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). The study is designed to include the following phases: Randomized Intervention Phase (Step 1), Analytical Treatment Interruption (ATI) Phase (Step 2), and Follow-up Phase (Step 3).

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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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 ; Sanchez, Marisa ; Wilches, Viviana ; Rolle, Charlotte-Paige ; Leone, Peter A ; 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）

2026-07-28

·今日头条

全球最大艾滋病大会将至，2400 余项前沿研究集中发布

全球规模最大的HIV领域国际会议即将开幕。红枫湾APP： i-base.info网消息，7月26日至30日，国际艾滋病大会（AIDS 2026）将在巴西里约热内卢举行。本次会议主题为Rethink·Rebuild·Rise（重新思考、重建、崛起），将围绕 HIV治疗、预防、药物研发及HIV治愈研究等多个方向展开讨论。长效HIV治疗研究 AIDS 2026将公布今年早些时候在CROI会议上提出的许多在研药物的最新结果，其中包括： ▶两项每周口服一次伊斯拉曲韦/来那帕韦（ISL/LEN）的Ⅲ期临床研究的48周结果——均为最新研究成果。两种药物分别作用于HIV复制过程中的不同环节，有望通过每周一次服药降低治疗负担。 ▶ 每6个月注射一次的LEN联合广谱中和抗体（bNAbs）的Ⅱ期研究104周数据。该组合疗法的两项Ⅲ期研究也已进入公布阶段。如果未来成功，这类方案可能实现——一年仅需少数几次注射，就能维持HIV病毒长期抑制。 ▶ 每4个月注射一次的广谱中和抗体lotivibart（LVB，N6LS）与长效卡博特韦（CAB-LA）联合用药的情况。 ▶ 每周口服一次ISL联合ulonivirine（ULO,MK-8507）方案的Ⅱ期研究。 ▶CAB-LA联合长效利匹韦林（RPV-LA）治疗青少年HIV感染者。红枫湾小编：从每天口服一次到每周口服一次、每半年注射一次，HIV治疗正在进入“低频给药时代”。其他重要治疗研究 ▶ ARTISTRY-1/2研究：公布每日口服比克替拉韦/来那帕韦（BIC/LEN）的最新数据，包括基线耐药情况、长期病毒抑制效果以及不同人群的疗效表现。 ▶ DOR/ISL研究：公布每日一次多拉韦林/伊斯拉曲韦（DOR/ISL）治疗携带M184V耐药突变患者96周结果，并发布初治及转换治疗Ⅲ期研究的亚组分析。 ▶ VOGUE研究：直接比较DTG/3TC（多伟托）双药方案与BIC/FTC/TAF（必妥维）三药方案的疗效和安全性。 ▶ BicDol研究：比较多替拉韦（DTG）与BIC三药方案在高病毒载量感染者中的治疗效果。 ▶ 儿童和青少年治疗：公布B必妥维在儿童及青少年感染者中的长期随访数据。红枫湾小编：从每天吃一把药，到每天只需1粒药；从三药方案到双药方案，HIV治疗正变得越来越简单。 HIV预防研究 ▶数十项关于LEN用于HIV暴露前预防（PrEP）的研究，包括PURPOSE 1/2研究后续随访、美国和非洲真实世界应用情况，以及推广过程中遇到的问题。 ▶数十项关于CAB-LA用于PrEP的研究，包括延迟注射是否影响保护效果、真实世界依从性及药物相互作用等。 ▶长效注射PrEP的实际应用问题，包括LEN和CAB-LA与芬太尼潜在药物相互作用的小鼠研究。 ▶每月口服一次PrEP候选药物MK-8527（现更名为Alimatravir）的药代动力学和耐药性研究；模型分析显示，如实现大规模生产，其成本有望降至每人每年约15美元。 ▶南非女性使用双广谱中和抗体（bNAbs）进行PrEP的随机Ⅱ期临床试验早期结果。红枫湾小编： HIV预防也正在进入长效时代，但真想用长效PrEP实现终结艾滋病的目标，还需让更多人用得起、用得到。治愈相关研究 ▶公布两例通过干细胞移植实现HIV长期缓解的新病例，分别来自德国和美国。研究人员还将分享HIV停药后控制、免疫治疗及病毒持续缓解等最新研究。 ▶其他治愈研究还包括： · CAR-T细胞疗法； · 基因编辑技术； · 广谱中和抗体（bNAbs）治疗。 ▶英国RIO研究将公布利用广谱中和抗体在停用抗病毒治疗后控制病毒反弹的最新数据。红枫湾小编：从“终身服药”到“长期缓解”，HIV治愈研究正不断取得突破。不过，距离真正实现人人可及的治愈仍有很长的路要走。未来，科学突破需要与药物可及性同步推进，才能让更多感染者真正受益。

