FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) today announced additional data from its pivotal Phase 3 PURPOSE 2 trial (NCT04925752) providing an overview of the efficacy and safety of twice-yearly lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention among a broad and geographically diverse range of cisgender men and gender-diverse people..

加利福尼亚州福斯特城（商业新闻短讯）--吉利德科学公司（Nasdaq:GILD）今天宣布了其关键的3期目的2试验（NCT04925752）的额外数据，概述了该公司每年两次的注射用HIV-1衣壳抑制剂lenacapavir的有效性和安全性，用于在广泛且地理位置不同的顺性男性和性别多样化人群中进行HIV预防的研究。。

The new data are being presented during an oral abstract session on October 8 at the 5th HIV Research for Prevention Conference (HIVR4P) in Lima, Peru and follow the unblinding of the trial at interim analysis in September, which showed that twice-yearly lenacapavir reduced HIV infections by 96% compared to background HIV incidence (bHIV) and demonstrated superiority to once-daily Truvada® (emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg; F/TDF) for HIV prevention as pre-exposure prophylaxis (PrEP)..

新数据将于10月8日在秘鲁利马举行的第五届艾滋病毒预防研究会议（HIVR4P）上的口头摘要会议上公布，并于9月在中期分析中揭秘试验结果，结果显示，与背景艾滋病毒发病率（bHIV）相比，每年两次的来那帕韦可将艾滋病毒感染率降低96%，并且在艾滋病毒预防方面显示出优于每日一次的Truvada®（恩曲他滨200 mg和富马酸替诺福韦酯300 mg；F/TDF）作为暴露前预防（PrEP）。。

“These data reinforce that twice-yearly lenacapavir could be a highly effective and potentially game-changing HIV prevention choice that we have long hoped for in our efforts to end the HIV epidemic,” said Colleen Kelley, MD, MPH, Professor of Medicine at Emory University and a PURPOSE 2 Principal Investigator.

埃默里大学医学博士、公共卫生硕士科琳·凯利（ColleenKelley）说：“这些数据表明，每年两次的lenacapavir可能是一种非常有效且可能改变游戏规则的艾滋病毒预防选择，我们长期以来一直希望这种选择能够结束艾滋病毒的流行。”。

“PURPOSE 2 was intentionally designed to reflect the lives and locations of many people who are disproportionately affected by HIV around the world by focusing on gender, racial, ethnic and geographic diversity.”.

“目的2旨在通过关注性别、种族、族裔和地理多样性，反映世界各地受艾滋病毒影响较大的许多人的生活和地点。”。

Lenacapavir was highly effective in PURPOSE 2, reducing HIV infections by 96% with two incident cases among 2,179 participants receiving lenacapavir

Lenacapavir在目的2中非常有效，在2179名接受Lenacapavir治疗的参与者中，有两起事件发生，将艾滋病毒感染率降低了96%

Lenacapavir was highly effective at reducing infections among trial participants: 99.9% of participants did not acquire HIV in the lenacapavir group, with 2 incident cases among 2,179 participants (0.10/100 person-years, 95% CI, 0.012 to 0.373). The results demonstrated superiority of twice-yearly lenacapavir over bHIV (2.37/100 person-years, 95% CI, 1.649 to 3.417; primary endpoint), with 96% relative risk reduction (IRR 0.04, 95% CI, p<0.0001), compared with 9 incident cases among 1,086 individuals in the Truvada group (0.93/100 person-years, 95% CI, 0.426 to 1.768; secondary endpoint).

Lenacapavir在减少试验参与者的感染方面非常有效：99.9%的参与者在Lenacapavir组中没有感染艾滋病毒，2179名参与者中有2例发生事件（0.10/100人年，95%可信区间，0.012至0.373）。结果显示，每年两次的来那帕韦优于bHIV（2.37/100人年，95%可信区间，1.649至3.417；主要终点），相对风险降低96%（IRR 0.04，95%可信区间，p＜0.0001），而特鲁瓦达组1086人中有9例发生事件（0.93/100人年，95%可信区间，0.426至1.768；次要终点）。

Additionally, twice-yearly lenacapavir was 89% more effective than once-daily Truvada (IRR 0.11, 95% CI, p=0.00245)..

