Background:
Antiretroviral viral therapy (ART) allows people living with human immunodeficiency (HIV) to live long, healthy lives. But ART is not a cure. HIV can remain in the body, in infected cells called reservoirs. If a person stops taking ART, the HIV can rebound and reach high levels in their blood. Researchers want to find ways to reduce the size of HIV reservoirs in people taking ART.
Objective:
To test a drug (lenacapavir) in people with HIV who are on effective ART. Lenacapavir, also called Sunlenca, is already approved for use in people with HIV who cannot be treated with standard ART.
Eligibility:
People aged 18 to 75 years with HIV that has been suppressed for at least 3 years with ART.
Design:
Participants will have 13 clinic visits over 2 years.
Participants will be screened. They will have a physical exam with blood tests. They will maintain their ART throughout the study.
Participants will undergo leukapheresis up to 6 times. Blood will be drawn via a tube in an arm. The blood will pass through a machine that separates out the white blood cells. The remaining blood will be returned to the body through a second tube.
Two-thirds of participants will take lenacapavir in addition to their regular ART. They will receive the drug as an injection under the skin 3 times at 6-month intervals. They will also take lenacapavir as 2 pills swallowed by mouth on the first 2 days of the study.
...

开始日期2025-08-28

申办/合作机构

National Institute of Allergy & Infectious Diseases

NCT07047716

/ Recruiting临床3期

A Phase 3, Single-Arm Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Once-Yearly Intramuscular Lenacapavir for HIV Pre-exposure Prophylaxis (PrEP) in People With an Indication for PrEP

The goal of this clinical study is to learn more about the study drug lenacapavir (LEN), safety, tolerability, and pharmacokinetics (how LEN is absorbed, modified, distributed, and removed from the body of the participants) of once-yearly intramuscular for HIV pre-exposure prophylaxis (PrEP) in people with an indication for PrEP.
The primary objective of this study is to evaluate the pharmacokinetics (PK) and the safety and tolerability of intramuscular (IM) every 12 months (Q12M) LEN for PrEP among people with an indication for PrEP.

开始日期2025-07-25

申办/合作机构

Gilead Sciences, Inc.

NCT06970223

/ Active, not recruiting临床1期

Phase 1, Open-Label, Randomised Crossover Study Assessing the Tolerability and Acceptability of Long Acting Cabotegravir Intramuscular and Lenacapavir Subcutaneous Injections Over Time in Healthy Adults Without HIV

This study will evaluate the tolerability and acceptability of injection site reactions (ISRs) of two long-acting (LA) injectables. Additional characteristics of the ISRs will be investigated and described as well as safety outcomes.

开始日期2025-04-22

申办/合作机构

ViiV Healthcare Ltd.

100 项与来那帕韦钠相关的临床结果

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100 项与来那帕韦钠相关的转化医学

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100 项与来那帕韦钠相关的专利（医药）

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213

项与来那帕韦钠相关的文献（医药）

2025-12-31·Virulence

Lenacapavir’s success: Revitalizing antiviral drug discovery

作者: Miranda, Daniel ; Sanchez, David Jesse

2025-12-01·Current HIV/AIDS Reports

Long-Acting Injectable Antiretroviral Therapy for Treatment of Human Immunodeficiency Virus: A Review

Review

作者: Brotherton, Amy L ; Beckwith, Curt G ; Rossi, Michael R ; Sanchez, Martha C ; Johnson, Jennie E

PURPOSE OF REVIEW:

Long-acting injectable (LAI) antiretroviral therapy (ART) for treatment of HIV-1 are approved both as a complete treatment regimen (cabotegravir/rilpivirine) and as an additional treatment option (lenacapavir) for those with multidrug resistant HIV-1. Here, we review the data supporting these approvals, pharmacokinetics, and additional patient populations that many benefit from LAI ART.

