{"id":15446,"date":"2025-09-25T09:58:41","date_gmt":"2025-09-25T07:58:41","guid":{"rendered":"https:\/\/saludporderecho.org\/?p=15446"},"modified":"2025-09-25T13:30:00","modified_gmt":"2025-09-25T11:30:00","slug":"the-new-agreement-on-generic-lenacapavir-still-does-not-guarantee-global-access","status":"publish","type":"post","link":"https:\/\/saludporderecho.org\/en\/the-new-agreement-on-generic-lenacapavir-still-does-not-guarantee-global-access\/","title":{"rendered":"The New Agreement on Generic Lenacapavir Still Fails to Guarantee Global Access"},"content":{"rendered":"<p>Today at Salud por Derecho, we joined organizations from around the world to denounce the restrictions Gilead has imposed on the voluntary license for long-acting lenacapavir (the twice-yearly injectable PrEP). Despite recent agreements, the drug would only be available at a generic price of $40 per year in 115 low- and middle-income countries and five territories, leaving out 26 countries where HIV incidence remains very high.<\/p>\n<p><iframe id=\"datawrapper-chart-0Vb5E\" style=\"width: 0; min-width: 100% !important; border: none;\" title=\"Tracking Gilead\u2019s Registration of Lenacapavir for PrEP (25\/09\/2025)\" src=\"https:\/\/datawrapper.dwcdn.net\/0Vb5E\/10\/\" height=\"796\" frameborder=\"0\" scrolling=\"no\" aria-label=\"Choropleth map\" data-external=\"1\"><\/iframe><script type=\"text\/javascript\">!function(){\"use strict\";window.addEventListener(\"message\",function(a){if(void 0!==a.data[\"datawrapper-height\"]){var e=document.querySelectorAll(\"iframe\");for(var t in a.data[\"datawrapper-height\"])for(var r,i=0;r=e[i];i++)if(r.contentWindow===a.source){var d=a.data[\"datawrapper-height\"][t]+\"px\";r.style.height=d}}})}();\n<\/script><\/p>\n<p><span data-teams=\"true\">This week, we learned of an agreement with two Indian generic manufacturers who will be able to produce lenacapavir starting in 2027. One of them, Dr. Reddy\u2019s, reached this point thanks to a <a href=\"https:\/\/unitaid.org\/news-blog\/lenacapavir-for-hiv-prevention\/\"><strong>deal brokered<\/strong><\/a> by Unitaid and CHAI, which provides financial, technical, and regulatory support to accelerate access in low- and middle-income countries. At the same time, the Gates Foundation has struck another agreement with Hetero Labs.<\/span><\/p>\n<p>However, <strong><a href=\"https:\/\/saludporderecho.org\/en\/lenacapavir-the-new-hiv-injection-that-gilead-is-delaying-in-the-countries-that-need-it-most\/\">these developments do not address the fundamental problem<\/a><\/strong>: Gilead\u2019s license excludes much of Latin America, as well as parts of Eastern Europe, Asia, and Africa\u2014including countries such as Argentina, Brazil, Mexico, and Peru, where pivotal clinical trials were carried out.<\/p>\n<p><iframe id=\"datawrapper-chart-Cgzyb\" style=\"width: 0; min-width: 100% !important; border: none;\" title=\"Countries with an increasing trend of new HIV infections since 2010 have been excluded from Gilead\u2019s lenacapavir license and will not benefit from the $40 price\" src=\"https:\/\/datawrapper.dwcdn.net\/Cgzyb\/1\/\" height=\"1005\" frameborder=\"0\" scrolling=\"no\" aria-label=\"Small multiple line chart\" data-external=\"1\"><\/iframe><script type=\"text\/javascript\">!function(){\"use strict\";window.addEventListener(\"message\",function(a){if(void 0!