2026-07-23

·红枫湾关艾

全球最大艾滋病大会即将开幕：2400余项研究将集中发布

点击蓝字关注我们点击了解HIV暴露前预防（PrEP），主动守护健康全球规模最大的HIV领域国际会议即将开幕。红枫湾APP：i-base.info网消息，7月26日至30日，国际艾滋病大会（AIDS 2026）将在巴西里约热内卢举行。本次会议主题为Rethink·Rebuild·Rise（重新思考、重建、崛起），将围绕HIV治疗、预防、药物研发及HIV治愈研究等多个方向展开讨论。长效HIV治疗研究 AIDS 2026将公布今年早些时候在CROI会议上提出的许多在研药物的最新结果，其中包括： ▶两项每周口服一次伊斯拉曲韦/来那帕韦（ISL/LEN）的Ⅲ期临床研究的48周结果——均为最新研究成果。两种药物分别作用于HIV复制过程中的不同环节，有望通过每周一次服药降低治疗负担。 ▶每6个月注射一次的LEN联合广谱中和抗体（bNAbs）的Ⅱ期研究104周数据。该组合疗法的两项Ⅲ期研究也已进入公布阶段。如果未来成功，这类方案可能实现——一年仅需少数几次注射，就能维持HIV病毒长期抑制。 ▶每4个月注射一次的广谱中和抗体lotivibart（LVB，N6LS）与长效卡博特韦（CAB-LA）联合用药的情况。 ▶每周口服一次ISL联合ulonivirine（ULO,MK-8507）方案的Ⅱ期研究。 ▶CAB-LA联合长效利匹韦林（RPV-LA）治疗青少年HIV感染者。红枫湾小编：从每天口服一次到每周口服一次、每半年注射一次，HIV治疗正在进入“低频给药时代”。其他重要治疗研究 ▶ARTISTRY-1/2研究：公布每日口服比克替拉韦/来那帕韦（BIC/LEN）的最新数据，包括基线耐药情况、长期病毒抑制效果以及不同人群的疗效表现。 ▶DOR/ISL研究：公布每日一次多拉韦林/伊斯拉曲韦（DOR/ISL）治疗携带M184V耐药突变患者96周结果，并发布初治及转换治疗Ⅲ期研究的亚组分析。 ▶VOGUE研究：直接比较DTG/3TC（多伟托）双药方案与BIC/FTC/TAF（必妥维）三药方案的疗效和安全性。 ▶BicDol研究：比较多替拉韦（DTG）与BIC三药方案在高病毒载量感染者中的治疗效果。 ▶儿童和青少年治疗：公布B必妥维在儿童及青少年感染者中的长期随访数据。红枫湾小编：从每天吃一把药，到每天只需1粒药；从三药方案到双药方案，HIV治疗正变得越来越简单。 HIV预防研究 ▶数十项关于LEN用于HIV暴露前预防（PrEP）的研究，包括PURPOSE 1/2研究后续随访、美国和非洲真实世界应用情况，以及推广过程中遇到的问题。 ▶数十项关于CAB-LA用于PrEP的研究，包括延迟注射是否影响保护效果、真实世界依从性及药物相互作用等。 ▶长效注射PrEP的实际应用问题，包括LEN和CAB-LA与芬太尼潜在药物相互作用的小鼠研究。 ▶每月口服一次PrEP候选药物MK-8527（现更名为Alimatravir）的药代动力学和耐药性研究；模型分析显示，如实现大规模生产，其成本有望降至每人每年约15美元。 ▶南非女性使用双广谱中和抗体（bNAbs）进行PrEP的随机Ⅱ期临床试验早期结果。红枫湾小编：HIV预防也正在进入长效时代，但真想用长效PrEP实现终结艾滋病的目标，还需让更多人用得起、用得到。治愈相关研究 ▶公布两例通过干细胞移植实现HIV长期缓解的新病例，分别来自德国和美国。研究人员还将分享HIV停药后控制、免疫治疗及病毒持续缓解等最新研究。 ▶其他治愈研究还包括： ·CAR-T细胞疗法； ·基因编辑技术； ·广谱中和抗体（bNAbs）治疗。 ▶英国RIO研究将公布利用广谱中和抗体在停用抗病毒治疗后控制病毒反弹的最新数据。红枫湾小编：从“终身服药”到“长期缓解”，HIV治愈研究正不断取得突破。不过，距离真正实现人人可及的治愈仍有很长的路要走。未来，科学突破需要与药物可及性同步推进，才能让更多感染者真正受益。重新思考、重建、崛起。参与本月“红枫湾日”活动，即可免费获取HIV检测试纸、梅毒检测试纸、安全套和男男专用安全套等礼品。持续存在高危行为，期望通过暴露前预防（PrEP）减少感染HIV的风险，可加群温馨提示 HIV 未发生高危的朋友不要仅凭“检测阴性”或主观判断放松警惕规范防护 + PrEP（暴露前预防）可将感染风险大幅降低（有效性可达99%+） ->点击查看HIV预防已经发生高危的朋友请在72小时内尽快采取PEP（暴露后阻断）措施 ——越早越有效关于艾滋，我们想多说一句不必恐惧，也不应忽视因为正视，所以不歧视因为了解，所以能预防因为治疗，所以有希望 AIDS