RECENT FINDINGS:

Persons with HIV and adherence challenges as well as those in low-and-middle income countries have high rates of adherence and viral suppression with LAI ART. LAI cabotegravir/rilpivirine (CAB/RPV) offers an alternative treatment approach to daily oral ART for people with HIV-1 infection that is associated with high rates of patient satisfaction when compared to daily oral ART. LAI CAB/RPV is currently only approved in those with HIV-1 viral suppression, however recent data support the use of LAI ART in populations with adherence challenges. Furthermore, given high rates of NNRTI resistance globally, CAB/RPV is not recommended in low-and-middle income countries presently, although this recommendation is likely to change based on recently published data. More research is needed among groups that may benefit from long-acting treatments for HIV-1.

2025-10-01·BIOCHEMICAL PHARMACOLOGY

Lenacapavir: A capsid inhibitor for HIV-1 treatment and prevention

Review

作者: Deng, Yelin ; Růžek, Daniel ; De Clercq, Erik ; Zhang, Yuya ; Tan, Li ; Khouri, Ricardo ; Król, Ewelina ; Li, Guangdi

Lenacapavir (GS-6207) is a capsid inhibitor approved for the treatment of human immunodeficiency virus type 1 (HIV-1) infection in heavily treatment-experienced people with multidrug-resistant HIV-1. Here, this study provides a comprehensive overview of lenacapavir, with a particular focus on its long-acting properties, pharmacodynamics, pharmacokinetics, clinical efficacy and safety, and resistance profile. Clinical trials have demonstrated that long-acting lenacapavir is highly effective not only for treating HIV-1 infection but also as a pre-exposure prophylactic agent. The future development of fixed-dose, long-acting combination regimens incorporating lenacapavir and other long-acting antiretroviral agents offers significant potential for durable and effective HIV-1 management in clinical settings.

519

项与来那帕韦钠相关的新闻（医药）

2025-08-21

·FiercePharma

For now, CVS declines to cover Gilead's long-acting HIV PrEP treatment Yeztugo

“As of this time, Yeztugo has not been added to our commercial template formularies, nor our ACA formularies," a CVS Health spokesperson said. The owner of the U.S.' largest pharmacy benefit manager is declining to cover Gilead Sciences’ long-acting HIV prevention breakthrough, at least for now.CVS Health, the parent of PBM juggernaut CVS Caremark, won’t presently add Gilead’s twice-yearly pre-exposure prophylaxis (PrEP) drug Yeztugo to its commercial plans or Affordable Care Act (ACA) formularies, a company spokesperson confirmed to Fierce Pharma.Yeztugo, which leverages Gilead’s proven HIV-1 capsid inhibitor lenacapavir, scored its FDA approval back in June. The green light has been trumpeted as a breakthrough in HIV prevention that could significantly improve convenience and adherence rates compared to daily pills.“As is typical with new-to-market products, we undergo a careful review of clinical, financial, and regulatory considerations, under the guidance of our external Pharmacy and Therapeutics (P&T) Committee of independent medical experts,” a CVS Health spokesperson said of the decision in an emailed statement.“As of this time, Yeztugo has not been added to our commercial template formularies, nor our ACA formularies. Also of note, the [United States Preventative Services Taskforce] has not added Yeztugo to its list of recommended PrEP therapies,” he explained.On the ACA decision specifically, that program is informed by recommendations from the Department of Health and Human Services’ Preventive Services Task Force (USPSTF), the current PrEP guidelines of which revolve around three older drugs, according to Reuters, which first broke the news of CVS’ coverage verdict.CVS Health supports those USPSTF guidelines and believes in providing easy access to PrEP medications for people living in the U.S., the company’s spokesperson stressed.“However, it is inappropriate for branded pharmaceutical manufacturers to try to manipulate pre-existing guidelines with clinically similar products that are priced far higher than what’s already on the market,” the spokesperson said.“In increasingly crowded therapy classes of highly effective options, a generics-first policy remains the best approach for affordability and, by extension, patient outcomes,” he continued.Yeztugo’s cost before discounts and rebates is roughly $28,000 for one year, according to multiple online sources. Despite the coverage rebuff, Gilead may still be negotiating with CVS on Yeztugo, Reuters wrote in its report, citing a person close to the matter.Mitchell Warren, executive director of the nonprofit AIDS Vaccine Advocacy Coalition, told Reuters that CVS' decision is “a grave disappointment and frankly a missed opportunity,” while admitting that it “does reflect a price that is too high and a U.S. pharmaceutical pricing structure that is frankly not sustainable.”Meanwhile, the outcry from the HIV+Hepatitis Policy Institute was even more fierce, with the organization's executive director, Carl Schmid, urging CVS to “reconsider their decision immediately.” “CVS Health’s decision is a clear violation of the ACA’s requirement to cover USPSTF-recommended preventive services, including PrEP,” he said in an emailed statement. He said that “the entire world is excited by [Yeztugo]” but cautioned that “a drug will only work if people can access it and right now, CVS Health ... is shamefully blocking people from taking it, unlike other payers.”Gilead, for its part, noted that it’s “extremely pleased” with how payer talks for Yeztugo are playing out so far. A spokesperson for the company said over email that Gilead is “well on our way to achieving 75% access for Yeztugo within six months of launch, and 90% within 12 months.”“Most payers continue to cover our HIV prevention products, including Descovy and Yeztugo with no cost sharing or medical management, and continue to follow the USPSTF Grade A recommendation for PrEP,” the spokesperson added.Analysts and doctors alike have predicted that uptake of Yeztugo will be sweeping and swift in the U.S. Back in June, an HIV physician told the team at Mizuho Securities that she expected a “majority” of her 125 PrEP-using patients to switch to Yeztugo over the next year, citing their desire for a less burdensome HIV prevention option.Yeztugo has been shown to be about 99% effective at preventing HIV and is dosed just once every six months. Oral PrEP options, on the other hand, must typically be taken daily, while comparable injectables are often administered every couple of months.Editor's note: This story has been updated with a statement from the HIV+Hepatitis Policy Institute.

