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..

持续了44年的流行病可能终于要被遏制了，首个每年两次注射、提供100%保护的艾滋病毒药物获得了里程碑式的批准。这一成就有望拯救全球数百万人的生命。该药物的制造商还正在美国及其他地区提供可负担的药物获取途径，并与六家仿制药生产商签署了免专利费的许可协议以生产和供应该药物。

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，食品和药物管理局 (FDA) 已批准新型药物来那卡帕韦（品牌名：Yeztugo）—— 一种被称为衣壳抑制剂的药物，其对目前每年影响 130 万人的 HIV 感染提供了近 100% 的保护。

In 2024, the journal

2024年，期刊

Science

科学

named lenacapavir the Breakthrough Invention of the Year, and we've extensively covered it on its

名为Lenacapavir的药物被评为年度突破性发明，我们已经对其进行了广泛报道。

way to market

市场之路

. The pre-exposure prophylaxis (PrEP) provides HIV-negative individuals around 99% protection from contracting the devastating virus through sex.

暴露前预防（PrEP）为艾滋病毒阴性人群提供了约99%的保护，防止通过性行为感染这种毁灭性的病毒。

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.

正如我们去年详细报道的那样，雷纳卡帕韦是一种衣壳抑制剂。在1型艾滋病毒（HIV-1）中，衣壳是一个蛋白质外壳，它容纳并保护病毒的遗传物质，对将病毒运输到宿主细胞内至关重要。一旦进入宿主细胞，衣壳便会脱落，病毒开始自我复制。

Lenacapavir stops that from happening..

Lenacapavir阻止了这种情况的发生。

“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..

“这是几十年来对抗艾滋病历史性的一天，”吉利德科学公司董事长兼首席执行官丹尼尔·奥戴在FDA批准的消息中说道。'Yeztugo是我们这个时代最重要的科学突破之一，提供了帮助终结艾滋病流行的巨大机会。'

“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.”.

“这是一种每年只需给药两次的药物，并且在临床研究中显示出显著的效果，这意味着它可能改变艾滋病预防的现状。吉利德的科学家们将终结艾滋病作为他们毕生的工作，现在，随着Yeztugo获得FDA批准，并与我们的众多合作伙伴携手，我们能够帮助实现这一目标。”

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，lenacapavir（品牌名Sunlenca）获批用于治疗已感染HIV的患者，但长效预防药物的实现要困难得多。

“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变革性的 PrEP 选择——它有望提高 PrEP 的使用率和持续性，并为我们终结艾滋病流行的任务增添了一项强有力的工具，”埃默里大学医学院传染病科杰出医学教授、亚特兰大埃默里艾滋病研究中心联合主任 Carlos del Rio 医学博士说道。

“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.”.

“一年两次的注射可以大大解决依从性和污名化等关键障碍，这些障碍是使用更频繁PrEP给药方案（尤其是每日口服PrEP）的个体所面临的。我们还知道，在研究中，许多需要或想要PrEP的人更喜欢不那么频繁的给药方式。”

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..

吉利德还向澳大利亚、巴西、加拿大、南非和瑞士的监管机构提交了审批申请，针对阿根廷、墨西哥和秘鲁的更多申请也在进行中。该公司还采取措施确保Yeztugo的价格可负担，符合条件的无保险人群预计可以通过其“推进获取”药物援助计划免费获得该药物。

Earlier this months, 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. 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.'.

本月初，吉利德宣布与抗击艾滋病、结核病和疟疾全球基金（Global Fund）达成合作，将在三年内为全球基金支持的国家提供足够覆盖两百万人的药物剂量，制药公司将不从中获取利润。该药物的无专利许可仿制药将被生产用于120个“高发病率、资源有限的国家，这些国家主要为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.

这种关键的药物获取途径，最终将利润置于人为之上，这是制药公司的一项大胆举措——但此举也认识到结束全球艾滋病疫情的迫切需求。

“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. “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.

“吉利德科学公司与全球基金之间的协议基于我们共同的意图，即通过这项HIV预防的突破性进展，尽可能快地让更多人受益，”吉利德科学公司董事长兼首席执行官丹尼尔·奥戴表示。“我们将以无利润的方式提供药物，并确保在仿制雷纳卡帕韦上市之前，向低收入和中低收入国家提供足够供应，以覆盖多达两百万人。”

This is all part of our unprecedented approach to access for a medicine that could help end the HIV epidemic.”.

这都是我们为可能帮助终结艾滋病流行的药物获取途径所采取的前所未有的方法的一部分。

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.

全球基金现在正与国际组织合作，迅速建立向中低收入国家提供雷纳卡帕韦所需的基础设施和资源，这些国家的需求最大。

“This is not just a scientific breakthrough – it’s a game-changer for HIV/AIDS,” said Peter Sands, Executive Director of the Global Fund. “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.

“这不仅是科学上的突破，更是对艾滋病的颠覆性改变，”全球基金执行主任彼得·桑兹表示。“我们首次拥有一个可以从根本上改变艾滋病毒流行轨迹的工具，但前提是必须将其送到最需要它的人手中。我们的目标是让两百万人获得长效PrEP。”

But we can only do that if the world steps up with the resources required. .

但是，只有当世界提供所需的资源时，我们才能做到这一点。

“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.”

“这是一个关键时刻——不仅对于抗击艾滋病而言，而且对于必须让救命的创新成果惠及那些最需要它们的人这一基本原则而言也是如此——无论他们是谁，无论他们身在何处。”

Source:

源：

Gilead Sciences

吉利德科学