The first 100% effective HIV prevention drug is approved and going global
An epidemic that’s been sustained for 44 years might finally be quelled, with the milestone approval of the first HIV drug that offers 100% protection with its twice-yearly injections. It’s a landmark achievement that stands to save millions of lives across the globe. The makers are also providing affordable access to the drug in the US and beyond, signing royalty-free licensing agreements with six generic manufacturers to produce and supply it.
这场持续了 44 年的流行病终于可能迎来终结的曙光——首款通过每年仅注射两次即可提供 100% 保护的艾滋病预防药物获得了里程碑式的批准。这是一个具有历史意义的成就，可能会拯救全球数百万人的生命。该药物制造商还在美国及其他国家提供可负担的获取途径，并与六家仿制药制造商签署免版税授权协议，以实现生产和供应。
In the US, the Food and Drug Administration (FDA) has approved the novel lenacapavir – sold under the brand name Yeztugo – a class of drugs known as capsid inhibitors, which provide almost 100% protection against HIV infection, which currently affects 1.3 million people every year.
在美国，食品药品监督管理局（FDA）已批准一种名为勒那卡帕韦（lenacapavir）的新型药物，该药以商品名“Yeztugo”销售，属于“衣壳抑制剂”类别。这种药物几乎可以提供 100% 的预防效果，而目前每年仍有约 130 万人感染艾滋病毒。
In 2024, the journal Science named lenacapavir the Breakthrough Invention of the Year, and we’ve extensively covered it on its way to market. The pre-exposure prophylaxis (PrEP) provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex.
2024 年，《科学》杂志将勒那卡帕韦评为“年度突破性发明”，我们也一直在报道其上市进展。这款暴露前预防药物（PrEP）为未感染艾滋病毒的人提供约 99% 的性传播预防保护。
As we detailed last year, lenacapavir is a capsid inhibitor. In the HIV type 1 (HIV-1) virus, the capsid is a protein shell that houses and protects viral genetic material and is crucial for transporting the virus into a host cell. Once inside the host cell, the capsid is shed, and the virus begins copying itself. Lenacapavir stops that from happening.
正如我们去年详细介绍的，勒那卡帕韦是一种衣壳抑制剂。在 HIV-1 病毒中，衣壳是包裹并保护病毒遗传物质的蛋白质外壳，负责将病毒传送到宿主细胞中。一旦病毒进入宿主细胞，衣壳就会被去除，病毒随即开始复制。勒那卡帕韦能够阻断这一过程。
“This is a historic day in the decades-long fight against HIV,” said Daniel O’Day, Chairman and Chief Executive Officer of Gilead Sciences on news of the FDA’s approval. “Yeztugo is one of the most important scientific breakthroughs of our time and offers a very real opportunity to help end the HIV epidemic.
“今天是抗击艾滋病数十年斗争中具有历史意义的一天，”吉利德科学公司董事长兼首席执行官丹尼尔·奥戴（Daniel O’Day）在 FDA 批准的消息公布后表示，“Yeztugo 是我们这个时代最重要的科学突破之一，为终结艾滋病流行提供了真正的希望。”
“This is a medicine that only needs to be given twice a year and has shown remarkable outcomes in clinical studies, which means it could transform HIV prevention. Gilead scientists have made it their life’s work to end HIV and now, with the FDA approval of Yeztugo and in collaboration with our many partners, we can help to make that goal a reality.”
“这是一种每年只需注射两次的药物，临床研究显示了其卓越的效果，这意味着它有潜力彻底改变艾滋病预防方式。吉利德的科学家毕生致力于终结艾滋病毒，而如今，凭借 Yeztugo 获得 FDA 批准并与众多合作伙伴联手，我们可以将这一目标变为现实。”
In 2022, lenacapavir was approved – under brand name Sunlenca – to treat HIV in those already infected, but long-acting prevention medication has been much more difficult to realize.
2022 年，勒那卡帕韦以商品名 Sunlenca 获批用于治疗已感染艾滋病病毒的患者，但开发长效预防药物一直是一个更大的挑战。
“Yeztugo could be the transformative PrEP option we’ve been waiting for – offering the potential to boost PrEP uptake and persistence and adding a powerful new tool in our mission to end the HIV epidemic,” said Carlos del Rio, MD, Distinguished Professor of Medicine in the Division of Infectious Diseases at Emory University School of Medicine and Co-Director of the Emory Center for AIDS Research in Atlanta.
“Yeztugo 可能是我们一直在等待的具有变革性的 PrEP 选项——它有望提高 PrEP 的使用率和持续性，为终结艾滋病流行的使命提供强有力的新工具，”艾默里大学医学院传染病学杰出医学教授、艾滋病研究中心联合主任 Carlos del Rio 医生表示。
“A twice-yearly injection could greatly address key barriers like adherence and stigma, which individuals on more frequent PrEP dosing regimens, especially daily oral PrEP, can face. We also know that, in research, many people who need or want PrEP preferred less frequent dosing.”