2026-07-21

·BioSpace

ViiV Healthcare to present phase IIIb data comparing Dovato with Biktarvy in treatment-naïve adults; alongside INSTI-powered long-acting injectable innovation at AIDS 2026

VOGUE is the first head-to-head, randomised daily orals study comparing 2-drug regimen Dovato with 3-drug regimen Biktarvy in treatment-naïve adults living with HIV Real-world OPERA data continues to strengthen the evidence base for Cabenuva, the only complete long-acting injectable HIV treatment regimen Six-month results from the CLARITY study will report participant experience and acceptability of long-acting cabotegravir versus lenacapavir injections after a single dose in HIV-negative adults LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Shionogi as a shareholder, today announced new clinical and real-world data highlighting its integrase strand transfer inhibitor (INSTI)-focused portfolio, including long-acting (LA) medicines and pipeline momentum, to be presented at the 26 th International AIDS Conference (AIDS 2026) in Rio de Janeiro, Brazil, from 26-31 July. VOGUE daily orals phase IIIb data will compare ViiV Healthcare’s established 2-drug regimen dolutegravir/lamivudine (DTG/3TC) with 3-drug regimen bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in treatment-naïve adults living with HIV 1 Additional data from VOGUE will examine the study population demographics, including adults with high viral loads. 2 A pooled analysis across clinical trials will examine on-study viraemic events and outcomes for DTG/3TC compared with 3-drug regimens. 3 Data evaluating long-acting injectable HIV treatment, including late-breaking LATA results and OPERA real-world data, will add to the evidence base for cabotegravir + rilpivirine long-acting (CAB+RPV LA) Late-breaking week 96 results from the LATA study, led by University College London, will evaluate the efficacy, safety and acceptability of CAB+RPV LA versus daily oral tenofovir disoproxil fumarate/lamivudine/dolutegravir in virologically suppressed adolescents living with HIV across sub-Saharan Africa. 4 New data from OPERA will be presented, including from the US-based cohort, comparing the virologic effectiveness of injectable CAB+RPV LA versus daily oral BIC/FTC/TAF in virologically suppressed adults living with HIV. 5,6,7 Week 96 results from the IMPALA study, led by London School of Hygiene and Tropical Medicine, will provide new insights into the use of CAB+RPV LA in adults living with HIV with prior adherence challenges in sub-Saharan Africa, including treatment outcomes over time. 8 Data from Ask Us Europe, a community co-produced survey, led by an academic team in London, will explore whether people living with HIV across Europe are having meaningful and equitable conversations with healthcare providers about long-acting HIV treatment options. 9,10,11 CAB LA for pre-exposure prophylaxis (PrEP) data, including CLARITY results comparing CAB LA with lenacapavir, will inform how long-acting injectable prevention options are used in practice ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Six-month results from the phase I CLARITY study will report participant experience and acceptability of CAB LA versus lenacapavir injections after a single dose, as well as late-breaking data on participant-reported outcomes, informing decision-making when initiating long-acting injectables for PrEP. 12,13 CAPTIVATE results will describe real-world use, acceptability and delivery of CAB LA for PrEP in routine US clinical practice. 14,15 Updated PrEPFACTS results will describe real-world use and adherence patterns for CAB LA for PrEP in the US, using healthcare administrative claims data. 16 EXTEND 4M will evaluate a new long-acting dosing candidate for HIV prevention Baseline data from the phase IIb registrational EXTEND 4M trial will describe the population being evaluated in the first study evaluating a new formulation of CAB LA dosed three times a year for HIV PrEP. 17 This study builds on the established evidence for CAB LA for PrEP dosed six times a year and will assess the pharmacokinetics, safety and tolerability of the new CAB LA formulation. Key ViiV Healthcare sponsored or supported studies to be presented at AIDS 2026: Abstract Name Presenter Presentation details DTG/3TC In