FOSTER CITY, Calif.--(BUSINESS WIRE) December 15, 2025 -- Gilead Sciences, Inc. (Nasdaq: GILD) today announced positive topline results from the Phase 3 ARTISTRY-2 trial. The double-blind trial evaluated the treatment responses of adults with HIV who are virologically suppressed switching from BIKTARVY.

福斯特城，加利福尼亚州——（商业资讯）2025年12月15日——吉利德科学公司（纳斯达克股票代码：GILD）今天宣布了三期ARTISTRY-2试验的积极顶线结果。这项双盲试验评估了病毒学抑制的成年HIV患者从BIKTARVY转换后的治疗反应。

®

®

(bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF) to a fixed-dose combination of bictegravir 75 mg/lenacapavir 50 mg (BIC/LEN). BIC/LEN efficacy was found to be statistically non-inferior to BIKTARVY. Gilead plans to file the Phase 3 results from the ARTISTRY trials with regulatory authorities and submit the detailed findings for presentation at a future scientific congress..

（比克替拉韦50毫克/恩曲他滨200毫克/替诺福韦艾拉酚胺25毫克片剂，B/F/TAF）转换为固定剂量组合的比克替拉韦75毫克/来那卡帕韦50毫克（BIC/LEN）。研究发现，BIC/LEN的疗效在统计学上不劣于BIKTARVY。吉利德计划将ARTISTRY试验的第三阶段结果提交给监管机构，并提交详细的研究结果以在未来的科学大会上展示。

In ARTISTRY-2, the once-daily single tablet regimen of BIC/LEN met the primary success criterion for non-inferiority to BIKTARVY. The primary efficacy endpoint was the percentage of participants with HIV-1 RNA levels ≥50 copies/mL at Week 48, defined by the FDA snapshot algorithm. The novel combination of BIC/LEN was generally well tolerated, with no significant or new safety concerns identified during the trial..

在ARTISTRY-2研究中，每日一次的BIC/LEN单片方案达到了与BIKTARVY相比非劣效性的主要成功标准。主要疗效终点是第48周时HIV-1 RNA水平≥50拷贝/mL的参与者比例，由FDA快照算法定义。BIC/LEN的这种新型组合通常耐受性良好，在试验期间未发现显著或新的安全性问题。

The investigational regimen combines bictegravir, a global guidelines-recommended integrase strand transfer inhibitor with a high barrier to resistance, and lenacapavir, a first-in-class capsid inhibitor with no overlapping resistance to other existing drug classes. A single-tablet regimen combining bictegravir and lenacapavir would potentially further transform the treatment landscape, expanding options to enable people with HIV to sustain virologic suppression while taking one of the latest advances in HIV drug development..

研究中的治疗方案结合了比克替拉韦（bictegravir）——一种全球指南推荐的、具有高耐药屏障的整合酶链转移抑制剂，以及来那卡帕韦（lenacapavir）——一种首创的衣壳抑制剂，对其他现有药物类别无交叉耐药性。将比克替拉韦和来那卡帕韦结合的单片治疗方案可能会进一步改变治疗格局，扩大选择范围，使HIV感染者在服用这一最新进展的HIV药物时能够持续维持病毒学抑制。

“Recent breakthroughs in medical research have led to the approval of new treatments that can help people with HIV sustain viral suppression, facilitating improved health outcomes while also helping to reduce spread of the virus,” said Eric Meissner, MD, PhD, Associate Professor, Director of HIV and Hepatitis Patient Care and Research, Medical University of South Carolina.

“近期医学研究的突破导致了新疗法的批准，这些疗法可以帮助 HIV 感染者维持病毒抑制，促进健康状况的改善，同时也有助于减少病毒的传播，”南卡罗来纳医科大学副教授、HIV 和肝炎患者护理与研究主任埃里克·梅斯纳 (Eric Meissner) 医学博士表示。

“The findings from ARTISTRY-2 provide evidence that the investigational combination of bictegravir—a standard-of-care integrase strand transfer inhibitor—and lenacapavir—a novel capsid inhibitor—has a comparable efficacy profile to a global guideline-recommended treatment regimen, demonstrating potential to expand current HIV treatment options.”.

“ARTISTRY-2 的研究结果表明，比克替拉韦（一种标准治疗的整合酶链转移抑制剂）与来那卡帕韦（一种新型衣壳抑制剂）的实验性组合，其疗效与全球指南推荐的治疗方案相当，展示了扩展当前 HIV 治疗选择的潜力。”

ARTISTRY-2 (NCT06333808) is a multicenter, double-blind, randomized Phase 3 clinical trial comparing the safety and efficacy of an investigational once-daily combination of bictegravir and lenacapavir versus BIKTARVY in people with HIV who are virologically suppressed. Participants on BIKTARVY were randomized 2:1 to switch onto bictegravir 75 mg/lenacapavir 50 mg or continue their BIKTARVY regimen.