上市批准疫苗临床研究

2025-08-18

·药事纵横

Science驱动破局：从“胚系靶向”到中国“天坛株”，全球艾滋病疫苗研发迎来新纪元

艾滋病由人类免疫缺陷病毒（HIV）引起，自发现以来便持续对全球公共卫生构成严峻挑战。尽管抗逆转录病毒疗法与暴露前预防等干预措施显著改善了患者预后并降低了传播风险，但彻底根除HIV流行的终极目标仍有赖于安全有效的预防性疫苗。然而，HIV疫苗的研发之路异常坎坷，全球已开展的300余项临床试验中，绝大多数未能诱导出足够且持久的保护性免疫。近年来，随着对病毒免疫逃逸机制、广谱中和抗体等关键科学问题的深入理解，疫苗研发领域迎来了新的曙光，多项国际合作的突破性成果与国产创新疫苗的崭露头角，为终结艾滋病疫情带来了新的希望。本文旨在系统梳理HIV疫苗领域的最新研究进展，深入剖析当前面临的核心挑战，并展望未来的发展方向与潜在路径。 2023年，联合国艾滋病规划署于瑞士日内瓦发布了题为《终结艾滋病之路》的最新报告。该报告揭示了2022年全球艾滋病疫情的严峻现状：据统计，全球共有3900万名HIV感染者，其中2980万人正在接受抗逆转录病毒治疗；同年，新增感染者达130万，另有63万人死于艾滋病相关疾病。 2015年和2022年全球艾滋病感染情况[1] 近年来，随着对病毒免疫逃逸及广谱中和抗体等关键科学的深入认知，推动了疫苗研发的实质性突破。国内外多项创新成果的涌现，正为终结艾滋病疫情带来前所未有的希望。 (一)国际团队合作在Science发表成果 1.1 艾滋病疫苗研发的挑战与突破艾滋病是由人类免疫缺陷病毒（HIV）引起的严重传染病，尽管近年来在抗逆转录病毒治疗（ART）方面取得了显著进展，HIV感染者的生存期和生活质量得到了极大改善，但目前仍缺乏有效的疫苗来预防HIV感染。HIV的包膜糖蛋白（Env）三聚体是病毒入侵细胞的关键，也是疫苗研发的主要靶点。但Env三聚体的高度变异性使得人体难以产生有效的广谱中和抗体（bnabs）。大多数B细胞本身缺乏成为bnab产生细胞的内在遗传能力，而那些具有潜力的B细胞又很难被传统疫苗激活。为了攻克这一难题，来自全球108位科研人员共同设计了一种“胚系靶向”（germline-targeting，GT）策略，其核心目标是首先激活罕见的bnab前体B细胞，再引导它们逐步成熟为能够产生bnabs的B细胞，并将研究成果成功发表在《Science》期刊[2]。研究成果发表[2] 1.2 精准激活bnab前体B细胞的GT1.1疫苗 2025年5月15日，研究人员以BG505 SOSIP三聚体为基础，精心设计了GT1.1疫苗，并与AS01B佐剂协同使用，在健康成年人开展了一项双盲、安慰剂对照的I期临床试验（IAVI C101），致力于激活bnab前体细胞，诱导VRC01类bnabs前体。VRC01类抗体因其广谱中和能力，并从多个HIV感染者中被分离出来而备受关注。试验结果显示，GT1.1疫苗不仅具有良好的安全性和耐受性，而且所有疫苗接种者均产生了针对GT1.1的IgG抗体，并至少持续六个月。更重要的是，大多数GT1.1疫苗接种者诱导了高频VRC01类bnab前体。这些bnab前体靶向CD4受体结合位点（CD4bs），展现出VRC01类抗体特有的体细胞超突变特征。来自疫苗接种者的VRC01类抗体群能够中和野生型假病毒，且在结构上与bnab VRC01高度相似。 HIV疫苗多阶段策略的早期临床试验[2] (二)国产艾滋病疫苗取得突破，“天坛株”载体疫苗I期临床成功 2025年8月4日，中国疾控中心艾防中心、北京协和医院等团队共同完成了我国首个复制型天坛痘苗载体艾滋病疫苗I期临床试验。研究团队创新性采用曾用于消灭天花的“天坛株”痘苗病毒为载体，构建重组疫苗，为艾滋病疫苗研发开辟新路径。 