VOGUE: Primary Endpoint Results Comparing DTG/3TC 2-drug regimen to BIC/FTC/TAF 3-drug regimen in a randomized trial in adults with HIV naive to treatment J. Ghosn Oral presentation OAB0106LB Tuesday, 28 July 2026 10:30 – 11:30 Who’s in VOGUE: a head‑to‑head clinical trial of dolutegravir/lamivudine (DTG/3TC) versus bictegravir/emtricitabine/tenofovir alafenamide (BIC/FTC/TAF) in adults naive to antiretroviral therapy (ART), including those with high viral loads M. Kisare In-person poster exhibition WEPEB094 Wednesday, 29 July 2026 12:00 – 13:00 Pooled analysis of on-study viremic events (VEs) and outcomes for dolutegravir + lamivudine (DTG+3TC) and comparator 3-drug regimens (3DRs) in clinical trials of people with HIV-1 P. Cahn In-person poster exhibition WEPEB095 Wednesday, 29 July 2026 12:00 – 13:00 CAB + RPV LA Every-8-weeks injectable cabotegravir and rilpivirine versus daily oral tenofovir disoproxil fumarate/lamivudine/dolutegravir in adolescents living with HIV in sub-Saharan Africa: LATA 96-week results M. B. Dangarembizi Oral presentation OAX1105LB Wednesday, 29 July 2026 10:30 – 11:30am Comparable virologic effectiveness with long-acting cabotegravir + rilpivirine vs. daily bictegravir/emtricitabine/tenofovir alafenamide in the US-based OPERA Cohort C. Millner In-person poster exhibition WEPEB099 Wednesday, 29 July 2026 12:00 – 13:00 Resuppression and resistance after confirmed virologic failure among women on CAB+RPV LA in the OPERA Cohort J. Altamirano In-person poster exhibition TUPEB129 Tuesday, 28 July 2026 12:00 – 13:00 High virologic suppression among individuals on cabotegravir + rilpivirine long-acting with viral loads ≥50 copies/mL regardless of body mass index in the OPERA Cohort C. Millner In-person poster exhibition TUPEB091 Tuesday, 28 July 2026 12:00 – 13:00 Efficacy and safety of long-acting cabotegravir and rilpivirine in adults with adherence or engagement challenges in sub-Saharan Africa: the IMPALA trial 96-week results J. Kitonsa In-person poster exhibition LB24 Tuesday 28, Wednesday 29, Thursday 30 July 2026 12:00 – 13:00 Perspectives of people living with HIV in Europe on their clinical consultations: an equity analysis M. Devonald In-person poster exhibition THPEE490 Thursday, 30 July 2026 12:00 – 13:00 Interest of people living with HIV in Europe in future long-acting modalities-Ask Us Europe results C. Orkin In-person poster exhibition TUPEB101 Tuesday, 28 July 2026 12:00 – 13:00 Complex support needs, adherence challenges and interest in long-acting HIV treatment among trans, non-binary, and gender-diverse people living with HIV: findings from the coproduced ‘Ask Us Europe’ survey M. Devonald In-person poster exhibition WEPEB122 Tuesday, 28, Wednesday 29, Thursday, 30 July 2026 12:00 – 13:00 CAB PrEP Presence, Severity, Interference With Usual and Daily Life Activities and Bothersomeness of Injection Site Reactions With Cabotegravir vs Lenacapavir: Insights From Participant Reported Outcomes in the CLARITY Study. L. Dupont-Benjamin In-person poster exhibition WEPEC177 Wednesday 29, July 2026 12:00 – 13:00 Participant and Provider Experiences With Long-Acting Cabotegravir vs Lenacapavir Injections: Results From the CLARITY Study N. Pilgrim In-person poster exhibition WEPEC177 Wednesday, 29 July 2026 12:00 – 13:00 Real-world experience using cabotegravir long-acting for HIV-1 pre-exposure prophylaxis in the United States from cross-sectional surveys and retrospective chart reviews: results from the CAPTIVATE study M. Brizzi In-person poster exhibition TUPEC177 Tuesday, 28 July 2026 12:00 – 13:00 Operational insights for long-acting cabotegravir for HIV-1 pre-exposure prophylaxis: findings from the CAPTIVATE United States healthcare provider survey K. Visnyei In-person poster exhibition TUPEC200 Tuesday, 28 July 2026 12:00 – 13:00 Real-world utilization and adherence of cabotegravir long-acting for HIV pre-exposure prophylaxis in the United States: Updated results from the PrEPFACTS study using healthcare administrative claims data A. Metzner In-person poster exhibition TUPEC179 Tuesday, 28 July 2026 12:00 – 13:00 PrEP modality preference and socio-structural HIV vulnerability among transgender women and transfeminine persons in the United States: A latent class analysis J. L. Glick In-person