An Exploratory Phase 1b, Multicenter, Randomized, Open-Label Study to Investigate the Impact of the Administration of Intravenous VH3810109 With or Without Oral Fostemsavir in Combination With Integrase Inhibitor-Based Antiretroviral Therapy on the Viral Reservoir in Adults Living With HIV-1

This study investigates the use of VH3810109 with or without FTR to reduce the size and activity of the HIV viral reservoir in two sub-populations of people living with HIV: treatment-naïve adults (Population 1) and treatment-experienced adults currently taking a standard of care (SOC) integrase strand transfer inhibitor (INSTI)-based antiretroviral therapy (ART) regimen (Population 2).

开始日期2025-07-10

申办/合作机构

ViiV Healthcare Ltd.

NCT05996471

/ Active, not recruiting临床2期

A Phase 2b Multicenter, Randomized, Open-Label Study Comparing the Efficacy, Safety, PK, and Tolerability of VH3810109, Administered Either Intravenously Or As A Subcutaneous Infusion With rHuPH20, in Combination With CAB LA to Standard of Care in Virologically Suppressed Adults Living With HIV

The study aims at evaluating the efficacy of VH3810109, dosed in accordance with the dosing schedule as either intravenous (IV) infusion or subcutaneous (SC) infusion with recombinant hyaluronidase (rHuPH20), in combination with cabotegravir (CAB) intramuscular (IM) dosed in accordance with the dosing schedule in virologically suppressed, Antiretroviral therapy (ART)-experienced adult participants living with HIV. VH3810109 plus rHuPH20 plus Cabotegravir arm of the study has been discontinued based on preliminary results. The study will be conducted in 3 parts followed by a Long-Term Follow-up phase (LTFU).

开始日期2023-08-17

申办/合作机构

ViiV Healthcare Ltd.

NCT05291520

/ Completed临床1期

A Phase 1, Open-Label, Single-Dose Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, GSK3810109, Administered Either Subcutaneously or Intravenously With Recombinant Human Hyaluronidase PH20 (rHuPH20) to Healthy Adults

An open-label, two part study to assess the safety, tolerability, and PK of VH3810109 in healthy adult participants. Participants will receive a single SC or IV dose of VH3810109 co-administered with rHuPH20 and will be followed up for 24 weeks.

开始日期2022-02-23

申办/合作机构

ViiV Healthcare Ltd.

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项与 Iotivibart 相关的文献（医药）

2025-12-20·JOURNAL OF INFECTIOUS DISEASES

VH3810109 Efficacy, Safety, Pharmacokinetics, and Incidence of Antidrug Antibodies in Adults With HIV-1 Naive to Antiretroviral Therapy: BANNER Study Results

Article

作者: Donatti, Christina ; D’Agostino, Riccardo ; Gandhi, Yash ; Klein, Marina ; Cahn, Pedro ; Benson, Paul ; Dorey, David ; Brown, Kathryn ; Ferro, Alejandro ; Losos, Jan ; Lupo, Sergio ; Bettacchi, Christopher ; Wannamaker, Paul ; Warwick-Sanders, Michael ; McGowan, Joseph ; Griesel, Rulan ; Gartland, Margaret ; Wilches, Viviana ; Sanchez, Marisa ; Leone, Peter A ; Rolle, Charlotte-Paige ; Schneider, Stefan

Abstract:

Background:

VH3810109 (N6LS) is a CD4-binding site antibody with broad and potent neutralizing activity in vitro. Here, we present efficacy, safety, and pharmacokinetic results from the phase 2a BANNER study in people with HIV-1.

Methods:

BANNER was a randomized, open-label, 2-part, multicenter study of N6LS in adults naive to antiretroviral therapy (ART) with HIV-1 RNA ≥5000 copies/mL. N6LS was evaluated during monotherapy after a single intravenous (IV) infusion at various doses or subcutaneous (SC) injection, followed by 48 weeks of standard-of-care ART. Antiviral activity, safety, pharmacokinetics, and antidrug antibodies (ADAs) were evaluated.