2.1 I期临床试验的关键成果 1) 安全性验证：在48名健康受试者中进行试验，所有受试者均未出现严重不良反应，仅有少数轻微局部和全身反应，如注射部位疼痛、红肿、低热等，且在短时间内自行缓解。 2) 免疫原性激发：受试者接种后体内产生针对HIV的特异性抗体和T细胞免疫应答，且在随访期间持续存在，显示疫苗激发的免疫记忆效果。 3) 为后续研究奠定基础：试验结果为II期临床试验提供了重要数据支持和经验积累，包括疫苗的最佳剂量、接种程序、免疫持久性等方面的信息。 2.2 与其他艾滋病疫苗研发进展的对比 1) 国际上mRNA技术的应用：美国的一项研究显示，使用mRNA技术的候选疫苗能引发强效免疫反应，但部分参与者出现荨麻疹等副作用，需进一步研究解决。 2) 国内ICVAX疫苗的成果：2024年11月，医克生物集团的ICVAX疫苗完成首次人体一期临床试验，各剂量下均展现良好安全性，受试者诱导出预期的T细胞免疫应答，且在接受最佳剂量的受试者中，T细胞反应增加2倍以上。关于后续即将开展的复制型天坛痘苗载体艾滋病疫苗II期临床试验，还进一步扩大样本量，以评估疫苗在更大人群中的安全性和有效性。除此之外，艾滋病防治领域已取得显著进展，如以长效药物来那帕韦（Yeztugo）为代表的治疗与预防方案已在多国获批上市；同时，以mRNA和痘苗载体等为代表的新型疫苗研发管线也日趋丰富，临床试验正在积极推进。疫苗上市与研发情况 (三)艾滋病疫苗的后续研发前景 3.1 面临的挑战 1) 病毒特性复杂：HIV病毒具有超高速变异能力，其逆转录酶缺乏纠错功能，单次复制即可产生约20个突变，同一感染者体内的病毒多样性可能超过全球流感病毒的年变异总和。此外，病毒可整合至宿主基因组进入休眠状态，形成潜伏库，逃避免疫监视，即使疫苗诱导免疫应答，也难以清除这类“定时炸弹”。病毒包膜蛋白env表面覆盖密集的糖分子，形成糖盾保护，遮蔽关键中和表位，使抗体难以稳定结合。 2) 免疫系统认知鸿沟：广谱中和抗体（bnabs）通常需要经历长达数年的体细胞超突变过程，而HIV感染初期即破坏CD4+T细胞，阻碍这一进化路径。90%的感染通过性传播发生，疫苗需在黏膜部位建立“第一道防线”，但黏膜免疫应答机制仍不完全明确。动物实验显示，部分候选疫苗虽能诱导短期应答，但保护效果随时间快速衰减。 3) 临床试验复杂：进行有效的HIV疫苗临床试验非常复杂且成本高昂。例如，RV144试验涉及了数千名参与者，并且结果显示疫苗效果仅为中等程度。此外，疫苗的安全性和耐受性问题也需要严格监测，即使是在初步显示出一定的保护效果的情况下，也需要确保疫苗的安全性和耐受性。 3.2 研发进展与突破 1) 广谱中和抗体的工程化策略：通过冷冻电镜解析bnab与env三聚体的结合模式，锁定v2-apex、CD4结合位等保守区域。使用工程化免疫原（如EOD-GT8）激活原始B细胞，逐步引导抗体亲和力成熟。例如，William Schief团队提出的靶向胚系B细胞的疫苗策略，开发了EOD-GT6人工蛋白，并证实它可高效结合到VRC01-胚系B细胞，后续优化成为EOD-GT8，可在转基因鼠体内诱导产生VRC01类的抗体谱系。 2) 新型载体技术的崛起：mRNA-LNP平台（如Moderna的mRNA-1644疫苗）通过编码env和gag蛋白，在小鼠中诱导出优于蛋白亚单位疫苗的应答。自复制RNA载体（基于委内瑞拉马脑炎病毒的复制子）可延长抗原表达时间，增强生发中心反应。 3) 细胞免疫的精准激活：嵌合抗原受体（CAR）策略将HIV特异性抗体的单链可变区（scfv）与T细胞受体融合，已在临床试验中清除潜伏感染细胞。异源初免-加强方案（如DNA疫苗初免联合MVA载体加强）可激活多维度T细胞应答。 (四)总结综上所述，尽管HIV疫苗研发之路因病毒的高度变异与免疫逃逸而异常崎岖，但全球科学界的协同创新正不断突破壁垒。从国际团队精准激活bnab前体的“胚系靶向”策略，到我国“天坛株”载体疫苗I期临床的成功，无不昭示着新的希望。