ARTISTRY-2 (NCT06333808) 是一项多中心、双盲、随机的 III 期临床试验，比较了一种在研的每日一次比克替拉韦和来那卡帕韦联合用药与 BIKTARVY 在病毒学抑制的 HIV 感染者中的安全性和有效性。原本使用 BIKTARVY 的参与者按 2:1 的比例随机分配，转换为每日一次比克替拉韦 75 毫克/来那卡帕韦 50 毫克组合或继续其原有的 BIKTARVY 方案。

The primary endpoint was the proportion of patients with HIV-1 RNA ≥50 copies/mL at Week 48 as determined by the US FDA-defined snapshot algorithm. Key secondary endpoints at Week 48 included the proportion of participants with virologic suppression (HIV viral load <50 copies/mL per US FDA Snapshot), change from baseline in CD4 cell count and the proportion of participants with treatment-emergent adverse events (TEAEs)..

主要终点是由美国FDA定义的快照算法确定的在第48周时HIV-1 RNA ≥50拷贝/mL的患者比例。第48周的关键次要终点包括实现病毒学抑制（根据美国FDA快照算法，HIV病毒载量<50拷贝/mL）的参与者比例、CD4细胞计数从基线的变化以及出现治疗相关不良事件（TEAEs）的参与者比例。

“The HIV treatment landscape is evolving. As a collective HIV community, we must look to the future of tailored treatments to meet the needs and preferences of people affected by HIV,” said Jared Baeten, MD, PhD, Senior Vice President, Clinical Development, Virology Therapeutic Area Head, Gilead Sciences.

“HIV治疗领域正在不断发展。作为HIV群体的一员，我们必须着眼于未来，提供满足HIV感染者需求和偏好的个性化治疗方案，” Jared Baeten医学博士、哲学博士、Gilead Sciences公司高级副总裁、临床开发部门负责人、病毒学治疗领域主管表示。

“These data support the potential of BIC/LEN as a meaningful additional treatment option for adults with HIV who are virologically suppressed. We look forward to sharing the full Phase 3 data from the ARTISTRY-1 and ARTISTRY-2 trials next year and submitting these data for regulatory approval.”.

“这些数据支持了BIC/LEN作为一种有意义的额外治疗选择，用于病毒学抑制的成年HIV感染者。我们期待明年分享ARTISTRY-1和ARTISTRY-2试验的完整三期数据，并提交这些数据以获得监管批准。”

The results of ARTISTRY-2 will be combined with the findings from the Phase 3 ARTISTRY-1 (NCT05502341) trial to form the basis of regulatory submissions. Top-line results from the ARTISTRY-1 trial announced in November 2025 showed that the investigational combination of BIC/LEN was well tolerated and statistically non-inferior to multi-tablet antiretroviral regimens..

ARTISTRY-2 的结果将与 3 期 ARTISTRY-1 (NCT05502341) 试验的发现相结合，作为监管提交的基础。2025 年 11 月公布的 ARTISTRY-1 试验的初步结果显示，研究中的 BIC/LEN 联合用药耐受性良好，并且在统计学上不劣于多种片剂的抗逆转录病毒治疗方案。

Bictegravir and lenacapavir in combination are investigational and not approved anywhere globally. The safety and efficacy of this combination use has not been established by the U.S. FDA.

比克替拉韦和来那卡帕韦的组合在全球任何地方均未获批，仍处于研究阶段。美国食品药品监督管理局（FDA）尚未确定该组合使用的安全性和有效性。

There is currently no cure for HIV or AIDS.

目前还没有治愈艾滋病的方法。

About Bictegravir

关于比克替拉韦

Bictegravir is a global guideline-recommended integrase strand transfer inhibitor (INSTI) with a high barrier to resistance. INSTIs are a class of antiretroviral agents that target the viral integrase. Bictegravir is used only in combination with other antiretroviral agents in the treatment of HIV.

比克替拉韦是一种全球指南推荐的整合酶链转移抑制剂（INSTI），具有较高的耐药屏障。INSTIs是一类靶向病毒整合酶的抗逆转录病毒药物。比克替拉韦仅在与其他抗逆转录病毒药物联合使用时，用于治疗HIV。

About Lenacapavir

关于Lenacapavir

Lenacapavir is approved in multiple countries as pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV in adults and adolescents who are at risk of HIV acquisition. Lenacapavir is also approved in multiple countries for the treatment of multi-drug-resistant HIV in adults, in combination with other antiretrovirals..

