{"title":"FDA approves first-in-class HIV prevention shot","authors":"","doi":"10.1038/s41587-025-02756-z","DOIUrl":null,"url":null,"abstract":"<p>The US Food and Drug administration has approved a drug that almost completely protects against human immunodeficiency virus type 1 (HIV-1) infection and only needs to be given twice a year. Gilead Sciences’ injectable antiretroviral drug Yeztugo (lenacapavir) is 100% protective for people who need to reduce the risk of sexually acquired HIV. It is a first-in-class medication that works by a novel mechanism that disrupts the HIV-1 capsid protein that makes up the virus shell. Other HIV medications have a different target.</p><p>Gilead’s chairman and CEO, Daniel O’Day, called the approval “historic” and, in a statement, said that the drug could “end the HIV epidemic.” The approval was based on two published clinical trials: PURPOSE 1, conducted in 5,000 women in South Africa and Uganda, where there were zero infections, and PURPOSE 2, in 3,200 cisgender men, transgender women and men, and gender non-binary people from several countries, including Argentina, Mexico, South Africa, Peru, Thailand and the United States, where only 2 participants were infected.</p>","PeriodicalId":19084,"journal":{"name":"Nature biotechnology","volume":"23 1","pages":""},"PeriodicalIF":33.1000,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Nature biotechnology","FirstCategoryId":"5","ListUrlMain":"https://doi.org/10.1038/s41587-025-02756-z","RegionNum":1,"RegionCategory":"生物学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"BIOTECHNOLOGY & APPLIED MICROBIOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
The US Food and Drug administration has approved a drug that almost completely protects against human immunodeficiency virus type 1 (HIV-1) infection and only needs to be given twice a year. Gilead Sciences’ injectable antiretroviral drug Yeztugo (lenacapavir) is 100% protective for people who need to reduce the risk of sexually acquired HIV. It is a first-in-class medication that works by a novel mechanism that disrupts the HIV-1 capsid protein that makes up the virus shell. Other HIV medications have a different target.
Gilead’s chairman and CEO, Daniel O’Day, called the approval “historic” and, in a statement, said that the drug could “end the HIV epidemic.” The approval was based on two published clinical trials: PURPOSE 1, conducted in 5,000 women in South Africa and Uganda, where there were zero infections, and PURPOSE 2, in 3,200 cisgender men, transgender women and men, and gender non-binary people from several countries, including Argentina, Mexico, South Africa, Peru, Thailand and the United States, where only 2 participants were infected.
美国食品和药物管理局已经批准了一种药物，这种药物几乎可以完全预防人类免疫缺陷病毒1型（HIV-1）感染，每年只需要注射两次。吉利德科学公司的可注射抗逆转录病毒药物Yeztugo （lenacapavir）对那些需要降低性获得性艾滋病毒风险的人具有100%的保护作用。这是一种一流的药物，通过一种新的机制来破坏构成病毒外壳的HIV-1衣壳蛋白。其他治疗艾滋病的药物有不同的目标。吉利德董事长兼首席执行官丹尼尔·奥戴（Daniel O 'Day）称这一批准是“历史性的”，并在一份声明中表示，这种药物可以“终结艾滋病毒的流行”。该批准基于两项已发表的临床试验：目的1，在南非和乌干达的5000名妇女中进行，其中没有感染；目的2，在来自几个国家的3200名无性别男性、变性女性和男性以及性别非二元性人群中进行，其中包括阿根廷、墨西哥、南非、秘鲁、泰国和美国，只有2名参与者感染。
期刊介绍：
Nature Biotechnology is a monthly journal that focuses on the science and business of biotechnology. It covers a wide range of topics including technology/methodology advancements in the biological, biomedical, agricultural, and environmental sciences. The journal also explores the commercial, political, ethical, legal, and societal aspects of this research.
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In summary, Nature Biotechnology is a comprehensive journal that covers both the scientific and business aspects of biotechnology. It strives to provide researchers with valuable research papers and news while also delivering important scientific advancements to the business community.
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