随着新型载体技术与免疫设计理念的日新月异，科研人员正前所未有地接近终结艾滋病流行的终极目标。总之，未来之路虽挑战犹存，但曙光已现，胜利可期！参考文献： [1] The path that ends AIDS. https://thepath.unaids.org/wp-content/themes/unaids2023/assets/files/2023_report.pdf [2] Willis JR, Prabhakaran M, Muthui M, Naidoo A, Sincomb T, Wu W, Cottrell CA, Landais E, deCamp AC, Keshavarzi NR, Kalyuzhniy O, Lee JH, Murungi LM, Ogonda WA, Yates NL, Corcoran MM, Phulera S, Musando J, Tsai A, Lemire G, Sein Y, Muteti M, Alamuri P, Bohl JA, Holman D, Himansu S, Leav B, Reuter C, Lin LA, Ding B, He C, Straus WL, MacPhee KJ, Regadas I, Nyabundi DV, Chirchir R, Anzala O, Kimotho JN, Kibet C, Greene K, Gao H, Beatman E, Benson K, Laddy D, Brown DM, Bronson R, Jean-Baptiste J, Gajjala S, Rikhtegaran-Tehrani Z, Benner A, Ramaswami M, Lu D, Alavi N, Amirzehni S, Kubitz M, Tingle R, Georgeson E, Phelps N, Adachi Y, Liguori A, Flynn C, McKenney K, Zhou X, Owuor DC, Owuor SA, Kim SY, Duff M, Kim JY, Gibson G, Baboo S, Diedrich J, Schiffner T, Shields M, Matsoso M, Santos J, Syvertsen K, Kennedy A, Schroeter M, Vekemans J, Yates JR 3rd, Paulson JC, Hyrien O, McDermott AB, Maenetje P, Nyombayire J, Karita E, Ingabire R, Edward V, Muturi-Kioi V, Maenza J, Shapiro AE, McElrath MJ, Edupuganti S, Taylor BS, Diemert D, Ozorowski G, Koup RA, Montefiori D, Ward AB, Karlsson Hedestam GB, Tomaras G, Hunt DJ, Muema D, Sok D, Laufer DS, Andrews SF, Nduati EW, Schief WR. Vaccination with mRNA-encoded nanoparticles drives early maturation of HIV bnAb precursors in humans. Science. 2025 Jul 31;389(6759):eadr8382. doi: 10.1126/science.adr8382 作者介绍：Ketty，主要从事药物研发和科普，制药行业政策和发展研究工作。立即扫码加入药事纵横交流群