此外，每年两次的lenacapavir比每天一次的Truvada有效89%（IRR 0.11，95%CI，p=0.00245）。。

PURPOSE 2 is a Phase 3, double-blind, multicenter, randomized study evaluating the safety and efficacy of twice-yearly subcutaneous lenacapavir for PrEP versus bHIV and once-daily oral Truvada in 3,273 cisgender gay, bisexual, and other men, transgender women, transgender men, and gender nonbinary individuals aged 16 years or older who have sex with partners assigned male at birth.

目的2是一项3期、双盲、多中心、随机研究，评估了3273名顺性同性恋、双性恋和其他男性、变性女性、变性男性和16岁或以上的性别非二元个体在出生时与指定男性伴侣发生性行为的PrEP与bHIV和每日一次口服Truvada的安全性和有效性。

The trial spanned 88 sites in Argentina, Brazil, Mexico, Peru, South Africa, Thailand and the United States and participants were randomized in a 2:1 ratio to lenacapavir and Truvada, respectively. Because effective PrEP options already exist, there is broad consensus in the PrEP field that a placebo group would be unethical; thus, the trial used bHIV as the primary comparator and Truvada as a secondary comparator..

该试验涵盖阿根廷，巴西，墨西哥，秘鲁，南非，泰国和美国的88个地点，参与者分别以2:1的比例随机分配给lenacapavir和Truvada。由于已经存在有效的PrEP选择，PrEP领域普遍认为安慰剂组是不道德的；因此，该试验使用bHIV作为主要比较器，Truvada作为次要比较器。。

This is the second pivotal Phase 3 trial to demonstrate superior efficacy for twice-yearly lenacapavir for the investigational use of HIV prevention as PrEP, and to be unblinded early because it met its key efficacy endpoints. In June 2024, the PURPOSE 1 trial (NCT04994509), studying lenacapavir for PrEP among cisgender women in sub-Saharan Africa, was also unblinded early because it met its key efficacy endpoints..

这是第二个关键的3期临床试验，证明每年两次的来那帕韦在HIV预防作为PrEP的研究性使用方面具有优越的疗效，并且由于其达到了关键的疗效终点，因此尽早公开。2024年6月，在撒哈拉以南非洲的顺性别女性中研究lenacapavir用于PrEP的PUSION 1试验（NCT04994509）也提前公开，因为它符合其关键疗效终点。。

Lenacapavir was well-tolerated among trial participants with few serious adverse events

Lenacapavir在试验参与者中耐受性良好，几乎没有严重不良事件

Safety and tolerability findings from PURPOSE 2 demonstrated no significant or new safety concerns identified, and lenacapavir was generally well-tolerated.

目的2的安全性和耐受性研究结果表明，没有发现重大或新的安全问题，lenacapavir的耐受性通常良好。

Aside from injection site reactions (ISRs), the most common adverse events (AEs) observed were rectal chlamydia infection (lenacapavir: 13.2%; Truvada: 11.8%), oropharyngeal gonococcal infection (lenacapavir: 13.0%; Truvada: 10.9%) and rectal gonococcal infection (lenacapavir: 10.7%; Truvada: 9.1%)..