poster exhibition TUPED349 Tuesday, 28 July 2026 12:00 – 13:00 Socio-structural HIV vulnerability and PrEP willingness among transgender women and transfeminine persons in the United States: A latent class analysis J. L. Glick In-person poster exhibition THPED316 Thursday, 30 July 2026 12:00 – 13:00 No HIV acquisitions among women on cabotegravir long-acting injectable PrEP despite mostly short injection delays in the US OPERA Cohort L. Armas-Kolostroubis Oral presentation OAC2805 Thursday, 30 July 2026 15:27 – 15:35 Evolving PrEP use in the long-acting injectable era: Findings from a cohort of transgender women in the United States and Puerto Rico, 2023–2025 C. Pontes In-person poster exhibition TUPEC210 Tuesday, 28 July 2026 12:00 – 13:00 DTG Cross-network, multicentre cohort study assessing real-world pregnancy and birth outcomes following prenatal dolutegravir exposure in Europe R. Sconza In-person poster exhibition TUPEB119 Tuesday, 28 July 2026 12:00 – 13:00 Risk of fracture with contemporary antiretrovirals within the RESPOND Consortium B. Neesgaard In-person poster exhibition TUPEB076 Tuesday, 28 July 2026 12:00 – 13:00 Association between integrase inhibitors (INSTIs) and tenofovir alafenamide (TAF) and moderate chronic kidney disease (CKD) and in the RESPOND HIV cohort collaboration L. Greenberg E-poster EP056 Monday, 27 July 2026 14:00 Dolutegravir Markedly Improves 6- and 12-Month Viral Suppression in Children ≤5 Years, South Africa K. Anderson In-person poster exhibition WEPEB121 Wednesday, 29 July 2026 12:00 – 13:00 Pipeline Baseline demographics in the phase 2b registrational EXTEND 4M trial: evaluating a novel every-4-month cabotegravir formulation in a population who could benefit from PrEP A. Rinehart In-person poster exhibition WEPEB096 Wednesday, 29 July 2026 12:00 – 13:00 Participants experiences switching from subcutaneous to intravenous lotivibart (LVB, N6LS, VH3810109) and cabotegravir long-acting injections for HIV-1 treatment in EMBRACE study C. Gutner In-person poster exhibition WEPEB097 Wednesday, 29 July 2026 12:00 – 13:00 Above Brand Stigma-Related Challenges for People Living with HIV and Gaps in Patient Advocacy Group Responses: Perspectives from HIV Organizational Personnel A. Appiah In-person poster exhibition THPED312 Thursday, 30 July 2026 12:00 – 13:00 About Cabenuva (cabotegravir + rilpivirine) Cabenuva is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA <50 c/ml) on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. The complete regimen combines the INSTI cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Johnson & Johnson. Rilpivirine tablets are approved in the US and when used with cabotegravir is indicated for short-term treatment of HIV-1 infection in adults and adolescents 12 years and older and weighing at least 35 kg who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. INSTIs inhibit HIV replication by preventing the viral DNA from integrating into the genetic material of human immune cells (T-cells). This step is essential in the HIV replication cycle and is also responsible for establishing chronic disease. Rilpivirine is an NNRTI that works by interfering with an enzyme called reverse transcriptase, which stops the virus from multiplying. Please consult the full Prescribing Information here . About Dovato (dolutegravir and lamivudine) Dovato is indicated for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg in the EU, and weighing at least 25 kg in the US, with no known or suspected resistance to the integrase inhibitor class, or lamivudine. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets . About Apretude (cabotegravir long acting) Apretude is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35 kg who are at high risk of being infected. It should be used in combination with safer sex practices, such as using condoms. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About ViiV Healthcare ViiV Healthcare is a global specialist HIV company established in November 2009 with GSK (LSE: GSK) and Shionogi as current shareholders. The company is dedicated to delivering advances in treatment and care for people living with HIV and for people who could benefit from HIV prevention. ViiV Healthcare’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 2025, and GSK’s Q1 Results for 2026. 