Results:

Sixty-two participants completed the monotherapy phase and 58 completed the standard-of-care phase. Most participants were male (94%), Hispanic (82%), and White (61%). Virologic response (reduction in HIV-1 RNA ≥0.5 log10 copies/mL from baseline) was achieved in 8/8 (100%; 40 mg/kg IV), 14/15 (93%; 700 mg IV), 5/6 (83%; 280 mg IV), 7/16 (44%; 70 mg IV), and 8/16 (50%; 700 mg SC) participants. Administered IV or SC, N6LS was well tolerated with few drug-related adverse events (n = 13) and no serious adverse events reported during monotherapy. Pharmacokinetic parameters increased proportionally with dose. Incidence of ADAs was dose-dependent and ranged from 6% to 83% in the IV groups; incidence was 19% in the SC group, with no indication that route of administration impacts incidence of ADAs.

Conclusions:

N6LS was efficacious and generally safe, supporting further development of N6LS dosed IV or SC for the treatment of HIV-1 (ClinicalTrials.gov, NCT04871113).

2025-09-03·ANTIMICROBIAL AGENTS AND CHEMOTHERAPY

VH3810109 (N6LS) broadly neutralizing antibody safety, pharmacokinetics, and anti-drug antibody incidence in adults without HIV: phase 1 SPAN study results

Article

作者: Donatti, Christina ; Gandhi, Yash ; Warwick-Sanders, Michael ; Wannamaker, Paul ; D’Agostino, Riccardo ; Losos, Jan ; Brown, Kathryn ; Wilches, Viviana ; Ghita, Gabriela L. ; Leone, Peter A.

ABSTRACT:

The CD4-binding site antibody VH3810109 (N6LS) demonstrated broad and potent neutralization activity in vitro and robust antiviral activity in people with HIV-1. We report safety, tolerability, pharmacokinetics, and anti-drug antibody (ADA) incidence for subcutaneous (SC) and intravenous (IV) N6LS. Safety and pharmacokinetics of a single dose of VH3810109 (also known as GSK3810109), administered either subcutaneously (SC) with rHuPH20 or intravenously (IV) [SPAN]) was an open-label, three-part, phase 1 study evaluating single-dose N6LS in adults without HIV (part 1, 20 mg/kg SC + recombinant human hyaluronidase PH20 [rHuPH20] 2,000 U/mL; part 2, 60 mg/kg IV; part 3, 3,000 mg SC + rHuPH20 2,000 U/mL). Over 24 weeks, adverse events (AEs), injection site reactions (ISRs), pharmacokinetics, and ADAs were monitored. Twenty-four participants (8/part) were enrolled and received a single N6LS dose. Overall AE incidence between SC doses was similar and higher compared with IV, driven by ISRs. No ISRs were reported for IV N6LS; for SC, 15/16 participants reported ISRs, and 17/32 events were grade 3 (all injection site erythema). All ISRs resolved without sequelae or treatment. All participants rated local reactions and pain as acceptable. No serious AEs or deaths occurred. Pharmacokinetics were as expected for a broadly neutralizing antibody; median terminal half-life ranged from 43 to 47 days. No ADAs were observed after IV N6LS (0/8); 5/16 participants had treatment-emergent ADAs after SC N6LS; however, a clear impact on pharmacokinetics was observed in only one participant. N6LS administered IV or SC + rHuPH20 had a favorable safety profile and was well tolerated. Results support the ongoing development of N6LS 3,000 mg SC + rHuPH20 and 60 mg/kg IV into phase 2b.

CLINICAL TRIALS:

Registered at ClinicalTrials.gov ( NCT05291520 ).

