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ViiV Healthcare将公布2024年艾滋病患者2药治疗方案Dovato与3药治疗方案Biktarvy的最大头对头随机临床试验数据

ViiV Healthcare to announce data from largest head-to-head randomised clinical trial for 2-drug regimen Dovato against 3-drug regimen Biktarvy at AIDS 2024

葛兰素史克 等信源发布 2024-07-15 20:31

可切换为仅中文


Findings from the SEIMC-GeSIDA Foundation (FSG) PASO-DOBLE study will include treatment efficacy, safety, and weight gain experienced by participants taking Dovato (dolutegravir/lamivudine) or Biktarvy (bictegravir/emtricitabine/ tenofovir alafenamide)

SEIMC GeSIDA Foundation(FSG)PASO-DOBLE研究的结果将包括服用Dovato(dolutegravir/拉米夫定)或Biktarvy(bictegravir/emtricitabine/tenofovir alafenamide)的参与者的治疗效果,安全性和体重增加

Additional key abstracts from ViiV Healthcare’s industry-leading, long-acting pipeline and portfolio include data introducing a third-generation integrase strand transfer inhibitor (INSTI) with potential for ultra long-acting applications; pregnancy data for Apretude (cabotegravir long-acting injectable) for PrEP; and real-world evidence for long-acting treatment regimen Cabenuva (cabotegravir + rilpivirine long-acting).

ViiV Healthcare业界领先的长效管道和投资组合的其他关键摘要包括引入具有超长效应用潜力的第三代整合酶链转移抑制剂(INSTI)的数据;PrEP的Apretude(cabotegravir长效注射剂)的妊娠数据;和长效治疗方案Cabenuva(cabotegravir+rilpivirine长效)的现实证据。

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, will be presenting the largest head-to-head, randomised clinical trial (RCT) of the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) compared against the 3-drug regimen, Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide [BIC/FTC/TAF]) at the 25th International AIDS Conference in Munich, Germany (22 – 26 July).

葛兰素史克股份有限公司(伦敦证交所/纽约证交所:葛兰素史克)宣布,由葛兰素史克控股的全球专业艾滋病毒公司ViiV Healthcare,以辉瑞和Shionogi为股东,将在7月22日至26日于德国慕尼黑举行的第25届国际艾滋病会议上,与三药方案Biktarvy(bictegravir/emtricitabine/tenofovir-alafenamide[BIC/FTC/TAF])进行最大规模的头对头随机临床试验(RCT)。

The presentation is one of 25 abstracts evaluating the company’s portfolio of marketed HIV treatment and prevention options alongside its next-generation pipeline assets..

该演讲是评估该公司上市的艾滋病毒治疗和预防方案组合及其下一代管道资产的25篇摘要之一。。

Harmony P. Garges, M.D., Chief Medical Officer at ViiV Healthcare, said: “The exciting findings we’ll be presenting at AIDS 2024 continue to underscore our position as industry leaders in the development of long-acting and 2-drug regimens and our pioneering approaches to both HIV treatment and prevention.

ViiV Healthcare首席医疗官Harmony P.Garges医学博士说:“我们将在2024年艾滋病大会上展示的令人兴奋的发现,继续突显了我们作为行业领导者在开发长效和双药治疗方案方面的地位,以及我们在艾滋病毒治疗和预防方面的开创性方法。

People living with HIV continue to tell us they want more treatment options to allow for more personal choice to address needs beyond viral suppression. The breadth of the data we’re announcing, including the head-to-head study between Dovato and Biktarvy, helps individuals better understand those options.

艾滋病毒感染者继续告诉我们,他们希望有更多的治疗选择,以便有更多的个人选择来满足病毒抑制以外的需求。我们所公布的数据的广度,包括Dovato和Biktarvy之间的头对头研究,有助于个人更好地理解这些选择。

We’re proud to be at the forefront of innovative science, driving advancements that have and will continue to transform the future of HIV care and contribute to ending the epidemic.”.

我们很自豪能够站在创新科学的前沿,推动已经并将继续改变艾滋病毒护理未来的进步,并为结束这一流行病做出贡献。”。

Key abstracts to be presented at AIDS 2024 by ViiV Healthcare and its study partners will include:

ViiV Healthcare及其研究合作伙伴将在2024年艾滋病大会上发表的主要摘要包括:

Head-to-head study comparing ViiV Healthcare’s oral 2-drug regimen against a commonly prescribed oral 3-drug regimen: The FSG-sponsored PASO-DOBLE head-to-head RCT of the 2-drug regimen Dovato (DTG/3TC) compared with the 3-drug regimen Biktarvy (BIC/FTC/TAF) will be presented as a late breaker abstract.

