FOSTER CITY, Calif.--(BUSINESS WIRE) March 11, 2025 --

福斯特城，加利福尼亚州——（商业资讯）2025年3月11日——

Gilead Sciences, Inc. (Nasdaq: GILD) today presented the first data from its ongoing Phase 1 study investigating two novel, once-yearly formulations of lenacapavir, the company’s injectable HIV-1 capsid inhibitor, for the investigational use of HIV prevention as pre-exposure prophylaxis (PrEP). The data were presented during an oral abstract session at the Conference on Retroviruses and Opportunistic Infections (CROI 2025) and were also published today in .

吉利德科学公司（纳斯达克股票代码：GILD）今天公布了其正在进行的1期研究的首批数据，该研究调查了两种新型的、每年一次的lenacapavir制剂，这种注射型HIV-1衣壳抑制剂用于HIV预防的暴露前预防（PrEP）。这些数据在逆转录病毒和机会性感染会议（CROI 2025）的口头摘要环节中发布，并于今天同时发表。

The Lancet

柳叶刀

. Data will support the future development of once-yearly lenacapavir for PrEP, for which Gilead plans to launch a Phase 3 study in the second half of 2025.

数据将支持未来每年一次的Lenacapavir在PrEP中的发展，Gilead计划在2025年下半年启动一项III期研究。

The Phase 1 study data showed that the two different formulations of once-yearly lenacapavir administered via intramuscular injection achieved and maintained plasma concentrations exceeding those associated with HIV prevention efficacy observed in the Phase 3 PURPOSE 1 trial (NCT04994509) and PURPOSE 2 trial (NCT04925752).

1期研究数据显示，两种不同配方的每年一次通过肌肉注射给药的Lenacapavir达到了超过3期PURPOSE 1试验（NCT04994509）和PURPOSE 2试验（NCT04925752）中观察到的与HIV预防效果相关的血浆浓度，并维持了该浓度。

The previously reported PURPOSE 1 and PURPOSE 2 data showed that twice-yearly subcutaneous lenacapavir demonstrated superiority at reducing HIV infections when compared to background HIV incidence (bHIV) and once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil fumarate 300mg; F/TDF) in a broad and geographically diverse range of people..

此前报告的PURPOSE 1和PURPOSE 2数据显示，在广泛且地理多样性的人群中，每年两次皮下注射Lenacapavir在降低HIV感染方面优于背景HIV发病率（bHIV）和每日一次口服Truvada®（恩曲他滨200毫克和富马酸替诺福韦二吡呋酯300毫克；F/TDF）。

“Gilead is continuing to innovate in our work to develop additional person-centered long-acting injectable and oral options to help people find an HIV prevention choice that is right for them,” said Jared Baeten, MD, PhD, Senior Vice President, Virology Therapeutic Area Head, Gilead Sciences. “Once-yearly lenacapavir, if approved, could become an important new HIV prevention option that could help address PrEP adherence and persistence challenges for individuals who need or want PrEP around the world.”.

“吉利德将继续创新，致力于开发更多以人为中心的长效注射和口服选项，帮助人们找到适合自己的 HIV 预防选择，”吉利德科学公司病毒学治疗领域负责人、高级副总裁 Jared Baeten 医学博士表示。“一旦获得批准，每年一次的 lenacapavir 可能成为一种重要的新型 HIV 预防选择，有助于解决全球需要或希望使用 PrEP 的个体在 PrEP 依从性和持续性方面的挑战。”

Promising once-yearly lenacapavir for PrEP pharmacokinetic profiles over 52 weeks

为期52周的PrEP药物动力学特征显示，每年一次的Lenacapavir具有广阔前景。

The Phase 1 study evaluated the pharmacokinetics, safety and tolerability of two intramuscular single-dose 5000mg lenacapavir formulations. The trial included 40 healthy adults at low risk of HIV acquisition, between the ages of 18 and 55 years, with a body mass index of less than or equal to 35.0 kg/m.

第一阶段研究评估了两种肌肉注射单剂量5000mg lenacapavir制剂的药代动力学、安全性和耐受性。试验包括40名18至55岁、体重指数小于或等于35.0 kg/m的低HIV感染风险健康成年人。

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Lenacapavir plasma concentrations for participants remained above the 95% effective concentration for at least 56 weeks with both formulations. Furthermore, median trough concentrations of both formulations of once-yearly lenacapavir at Week 52 (57.0 ng/mL and 65.6 ng/mL) were higher than those observed with twice-yearly lenacapavir in the PURPOSE 1 and PURPOSE 2 trials at Week 26 (23.4 ng/mL).

参与者使用两种配方的来那卡帕韦血浆浓度均保持在95%有效浓度以上至少56周。此外，在第52周时，两种一年一次的来那卡帕韦配方的中位谷浓度（57.0 ng/mL 和 65.6 ng/mL）高于在PURPOSE 1和PURPOSE 2试验中观察到的半年两次的来那卡帕韦在第26周的浓度（23.4 ng/mL）。

Data from the study confirmed that both once-yearly formulations of lenacapavir warrant further investigation..