2025-07-01·Lancet HIV

Safety and pharmacokinetics of N6LS, a broadly neutralising monoclonal antibody for HIV: a phase 1, open-label, dose-escalation study in healthy adults

Article

BACKGROUND:

Broadly neutralising antibodies (bNAbs) have shown promise as both prevention and treatment strategies against HIV-1. The clinical effectiveness of bNAbs depends on enhancing their neutralisation breadth and extending their serum half-lives. In this study, we aimed to assess the safety, tolerability, pharmacokinetic profile, and neutralisation activity in serum of N6LS, a HIV-1 bNAb.

METHODS:

In this first-in-human, dose-escalation, open-label, phase 1 trial, healthy adult participants (aged 18-50 years) who were HIV-1 negative were recruited to the National Institutes of Health Clinical Center (Bethesda, MD, USA). Three groups received one intravenous administration of N6LS at 5 mg/kg (n=3), 20 mg/kg (n=3), or 40 mg/kg (n=3); one group received one subcutaneous administration of 5 mg/kg N6LS (n=3); two groups received three administrations of either 5 mg/kg subcutaneous (n=5) or 20 mg/kg intravenous (n=5) N6LS every 12 weeks; and two groups received one subcutaneous administration of either 5 mg/kg (n=5) or 20 mg/kg (n=5) N6LS with ENHANZE drug product (EDP), recombinant human hyaluronidase PH20. The primary objectives were the safety and tolerability of N6LS with and without EDP. All participants who received N6LS were included in the primary safety analyses. This trial is registered at ClinicalTrials.gov, NCT03538626, and is complete.

FINDINGS:

Between June 18, 2018, and April 11, 2022, we enrolled 33 healthy adults (19 female individuals and 14 male individuals). One participant did not receive N6LS and one participant was lost to follow-up after 8 weeks. N6LS had an encouraging safety profile similar to other HIV-1 bNAbs, with no serious adverse events. Local reactogenicity was observed after administration of N6LS, with the most common symptom being mild to moderate injection site pain or tenderness in subcutaneous groups, reported in six of eight participants. All ten participants who received N6LS with EDP had mild to severe injection site erythema, which, despite being graded as severe in size, was generally not noticed by participants or deemed bothersome, and resolved without intervention. Systemic reactogenicity was mild in all groups. N6LS had an overall mean serum half-life of 48·6 days and retained its broad and potent neutralisation characteristics in serum. EDP administration increased N6LS bioavailability. No functional anti-drug antibodies to N6LS were detected following administration.

INTERPRETATION:

N6LS showed a promising safety and pharmacokinetics profile while retaining its potent neutralisation characteristics in serum, making it a promising candidate for inclusion in HIV-1 prevention and therapeutic combination strategies. The addition of EDP can enable safe subcutaneous administration of higher doses and larger volumes of N6LS, supporting additional methods for prophylactic and therapeutic bNAb administration.

FUNDING:

US National Institute of Allergy and Infectious Diseases Intramural Research Program, National Institutes of Health.

