That\u2019s the reason why, by 2023, only about 6 million people worldwide were on PrEP, a fraction of the tens of millions who could benefit. Each year, another 1.3 million people still acquire HIV.<\/p>\n
But a discreet shot taken just twice a year, like the newly approved lenacapavir, takes forgetfulness \u2014 and some stigma \u2014 out of the equation. For a field where breakthroughs have been rare, lenacapavir has almost vaccine-like efficacy (even though it\u2019s not one). In clinical trials, the drug showed 100 percent protection in women and approximately 96 percent in men, transgender and nonbinary people. Those are the kind of numbers policymakers can\u2019t ignore.<\/p>\n
The US Food and Drug Administration approved it in June, the World Health Organization endorsed it in July, and the European Union followed in August. And the Trump administration \u2014 which grounded its live-saving global health work to a complete stop<\/a> eight months ago \u2014 has recently made lenacapavir the center of its \u201cAmerica First<\/a>\u201d global health strategy. The administration plans to roll out the drug in about a dozen low-income countries by early 2026.<\/p>\n That\u2019s all remarkable news. Low-income countries typically have had to wait decades, if not more, before newer, better drugs trickled down. This time, at least in theory, access could come almost simultaneously.<\/p>\n But whether lenacapavir actually makes a dent in the HIV epidemic will depend less on science than on politics.<\/p>\n AIDS-related deaths have dropped dramatically since 2005, in large part because of PEPFAR. Council on Foreign Relations<\/p>\n Four decades ago, an HIV infection was a near-death sentence. But since then, we\u2019ve marched toward progress \u2014 making better drugs with simpler regimens and widening access.<\/p>\n But even after all that work, we still don\u2019t have a cure or a true vaccine. That\u2019s why an innovation like lenacapavir feels notable.<\/p>\n For years, HIV drugs targeted the virus\u2019s enzymes, and it wasn\u2019t obvious that targeting anything else would work. Then in the 1990s, researchers backed by the National Institutes of Health began studying how the virus builds its cone-shaped shell, called the capsid. Most scientists dismissed it<\/a> as \u201cundruggable\u201d \u2014 a smooth protein structure with no obvious place for a medicine to stick.<\/p>\n But a small band of virologists thought differently. They spent years hunting for a molecule that could jam the capsid\u2019s formation. After countless dead ends, that hunch paid off: The work led to lenacapavir, the first drug to successfully attack the virus\u2019s shell and block multiple steps in its life cycle.<\/p>\n \u201cThis drug is extraordinary \u2014 the closest thing to a vaccine that we have.\u201d<\/p>\n \u2014 Dr. Megan Ranney, Yale School of Public Health dean<\/p>\n In a landmark clinical trial that began in 2021 and enrolled more than 2,000 teen girls and young women from South Africa and Uganda, no one who received lenacapavir contracted HIV. The effect was so striking that, in June 2024, an independent safety board told researchers to end the trial\u2019s blinded phase early \u2014 continuing would\u2019ve meant withholding an obviously effective drug from some participants.<\/p>\n \u201cIt would\u2019ve been unethical not to,\u201d said Linda-Gail Bekker, an infectious disease physician at the University of Cape Town and one of the trial\u2019s lead investigators.<\/p>\n Those numbers are really impressive, but lenacapavir\u2019s efficacy as an injectable is another plus. In much of sub-Saharan Africa, where HIV burden is among the heaviest, injectable contraception is already the most widely used form of birth control. For many women, injections are more discreet and practical than taking a daily pill. \u201cIt\u2019s a very recognized concept\u2026injections are a very attractive option,\u201d Bekker said. That familiarity could be the difference between a prevention tool that works in theory and one people actually use.<\/p>\n As lenacapavir emerged from late-stage trials, with results showing near-perfect protection, the world took notice. In 2024, the editors of Science, the prestigious scientific journal, named lenacapavir their breakthrough of the year<\/a>. \u201cThis drug is extraordinary \u2014 the closest thing to a vaccine that we have,\u201d said Dr. Megan Ranney, the dean of the Yale School of Public Health and one of the Science editors.<\/p>\n A twice-yearly shot that can nearly eliminate new infections should be the stuff of celebration. Lenacapavir could mark the beginning of the end of HIV.<\/p>\n But as always in public health, the science is only half the story.<\/p>\n A breakthrough only matters if it gets off the shelf and reaches the people who need it most. And in much of the world, that depends on policymakers.