头对头研究比较了ViiV Healthcare的口服2药方案与常用的口服3药方案:FSG赞助的2药方案Dovato(DTG/3TC)的PASO-DOBLE头对头RCT与3药方案Biktarvy(BIC/FTC/TAF)将作为晚期破坏者摘要呈现。

The non-inferiority study assessed virologically suppressed adults on an established treatment regimen and who could benefit from treatment optimisation, who were randomised to switch to treatment with DTG/3TC or BIC/FTC/TAF. Researchers will share 48-week findings on treatment efficacy and safety, as well as changes in weight experienced by participants while taking either regimen.1.

非劣效性研究评估了既定治疗方案中病毒学抑制的成年人,他们可以从治疗优化中受益,他们被随机分配到DTG/3TC或BIC/FTC/TAF治疗。研究人员将分享48周的治疗效果和安全性研究结果,以及参与者在服用任一方案时体重的变化。

Additional findings for DTG/3TC will include the DYAD study, presenting 48-week findings among virologically suppressed participants with no prior virologic failure who either switched to DTG/3TC or remained on BIC/FTC/TAF;2 and 96-week findings from the SOUND study, which followed virologically suppressed participants with unknown resistance history who switched from BIC/FTC/TAF to DTG/3TC.3.

DTG/3TC的其他发现将包括二元研究,在病毒学抑制的参与者中提供48周的发现,这些参与者既往没有病毒学失败,要么改用DTG/3TC,要么继续使用BIC/FTC/TAF;SOUND研究的第2周和第96周发现,该研究追踪了从BIC/FTC/TAF转换为DTG/3TC的具有未知耐药史的病毒学抑制参与者。

Pregnancy data from the HPTN 084 open label extension study for Apretude: New findings will be presented from the HPTN 084 trial that assess the impact of cabotegravir long-acting (LA) for PrEP exposure during pregnancy.4,5 The study focuses on maternal, pregnancy, and infant safety outcomes among participants who became pregnant during the open label extension of HPTN 084 and continued with injections of cabotegravir LA for PrEP..

HPTN 084 Apretude开放标签扩展研究的妊娠数据:HPTN 084试验将提供新的发现,评估卡博格雷韦长效(LA)对妊娠期PrEP暴露的影响。4,5该研究重点关注在HPTN 084开放标签扩展期间怀孕并继续注射卡博格雷韦LA进行PrEP的参与者的孕产妇,妊娠和婴儿安全结果。。

New pipeline data from ViiV Healthcare’s third generation INSTI: Researchers will share phase I findings from the first-time-in-human study of VH184, a third-generation integrase inhibitor (INSTI), along with analysis showing potent activity in vitro against multiple INSTI resistant mutations.6 This is the first data presentation of the company’s next INSTI as a part of its ultra long-acting development strategy.

ViiV Healthcare第三代INSTI的新管道数据:研究人员将分享第一次对第三代整合酶抑制剂(INSTI)VH184进行人体研究的第一阶段发现,以及显示体外对多种INSTI耐药突变具有有效活性的分析。6这是该公司下一代INSTI的首次数据展示,是其超长效发展战略的一部分。

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Real-world evidence from long-acting treatment regimen: Findings from several real-world studies of the complete long-acting HIV treatment regimen cabotegravir + rilpivirine long-acting (CAB+RPV LA) will be presented, including the perspectives of people living with HIV 12 months after switching their treatment regimen to CAB+RPV LA from the BEYOND study;7,8 effectiveness, participant adherence to injections, and patient reported outcomes from the German cohort of the CARLOS study;9 and utilisation and effectiveness of CAB+RPV LA among virologically suppressed, treatment-experienced individuals from the COMBINE-2 study.10.