项与 Iotivibart 相关的新闻（医药）

2026-02-26

·药明康德

同行致远 | 从长效注射到双药方案，多款HIV疗法公布最新结果 | CROI 2026

编者按：随着抗逆转录病毒药物的广泛应用，艾滋病已从一种致命性疾病逐步转变为可长期管理的慢性疾病。然而，艾滋病病毒（HIV）感染者仍面临诸多未被满足的临床需求，尤其是对已产生耐药性或难以长期坚持复杂治疗方案的患者而言，治疗选择仍有进一步优化空间。为应对这些挑战，全球范围内已有上百个创新药研发项目持续推进，旨在不断拓展HIV感染治疗的临床边界与更多可能性。作为全球医药创新的赋能者，药明康德始终致力于提供一体化、端到端的新药研发与生产服务，助力全球合作伙伴加速包括HIV感染在内的各类感染性疾病创新疗法的研发进程，惠及更多患者。本周，第33届逆转录病毒与机会性感染会议（CROI）在美国科罗拉多州丹佛市召开，多项HIV在研疗法的最新研究进展相继公布。本文将对相关研究进行盘点，梳理HIV领域的最新动态与发展趋势。药物：Doravirine/islatravir 开发公司：默沙东（MSD）进展：三项关键3期试验达主要终点默沙东公布了三项关键3期临床试验结果，这些研究评估旗下每日一次口服双药单片复方方案doravirine/islatravir（DOR/ISL；100 mg/0.25 mg）在HIV-1成人患者中的疗效与安全性。Doravirine是由默沙东开发的一种每日一次的口服创新非核苷逆转录酶抑制剂。它通过与HIV-1的逆转录酶结合，防止病毒将RNA逆转录为DNA，从而阻断HIV-1病毒复制。它已在美国获批用于治疗未接受过抗病毒疗法的成年HIV-1感染患者。Islatravir则是默沙东研发的一种核苷类逆转录酶易位抑制剂（NRTTI）。 3期双盲临床试验MK-8591A-053在初治的HIV-1成人患者中，评估DOR/ISL与bictegravir/emtricitabine/tenofovir alafenamide（BIC/FTC/TAF；50 mg/200 mg/25 mg）三联疗法相较的疗效与安全性。结果显示，研究达到主要疗效终点，即实现病毒学抑制（HIV-1 RNA＜50拷贝/毫升）的受试者比例。在第48周时，DOR/ISL相较BIC/FTC/TAF达到非劣效性，病毒抑制率分别为91.8%和90.6%（治疗差异1.2%，95% CI：-3.7，6.2，p＜0.001）。两组治疗的安全性特征相似，并与既往研究观察结果一致。药物相关不良事件（AEs）及因药物相关不良事件导致的停药比例在两组间相近（DOR/ISL为14%，BIC/FTC/TAF为18%；因药物相关AEs停药比例分别为1.1%和2.2%）。此外，研究人员还公布了3期MK-8591A-052与MK-8591A-051试验的最新96周数据。这两项研究评估了在病毒学抑制的HIV-1患者中，由原治疗方案转换至DOR/ISL治疗后，与BIC/FTC/TAF或基线抗逆转录病毒治疗（bART）相较的疗效与安全性。两项研究均显示，DOR/ISL在第96周维持了较高水平的病毒抑制率，其安全性特征与BIC/FTC/TAF及bART相似。这些研究的48周数据支持美国FDA此前所受理DOR/ISL用于HIV-1感染成人患者的新药申请（NDA），拟用于将目前在抗病毒方案下已获得稳定病毒学抑制的成人患者转换至DOR/ISL方案治疗。FDA已将目标审评完成日期设定为2026年4月28日。药物：Bictegravir/lenacapavir 开发公司：吉利德科学（Gilead Sciences）进展：两项3期试验数据公布吉利德科学公布了3期ARTISTRY-1与ARTISTRY-2临床试验的最新数据。结果显示，将病毒学抑制的HIV感染者转换至旗下在研单片复方方案bictegravir/lenacapavir（BIC/LEN；75 mg/50 mg）治疗具有良好的疗效与安全性。 ARTISTRY-1研究结果表明，在既往接受复杂多片治疗方案并实现病毒学抑制的患者中，转换至BIC/LEN单片方案在第48周维持病毒抑制方面达到非劣效性。结果显示，BIC/LEN组中HIV-1 RNA≥50拷贝/毫升的比例为0.8%，对照组为1.1%。两组患者的CD4细胞计数均保持稳定，且未出现治疗过程中产生的耐药性。此外，转换至BIC/LEN治疗与空腹血脂指标改善相关，总胆固醇中位变化为-15 mg/dL，而继续原复杂方案治疗的患者为+2 mg/dL。 