<\/p>\n Since 2003, the US President\u2019s Emergency Plan for AIDS Relief<\/a>, or PEPFAR, has been an essential, global lever for HIV treatment access. PEPFAR is a George W. Bush-era program that has delivered lifesaving HIV treatment to poor countries and has helped save more than 25 million lives<\/a> over its 22-year history. The program is funded by the US Congress, which renews its authority and budget \u2014 both of which can get caught up in politics.<\/p>\n When President Donald Trump returned to office in January, he ordered a broad freeze on US foreign aid, throwing PEPFAR into limbo<\/a>. Grants were halted, drug shipments stalled and USAID \u2014 the program\u2019s main implementer \u2014 was dismantled almost overnight, stoking fears that the world\u2019s most successful HIV program was about to be killed off.<\/p>\n Then last month, the administration announced its plans to revive PEPFAR<\/a> to deliver the breakthrough drug lenacapavir. (But right now, it\u2019s unclear how the ongoing government shutdown will affect PEPFAR funding.)<\/p>\n The administration says it will prioritize delivering lenacapavir to pregnant and breastfeeding people in eight to 12 yet-to-be-announced countries, as part of Trump\u2019s push to end mother-to-child transmission of HIV<\/a> by the end of his term. On paper, that\u2019s a tidy goal \u2014 two injections can protect both mother and baby through pregnancy and nursing \u2014 but advocates say that choice isn\u2019t rooted in science.<\/p>\n In sub-Saharan Africa, young women, broadly, account for the majority of new infections, and elsewhere, it\u2019s gay and bisexual men, trans people, sex workers, and people who use drugs \u2014 those who were disproportionately infected and died in the early decades of the HIV epidemic. Now, channeling the new drug only through maternal health programs risks leaving those communities out yet again.<\/p>\n \u201cPrioritizing pregnant and breastfeeding people is ideological, not scientific,\u201d said Asia Russell of HealthGAP<\/a>, a New York City-based AIDS advocacy organization. \u201cThey\u2019re a very, very small fraction of those at risk.\u201d In sub-Saharan Africa, pregnant and breastfeeding people face real risk \u2014 a few out of every hundred contract HIV each year \u2014 but they\u2019re still a small slice of a larger epidemic that\u2019s largely driven by young women and queer men.<\/p>\n Patients wait to be seen at the maternal and child health unit at Kuoyo Sub-county Hospital in Kisumu, Kenya \u2014 a region with one of the highest HIV rates in the country. Clinics like this have been hit hard by recent US aid freezes, leaving gaps in care and prevention. Michel Lunanga\/Getty Images<\/p>\n State Department official Jeremy Lewin also made their philosophy clear during the administration\u2019s announcement<\/a>. \u201cThere are no NGOs involved in this \u2014 none of those sort of beltway bandits here,\u201d he said, referring to the aid groups that have traditionally implemented US-funded HIV programs. (It\u2019s a loaded term and a misleading one, given that oversight bodies<\/a> haven\u2019t uncovered corruption at scale.) \u201cIt\u2019s going to be the countries [who are] responsible for distributing it through their national healthcare systems.\u201d<\/p>\n That might sound efficient in Washington, but it\u2019s more complicated on the ground.<\/p>\n That\u2019s because HIV isn\u2019t like cholera or the flu \u2014 something you can beat with a one-size-fits-all campaign. It affects some groups more than others and carries deep stigma, because it\u2019s tied to sex, sexuality, and drug use, all of which are moralized in many societies. And in many countries, the state is the very institution that enforces, even criminalizes, that stigma.<\/p>\n Bekker, who runs an HIV research center in South Africa, said that even in places without formal bans, public clinics can feel hostile to sexual and gender minorities. \u201cThe result,\u201d she said, \u201cis that people just don\u2019t show up.\u201d<\/p>\n PEPFAR\u2019s own history<\/a> shows that prevention works best when community-led groups such as LGBTQ+ clinics or drop-in centers are included in the response. Those are the spaces that reach groups left out by official systems. Jirair Ratevosian, a former senior PEPFAR adviser, said ending infant infections is crucial, but so is supporting community- and faith-based clinics \u201cwhere people actually feel safe.\u201d<\/p>\n Gilead Sciences, headquartered in Foster City, California, developed lenacapavir \u2014 the twice-yearly HIV prevention shot now at the center of the US rollout. David Paul Morris\/Bloomberg via Getty Images<\/p>\n Besides the Trump administration (and all its political theater), there\u2019s one more key player: Gilead Sciences, the California-based company that developed lenacapavir.