疫苗临床1期

2025-08-12

·医药速览

曾最畅销的细胞治疗产品，销售正在下滑

曾最畅销的细胞疗法产品Yescarta如今销售下滑。在吉利德科学发布了其第二季度财报时，公司上下都对革命性的艾滋病暴露前预防（PrEP）新药 Yeztugo 的上市前景充满期待，但其细胞疗法CAR-T产品的销售额竟整体下滑了 7%。吉利德的这两款CAR-T明星产品表现不佳。其中，Yescarta（axicabtagene ciloleucel）的季度营收为3.93亿美元，与去年同期相比下降了 5%。而另一款产品 Tecartus 则经历了更为显著的下滑，营收为9200万美元，同比骤降14%。吉利德的解释是，这主要是由于美国市场对这些产品的需求有所下降。市场需求一直在，主要是竞品在反扑。 Yescarta曾是全球最畅销的细胞或基因疗法，在2023年销售接近15亿美元，远超诺华CD19CART疗法的5.08亿美元，还有强生的BCMA CART疗法的5亿美元，百时美施贵宝的BCMA CART 4.72亿美元。 Yescarta去年创造了16亿美元的销售额，但今年公司预计其销售额将略有下降。今年上半年，Yescarta的销售额为7.79亿美元。吉利德这两款用于血液癌症治疗的CAR-T产品之所以面临下滑，很大程度上是因为市场格局正在发生变化。一方面，新型的双特异性抗体疗法正在获得批准并迅速扩大销售份额。另一方面，一些竞争对手的CAR-T疗法却逆势上扬，表现抢眼。百时美施贵宝的 Breyanzi，作为Yescarta的同类竞争产品，其销售额同比飙升了 125%，达到3.44亿美元。强生与传奇生物共同推出的多发性骨髓瘤疗法 Carvykti 也表现出色，第二季度销售额高达4.39亿美元，远超2024年同期的1.86亿美元。然而上市最早的诺华的Kymriah在第二季度经历了销售下滑，下降了5%至1.25亿美元。从区域销售来看，Yescarta在海外市场的销售额（2.31亿美元）超过了美国本土（1.62亿美元），而BMS的Breyanzi则恰好相反，其美国本土销售额（2.55亿美元）远高于海外（8800万美元）。为了应对挑战，吉利德旗下的Kite公司最近获得了美国FDA的批准，采用新的CAR-T制造工艺，以期缩短Yescarta的制备周期。推文用于传递知识，如因版权等有疑问，请于本文刊发30日内联系医药速览。原创内容未经授权，禁止转载至其他平台。有问题可发邮件至yong_wang@pku.edu.cn获取更多信息。 ©2021 医药速览保留所有权利往期链接 “小小疫苗”养成记 | 医药公司管线盘点人人学懂免疫学| 人人学懂免疫学（语音版）综述文章解读 | 文献略读 | 医学科普|医药前沿笔记 PROTAC技术| 抗体药物| 抗体药物偶联-ADC 核酸疫苗 | CAR技术| 化学生物学温馨提示医药速览公众号目前已经有近12个交流群（好学，有趣且奔波于医药圈人才聚集于此）。进群加作者微信（yiyaoxueshu666）或者扫描公众号二维码添加作者，备注“姓名/昵称-企业/高校-具体研究领域/专业”，此群仅为科研交流群，非诚勿扰。简单操作即可星标⭐️医药速览，第一时间收到我们的推送 ①点击标题下方“医药速览” ②至右上角“...” ③点击“设为星标