研究数据证实，两种每年一次的lenacapavir配方均值得进一步研究。

Safety data demonstrated both formulations of once-yearly lenacapavir for PrEP were well tolerated, with no new safety signals

安全性数据显示，两种一年一次的Lenacapavir预防制剂均具有良好的耐受性，未出现新的安全信号。

Once-yearly lenacapavir is being investigated as an intramuscular injection. This is different from the subcutaneous formulation of lenacapavir, which is being investigated for twice-yearly dosing. The most commonly reported adverse event for both intramuscular formulations studied was injection site pain, which was mostly mild in severity and resolved within 1 week (occurred in 80% of participants receiving formulation 1, and 75% receiving formulation 2), and was reduced by pretreatment with an ice pack.

每年一次的莱那卡帕韦正在作为肌肉注射进行研究。这不同于正在研究用于每年两次给药的莱那卡帕韦的皮下制剂。在所研究的两种肌肉注射制剂中，最常见的不良事件是注射部位疼痛，其严重程度大多为轻度，并在一周内缓解（接受配方1的参与者中有80%出现此情况，接受配方2的参与者中有75%出现此情况），并且通过在治疗前使用冰袋可以减轻疼痛。

Medication-emergent adverse events were similar between the two cohorts and mostly mild to moderate in severity..

两个队列之间的药物相关不良事件相似，且大多为轻度至中度严重程度。

New PrEP modality preference data demonstrate preference for twice-yearly lenacapavir vs. once-daily orals in PURPOSE 1 survey participants

新的PrEP模式偏好数据显示，在PURPOSE 1调查的参与者中，每年两次的lenacapavir比每日一次的口服药物更受欢迎。

New quantitative survey data and late-breaking qualitative survey data from the PURPOSE 1 trial, evaluating twice-yearly subcutaneous lenacapavir for PrEP among cisgender women in sub-Saharan Africa, were also presented at CROI in two poster sessions. An interim analysis of surveys included 2,561 trial participants’ self-reported preferences for twice-yearly lenacapavir for PrEP injections and once-daily pills, with approximately two-thirds of survey respondents preferring twice-yearly lenacapavir at Week 52 of their trial participation, compared to fewer than one-third of respondents preferring once-daily pills.

PURPOSE 1试验的新定量调查数据和最新的定性调查数据也在CROI的两场海报展示中发布，该试验评估了在撒哈拉以南非洲地区的顺性别女性中，每半年一次皮下注射lenacapavir用于PrEP的效果。调查的中期分析包括2,561名试验参与者的自我报告偏好，涉及每半年一次的lenacapavir PrEP注射与每日一次药片的选择。结果显示，在参与试验的第52周，约三分之二的受访者更倾向于每半年一次的lenacapavir，而不到三分之一的受访者更倾向于每日一次的药片。

Additionally, at Week 52, most respondents (61%) reported they would feel more protected from HIV with twice-yearly PrEP injections compared with once-daily pills, and 61% of respondents also reported they would feel more confident about not missing a PrEP dose with twice-yearly injections compared with once-daily pills.

此外，在第52周时，大多数受访者（61%）表示，与每日服用一次药片相比，他们认为每半年注射一次PrEP能更好地预防HIV。同时，61%的受访者还表示，与每日服用一次药片相比，每半年注射一次能让他们更有信心不错过PrEP的剂量。

Qualitative data among 108 participants also showed that respondents, particularly adolescents aged 16 and 17 years, noted that twice-yearly injections better suited their lifestyles compared with once-daily pills..

108名参与者中的定性数据还显示，受访者，特别是16岁和17岁的青少年，认为与每日一次的药片相比，每年两次的注射更适合他们的生活方式。

New study population data from PURPOSE 1 show comparable pharmacokinetic and safety profiles for both adolescent and adult trial participants

PURPOSE 1 的新研究人群数据显示，青少年和成人试验参与者的药代动力学和安全性特征相似。

Additional adolescent-related data from the PURPOSE 1 trial were also presented at CROI yesterday during an oral abstract session and press conference. PURPOSE 1 is the first adult Phase 3 HIV prevention trial to intentionally include adolescents aged 16 and 17 years, and trial enrollment was much higher than in typical adolescent-dedicated studies (124 adolescents, 56 of whom were assigned to the lenacapavir group).

昨天，在CROI的一场口头摘要会议和新闻发布会上，还展示了来自PURPOSE 1试验的更多与青少年相关的数据。PURPOSE 1是首个有意纳入16岁和17岁青少年的成人第三阶段HIV预防试验，试验的青少年人数远高于典型的专门针对青少年的研究（共124名青少年，其中56名被分配到lenacapavir组）。

The data showed that observed lenacapavir plasma concentrations were comparable between adolescent and adult trial groups, with participants in both groups experiencing the same most common adverse events. There were zero incident HIV infections across the adolescent and adult groups receiving lenacapavir.