<\/p>\n In September, Gilead made two big promises. First, it agreed to sell lenacapavir to PEPFAR at \u201cno profit<\/a>,\u201d although it\u2019s unclear what that actually means. Second \u2014 and more importantly \u2014 it signed licensing deals with six generic manufacturers, sharing its technology so those companies can start preparing to make cheaper versions.<\/p>\n Typically, drug companies fiercely guard new medicines under patents for 20 years, during which time they alone can make and sell the drugs \u2014 and only countries that can afford the list price get access. Once those patents expire, generics can enter the market and drive costs down.<\/p>\n By making these licensing deals, Gilead is trying to shorten that wait time so, if all goes to plan, poorer countries could get lenacapavir in just a few years instead of decades later.<\/p>\n The licensing deal allows generics to be sold in 120 low- and lower-middle-income countries, covering most of the world\u2019s poorest nations. Once those versions hit the market, they\u2019ll cost a fraction of Gilead\u2019s price tag \u2014 which in the US is $28,128 a year per patient, though few people pay that sticker price.<\/p>\n But the deal leaves out many upper-middle-income countries such as Brazil or Argentina, where infections have been rising. Those nations fall into a gray zone \u2014 too rich for cheap generics, too poor to afford Gilead\u2019s prices.<\/p>\n For Gilead, a for-profit company, sharing its drug formula with generic makers might sound generous, but it\u2019s not as straightforward as it looks. The licenses \u201ccarve the world into low-value markets where generics can operate [where Gilead won\u2019t be making money anyway], and profitable ones where Gilead keeps its grip,\u201d said Tahir Amin, an intellectual-property lawyer and co-founder of Initiative for Medicines, Access, and Knowledge<\/a>, a nonprofit that advocates for patent reform.<\/p>\n Meanwhile, major philanthropists \u2014 the Gates Foundation<\/a>, Unitaid, Clinton Health Access Initiative, and Wits RHI<\/a> \u2014 are doing their part to help generics reach the market faster. They\u2019re backing two Indian generic manufacturers with funding and technical support to help scale production so that low-cost versions of the drug are available by 2027. If that works, it would cost just $40 per person per year \u2014 roughly what daily oral PrEP costs today.<\/p>\n If that happens \u2014 that is if we\u2019re able to make cheaper generics faster, roll them out equitably, and deliver them where people feel safe \u2014 lenacapavir could make a real dent in the HIV epidemic.<\/p>\n Breakthrough science doesn\u2019t guarantee a breakthrough in public health. That will depend on the choices made now.<\/p>\n You\u2019ve read 1 article in the last month<\/p>\n Here at Vox, we’re unwavering in our commitment to covering the issues that matter most to you \u2014 threats to democracy, immigration, reproductive rights, the environment, and the rising polarization across this country.<\/p>\n Our mission is to provide clear, accessible journalism that empowers you to stay informed and engaged in shaping our world. By becoming a Vox Member, you directly strengthen our ability to deliver in-depth, independent reporting that drives meaningful change.<\/p>\n We rely on readers like you \u2014 join us.<\/p>\n Swati Sharma<\/p>\n Vox Editor-in-Chief<\/p>\n","protected":false},"excerpt":{"rendered":"How often, on average, do you forget to take your daily meds? For me, it\u2019s about twice a…\n","protected":false},"author":2,"featured_media":212193,"comment_status":"","ping_status":"","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[10],"tags":[49,48,8050,84,2993,2100,2727],"class_list":["post-212192","post","type-post","status-publish","format-standard","has-post-thumbnail","category-health","tag-ca","tag-canada","tag-future-perfect","tag-health","tag-infectious-disease","tag-policy","tag-public-health"],"_links":{"self":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/212192","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/comments?post=212192"}],"version-history":[{"count":0,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/posts\/212192\/revisions"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media\/212193"}],"wp:attachment":[{"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/media?parent=212192"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/categories?post=212192"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.newsbeep.com\/ca\/wp-json\/wp\/v2\/tags?post=212192"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}![\"Line](\"https:\/\/www.newsbeep.com\/ca\/wp-content\/uploads\/2025\/10\/image_len.jpg\"\/)
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