FDA approves long-lasting HIV-prevention drug
1 of 2 | A man photographs a portion of the AIDS quilt during an HIV/AIDS rally on the National Mall in Washington, D.C., in 2021. The Food and Drug Administration has said that it has approved a new drug that could prevent HIV infections with just two shots every year. File Photo by Kevin Dietsch/UPI | License Photo
June 18 (UPI) -- The Food and Drug Administration has approved a new drug that could prevent HIV infections with just two shots every year and possibly eradicate the disease.
The drug's scientific name is lenacapavir and it will be marketed as Yeztugo, which requires one injection every six months to maintain its effectiveness in preventing HIV infections.
Other drugs exist that also prevent HIV, but they require daily dosages in pill form and have not significantly affected the disease on a global level.
"We're on the precipice of now being able to deliver the greatest prevention option we've had in 44 years of this epidemic," AVAC executive director Mitchell Warren told the New York Times. AVAC is an anti-HIV organization.
He said recent funding cuts by the Trump administration will make it hard to distribute the drug globally.
"It's as if that opportunity is being snatched from out of our hands by the policies of the last five months," Warren said.
Gilead Sciences is producing the drug, which is the second long-lasting HIV prevention drug available.
The other option is cabotegravir, which is sold under the brand name Apretude and requires an injection every two months.
About 21,000 Americans use Apretude, while about 500,000 use daily oral medications to prevent HIV.
Clinical trials showed most participants who received two shots of lenacapavir every year had nearly full protection against HIV.
More than 39,000 people in the United States contracted HIV in 2023, which carries an estimated lifetime treatment cost of $1.1 million per patient, Gilead Chairman and Chief Executive Officer Daniel O'Day told the New York Times.
Lenacapavir already is being prescribed to treat people with HIV infections that resist other medications and at an annual cost of $42,000 per patient, but most patients don't pay the full cost.
Health insurance coverage and patient-assistance programs would cover the cost for most people using lenacapavir, according to Gilead.
The cost for oral pills taken daily is just $1 per pill, while Apretude carries an annual cost of about $24,000.
Proposed funding reductions for Medicaid and the President's Emergency Program for AIDs Relief, commonly called PEPFAR, might greatly reduce access to the drug, according to advocacy groups.
The PrEP oral treatment still would be available, but it does not work for many people, Health Gap Executive Director Asia Russell told the New York Times.
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Bloomberg
an hour ago
- Bloomberg
UNAIDS Executive Director: ‘The HIV Response Is in Crisis'
Winnie Byanyima says her organization has lost almost 50% of its funding, a gap that is undermining global efforts to combat HIV/AIDS. By Are we unraveling years of progress on fighting HIV/AIDS? For the past two decades, the US has led the global response to a virus and disease that have together claimed more than 40 million lives. But there are still more than a million new infections every year; with no vaccine or cure, preventing further spread is critical. This is why there was so much alarm from campaigners and experts when the US Department of Government Efficiency, led by Elon Musk, started slashing foreign aid. In an interview last month, Musk himself told me that HIV-prevention programs were ongoing. But Winnie Byanyima, executive director of the Joint United Nations Programme on HIV and AIDS, tells a different story. Her organization is one of the key bodies fighting the virus globally — UNAIDS operates in nearly 100 countries — and Byanyima says the disruption she's seeing is both real and deadly. We spoke while Byanyima was on a visit to South Africa, where the rollout of one of the most promising HIV-prevention tools in a generation is now in doubt. 'Even if I get the next batch of medicines,' one aid worker in Soweto told her, 'they may expire because the two people I had who go out and reach people in their communities [are no longer there].' This interview has been edited for length and clarity. First of all, are you able to set the record straight? To what extent has your work at UNAIDS been affected by the DOGE-led cuts to USAID? First, globally, the HIV response is in crisis. Clinics have closed. Prevention services have halted. People are losing access to lifesaving medicines. People are scared. Our work as the UN leader of the global HIV response is also affected severely. We've lost close to 50% of our funding. It came from two pockets of the United States government. So we are also struggling to stay alive. But there is a crisis and a huge disruption, the biggest since the global response was created about 25 years ago. I know that Elon Musk has doubted that these disruptions are there,[and] has even said that if they are there, he would fix them. 1 I know he has