免疫疗法细胞疗法财报疫苗抗体药物偶联物

100 项与来那帕韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	-	DB15673

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	欧盟	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	冰岛	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	列支敦士登	Gilead Biopharmaceutics Ireland UC	2022-08-17
HIV感染	挪威	Gilead Biopharmaceutics Ireland UC	2022-08-17

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04994509 \| NCT04925752 (PURPOSE 2, NEWS) 人工标引	临床3期	HIV感染	-	lenacapavir (每年两次)	範簾築鹽遞壓鏇築廠製(願鬱製鹽鹽獵膚繭鑰鹽) = 孕妇与非孕妇安全性相似，按妊娠期或产后状态预测的Yeztugo 暴露无临床显著差异，母乳喂养婴儿暴露量也极小。網鑰蓋廠獵膚廠餘顧範 (蓋夢襯夢觸範齋觸鏇壓 ) 更多	积极	2025-07-16
NCT05729568 (CTgov)	临床2期	HIV感染	83	Antiretroviral Therapy	簾糧壓鬱鹽廠夢憲衊襯 = 鑰醖觸鹽齋餘積壓鬱獵觸製壓壓膚範簾鑰範蓋 (選鑰築壓網鑰製鏇網憲, 願衊鬱醖憲簾選積夢膚 ~ 壓鹽繭製醖醖夢齋製蓋) 更多	-	2025-07-15
NCT04994509 \| NCT04925752 (PURPOSE 2, FDA_CDER) 人工标引	临床3期	HIV感染	-	YEZTUGO (PURPOSE 1)	鏇淵淵願鬱淵鏇範鹽齋(餘積襯襯鏇鏇鏇憲獵衊) = 製鹽構衊鹹齋艱淵獵遞鑰夢鹹鹹廠膚積鹽鹹窪 (窪壓範遞鏇窪壓鑰鏇齋 )	积极	2025-06-18
				TRUVADA (PURPOSE 1)	鏇淵淵願鬱淵鏇範鹽齋(餘積襯襯鏇鏇鏇憲獵衊) = 艱膚繭鑰鬱顧構築網淵鑰夢鹹鹹廠膚積鹽鹹窪 (窪壓範遞鏇窪壓鑰鏇齋 )
NCT04150068 (Phase 2/3 Trial, Pubmed \| Clin Infect Dis)	临床2/3期	HIV感染 multidrug-resistant HIV-1	72	Lenacapavir + OBR	廠餘醖顧網網獵鹹醖壓(鬱繭簾鹹壓憲夢廠構網) = There were no Grade 4 or serious treatment-related adverse events 顧艱觸願鹹遞鹹選製繭 (構鹽壓構顧遞餘蓋鏇構 ) 更多	积极	2025-03-17
PipelineReview \| Pubmed 人工标引	临床1期	HIV感染	40	ventrogluteal intramuscular injection lenacapavir with 5% w/w ethanol	襯製觸壓蓋醖蓋網醖夢(廠製鬱築襯齋淵選鑰鹹) = 繭積築壓鹽顧願鏇鑰鑰鹹憲憲範網築築鹽製蓋 (鬱選獵積選糧衊範製繭, 56.1 ~ 112.0) 更多	积极	2025-03-12
				ventrogluteal intramuscular injection lenacapavir with 10% w/w ethanol	襯製觸壓蓋醖蓋網醖夢(廠製鬱築襯齋淵選鑰鹹) = 築壓網構壓範齋選糧繭鹹憲憲範網築築鹽製蓋 (鬱選獵積選糧衊範製繭, 55.3 ~ 105.5) 更多