ARTISTRY-2研究则显示，在第48周时，BIC/LEN组与HIV获批疗法Biktarvy（bictegravir/emtricitabine/tenofovir alafenamide，B/F/TAF；50 mg/200 mg/25 mg）组维持病毒学抑制的比例相近，分别有1.3%与1.0%的患者出现HIV-1 RNA≥50拷贝/毫升。两组CD4细胞计数及体重指数均保持稳定。耐药性分析显示，大多数病例未检测到治疗相关耐药，仅在BIC/LEN组一名患者中发现孤立的整合酶位点替代，但未表现出表型耐药，也未检测到衣壳突变。安全性方面，两组药物相关不良事件发生率相似，分别为10.4%与12.0%。药物：VH184、VH499 开发公司：ViiV Healthcare 进展：公布1期临床研究结果 ViiV Healthcare公布其第三代整合酶链转移抑制剂（INSTI）长效制剂VH184的1期临床研究数据。结果显示，单次注射即可维持药物体内浓度长达6个月，展现出每年两次给药的潜力。体外研究进一步表明，VH184在耐药HIV株中较bictegravir具有更强活性和更优化的耐药性特征。安全性方面，该药总体耐受性良好，不良反应主要为轻度1级注射部位反应，如红斑、疼痛和结节，较少出现2级或3级反应，其安全性特征与既往研究及已获批INSTI药物相似。与此同时，ViiV Healthcare还公布了在研衣壳抑制剂VH499的1期研究数据，该药同样显示出实现超长效（ULA）半年一次给药的潜力。在正在进行的研究中，未感染HIV的成人受试者接受100 mg至1200 mg剂量范围内的单次肌内或皮下注射，结果显示两种给药方式均可在较长时间内维持稳定药物浓度。VH499整体耐受性良好，最常见的不良反应为注射部位反应，主要表现为1级或2级注射部位疼痛，多为轻至中度且持续时间较短。研究期间未报告严重不良事件，也未出现因不良事件导致的退出病例。研究人员表示，后续研究将基于当前数据进一步优化VH499的给药方案。药物：Lotivibart、cabotegravir 开发公司：ViiV Healthcare 进展：公布2b期临床研究结果 ViiV Healthcare公布其2b期EMBRACE研究的12个月期中疗效与耐受性数据。该研究评估了在接受稳定抗HIV治疗的成人患者中，每4个月给药一次的广谱中和抗体lotivibart（N6LS）联合每月一次肌内注射长效cabotegravir（CABLA）方案的治疗效果。结果显示，该联合方案在维持病毒学抑制方面表现良好，其中接受静脉注射（IV）lotivibart的患者中有94%维持病毒抑制，皮下注射（SC）组为82%，而标准治疗组为88%。在12个月期中分析中，联合治疗方案在大多数受试者中持续维持病毒学抑制，仅少数患者出现确证的病毒学失败：IV组为4%（2/50），SC组为6%（3/49），而每日口服标准治疗组为4%（1/26）。安全性方面，lotivibart总体耐受性良好，受试者对治疗的接受度较高。研究期间，关于注射部位反应困扰程度、身体影响、睡眠影响及整体可接受性的平均评分始终维持在“非常可接受”至“完全可接受”范围内。与药物相关的不良事件在IV组发生率较低（24%），低于SC组（53%）。此外，3至4级输注部位反应仅在SC组中报告（16%），IV组未出现此类事件，进一步支持该方案的可耐受性特征。图片来源：123RF 从本届CROI大会公布的多项研究可以看出，HIV治疗领域正持续向更长效、更简化的治疗模式演进。无论是双药口服方案还是长效注射药物与广谱中和抗体联合策略，研发重点均聚焦于在维持稳定病毒学控制的同时，进一步降低患者治疗负担并改善长期依从性。这些创新方向不仅体现了通过机制优化与给药方式革新推动治疗升级的趋势，也标志着HIV治疗正从“有效控制”迈向“长期高质量管理”的新阶段。当前，全球仍有百余项HIV在研管线处于临床阶段，涵盖小分子、抗体、疫苗、核酸药物、多肽及细胞治疗等多种技术类型。在这一不断演进的创新生态中，研发模式本身也在发生转变。随着药物复杂度持续提升，从早期研究到商业化生产各阶段的高效协同，正日益成为推动创新成果落地的关键基础。长期以来，药明康德都在支持全球合作伙伴从药物研究（R）、开发（D）到商业化生产（M）各个阶段的需求，通过独特的一体化、端到端CRDMO模式，助力突破性疗法加速研发进程。例如，药明康德的传染病平台能够为抗病毒药物和疫苗从早期研究到临床试验的全流程开发提供全面支持。