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 References _________________________________ 1 J Ghosn, et al. In VOGUE: DTG/3TC 2-drug regimen is non-inferior to BIC/FTC/TAF 3-drug regimen in a randomized trial in adults with HIV naive to treatment. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 2 F Pulido, et al. Who’s in VOGUE: A Head-to-Head Clinical Trial of Dolutegravir/Lamivudine Versus Bictegravir/Emtricitabine/Tenofovir Alafenamide in Adults Naive to Antiretroviral Therapy, Including Those With High Viral Loads. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 3 P. Cahn et al. Pooled analysis of on-study viremic events (VEs) and outcomes for dolutegravir + lamivudine (DTG+3TC) and comparator 3-drug regimens (3DRs) in clinical trials of people with HIV-1. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 4 M. B. Dangarembiz, et al. Eight-weekly injectable cabotegravir and rilpivirine is superior to daily oral tenofovir disoproxil fumarate/lamivudine/dolutegravir in adolescents living with HIV in sub-Saharan Africa: LATA 96-week results. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 5 R. Hsu, et al. Comparable virologic effectiveness with long-acting cabotegravir + rilpivirine vs. daily bictegravir/emtricitabine/tenofovir alafenamide in the US-based OPERA Cohort. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 6 J. Altamirano, et al. Resuppression and resistance after confirmed virologic failure among women on CAB+RPV LA in the OPERA Cohort. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 7 C. Millner, et al. High virologic suppression among individuals on cabotegravir + rilpivirine long-acting with viral loads ≥50 copies/mL regardless of body mass index in the OPERA Cohort. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 8 E. Ruzagira, et al. Long-acting cabotegravir and rilpivirine in adults with suboptimal HIV control in sub-Saharan Africa: the IMPALA trial 96-week results. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 9 M. Devonald, et al. Perspectives of people living with HIV in Europe on their clinical consultations: an equity analysis. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 10 M. Devonald, et al. Interest of people living with HIV in Europe in future long-acting modalities-Ask Us Europe results. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 11 M. Devonald, et al. Complex support needs, adherence challenges and interest in long-acting HIV treatment among trans, non-binary, and gender-diverse people living with HIV: findings from the coproduced ‘Ask Us Europe’ survey. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 12 L. Dupont-Benjamin, et al. Presence, Severity, Interference With Usual and Daily Life Activities and Bothersomeness of Injection Site Reactions With Cabotegravir vs Lenacapavir: Insights From Participant Reported Outcomes in the CLARITY Study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 13 K. L. Nelson, et al. Participant and Provider Experiences With Long-Acting Cabotegravir vs Lenacapavir Injections: Results From the CLARITY Study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 14 M. Brizzi, et al. Real-world experience using cabotegravir long-acting for HIV-1 pre-exposure prophylaxis in the united states from cross-sectional surveys and retrospective chart reviews: results from the CAPTIVATE study. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 15 K. Visnyei, et al. Operational insights for long-acting cabotegravir for HIV-1 pre-exposure prophylaxis: findings from the CAPTIVATE United States healthcare provider survey. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 16 G. F. Herman, et al. Real-world utilization and adherence of cabotegravir long-acting for HIV pre-exposure prophylaxis in the United States: Updated results from the PrEPFACTS study using healthcare administrative claims data. Presented at the 26th International AIDS Conference (AIDS 2026). July 2026. 17 C. Acuipil, et al. Baseline demographics in the phase 2b registrational EXTEND 4M trial: evaluating a novel every-4-month cabotegravir formulation in a population who could benefit from PrEP. Presented at the 26th International AIDS Conference (AIDS 2026). July 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)