除注射部位反应（ISR）外，观察到的最常见不良事件（AE）是直肠衣原体感染（lenacapavir:13.2%；Truvada:11.8%），口咽淋菌感染（lenacapavir:13.0%；Truvada:10.9%）和直肠淋菌感染（lenacapavir:10.7%；Truvada:9.1%）。。

Serious AEs were reported in 3.3% of participants in the lenacapavir group, compared to 4.0% in the Truvada group. Frequency of AEs was consistent between study groups.

lenacapavir组有3.3%的参与者报告了严重的AE，而Truvada组为4.0%。研究组之间AE的频率是一致的。

Few discontinuations due to injection site reactions

由于注射部位反应而很少中断

Lenacapavir is injected into the subcutaneous layer of fat in the abdomen to form a drug depot, which should get smaller and resolve, or reduce in size substantially, prior to the next lenacapavir injection. The drug depot may be palpable as a bump or nodule but is usually not visible.

Lenacapavir被注射到腹部的皮下脂肪层中以形成药物贮库，在下一次注射Lenacapavir之前，药物贮库应该变小并分解，或者大大减小尺寸。药物仓库可以触及肿块或结节，但通常不可见。

A total of 15,239 lenacapavir and placebo injections were administered during the trial. The most commonly reported ISRs were subcutaneous nodules (lenacapavir: 63.4%; placebo: 39.2%), injection site pain (lenacapavir: 56.4%; placebo: 53.4%) and erythema (lenacapavir: 17.3%; placebo: 19.4%). Twenty-nine people (<1%) across both groups discontinued due to ISRs.

试验期间共进行了15239次来那帕韦和安慰剂注射。最常报告的ISR是皮下结节（lenacapavir:63.4%；安慰剂：39.2%），注射部位疼痛（lenacapavir:56.4%；安慰剂：53.4%）和红斑（lenacapavir:17.3%；安慰剂：19.4%）。由于ISR，两组中有29人（<1%）停药。

ISR incidence, including nodules, decreased with subsequent injections..

包括结节在内的ISR发病率随着随后的注射而下降。。

High level of diversity among trial participants and geographic regions

试验参与者和地理区域之间的高度多样性

The importance of studying HIV prevention across diverse global communities and populations, including gender-diverse populations, was one of the key recommendations from the PURPOSE 2 Global Community Advisory Group (G-CAG) and other community members. As a result, the study enrolled participants from seven countries across four continents and was the first Phase 3 HIV prevention trial to intentionally include transgender men and non-binary individuals..

目标2全球社区咨询小组（G-CAG）和其他社区成员的主要建议之一是，研究全球不同社区和人群（包括性别不同人群）的艾滋病毒预防工作的重要性。因此，这项研究招募了来自四大洲七个国家的参与者，这是第一个有意包括变性男性和非二元个体的第三阶段艾滋病毒预防试验。。

Among trial participants, 67% were non-White, including 38% Black participants, and 63% were of Hispanic/Latine ethnicity. More than 20% were gender-diverse: 15% were transgender women, 1% were transgender men and 6% were gender non-binary.

在试验参与者中，67%是非白人，包括38%的黑人参与者，63%是西班牙裔/拉丁裔。超过20%的人是性别多样化的：15%是变性女性，1%是变性男性，6%是性别非二元的。

Community advocates also stressed the importance of including adolescents and young people in PURPOSE 2, which, along with PURPOSE 1, is the first Phase 3 HIV prevention trial to intentionally include adolescents. About one-third of PURPOSE 2 trial participants were aged 25 years or younger, and the median age of participants was 29..

社区倡导者还强调了将青少年和年轻人纳入目标2的重要性，该目标与目标1一起，是第一个有意将青少年纳入艾滋病毒预防试验的第三阶段。目的2试验参与者中约有三分之一年龄在25岁或以下，参与者的中位年龄为29岁。。

More detailed data from PURPOSE 2 will be presented at a future conference and in a future publication.