平台覆盖包括HIV在内的20多种病毒的抗病毒药物和疫苗发现，并且对130多种细菌和真菌的抗菌疗法开发同样提供了广泛的支持。在全球科研与产业协作不断深化的背景下，HIV治疗模式正加速向以患者为中心、兼顾疗效稳定性与长期治疗体验优化的方向演进。随着创新生态不断成熟，推动更多创新疗法更快惠及患者，仍将是产业各方共同努力的目标。参考资料： [1] Merck Announces Late-Breaking Data from Three Phase 3 Trials Evaluating Doravirine/Islatravir (DOR/ISL), an Investigational, Once-Daily, Two-Drug Regimen for the Treatment of Adults Living with HIV-1 at CROI 2026. Retrieved February 25, 2026 from https://www.merck.com/news/merck-announces-late-breaking-data-from-three-phase-3-trials-evaluating-doravirine-islatravir-dor-isl-an-investigational-once-daily-two-drug-regimen-for-the-treatment-of-adults-living-with-hiv-1/ [2] Gilead’s Single-Tablet Regimen of Bictegravir and Lenacapavir Maintained Virological Suppression in People With HIV Who Switched Antiretroviral Therapy. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260224254904/en/Gileads-Single-Tablet-Regimen-of-Bictegravir-and-Lenacapavir-Maintained-Virological-Suppression-in-People-With-HIV-Who-Switched-Antiretroviral-Therapy [3] ViiV Healthcare presents pipeline data for two investigational HIV treatment therapies with potential for twice-yearly dosing. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260225546292/en/ViiV-Healthcare-presents-pipeline-data-for-two-investigational-HIV-treatment-therapies-with-potential-for-twice-yearly-dosing [4] ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen. Retrieved February 25, 2026 from https://www.businesswire.com/news/home/20260225354805/en/ViiV-Healthcare-reports-positive-12-month-data-showing-investigational-bNAb-lotivibart-N6LS-maintains-high-levels-of-viral-suppression-in-long-acting-HIV-treatment-regimen 免责声明：本文仅作信息交流之目的，文中观点不代表药明康德立场，亦不代表药明康德支持或反对文中观点。本文也不是治疗方案推荐。如需获得治疗方案指导，请前往正规医院就诊。版权说明：欢迎个人转发至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。转载授权请在「药明康德」微信公众号回复“转载”，获取转载须知。分享，点赞，在看，聚焦全球生物医药健康创新