Lenacapavir已在多个国家获批作为暴露前预防（PrEP）用药，用于降低有感染风险的成年人和青少年通过性行为感染HIV的风险。Lenacapavir还被多个国家批准用于与其他抗逆转录病毒药物联合治疗成人多药耐药HIV。

The multi-stage mechanism of action of lenacapavir is distinguishable from other currently approved classes of antiretroviral agents. While most antiretrovirals 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 的多阶段作用机制不同于其他目前获批的抗逆转录病毒药物类别。大多数抗逆转录病毒药物仅作用于病毒复制的一个阶段，而 Lenacapavir 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，作为长效选择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，以满足受HIV影响的个人和社区的需求与偏好。

Lenacapavir was chosen as one of TIME’s Best Inventions, recognized on Fortune’s Change the World list, named the 2024 Breakthrough of the Year by the journal .

Lenacapavir 被选为《时代》杂志最佳发明之一，被列入《财富》改变世界榜单，并被该期刊评为2024年度突破。

Science

科学

, and selected as the 2025 Prix Galien USA Award for Best Pharmaceutical Product.

，并被评为2025年美国盖伦奖最佳药品产品。

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 13 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13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，以及首款每年两次注射的长效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可治疗、可预防的慢性病，惠及数百万人。

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 worldwide.

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，目标是终结全球艾滋病流行。

Gilead has been repeatedly recognized as one of the top two leading philanthropic funders of HIV-related programs in a report released by Funders Concerned About AIDS..

吉利德 repeatedly 被 Funders Concerned About AIDS 发布的报告评为 HIV 相关项目的前两大慈善资助者之一。

Discover more about Gilead’s unique collaborations worldwide and the work to help end the HIV epidemic.

了解有关吉利德在全球的独特合作及其为帮助终结艾滋病毒流行所做的工作的更多信息。

About Gilead Sciences

关于吉利德科学公司

Gilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis, COVID-19, cancer and inflammation.

吉利德科学公司是一家生物制药公司，三十多年来一直致力于医学领域的突破，旨在为全人类创造一个更健康的世界。公司致力于推进创新药物的研发，以预防和治疗危及生命的疾病，包括艾滋病、病毒性肝炎、新冠肺炎、癌症和炎症等。

In 2025, Gilead announced a planned $32 billion investment to further strengthen its U.S. footprint to power the next era of discovery, job creation and public health preparedness – while continuing to invest globally to ensure patients everywhere benefit from its scientific innovation. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, Calif..

2025年，吉利德宣布计划投资320亿美元，进一步巩固其在美国的布局，推动下一个发现、就业创造和公共卫生准备的时代，同时继续在全球范围内进行投资，确保世界各地的患者都能从其科学创新中受益。吉利德在全球35多个国家开展业务，总部位于加利福尼亚州福斯特城。

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 or complete clinical trials or studies within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing and additional clinical trials or studies, including those involving bictegravir and lenacapavir (such as ARTISTRY-1 and ARTISTRY-2); uncertainties relating to regulatory applications and related filing and approval timelines, including potential applications for programs and/or indications currently under evaluation, such as the combination of bictegravir and lenacapavir for HIV-1 infection, 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 these programs and, as a result, these programs may never be successfully commercialized for the indications currently under evaluation; 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》意义上的前瞻性声明，这些声明受到风险、不确定性和其他因素的影响，包括吉利德能否在目前预期的时间内或根本无法启动、推进或完成临床试验或研究，以及来自正在进行和额外临床试验或研究（包括涉及比克替拉韦和来那卡帕韦的试验，如ARTISTRY-1和ARTISTRY-2）可能出现不利结果的可能性；与监管申请及相关的提交和批准时间线有关的不确定性，包括针对目前正在评估的项目和/或适应症的潜在申请，例如比克替拉韦和来那卡帕韦联合用于HIV-1感染，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；吉利德可能作出战略性决定停止开发这些项目，从而导致这些项目可能永远不会针对当前正在评估的适应症成功商业化；以及上述任何假设作为基础的情况。

These and other risks, uncertainties and factors are described in detail in Gilead’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, 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公司截至2025年9月30日的季度Form 10-Q季度报告中已详细说明，并已提交给美国证券交易委员会。这些风险、不确定性及其他因素可能导致实际结果与前瞻性陈述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 statem.

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。

BIKTARVY, Gilead and the Gilead logo are trademarks of Gilead Sciences, Inc., or its related companies.

BIKTARVY、Gilead 以及 Gilead 徽标是吉利德科学公司或其相关公司的商标。

For more information about Gilead, please visit the company’s website at

有关吉利德的更多信息，请访问该公司网站

www.gilead.com

www.gilead.com

, follow Gilead on X

，关注吉利德在X上的账号

(@Gilead Sciences

(@吉利德科学

) and

) 和

LinkedIn

领英

, or

，或者

contact

联系

Gilead Public Affairs.

吉利德公共事务部。

Source: Gilead Sciences, Inc.

来源：吉利德科学公司

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