NCT04811040 (CTgov)	临床1期	HIV感染	32	LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 10 mg/kg)	齋築觸簾夢遞壓淵鑰繭 = 壓製膚餘衊淵鏇廠構壓齋齋壓餘選製糧範遞積 (簾憲觸構範觸範艱積艱, 餘製鑰膚簾鏇壓鏇夢膚 ~ 網觸獵構窪築鑰範簾選) 更多	-	2025-01-27
				LEN+Zinlirvimab+Teropavimab (Primary Cohort: LEN+Teropavimab+Zinlirvimab 30 mg/kg)	齋築觸簾夢遞壓淵鑰繭 = 觸夢糧齋繭衊艱積鹹鑰齋齋壓餘選製糧範遞積 (簾憲觸構範觸範艱積艱, 鹹艱鑰夢廠積繭築鹹願 ~ 簾網選窪淵襯構觸獵選) 更多
NCT05052996 (CTgov)	临床2期	HIV感染	142	LEN+ISL (Cohort 1- Group 1 (ISL+LEN))	積憲壓網廠鏇齋醖獵衊(築鬱醖觸繭鹹遞齋襯積) = 製夢膚齋窪襯糧壓憲範製膚膚鹹獵艱鹹窪願鑰 (鏇簾選簾繭網窪鹹構淵, 265.0) 更多	-	2025-01-14
				LEN+ISL (Cohort 1- Group 2 (B/F/TAF to ISL+LEN))	積憲壓網廠鏇齋醖獵衊(築鬱醖觸繭鹹遞齋襯積) = 鬱遞襯窪鏇鹽鏇齋衊艱製膚膚鹹獵艱鹹窪願鑰 (鏇簾選簾繭網窪鹹構淵, 304.8) 更多
NCT04925752 (PURPOSE 2, Pubmed \| N Engl J Med) 人工标引	临床3期	HIV感染	3,265	Lenacapavir	膚夢蓋鏇獵獵衊簾鬱鹽(餘範繭鹹鹽製蓋獵獵鹽) = 願膚選鏇鹽鬱積鏇獵蓋築積選獵鹽餘膚廠構獵 (鬱顧淵衊觸顧襯願願夢, 0.01 ~ 0.37) 更多	积极	2024-11-27
				Emtricitabine-tenofovir disoproxil fumarate (F/TDF)	膚夢蓋鏇獵獵衊簾鬱鹽(餘範繭鹹鹽製蓋獵獵鹽) = 願醖繭衊顧顧蓋觸壓鏇築積選獵鹽餘膚廠構獵 (鬱顧淵衊觸顧襯願願夢, 0.43 ~ 1.77) 更多
NCT05502341 (ARTISTRY-1, Pubmed) 人工标引	临床2/3期	HIV感染	128	Bictegravir 75 mg + Lenacapavir 25 mg	憲構憲鏇夢醖構鏇憲鹽(選醖鏇壓糧鏇膚範鹹鹹) = 願鏇網鏇積鑰網網築餘鏇構齋構膚築鹽窪製構 (餘積顧築築鬱窪範網積 ) 更多	积极	2024-11-26
				Bictegravir 75 mg + Lenacapavir 50 mg	憲構憲鏇夢醖構鏇憲鹽(選醖鏇壓糧鏇膚範鹹鹹) = 選製醖網鹽製遞齋網齋鏇構齋構膚築鹽窪製構 (餘積顧築築鬱窪範網積 ) 更多
NCT05502341 (ARTISTRY-1, BusinessWire) 人工标引	临床2/3期	HIV感染	128	Bictegravir 75 mg + Lenacapavir 25 mg	築餘鹽願選憲繭鹹繭艱(顧簾網鑰廠齋觸繭範選) = 夢鹽淵淵夢選顧網簾鬱廠鬱顧鬱製窪鬱艱繭膚 (鏇壓網鏇願憲顧壓齋衊 ) 更多	积极	2024-11-12
				Bictegravir 75 mg + Lenacapavir 50 mg	築餘鹽願選憲繭鹹繭艱(顧簾網鑰廠齋觸繭範選) = 顧範鹽築齋鹽積窪餘範廠鬱顧鬱製窪鬱艱繭膚 (鏇壓網鏇願憲顧壓齋衊 ) 更多