目的2的更详细数据将在未来的会议和未来的出版物中提供。

Gilead to begin regulatory filings for lenacapavir for PrEP by the end of 2024 and recently announced voluntary licensing partners to increase access in high-incidence, resource-limited countries

吉利德将于2024年底开始为lenacapavir提交PrEP的监管文件，最近宣布自愿许可合作伙伴，以增加高发病率、资源有限的国家的准入

To ensure the results from PURPOSE 1 and PURPOSE 2 help translate into decreased HIV incidence globally if lenacapavir for PrEP is approved, Gilead is executing an access strategy, informed by more than 100 global health advocates and organizations, that prioritizes speed and enables the most efficient paths for the regulatory review and approval of lenacapavir for PrEP in regions around the world.

如果lenacapavir for PrEP获得批准，为了确保目标1和目标2的结果有助于降低全球艾滋病毒发病率，吉利德正在执行一项获取策略，该策略由100多个全球健康倡导者和组织提供信息，该策略优先考虑速度，并为世界各地监管部门审查和批准lenacapavir for PrEP提供最有效的途径。

Data from both trials will support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024..

这两项试验的数据将支持lenacapavir于2024年底开始的一系列全球监管文件。。

On October 2, Gilead announced that it had signed non-exclusive, royalty-free voluntary licensing agreements with six pharmaceutical companies to manufacture and supply high-quality, low-cost versions of lenacapavir for 120 primarily low- and lower-middle income countries. These agreements are just one component of Gilead’s overall global strategy to enable broad, sustainable access to lenacapavir for PrEP, if approved.

10月2日，吉利德宣布，它已与六家制药公司签署了非排他性、免版税的自愿许可协议，为120个主要是中低收入国家生产和供应高质量、低成本的lenacapavir。这些协议只是吉利德整体全球战略的一个组成部分，如果获得批准，将能够广泛、可持续地使用lenacapavir进行PrEP。

Gilead is actively working on additional ways to support access in upper-middle and high-income countries to establish fast, efficient pathways to help reach people who need or want PrEP, including timely regulatory filings, engagement with partners and governments, and manufacturing planning. This includes the countries with PURPOSE 2 trial sites, including Argentina, Brazil, Mexico, Peru and the United States, where trial participants have been offered and will be able to stay on open-label lenacapavir until it is available in their country..

吉利德正在积极研究其他方法，以支持中上收入和高收入国家的准入，建立快速有效的途径，帮助接触需要或想要PrEP的人，包括及时提交监管文件、与合作伙伴和政府接触以及制定制造计划。这包括有目的2试验地点的国家，包括阿根廷、巴西、墨西哥、秘鲁和美国，这些国家已经为试验参与者提供了服务，并且将能够在开放标签lenacapavir上停留，直到它在本国上市。。

“The PURPOSE clinical trial program continues to set new standards for innovative science, trial design, community input and intentional recruitment, all coming together to yield stellar results,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development and Virology Therapeutic Area Head, Gilead Sciences.

Gilead Sciences临床开发和病毒学治疗领域高级副总裁Jared Baeten医学博士说：“目的临床试验计划继续为创新科学、试验设计、社区投入和有意招募制定新标准，所有这些共同产生了卓越的结果。”。

“Gilead is committed to employing the same kind of rigorous, thoughtful and collaborative approach to ensure that lenacapavir for PrEP has the most transformative impact possible if approved.”.

“Gilead致力于采用同样严格、周到和协作的方法，以确保lenacapavir for PrEP在获得批准后尽可能产生最大的变革性影响。”。

Updates on regulatory filings for lenacapavir for PrEP will be shared as discussions with regulatory bodies progress.

随着与监管机构的讨论进展，将分享lenacapavir for PrEP监管文件的最新信息。

The use of lenacapavir for the prevention of HIV is investigational and has not been determined to be safe or efficacious and is not approved anywhere globally.

lenacapavir用于预防艾滋病毒的用途正在研究中，尚未确定其安全或有效，并且尚未在全球任何地方获得批准。

There is currently no cure for HIV or AIDS.

目前还没有治愈艾滋病毒或艾滋病的方法。

About the PURPOSE Program

关于目的计划

Gilead’s landmark PURPOSE program is the most comprehensive and diverse HIV prevention trial program ever conducted. The program comprises five HIV prevention trials around the world that are focused on innovation in science, trial design, community engagement and health equity.