来自长效治疗方案的现实世界证据:将介绍几项关于完整长效HIV治疗方案卡博格雷韦+利匹韦林长效(CAB+RPV-LA)的现实世界研究的结果,包括艾滋病毒感染者的观点从BEYOND研究将治疗方案改为CAB+RPV-LA后12个月;7,8 CARLOS研究的德国队列的有效性,参与者坚持注射以及患者报告的结果;9以及COMBINE-2研究中病毒学抑制,治疗经验丰富的个体中CAB+RPV LA的利用和有效性。

Here is a list of ViiV Healthcare-sponsored or supported studies to be presented at AIDS 2024:

以下是将在2024年艾滋病大会上提交的第四届医疗保健赞助或支持的研究清单:

Title

标题

First Author

第一作者

Presentation Number

演示文稿编号

Presentation

演示文稿

Dolutegravir/3TC

多乐替拉韦/3TC

Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomized clinical trial

在病毒学抑制的HIV感染者(PWH)中,改用DTG/3TC比改用BIC/FTC/TAF的疗效不差,体重增加更少:PASODOBLE(GeSIDA 11720)随机临床试验

P. Ryan

P、 瑞安

OAB3606LB

OAB3606LB

Oral

口头

Session date: Friday, 26 July

会议日期:7月26日星期五

Session time: 12:00-13:00 CEST

会议时间:CEST 12:00-13:00

PAIRED - Patient reported experiences and perceived benefit of treatment with dolutegravir/lamivudine - qualitative interviews: diverse group of people with HIV-1 (PWH) reflect on life and health

配对-患者报告的使用dolutegravir/拉米夫定治疗的经验和感知益处-定性访谈:不同人群的HIV-1(PWH)患者反映了生活和健康

J. Slim

J、 苗条的

THPEB094

THPEB094

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Real-world effectiveness and tolerability of the 2-drug regimen dolutegravir and lamivudine (DTG/3TC) in people living with HIV: a systematic literature review and meta-analysis from clinical practice

双药方案dolutegravir和拉米夫定(DTG/3TC)在HIV感染者中的真实有效性和耐受性:系统文献综述和临床实践的荟萃分析

J. Fraysse

J、弗雷泽

TUPEB101

TUPEB101

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Effectiveness and durability of dolutegravir/lamivudine in older people with HIV from the Veterans Aging Cohort Study (VACS)

退伍军人老龄化队列研究(VACS)中dolutegravir/拉米夫定对老年HIV感染者的有效性和持久性

L. Yan

五十、 严

WEPEB111

WEPEB111

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Switch to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1 suppressed on bictegravir/emtricitabine/ tenofovir alafenamide (B/F/TAF): 96-week final analysis from the SOUND study

双替格韦/恩曲他滨/替诺福韦-阿拉芬胺(B/F/TAF)抑制的HIV-1感染者改用dolutegravir/拉米夫定(DTG/3TC):SOUND研究的96周最终分析

J. Slim

J、 苗条的

THPEB092

THPEB092

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide - 48-week results from the DYAD study

双曲格韦/恩曲他滨/替诺福韦-阿拉芬胺对病毒学抑制的HIV感染者改用dolutegravir/拉米夫定的疗效,安全性和耐受性-DYAD研究的48周结果

C. Rolle

C.罗尔

THPEB089

THPEB089

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Dolutegravir

多乐替拉韦

Viral suppression, viral failure and safety outcomes in children and adolescents on dolutegravir (DTG) in Europe and Thailand

欧洲和泰国儿童和青少年使用dolutegravir(DTG)的病毒抑制,病毒衰竭和安全性结果

K. Scott

K、 斯科特

OAB3803

OAB3803

Oral

口头

Session date: Friday, 26 July

会议日期:7月26日星期五

Session time: 13:30-14:30 CEST

会议时间:CEST 13:30-14:30

Changes in body mass index in children and adolescents in Europe and Thailand before and after starting dolutegravir and compared to protease inhibitors using propensity scoring analysis

欧洲和泰国儿童和青少年服用dolutegravir前后体重指数的变化,并使用倾向评分分析与蛋白酶抑制剂进行比较

S. Crichton

S、 克莱顿

TUPEB086

TUPEB086

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Prenatal dolutegravir-based regimen use, and pregnancy and birth outcomes: data from the Antiretroviral Pregnancy Registry

产前基于dolutegravir的方案使用以及妊娠和出生结局:来自抗逆转录病毒妊娠登记处的数据

V. Vannappagari

V.万纳帕加利

TUPEB128

管子B128

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Effectiveness and durability of dolutegravir/ rilpivirine in older people with HIV from the Veterans Aging Cohort Study (VACS)