“每年仅需注射两次的方式，可以有效克服常规 PrEP 使用中面临的依从性差和社会污名问题，尤其是每日口服 PrEP 带来的困扰。我们也知道，在研究中，很多有需要的人更倾向于使用低频次的预防方案。”
Gilead has also filed for regulatory approval with authorities in Australia, Brazil, Canada, South Africa and Switzerland, with additional applications in the works for Argentina, Mexico and Peru. The company has also made moves to ensure Yeztugo is affordable, with uninsured individuals likely able to access the drug free of cost, if eligible, through its Advancing Access medication assistance program.
吉利德也已向澳大利亚、巴西、加拿大、南非和瑞士的监管机构提交了审批申请，阿根廷、墨西哥和秘鲁的相关申请也正在进行中。公司还采取措施确保 Yeztugo 具有可负担性，符合条件的无保险人群可能可以通过“Advancing Access”药物援助项目免费获得该药。
Earlier this month, Gilead announced a partnership with the Global Fund to Fight AIDS, Tuberculosis and Malaria (Global Fund) to supply enough doses of the drug to reach up to two million people over three years in countries supported by the Global Fund, at no profit to the pharmaceutical company.
本月早些时候，吉利德宣布与全球基金（Global Fund）建立合作关系，三年内向其资助的国家提供足够剂量的药物，覆盖最多 200 万人，并且不从中盈利。
License-free generics of the drug will be manufactured for use across 120 “high-incidence, resource-limited countries, which are primarily low- and lower-middle-income countries.”
该药的免授权仿制版本也将被用于全球 120 个“高发病率、资源有限”的国家，主要是低收入和中低收入国家。
This crucial access to the drug, which ultimately sets aside profit for people, is a bold move from a pharmaceutical company – but one that recognizes the desperate need to end the global HIV epidemic.
将利润置于一边，为人们提供获取药物的关键途径，这对于一家制药公司来说是大胆之举，但也体现了其对终结全球艾滋病流行紧迫需求的深刻认知。
“The agreement between Gilead Sciences and the Global Fund is based on our shared intention to benefit as many people as possible, as quickly as possible with this breakthrough in HIV prevention,” said Daniel O’Day, Chairman and Chief Executive Officer, Gilead Sciences.
“吉利德与全球基金的协议基于我们共同的初衷：尽可能多地、尽可能快地让这项 HIV 预防领域的突破性成果惠及更多人，”吉利德董事长兼首席执行官丹尼尔·奥戴说。
“We are providing the medicine at no profit to Gilead, and in enough supply to reach up to two million people in low- and lower-middle-income countries ahead of generic lenacapavir becoming available. This is all part of our unprecedented approach to access for a medicine that could help end the HIV epidemic.”
“在仿制药尚未上市之前，我们将不计利润地提供足够的药品供应，覆盖多达 200 万低收入和中低收入国家的民众。这一切，都是我们为一款可能终结艾滋病流行的药物所采取的前所未有的获取策略的一部分。”
The Global Fund is now working with international organizations to rapidly establish the infrastructure and resources needed to deliver lenacapavir to the middle- and low-income nations most at need.
全球基金目前正与国际组织合作，迅速建立基础设施和资源，以将勒那卡帕韦送往最需要的中低收入国家。
“This is not just a scientific breakthrough – it’s a game-changer for HIV/AIDS,” said Peter Sands, Executive Director of the Global Fund.
“这不仅仅是一次科学突破——它是改变艾滋病防控格局的关键转折点，”全球基金执行董事彼得·桑兹说。
“For the first time, we have a tool that can fundamentally change the trajectory of the HIV epidemic – but only if we get it to the people who need it most. Our ambition is to reach two million people with long-acting PrEP. But we can only do that if the world steps up with the resources required.
“这是我们第一次拥有一种可以从根本上改变艾滋病流行趋势的工具——但前提是我们必须让它落到最需要的人手中。我们的目标是为 200 万人提供这种长效 PrEP，但这需要全球社会投入必要的资源。”
“This is a pivotal moment – not just for the fight against HIV, but for the fundamental principle that lifesaving innovations must reach those who need them most – whoever they are, and wherever they live.”
“这是关键时刻——不仅关乎抗击艾滋病，更是对一个根本原则的呼唤：挽救生命的创新必须送达最需要它们的人——无论他们是谁，无论他们身处何地。”
消息来源：
https://www.gilead.com/news/news-details/2025/yeztugo-lenacapavir-is-now-the-first-and-only-fda-approved-hiv-prevention-option-offering-6-months-of-protection
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