临床3期临床结果

2026-02-26

·BioSpace

ViiV Healthcare reports positive 12-month data showing investigational bNAb lotivibart (N6LS) maintains high levels of viral suppression in long-acting HIV treatment regimen

94% of adults on stable therapy maintained viral suppression with intravenous lotivibart dosed every four months in combination with long-acting cabotegravir These phase IIb results reinforce lotivibart’s ultra long-acting potential, with the trial progressing to evaluate a twice-yearly intravenous dosing interval LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced positive 12-month interim efficacy and tolerability data from the phase IIb EMBRACE study. 1 In adults living with HIV on stable therapy, a regimen of lotivibart (N6LS), a broadly neutralising antibody, administered every four months combined with monthly intramuscular (IM) long-acting cabotegravir (CAB LA), maintained viral suppression in 94% of participants receiving lotivibart intravenously (IV) and 82% subcutaneously (SC), compared with 88% in the standard of care group. These favourable data reinforce lotivibart’s ultra long-acting potential (dosing every four months or longer) and support the progression of the study, which will evaluate a twice-yearly IV dosing interval for lotivibart. Results were presented today at the 33 rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado. Kimberly Smith, M.D., MPH, Head of Research & Development at ViiV Healthcare, said: “These positive 12-month data from EMBRACE strengthen the evidence that lotivibart has the potential to be a part of an ultra long-acting HIV treatment regimen and support our efforts to evaluate lotivibart in a twice-yearly dosing interval. These results build on our legacy of developing innovative long-acting options for HIV treatment that offer greater choice for people living with HIV.” At the 12‑month interim analysis, lotivibart combined with CAB LA maintained viral suppression in a high proportion of adults living with HIV on stable therapy, with confirmed virologic failure observed in two participants (4%; n=2/50) from the IV group and three participants (6%; n=3/49) in the SC group, compared to one (4%; n=1/26) receiving a daily oral standard of care. Lotivibart was generally well tolerated, with participants in both groups reporting high acceptability through month 12. Mean perception of injection (PIN) scores for “bother of ISRs,” “physical impact,” “sleep” and “acceptability” remained “very acceptable” to “totally acceptable” throughout the study in both groups. Adverse events related to lotivibart were less common in the IV group (24%; n=12/50) compared with the SC group (53%; n=26/49). Higher grade (grade 3-4) infusion-site reactions were reported in 16% (n=8/49) of participants in the SC group, while none were reported in the IV group. These findings build on the six-month EMBRACE data presented at CROI 2025, which first showed that lotivibart, administered every four months in combination with monthly CAB LA, effectively maintained an undetectable viral load in adults living with HIV on stable therapy. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 by GSK (LSE: GSK) and Pfizer (NYSE: PFE) dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. Shionogi became a ViiV shareholder in October 2012. The company’s aims are to take a deeper and broader interest in HIV and AIDS than any company has done before and take a new approach to deliver effective and innovative medicines for HIV treatment and prevention, as well as support communities affected by HIV. For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com . About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com . Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024, and GSK’s Q4 Results for 2025. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY *On 20 January 2026, GSK plc and Shionogi & Co., Ltd announced that they have reached agreement together with Pfizer Inc. for the economic interest in ViiV Healthcare Limited currently held by Pfizer to be replaced with an investment by Shionogi. Completion of the transaction is subject to certain regulatory clearances in relevant markets, and is expected to occur during the first quarter of 2026. References 1 CP. Rolle et al. Maintenance of HIV Suppression at 12 Months With VH3810109 (N6LS) Q4M + CAB LA QM: The EMBRACE Study. Presented at the 33 rd Conference on Retroviruses and Opportunistic Infections (CROI). February 2026. Contacts ViiV Healthcare enquiries: Media: Kate Senter, +44 (0) 77 9670 7446 (London) Melinda Stubbee, +1 919 491 0831 (North Carolina) GSK enquiries: Media: Tim Foley, +44 (0) 20 8047 5502 (London) Sarah Clements, +44 (0) 20 8047 5502 (London) Kathleen Quinn, +1 202 603 5003 (Washington, DC) Alison Hunt, +1 540 742 3391 (Washington, DC) Investor Relations: Constantin Fest, +44 (0) 7831 826525 (London) James Dodwell, +44 (0) 20 8047 2406 (London) Mick Readey, +44 (0) 7990 339653 (London) Steph Mountifield, +44 (0) 7796 707505 (London) Sam Piper, +44 (0) 7824 525779 (London) Jeff McLaughlin, +1 215 751 7002 (Philadelphia) Frannie DeFranco, +1 215 751 3126 (Philadelphia)

临床结果临床2期

2026-02-25

·viivhealthcare.com

ViiV HEALTHCARE REPORTS POSITIVE 12-MONTH DATA SHOWING INVESTIGATIONAL BNAB LOTIVIBART (N6LS) MAINTAINS HIGH LEVELS OF VIRAL SUPPRESSION IN LONG-ACTING HIV TREATMENT REGIMEN

London, 25 February 2026 – ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders,* today announced positive 12-month interim efficacy and tolerability data from the phase IIb EMBRACE study.1 In adults living with HIV on stable therapy, a regimen of lotivibart (N6LS), a broadly neutralising antibody, administered every four months combined with monthly intramuscular (IM) long-acting cabotegravir (CAB LA), maintained viral suppression in 94% of participants receiving lotivibart intravenously (IV) and 82% subcutaneously (SC), compared with 88% in the standard of care group. These favourable data reinforce lotivibart’s ultra long-acting potential (dosing every four months or longer) and support the progression of the study, which will evaluate a twice-yearly IV dosing interval for lotivibart. Results were presented today at the 33rd Conference on Retroviruses and Opportunistic Infections (CROI 2026) in Denver, Colorado.