退伍军人老龄化队列研究(VACS)中dolutegravir/rilpivirine对老年HIV感染者的有效性和持久性

L. Yan

五十、 严

THPEB090

THPEB090

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Cabotegravir for treatment

Cabotegravir治疗

Subcutaneous injections of cabotegravir + rilpivirine in virally suppressed adults with HIV-1: a substudy of the phase 3 FLAIR study

在HIV-1病毒抑制的成年人中皮下注射卡博格雷韦+利匹韦林:3期FLAIR研究的子研究

R. D’Amico

R.达米科

OAB2604

OAB2604

Oral

口头

Session date: Thursday, 25 July 2024

会议日期:2024年7月25日,星期四

Session time: 15:00-16:00 CEST

会议时间:CEST 15:00-16:00

Clinical outcomes at month 12 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND)

在一项观察性现实世界研究(BEYOND)中,开始使用卡博特格雷韦和利匹韦林长效(CAB+RPV LA)后第12个月的临床结果

S. Schneider

S、 施耐德

THPEB099

THPEB099

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND)

在美国的一项观察性现实世界研究(BEYOND)中,艾滋病毒(PWH)感染者在改用卡博格雷韦和利匹韦林长效(CAB+RPV LA)12个月后的观点

W. Valenti

W、 瓦伦蒂

TUPEB116

B116管

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

12-Month outcomes of cabotegravir plus rilpivirine long-acting every 2 months in a real-world setting: effectiveness, adherence to injections, and patient-reported outcomes from people with HIV-1 in the German CARLOS cohort

在现实世界中,每2个月卡博格雷韦联合利匹韦林长效治疗12个月的结果:德国卡洛斯队列中HIV-1感染者的有效性、坚持注射以及患者报告的结果

C. Jonsson-Oldenbüttel

C.琼森·奥尔登比特尔

TBUPEB095

TBUPEB095

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Increased screening for sexually transmitted infections and HIV surrogate marker testing among long-acting injectable versus daily oral antiretroviral therapy users in the OPERA® cohort

在OPERA®队列中,长效注射剂与每日口服抗逆转录病毒治疗使用者之间的性传播感染筛查和HIV替代标志物检测增加

P. C. Lackey

P、 C.仆人

WEPEC319

WEPEC319

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment experienced individuals in Europe: data from COMBINE-2 cohort study

长效卡博格雷韦+利匹韦林在欧洲病毒学抑制治疗经验丰富的个体中的实际应用和有效性:来自COMBINE-2队列研究的数据

A. Pozniak

A.波兹尼亚克

TUPEC278

图佩278

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Re-thinking ‘community’ in the implementation of long-acting injectable cabotegravir and rilpivirine: qualitative findings from the ILANA study

重新思考长效注射卡博格雷韦和利匹韦林实施中的“社区”:ILANA研究的定性发现

R. Hayes

R、 海斯

TUPEE529

图529

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Adherence through the prism of long-acting injectable therapy: qualitative findings from the ILANA implementation study

通过长效注射疗法的棱镜坚持:ILANA实施研究的定性发现

S. Paparini

S.纸张

TUPED306

嘟嘟车306

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

“Closer to a cure:” mixed-methods analysis of reasons for switching to cabotegravir + rilpivirine

“更接近治愈”:混合方法分析改用卡博特格雷韦+利匹韦林的原因

S. Paparini

S.纸张

WEPEE551

WEPEE551

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Cabotegravir for PrEP

Cabotegravir用于PrEP

“The simplest way to go:” A mixed methods analysis of why women who inject drugs selected long-acting injectable cabotegravir instead of daily oral PrEP

“最简单的方法:”一项混合方法分析,为什么注射药物的女性选择长效注射卡博特格雷韦而不是每日口服制剂

A. M. Roth

A、 M.罗斯

OAD07

OAD07

Oral

口头

Session date: Tuesday, 23 July

会议日期:7月23日星期二

Session time: 17:05-17:13 CEST

会议时间:CEST 17:05-17:13

Knowledge, awareness, feasibility, and acceptability of long-acting cabotegravir for HIV prevention: results from the SEARCH Dynamic Choice HIV prevention trial

长效卡博格雷韦预防艾滋病毒的知识、意识、可行性和可接受性:SEARCH动态选择艾滋病毒预防试验的结果

E. Kakande

E.卡坎德

OAE12

OAE12

Oral

口头

Session date: Wednesday, 24 July

会议日期:7月24日,星期三

Session time:10:41-10:49 CEST

会议时间:CEST 10:41-10:49

Location preferences for accessing long-acting injectable pre-exposure prophylaxis (LA-PrEP) among men who have sex with men (MSM) in the US currently using daily-oral PrEP