left government, but I'll be happy to go with him anywhere in Africa or Asia to show him, or take any other American official to see what the real impacts are for people living with HIV and for people at risk of HIV, like gay men [or] women and girls in Africa. In our May conversation, Musk said he did not believe many HIV-prevention programs had stalled: 'If in fact this is true, which I doubt it is, then we'll fix it.' But he also questioned the assertion that cutting USAID would result in any fatalities, saying that recipient organizations 'don't even try to come up with a show orphan' to back up their claims of saving lives. When you say the HIV response globally is in crisis, how much of that is to do with US funding cuts? How great is America 's responsibility for that situation? Huge. The United States government and US taxpayers were contributing a lion's share of the support to developing countries to fight this disease, up to 73%. You might say, why the United States? Well, it's the wealthiest country in the world, and these are the poorest countries in the world. By pulling its funding away very quickly, the US didn't [give] these highly indebted countries — that are heavily impacted by [the] climate crisis, that have huge burdens of disease beyond HIV — enough time to be able to fill the gap. 2 UNAIDS created a portal to track the real-time effects of US funding cuts in the developing countries in which it operates, including observations from officials in the field. 'My greatest fear is that we will return to the dark days of the epidemic,' says the director of UNAIDS in Zambia. But what about other donors? What about rich countries in the Middle East or other G-7 countries or philanthropists with deep pockets? There have been two main sources of funding to support developing countries [on HIV/AIDS]. One is the American program, PEPFAR, the presidential initiative, and the other is called the Global Fund, where other donors — the Europeans, the Japanese, the Chinese — all put money together and help the developing countries. When the major contributor pulls out with little notice, things collapse. That is what has happened. In South Africa, which funds 80% of its own response and has been getting US support for only 17%, I visited a clinic in Soweto and saw the impact. A man who works [there] told me, 'Even if I get the next batch of medicines, they may expire because the two people I had who go out and reach people in their communities and bring them for service [are no longer there].' He's seeing a drop in the numbers of people coming forward to get what they need to prevent or to be treated. 3 This is backed up by recent Bloomberg reporting from South Africa, which has the world's largest HIV-treatment program with 80% of 7.8 million infected people on medication. So we are seeing that even in a country that's not so dependent, there are disruptions. Even in a country where the will is so strong, like South Africa, you're still seeing a gap that is definitely going to result in more new infections and more deaths. We know from our modeling that if the gap is not filled by other funding, in the next four years we are going to see up to 6.6 million additional new infections and additional deaths of 4.2 million. And that's in addition to what we were already estimating. PEPFAR, the program that you are referring to, 4 is the responsibility of the State Department. Marco Rubio, the Secretary of State, says 85% of PEPFAR is functional. PEPFAR stands for the President's Emergency Plan for AIDS Relief. It was a US policy choice that began during the George W. Bush administration in 2003, and has since then provided cumulative funding of $120 billion for HIV/AIDS treatment. That's roughly as much as the US government spends on its Supplemental Nutrition Assistance Program (food stamps) in a single year. It isn't exactly that because the PEPFAR program on the ground is implemented by two parts of the American government, the CDC [Centers for Disease Control and Prevention] in Atlanta and USAID. Now USAID has been shut. So there's no work that was done by USAID that's going on right now, though some work by the CDC is still going on. 'I say to President Trump: You are a man who likes to do a deal. Here's a deal.' But over and above that, there has been confusion. First, the cut was a stop-work order for everything. Then, within a week — and we thank the American administration for realizing that this was going to cost lives — they said it can come back, but only some of it. We see testing and treatment coming back by the CDC. We don't see much progress on prevention. So in many places, prevention clinics where people get their condoms, their PrEP, vaginal ring, whatever — these are not open. So we do see many gaps, particularly for women and girls in Africa, gay men, sex workers and people who inject drugs. They have their special clinics; those too have closed. It seems then that you think the statement '85% of PEPFAR is functional' is inaccurate, or misleading. It is inaccurate to the extent that the impact for the very low-income countries is huge. Our own data shows us that