吉列德具有里程碑意义的目标计划是有史以来进行的最全面和多样化的艾滋病毒预防试验计划。该计划包括世界各地的五项艾滋病毒预防试验，重点是科学创新、试验设计、社区参与和健康公平。

The PURPOSE trials are evaluating the safety and efficacy of an investigational, twice-yearly injectable medicine, lenacapavir, to reduce the chance of getting HIV. The Phase 2 and 3 program, consisting of PURPOSE 1-5, is assessing the potential of lenacapavir to help a diverse range of people around the world who could benefit from PrEP..

目的试验是评估一种每年两次的研究性注射药物lenacapavir的安全性和有效性，以减少感染艾滋病毒的机会。第二阶段和第三阶段计划由目标1-5组成，正在评估lenacapavir的潜力，以帮助世界各地可以从PrEP中受益的各种各样的人。。

More information about the PURPOSE program, including individual trial descriptions, populations and locations, can be found at www.purposestudies.com.

有关目的计划的更多信息，包括个人试验描述，人群和地点，请访问www.purposetudies.com。

About Lenacapavir

可怕的鬼魂关于Lenacapavir

Lenacapavir is approved in multiple countries for the treatment of adults with multi-drug resistant HIV in combination with other antiretrovirals. The use of lenacapavir for HIV prevention is investigational and the safety and efficacy of lenacapavir for this use have not been established.

Lenacapavir在多个国家被批准与其他抗逆转录病毒药物联合用于治疗患有多重耐药艾滋病毒的成年人。lenacapavir用于艾滋病毒预防的研究正在进行中，lenacapavir的安全性和有效性尚未确定。

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiviral agents. While most antivirals act on just one stage of viral replication, lenacapavir is designed to inhibit HIV at multiple stages of its lifecycle and has no known cross resistance exhibited in vitro to other existing drug classes..

lenacapavir的多阶段作用机制与其他目前批准的抗病毒药物有区别。虽然大多数抗病毒药物仅作用于病毒复制的一个阶段，但lenacapavir旨在在其生命周期的多个阶段抑制HIV，并且在体外对其他现有药物类别没有已知的交叉耐药性。。

Lenacapavir is being evaluated as a long-acting option in multiple ongoing and planned early and late-stage clinical studies in Gilead’s HIV prevention and treatment research program. Lenacapavir is being developed as a foundation for potential future HIV therapies with the goal of offering both long-acting oral and injectable options with several dosing frequencies, in combination or as a mono agent, that help address individual needs and preferences of people and communities affected by HIV..

在吉利德艾滋病毒预防和治疗研究项目的多项正在进行和计划中的早期和晚期临床研究中，Lenacapavir被评估为一种长效选择。Lenacapavir正在被开发为未来潜在的艾滋病毒治疗的基础，其目标是提供长效口服和注射选择，具有多种给药频率，联合或作为单一药物，有助于解决受艾滋病毒影响的人和社区的个人需求和偏好。。

About Gilead HIV

关于Gilead HIV

For more than 35 years, Gilead has been a leading innovator in the field of HIV, driving advances in treatment, prevention and cure research. Gilead researchers have developed 12 HIV medications, including the first single-tablet regimen to treat HIV, the first antiretroviral for pre-exposure prophylaxis (PrEP) to help reduce new HIV infections, and the first long-acting injectable HIV treatment medication administered twice-yearly.

35多年来，吉利德一直是艾滋病毒领域的领先创新者，推动了治疗、预防和治疗研究的进步。吉利德研究人员开发了12种艾滋病毒药物，包括第一种治疗艾滋病毒的单片剂方案，第一种用于暴露前预防的抗逆转录病毒药物（PrEP），以帮助减少新的艾滋病毒感染，以及第一种每年两次服用的长效注射艾滋病毒治疗药物。

Our advances in medical research have helped to transform HIV into a treatable, preventable, chronic condition for millions of people..