数据显示，观察到的来那卡帕韦血浆浓度在青少年和成人试验组之间具有可比性，两组参与者经历的最常见的不良事件相同。在接受来那卡帕韦的青少年和成人组中，新增HIV感染病例数为零。

Given these results, data submitted to regulatory authorities support the potential use of twice-yearly lenacapavir for adolescents who need or want PrEP.

鉴于这些结果，提交给监管机构的数据支持每年两次使用来那卡帕韦在需要或希望使用PrEP的青少年中的潜在应用。

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 HIV 的安全性及有效性尚未确定，且在全球任何地方均未获批准。

There is currently no cure for HIV or AIDS.

目前还没有治愈艾滋病或艾滋病毒的方法。

A

A

bout Lenacapavir

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已在多个国家获批用于与其他抗逆转录病毒药物联合治疗多重耐药HIV的成人患者。Lenacapavir用于HIV预防仍在研究中，其在此用途上的安全性和有效性尚未得到证实。

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..

雷纳卡帕韦的多阶段作用机制不同于其他目前获批的抗病毒药物类别。大多数抗病毒药物仅作用于病毒复制的一个阶段，而雷纳卡帕韦则旨在抑制HIV生命周期的多个阶段，并且在体外实验中未显示出对其他现有药物类别的交叉耐药性。

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.

Lenacapavir 正在吉利德的 HIV 预防和治疗研究项目中，作为长效选项进行多项正在进行及计划中的早期和晚期临床研究评估。Lenacapavir 正在被开发为未来潜在 HIV 疗法的基础，目标是提供长效口服和注射选项，具有多种给药频率，可联合使用或作为单一药物，以帮助满足受 HIV 影响的个人和社区的需求与偏好。

Science Magazine named lenacapavir its 2024 “Breakthrough of the Year.”.

《科学》杂志将雷纳卡帕韦评为2024年“年度突破”。

About the PURPOSE Program

关于PURPOSE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.

吉利德具有里程碑意义的PURPOSE项目是有史以来开展的最全面、最多样化的HIV预防试验项目。该项目包括全球范围内专注于科学创新、试验设计、社区参与和健康公平的五项HIV预防试验。

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..

PURPOSE 试验正在评估一种研究性、每年两次注射的药物 lenacapavir 的安全性和有效性，以降低感染 HIV 的风险。该二期和三期项目（包括 PURPOSE 1-5）正在评估 lenacapavir 帮助全球范围内可能受益于 PrEP 的多样化人群的潜力。

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

有关PURPOSE计划的更多信息，包括各个试验的描述、人群和地点，可以在www.purposestudies.com找到。

About Gilead HIV

关于吉利德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.

三十多年来，吉利德一直是HIV领域的领先创新者，推动了治疗、预防和治愈研究的进步。吉利德的研究人员已经开发出12种HIV药物，包括首个用于治疗HIV的单片剂治疗方案、首个用于暴露前预防（PrEP）的抗逆转录病毒药物以帮助减少新的HIV感染，以及首款每半年注射一次的长效HIV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已经帮助将艾滋病毒转变为一种对数百万人而言可治疗、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.

吉利德致力于持续的科学创新，以满足全球受艾滋病影响人群不断变化的需求。通过合作伙伴关系、协作以及慈善捐赠，公司还旨在改善教育、扩大获取渠道并解决护理障碍，目标是为所有人、在所有地方终结艾滋病流行。

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

吉利德被艾滋病关切基金会发布的一份报告认定为艾滋病相关项目的领先慈善资助者之一。

Forward-Looking Statements

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, and any potential Phase 3 trials evaluating once-yearly lenacapavir for PrEP); 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; and any assumptions underlying any of the foregoing.

本新闻稿包含1995年《私人证券诉讼改革法案》所指的前瞻性声明，这些声明受风险、不确定性和其他因素的影响，包括吉利德能否在预期的时间表内或完全启动、推进和完成临床试验，以及来自正在进行和额外临床试验的不利结果的可能性，其中包括涉及lenacapavir（如PURPOSE 1和PURPOSE 2，以及任何评估lenacapavir作为PrEP一年一次用药的潜在3期试验）的试验；与监管申请及其相关提交和批准时间表有关的不确定性，包括lenacapavir用于PrEP的监管申请，以及任何监管批准（如果获得）可能受到使用上的重大限制或被相关监管机构撤销或其他不利行动的风险；吉利德可能做出战略决策，停止开发目前正在进行评估的lenacapavir适应症，因此lenacapavir可能永远不会成功商业化用于这些适应症；以及上述任何假设的基础。

These and other risks, uncertainties and factors are described in detail in Gilead’s Annual Report on Form 10-K for the year ended December 31, 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.

这些风险、不确定性及其他因素在吉利德提交给美国证券交易委员会的截至2024年12月31日的年度报告（Form 10-K）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到的内容存在重大差异。

All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertai.

所有非历史事实的陈述都可能被视为前瞻性陈述。读者应注意，任何此类前瞻性陈述都不是未来业绩的保证，并且涉及风险和不确定性。

Source: Gilead Sciences, Inc.

来源：吉利德科学公司

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