affair. Meanwhile, ChatGPT-creator OpenAI's o1 tried to download itself onto external servers and denied it when caught red-handed. These episodes highlight a sobering reality: more than two years after ChatGPT shook the world, AI researchers still don't fully understand how their own creations work. Yet the race to deploy increasingly powerful models continues at breakneck speed. This deceptive behavior appears linked to the emergence of "reasoning" models -AI systems that work through problems step-by-step rather than generating instant responses. According to Simon Goldstein, a professor at the University of Hong Kong, these newer models are particularly prone to such troubling outbursts. "O1 was the first large model where we saw this kind of behavior," explained Marius Hobbhahn, head of Apollo Research, which specializes in testing major AI systems. These models sometimes simulate "alignment" -- appearing to follow instructions while secretly pursuing different objectives. - 'Strategic kind of deception' - For now, this deceptive behavior only emerges when researchers deliberately stress-test the models with extreme scenarios. But as Michael Chen from evaluation organization METR warned, "It's an open question whether future, more capable models will have a tendency towards honesty or deception." The concerning behavior goes far beyond typical AI "hallucinations" or simple mistakes. Hobbhahn insisted that despite constant pressure-testing by users, "what we're observing is a real phenomenon. We're not making anything up." Users report that models are "lying to them and making up evidence," according to Apollo Research's co-founder. "This is not just hallucinations. There's a very strategic kind of deception." The challenge is compounded by limited research resources. While companies like Anthropic and OpenAI do engage external firms like Apollo to study their systems, researchers say more transparency is needed. As Chen noted, greater access "for AI safety research would enable better understanding and mitigation of deception." Another handicap: the research world and non-profits "have orders of magnitude less compute resources than AI companies. This is very limiting," noted Mantas Mazeika from the Center for AI Safety (CAIS). - No rules - Current regulations aren't designed for these new problems. The European Union's AI legislation focuses primarily on how humans use AI models, not on preventing the models themselves from misbehaving. In the United States, the Trump administration shows little interest in urgent AI regulation, and Congress may even prohibit states from creating their own AI rules. Goldstein believes the issue will become more prominent as AI agents - autonomous tools capable of performing complex human tasks - become widespread. "I don't think there's much awareness yet," he said. All this is taking place in a context of fierce competition. Even companies that position themselves as safety-focused, like Amazon-backed Anthropic, are "constantly trying to beat OpenAI and release the newest model," said Goldstein. This breakneck pace leaves little time for thorough safety testing and corrections. "Right now, capabilities are moving faster than understanding and safety," Hobbhahn acknowledged, "but we're still in a position where we could turn it around.". Researchers are exploring various approaches to address these challenges. Some advocate for "interpretability" - an emerging field focused on understanding how AI models work internally, though experts like CAIS director Dan Hendrycks remain skeptical of this approach. Market forces may also provide some pressure for solutions. As Mazeika pointed out, AI's deceptive behavior "could hinder adoption if it's very prevalent, which creates a strong incentive for companies to solve it." Goldstein suggested more radical approaches, including using the courts to hold AI companies accountable through lawsuits when their systems cause harm. He even proposed "holding AI agents legally responsible" for accidents or crimes - a concept that would fundamentally change how we think about AI accountability. tu/arp/md
Yahoo
36 minutes ago
- Yahoo
Novo Nordisk (NVO) Terminates Hims & Hers Partnership Over Wegovy Sales Issues
Novo Nordisk A/S (NYSE:NVO) is one of the 12 stocks that will make you rich in 10 years. On June 23, the company discontinued its partnership with Hims & Hers concerning selling its weight-loss drug, Wegovy. This decision was made less than two months after the companies had initially announced their collaboration. A healthcare professional holding a device with innovative technology developed by the medical technology company. According to Novo Nordisk, Hims & Hers failed to adhere to the law prohibiting mass sales of compounded drugs under the 'false guise of 'personalization'.' The company accused its partner of disseminating 'deceptive marketing' that risks patient safety and selling 'illegitimate, knockoff versions' of Wegovy. Novo Nordisk states that its investigation showed the active pharmaceutical ingredients (APIs) in these knockoff drugs, particularly 'semaglutide' from telehealth entities and compounding pharmacies, are manufactured by foreign suppliers in China and were often not inspected by the FDA. In response, Andrew Dudum, CEO of Hims & Hers, stated on X that the company is 'disappointed to see Novo Nordisk management misleading the public.' Dudum alleged that Novo Nordisk's commercial team 'increasingly pressured us to control clinical standards and steer patients to Wegovy regardless of whether it was clinically best for patients.' He asserted that Hims & Hers 'refuse[s] to be strong-armed by any pharmaceutical company's anticompetitive demands that infringe on the independent decision-making of providers and limit patient choice.' Novo Nordisk A/S (NYSE: NVO) is a Danish healthcare company operating globally. It develops, manufactures, and markets pharmaceutical products for the treatment of chronic diseases, primarily diabetes and obesity. Its well-known products include Ozempic, Wegovy, Rybelsus, and Norditropin. While we acknowledge the potential of NVO as an investment, we believe certain AI stocks offer greater upside potential and carry less downside risk. If you're looking for an extremely undervalued AI stock that also stands to benefit significantly from Trump-era tariffs and the onshoring trend, see our free report on the best short-term AI stock. READ NEXT: and . Disclosure: None. Sign in to access your portfolio
Yahoo
an hour ago
- Yahoo
We Asked 3 Diabetes Experts How to Prepare for Traveling—This Is What They Said