the impact is much bigger than that. 5 We asked the State Department to respond to UNAIDS' assertion that many HIV-prevention programs supported by the US have stalled. They told us they continue to support testing, care, treatment and prevention of mother-to-child transmission, and that an estimated 85% of beneficiaries could be receiving lifesaving treatment and prevention of mother-to-child transmission. All other PEPFAR-funded services are under review. Did you have any contact with Elon Musk's team at DOGE? We appealed to him publicly. I am very loud on social media and said I'm happy to meet him and take him to see. Anyway, he's left government. We are addressing ourselves now to the American government to say, 'You started something strong.' A Republican government, President Bush, came out at a time of the worst pandemic of the century and [began] a program to save lives. Right now, there are tools that could end this pandemic, and I say to President Trump: You are a man who likes to do a deal. Here's a deal. There is an American innovation called lenacapavir that's 100% effective to stop infections. An American innovation that creates American jobs that could be rolled out and we could cut down new infections almost to zero. Why not do this? That would be another Republican president bringing a revolution on prevention. This could be a win-win. Get the Bloomberg Weekend newsletter. Big ideas and open questions in the fascinating places where finance, life and culture meet. Sign Up By continuing, I agree to the Privacy Policy and Terms of Service. It is a US pharmaceutical company, Gilead, that's behind lenacapavir, which has been through lots of trials. But there would still be an issue, wouldn't there? It is likely to be extremely expensive. Wouldn't access to the drug possibly be like antiretrovirals in their early years, when they were out of the reach of the world's poorest people? You are right. We are hearing rumors in the media of $25,000 per person per year, and [if] it comes out at that price, then it will not bring new infections down to zero. 6 When they first came out, antiretrovirals used to treat HIV infections could cost more than $10,000 a year, but they eventually became widely available thanks to the work of aid organizations. Now lencapavir promises to provide six-month protection from infection, eliminating the need to take daily pills. On June 18, Gilead said that lenacapavir, marketed as Yeztugo, has a list price of $28,218 per year. It sounds as if this has been an extraordinary rollercoaster. You had immense hope that 2025 could be a breakthrough year, and instead you spent the first half of it almost battling for the organization's survival? That's true. I'm letting people go. People who have, over 20 years, built the experience to support this response. It's sad and it's unnecessary considering the billions that are being spent on building up new weapons systems and fighting wars. My core budget was not even $150 million [a year], but now it's been slashed by almost half. It's a sad moment, but we won't give up. I'm inspired by the governments and the people in countries [that] aren't giving up. They are stretching themselves, volunteering, doing things differently. We've got to keep people alive. So we are pushing on. We will continue fighting. I read that you are having to fight on another front at this moment, a personal front. You grew up in Uganda, you served your country as a political leader before you moved into international work, 7 and your husband is a longtime opposition leader in Uganda. Is it the case that he remains imprisoned, as we speak, on very serious charges? Byanyima has had quite a career. She was a flight engineer for Uganda Airlines, a combatant (alongside her husband) in the National Resistance Army and Uganda's ambassador to France from 1989 until 1994. She helped draft Uganda's 1995 constitution, and served two consecutive terms as a member of parliament before serving in leadership roles at the African Union and Oxfam International. She became executive director of UNAIDS in August 2019. That is true, Mishal. My country has struggled through crises since independence. We thought we had turned the corner through a revolution that brought back democracy, but we've seen reversals in the last 10 to 15 years. My husband has been an opposition leader for the last 25 years. But for most of those, he's been in and out of jail — always criminalized, but always being exonerated by the courts. Last November he was abducted from neighboring Kenya and taken across the border. It's now six months he's been in jail. He hasn't been tried. For a long time he was not even charged, he was just illegally being held. He's not the only political prisoner, but we have the international human rights organizations supporting his cause, supporting that he should be released on bail, so that he can fight whatever charge they may have against him. 8 In February, Byanyima's husband Kizza Besigye was charged with treason over an alleged plot to overthrow Ugandan President Yoweri Museveni. Besigye has unsuccessfully tried to unseat Museveni — who has been in power since 1986 — in four elections. How is he and are you able to be in contact with him? We are in contact with him and able to visit him. But he's not in a good condition. He's in a tiny cell where you can hardly even sit by his bedside, there's not enough room. So yes, I am angry at how he's being treated. I'm angry at the illegality that the president has shown. The Supreme Court decided that as a civilian, he should not be tried by the military. [President Yoweri Museveni] reversed it by bringing a law before Parliament to allow civilians to be tried by the military. 