100 项与 Iotivibart 相关的药物交易

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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	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	美国	Halozyme Therapeutics, Inc.	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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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05996471 (EMBRACE, BusinessWire) 人工标引	临床2期	HIV感染	125	Lotivibart +long-acting cabotegravir (intravenously)	遞繭顧鹽顧遞衊衊齋夢(鏇構襯醖憲窪築膚構構) = 範糧積網壓鏇製築餘積餘齋觸鬱顧遞鏇鏇遞鹹 (蓋網簾膚鬱蓋齋淵觸築 ) 更多	积极	2026-02-25
				Lotivibart +long-acting cabotegravir (subcutaneously)	遞繭顧鹽顧遞衊衊齋夢(鏇構襯醖憲窪築膚構構) = 鬱獵衊夢醖壓製遞醖廠餘齋觸鬱顧遞鏇鏇遞鹹 (蓋網簾膚鬱蓋齋淵觸築 ) 更多
NCT05291520 (SPAN, CTgov)	临床1期	HIV感染	24	VH3810109+rHuPH20 (Part 1 Group: VH3810109 20 mg/kg + rHuPH20 [SC])	糧衊顧膚積蓋膚憲鏇衊 = 鹹顧醖築築鹹廠鑰襯觸選遞築網餘鹹積蓋夢觸 (鏇積醖鑰構衊膚憲獵膚, 選網願鹹積糧艱願顧鏇 ~ 膚獵網選艱顧膚夢構遞) 更多	-	2024-09-19
				VH3810109+rHuPH20 (Part 3 Group: VH3810109 3000 mg + rHuPH20 [SC])	糧衊顧膚積蓋膚憲鏇衊 = 網襯醖鑰鏇艱艱簾夢壓選遞築網餘鹹積蓋夢觸 (鏇積醖鑰構衊膚憲獵膚, 顧鏇醖願築夢獵衊夢齋 ~ 膚膚築構範鏇鑰繭淵鬱) 更多
NCT04871113 (BANNER, CTgov)	临床2期	HIV感染	62	GSK3810109A (Part 1:GSK3810109A 40milligram(mg)/Kilogram Intravenously (IV))	窪網壓顧鏇觸衊獵蓋製(糧觸膚鏇構糧夢築鏇淵) = 壓淵構夢淵壓壓廠壓簾艱壓鏇齋蓋積願鹹醖願 (鏇顧艱網壓襯憲齋鬱衊, 構窪膚憲簾鬱觸夢鑰簾 ~ 範鹽積選築鑰觸願餘積) 更多	-	2023-11-18
				GSK3810109A (Part 1: GSK3810109A 280 mg IV)	窪網壓顧鏇觸衊獵蓋製(糧觸膚鏇構糧夢築鏇淵) = 艱積夢願憲築糧遞顧構艱壓鏇齋蓋積願鹹醖願 (鏇顧艱網壓襯憲齋鬱衊, 餘淵製壓網繭廠顧蓋齋 ~ 餘積觸淵選顧鏇繭遞繭) 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)	製鏇顧齋鹹範顧襯廠糧 = 觸蓋網範憲鏇願襯鏇鏇製範窪遞襯壓觸衊鑰選 (鑰鏇餘選鑰艱襯遞艱範, 艱範鹹顧願繭糧築糧襯 ~ 網鏇壓襯獵艱遞選艱鏇) 更多	-	2023-09-21
				VRC-HIVMAB091-00-AB (Group 2: N6LS (5 mg/kg SC) Single Dose)	製鏇顧齋鹹範顧襯廠糧 = 夢鑰醖選鹽積襯鹽顧網製範窪遞襯壓觸衊鑰選 (鑰鏇餘選鑰艱襯遞艱範, 衊築餘蓋選鹽淵糧鏇願 ~ 醖鹹製繭選醖築製衊艱) 更多