临床结果临床2期

100 项与 Iotivibart 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床2期	美国	Halozyme Therapeutics, Inc.	2021-06-22
HIV感染	临床2期	美国	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	美国	National Institute of Allergy & Infectious Diseases	2021-06-22
HIV感染	临床2期	阿根廷	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	巴西	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	加拿大	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	墨西哥	ViiV Healthcare Ltd.	2021-06-22
HIV感染	临床2期	秘鲁	ViiV Healthcare Ltd.	2021-06-22

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临床结果

适应症

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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


NCT05291520 (SPAN, CTgov)	临床1期	HIV感染	24	VH3810109+rHuPH20 (Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC])	餘簾簾選獵範網鑰顧鬱 = 鹽窪網鹹網艱艱膚艱糧鏇淵蓋壓網鹹蓋艱齋鏇 (構醖選製蓋積鹹遞獵鹹, 夢遞醖顧鏇醖簾獵糧鬱 ~ 窪築餘淵糧襯糧選憲簾) 更多	-	2024-09-19
				VH3810109+rHuPH20 (Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC])	餘簾簾選獵範網鑰顧鬱 = 廠鏇簾窪廠夢鹽鬱糧鏇鏇淵蓋壓網鹹蓋艱齋鏇 (構醖選製蓋積鹹遞獵鹹, 膚窪廠獵齋襯願夢鏇廠 ~ 鑰醖衊壓廠襯網選襯網) 更多
NCT04871113 (BANNER, CTgov)	临床2期	HIV感染	62	GSK3810109A (Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV))	齋遞糧遞鏇糧遞築膚構(憲艱鹹糧築鏇顧憲鏇艱) = 鏇糧願願簾鹹廠餘衊壓醖艱壓選衊觸遞範顧鹹 (廠鏇鹹獵憲鬱觸憲獵壓, 製鬱顧簾願艱顧積醖餘 ~ 觸製糧簾襯獵夢襯鹹襯) 更多	-	2023-11-18
				GSK3810109A (Part 1: GSK3810109A 280 mg IV)	齋遞糧遞鏇糧遞築膚構(憲艱鹹糧築鏇顧憲鏇艱) = 繭觸簾簾廠艱憲顧壓鑰醖艱壓選衊觸遞範顧鹹 (廠鏇鹹獵憲鬱觸憲獵壓, 遞憲積鹽築齋窪蓋膚網 ~ 鹽鏇鹽糧憲廠簾選衊夢) 更多
NCT03538626 (VRC 609, CTgov)	临床1期	HIV感染	33	VRC-HIVMAB091-00-AB (Group 1: N6LS (5 mg/kg IV) Single Dose)	衊繭鏇繭鑰遞築積醖製 = 積窪鬱糧遞鬱醖獵鏇鹹鏇壓膚齋積選積餘膚糧 (構構積廠獵積窪簾鬱鬱, 繭簾夢鑰網繭觸膚壓憲 ~ 廠築遞淵壓願醖醖遞糧) 更多	-	2023-09-21
				VRC-HIVMAB091-00-AB (Group 2: N6LS (5 mg/kg SC) Single Dose)	衊繭鏇繭鑰遞築積醖製 = 窪鏇淵製餘觸壓鹽積簾鏇壓膚齋積選積餘膚糧 (構構積廠獵積窪簾鬱鬱, 觸淵簾鹽襯齋鹹鑰鬱淵 ~ 願憲範築窪糧蓋淵願憲) 更多