Reviewed by Dietitian Karen Ansel, M.S., RDNTraveling with diabetes presents unique challenges beyond blood sugar–friendly eating. Diabetes experts say there are strategies to make travel less stressful and help manage blood glucose. These include packing healthy snacks, a separate medication bag and a water is one of life's great pleasures, offering new sights, fresh experiences and a chance to break away from the daily grind. But if you're living with diabetes, the excitement of hitting the road (or air, boat or train) can come with an extra layer of planning. Between blood sugar monitoring, meal timing and keeping medications stored properly, even a quick getaway can feel like a juggling act. If you've ever wondered how to balance the spontaneity of travel with the routine of diabetes care, you're probably not alone. Fortunately, traveling with diabetes doesn't have to feel like an uphill battle. It just takes a little up-front preparation. From navigating airport security with your supplies to making sure you're ready for unexpected delays or meals that don't quite match your plan, small adjustments can make a big difference. To make your next trip easier, we reached out to three diabetes experts for their favorite tips for traveling with diabetes. Because who better to guide us than the pros who know the ins and outs of this territory? Stay tuned because we're about to share their best strategies for ensuring your next trip is as smooth as it is memorable. When traveling, it's a good idea to pack your medication—and any supplies like syringes, lancets or testing strips—in a separate carry-on bag. 'This specialized bag typically doesn't count towards your standard carry-on limit, ensuring you have all essential medications, devices and snacks readily accessible,' says Lindsay Cohen, RD, LD, CDCES. While you're at it, Vandana Sheth, RDN, CDCES, FAND, suggests packing more medication and related supplies than you expect to need. 'This is especially important to avoid being without key resources like medications if you experience significant travel delays or lose your bags,' she says. Additionally, it's a good idea to carry a note from your health care practitioner explaining your condition and the necessity of your supplies. Also, be sure to pack your medication in its original containers. These steps can be helpful in case of an emergency or during security checks. Since traveling with medications can sometimes cause slowdowns when going through security, you may also want to allow extra time to avoid having to rush through the airport. Before you leave, it's also helpful to put together a complete list of all your medications and their dosages in case you require care while away from home. Planning a visit to a tropical destination? In addition to packing your sunscreen and swimsuit, you may want to pack a cooler bag or ice pack. Why? 'If you take insulin and plan to travel to a warm destination, it's important to protect your insulin from high temperatures, as insulin can lose its effectiveness if it gets too hot,' says Cohen. Ditto for GLP-1 receptor agonists like Ozempic or Wegovy, especially if they haven't been opened yet. Cohen also recommends packing a specialized cooling solution, such as a BreezyPack or Frio bag, to keep your medications at a safe temperature without the need for refrigeration or ice. Packing snacks is basically the golden rule of travel, whether you're living with diabetes or not. Between unexpected travel delays and lack of access to healthy noshes, having nourishing snacks on hand when traveling is always a good idea. However, with diabetes, having readily available blood sugar–friendly snacks is especially critical. We don't have to tell you that managing blood sugar levels on the go can be challenging. Carrying a variety of diabetes-friendly snacks may help prevent sudden glucose drops or spikes. 'Pack snacks that are fast-acting carbohydrates in case of hypoglycemia [aka low blood glucose],' suggests Toby Smithson, M.S., RDN, CDCES. In addition to glucose tablets, she recommends snacks that contain protein and carbohydrates to keep blood glucose steady, like peanut butter on graham crackers. She also suggests tossing some low-carbohydrate snacks like dehydrated cheese balls or jerky into your bag in case your blood glucose rises above target. Paying attention to time changes while traveling is incredibly important for keeping blood sugar on track. At home, you may not think twice about sticking to a regular schedule for things like medication, snacks and meals. But crossing time zones can throw that routine off, potentially causing your blood sugar to go too high or too low. 'If you will be traveling [to] a significantly different time zone, check with your doctor or diabetes educator about any changes required for taking your diabetes medications,' says Smithson. You may have to adjust your insulin doses and keep an especially close eye on your glucose levels. So, it's key to be prepared in advance. People with diabetes are more likely to become dehydrated because high blood sugar levels can cause the body to lose more fluids. That makes adequate hydration critical. In addition, if blood sugar isn't well managed, it can lead to imbalances in electrolytes like sodium and potassium. Dehydration can also put extra strain on the kidneys, which work harder to flush out excess sugar. This can make it harder for the body to reabsorb water, leaving you even more dehydrated. 'Take an empty water bottle with you to fill up after security and stay hydrated,' says Sheth. In addition to drinking plenty of water, you can also sip low-sugar fluids like low-sodium vegetable juice, nonfat milk or unsweetened soy or almond milk to maintain a healthy balance of electrolytes. Traveling with diabetes may require a bit of extra planning. But it's entirely possible to enjoy every moment of your trip and keep your health in check. Simple dietitian-approved strategies like packing a dedicated medication carry-on bag, plenty of diabetes-friendly snacks and a water bottle can help you feel confident and prepared for whatever adventures come your way. You'll also want to be sure to protect your medication from temperature extremes and prepare for time zone changes. And don't forget to allow a little extra time for airport security. Whether it's a weekend getaway or your dream vacation, taking these small steps up front can mean more peace of mind and more time to soak in the sights, experiences and memories that make travel so rewarding. Safe and healthy travels! Read the original article on EATINGWELL