'No one anywhere — in any country in the world, rich or poor — should take freedom for granted, should assume that because they're enjoying human rights, because there's rule of law at a certain point in time, that it'll always be there.' Didn't he used to be a friend of yours, President Museveni? He is a family friend. I first met him when I was little. He was always in and out of the family home. He was a friend of my parents. This is just about politics and power. President Museveni has never quite accepted the idea of being a democratically elected leader who respects an opposition and competes with them fairly. I wonder what this leads you to conclude about the nature of power and authority. Your generation knows what dictatorship was like when you were growing up, the time of Idi Amin. You ended up having to leave Uganda, you came back, and you were part of building institutional governance. What are the lessons of how to build a nation to ensure structures that safeguard people's rights? You raise a very important point. No one anywhere — in any country in the world, rich or poor — should take freedom for granted, should assume that because they're enjoying human rights, because there's rule of law at a certain point in time, that it'll always be there. You can have reversals. Sudden reversals or slow reversals, but reversals do happen. You must always be working as a citizen, doing your duty to protect your constitution, to defend the rule of law, to defend the human rights of others, not just for yourself. May I close, Winnie, by asking you what gives you strength? To be battling on these two fronts — one professional, one personal — at the same time, it would take a lot out of anyone. It is tough, but the truth is that I have lived a life of struggle. I don't say my life was always rough. I've had, and I still have, very many happy moments. But at every point I have had to be a part of struggles, to make lives better — for myself and for others. What's happening to me on the personal front, what's happening on the professional side, I see them all as a struggle for justice. Justice for my husband, justice for people living with HIV, justice for those who are denied their rights because of their sexual orientation, because of who they are. So I live day by day and think everybody has their load to carry. And that's mine. Mishal Husain is Editor at Large for Bloomberg Weekend. More On Bloomberg
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Protein is essential not only for building and repairing tissues but also for keeping you feeling full and satisfied. This makes hummus a great option for curbing hunger between meals. While not as protein-heavy as some animal-based snacks, hummus still delivers a solid 2-3 grams of protein per tablespoon, making it an excellent choice for a quick energy boost. Healthy fats for brain and heart health The healthy fats in hummus mainly come from tahini and olive oil. These unsaturated fats are known to support cardiovascular health by improving cholesterol levels and reducing inflammation. Plus, healthy fats may help keep your brain sharp and your skin glowing. Fiber for digestion and satiety Most Americans are not eating nearly enough fiber every day, resulting in what scientists call the "fiber gap." Chickpeas are a natural source of fiber, so consuming them can help people meet their needs. Yes, even if they are pulverized into a chickpea-based spread. 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Surround it with pita chips, olives, crunchy vegetables and even pickles for a spread that looks as good as it tastes. While hummus is an incredible snack, it's worth noting that portion size matters. Eating an entire tub in one sitting (we've all been there!) can lead to excess calorie intake, especially if your dippers are heavy on refined carbs like white pita bread. For the best nutritional benefits, try pairing hummus with fiber-rich veggies or whole-grain crackers. Also, store-bought hummus can sometimes contain extra sodium or preservatives, so be sure to check the label if you're buying premade versions. From its rich nutritional profile to its versatility in the kitchen, hummus certainly makes a strong case for itself as the ultimate snack. It's affordable, easy to prepare and packed with nutrients that support your health. Whether you're dipping, spreading or dolloping, hummus can fit into your meals in countless delicious ways. If you're not already reaching for it regularly, now's the time to start letting hummus shine as your go-to snack.