我们在医学研究方面的进步帮助数百万人将艾滋病毒转化为可治疗、可预防的慢性病。。

Gilead is committed to continued scientific innovation to provide solutions for the evolving needs of people affected by HIV around the world. Through partnerships, collaborations and charitable giving, the company also aims to improve education, expand access and address barriers to care, with the goal of ending the HIV epidemic for everyone, everywhere.

吉利德致力于继续进行科学创新，为世界各地艾滋病毒感染者不断变化的需求提供解决方案。通过伙伴关系、合作和慈善捐赠，该公司还旨在改善教育，扩大获得护理的机会并解决护理障碍，目标是在任何地方结束艾滋病毒在每个人身上的流行。

Gilead was recognized as one of the leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS..

在关注艾滋病的资助者发布的一份报告中，吉利德被公认为艾滋病相关项目的主要慈善资助者之一。。

Forward-Looking Statement

前瞻性声明

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead’s ability to initiate, progress and complete clinical trials in the anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials, including those involving lenacapavir (such as PURPOSE 1 and PURPOSE 2); uncertainties relating to regulatory applications and related filing and approval timelines, including regulatory applications for lenacapavir for PrEP, and the risk that any regulatory approvals, if granted, may be subject to significant limitations on use or subject to withdrawal or other adverse actions by the applicable regulatory authority; the possibility that Gilead may make a strategic decision to discontinue development of lenacapavir for indications currently under evaluation and, as a result, lenacapavir may never be successfully commercialized for such indications; Gilead’s ability to effectively manage the supply and distribution of lenacapavir, including through direct supply as well as indirect supply through the voluntary licensing agreements, and the ability of the parties to meet potential demand for lenacapavir, in each case, subject to necessary regulatory approvals; and any assumptions underlying any of the foregoing.

本新闻稿包括1995年《私人证券诉讼改革法案》所指的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德在预期时间表内或根本没有启动、进展和完成临床试验的能力，以及正在进行的和其他临床试验（包括涉及lenacapavir的临床试验（如目的1和目的2））产生不利结果的可能性；与监管申请和相关备案和批准时间表相关的不确定性，包括lenacapavir for PrEP的监管申请，以及任何监管批准（如果获得批准）可能会受到使用上的重大限制或相关监管机构撤回或其他不利行动的风险；；吉利德有效管理来那帕韦的供应和分销的能力，包括通过自愿许可协议的直接供应和间接供应，以及各方满足来那帕韦潜在需求的能力，在每种情况下都需要获得必要的监管批准；以及基于上述任何一项的任何假设。

These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2024, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements.

这些以及其他风险、不确定性和因素在吉利德提交给美国证券交易委员会的截至2024年6月30日的季度10-Q表季度报告中有详细描述。这些风险、不确定性和其他因素可能导致实际结果与前瞻性声明中提及的结果存在重大差异。

All statements o.

所有声明o。

U.S. full Prescribing Information for Truvada, including Boxed Warning, and lenacapavir are available at www.gilead.com.

U、 有关特鲁瓦达的完整处方信息，包括盒装警告和lenacapavir，请访问www.gilead.com。

Gilead and the Gilead logo, Truvada, and Truvada for PrEP are registered trademarks of Gilead Sciences, Inc., or its related companies.

Gilead和Gilead徽标、Truvada和Truvada for PrEP是Gilead Sciences，Inc.或其关联公司的注册商标。

For more information about Gilead, please visit the company’s website at www.gilead.com, follow Gilead on X/Twitter (@Gilead Sciences) and LinkedIn (@Gilead-Sciences).

有关吉利德的更多信息，请访问公司网站www.Gilead.com，在X/Twitter（@Gilead Sciences）和LinkedIn（@Gilead Sciences）上关注吉利德。