==a.data[\"datawrapper-height\"]){var e=document.querySelectorAll(\"iframe\");for(var t in a.data[\"datawrapper-height\"])for(var r,i=0;r=e[i];i++)if(r.contentWindow===a.source){var d=a.data[\"datawrapper-height\"][t]+\"px\";r.style.height=d}}})}();\n<\/script><\/p>\n<p>During the United Nations General Assembly in New York, organizations reminded the world that more than 20 million people need PrEP. Yet under Gilead\u2019s current plan, only about 2 million people in 9 to 12 countries would gain access over the next three years. Meanwhile, in May 2025, new HIV infections surged from 3,500 to 5,800 per day after the Trump administration abandoned prevention programs\u2014programs that continue to hold back $2.3 billion already allocated to PEPFAR for PrEP procurement.<\/p>\n<p>\u201cThe agreement sets lenacapavir\u2019s price at the same level as oral PrEP, which is excellent news. What is not acceptable is that Gilead restricts access through its license, excluding far too many people. This price should be global\u2014affordable and available to everyone, everywhere,\u201d said Jaime Manzano, researcher and head of policy at Salud por Derecho.<\/p>\n<p><iframe id=\"datawrapper-chart-fo4Sy\" style=\"width: 0; min-width: 100% !important; border: none;\" title=\"How long will Gilead\u2019s monopoly last?\" src=\"https:\/\/datawrapper.dwcdn.net\/fo4Sy\/2\/\" height=\"270\" frameborder=\"0\" scrolling=\"no\" aria-label=\"Arrow Plot\" data-external=\"1\"><\/iframe><script type=\"text\/javascript\">!function(){\"use strict\";window.addEventListener(\"message\",function(a){if(void 0!==a.data[\"datawrapper-height\"]){var e=document.querySelectorAll(\"iframe\");for(var t in a.data[\"datawrapper-height\"])for(var r,i=0;r=e[i];i++)if(r.contentWindow===a.source){var d=a.data[\"datawrapper-height\"][t]+\"px\";r.style.height=d}}})}();\n<\/script><\/p>\n<p>We will continue to emphasize that access to injectable PrEP cannot depend on monopolies, excessive pricing, or regulatory delays. It is urgent to ensure this tool reaches everyone who needs it\u2014universally and affordably.<\/p>\n<p>For more information, you can read the press release we published together with other organizations: <a id=\"menur1cr\" class=\"fui-Link ___1q1shib f2hkw1w f3rmtva f1ewtqcl fyind8e f1k6fduh f1w7gpdv fk6fouc fjoy568 figsok6 f1s184ao f1mk8lai fnbmjn9 f1o700av f13mvf36 f1cmlufx f9n3di6 f1ids18y f1tx3yz7 f1deo86v f1eh06m1 f1iescvh fhgqx19 f1olyrje f1p93eir f1nev41a f1h8hb77 f1lqvz6u f10aw75t fsle3fq f17ae5zn\" title=\"https:\/\/docs.google.com\/document\/d\/e\/2pacx-1vswlmsxrsomd_z22uzfjkmeis9-48dw7p-zv02dasmiqg30xuug5empnzbndndobq6nvt-hn-yzmje8\/pub\" href=\"https:\/\/docs.google.com\/document\/d\/e\/2PACX-1vSwLmsxrsomd_Z22uZfJkmEIs9-48dw7p-ZV02dAsMIQG30xuUg5EmpNZbNDNdOBq6nVT-hn-yzMjE8\/pub\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"V\u00ednculo Announcement $40\"><strong>Announcement $40<\/strong><\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Today at Salud por Derecho, we joined organizations from around the world to denounce the restrictions Gilead has imposed on the voluntary license for long-acting lenacapavir (the twice-yearly injectable PrEP).<\/p>\n","protected":false},"author":2,"featured_media":15437,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[309,3],"tags":[1210],"class_list":["post-15446","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-home-slider-en","category-uncategorized","tag-lenacapavir-en"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.2 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>The New Agreement on Generic Lenacapavir Still Fails to Guarantee Global Access | Salud por Derecho<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" 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