美国目前使用每日口服PrEP的男男性行为者(MSM)获得长效注射暴露前预防(LA PrEP)的位置偏好

J. L. Glick

J、L.格里克

WEPEC269

WEPEC269

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

HIV pre-exposure prophylaxis awareness, willingness, and use among transfeminine persons with high likelihood of HIV in the United States: recent results from the Transgender Women’s Internet Survey and Testing (TWIST)

美国极有可能感染艾滋病毒的跨女性人群的艾滋病毒暴露前预防意识、意愿和使用情况:变性妇女互联网调查和测试(TWIST)的最新结果

D. I. Yaras

D.I.亚拉斯

THPEC186

THPEC186

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Preference for long-acting HIV prevention methods among transgender women at greatest risk for HIV acquisition in eastern and southern United States: findings from the LITE cohort

美国东部和南部艾滋病毒感染风险最高的变性妇女对长效艾滋病毒预防方法的偏好:LITE队列的研究结果

E. E. Cooney

E.E.库尼

THPED410

THPED410

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Influencers and decision-making factors for choosing injectable PrEP among men who have sex with men and transgender men in the United States

美国男男性行为者和变性男性选择注射用PrEP的影响因素和决策因素

D. Dandachi

D、丹达奇

THPEE504

THPEE504

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

STime of presentation: 12:00-13:00 CEST

ST演示时间:12:00-13:00 CEST

Need for increased HIV testing prior to and during pre-exposure prophylaxis with cabotegravir long-acting injections in routine clinical care in the United States

在美国的常规临床护理中,需要在暴露前和暴露前使用卡博格雷韦长效注射剂进行艾滋病毒检测

R. K. Hsu

WEPEB046

WEPEB046

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Pre-exposure prophylaxis (PrEP) product choice of participants in HPTN 083

HPTN 083参与者的暴露前预防(PrEP)产品选择

M. E. Clement

M、 E.克莱门特

TUPEC184

图佩184

Poster

海报

Date of presentation: Tuesday, 23 July

提交日期:7月23日星期二

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

“Everyone should have access to it”: Perspectives on PrEP product choice and implementation from MSM and TGW in an injectable PrEP trial

“每个人都应该可以使用它”:MSM和TGW在可注射PrEP试验中对PrEP产品选择和实施的观点

C. Psaros

C.普萨罗斯

WEPEC206

WEPEC206

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Pipeline

管道

Phase 1 study of VH4524184 (VH-184), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile

VH4524184(VH-184)的第一阶段研究,VH4524184是一种新的第三代整合酶链转移抑制剂(INSTI),具有独特的耐药性

L. Rogg

五十、 罗格

OAB26

OAB26

Oral

口头

Session date: Thursday, 25 July

会议日期:7月25日星期四

Session time: 15:00-16:00 CEST

会议时间:CEST 15:00-16:00

Preclinical assessments of a cabotegravir prodrug predicting human dosing durations of >6 months

卡博特格雷韦前药的临床前评估预测人类给药持续时间>6个月

M. Baker

M、 面包师

WEPEA028

WEPEA028

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Pre-clinical profiles of HIV-1 capsid inhibitors VH4004280 (VH-280) and VH4011499 (VH-499)

HIV-1衣壳抑制剂VH4004280(VH-280)和VH4011499(VH-499)的临床前概况

C. Wang

C、 王

WEPEA027

WEPEA027

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Clinical pharmacokinetics and safety of orally administered VH4004280 (VH-280), a novel HIV-1 capsid inhibitor, in healthy volunteers

新型HIV-1衣壳抑制剂VH4004280(VH-280)在健康志愿者中的临床药代动力学和安全性

R. Griesel

R.格里塞尔

THPEB093

THPEB093

Poster

海报

Date of presentation: Thursday, 25 July

提交日期:7月25日,星期四

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Clinical pharmacokinetics and safety of orally administered VH4011499 (VH-499), a novel HIV-1 capsid inhibitor, in healthy volunteers

新型HIV-1衣壳抑制剂VH4011499(VH-499)在健康志愿者中的临床药代动力学和安全性

N. Thakkar

N.塔卡尔

WEPEB105

WEPEB105

Poster

海报

Date of presentation: Wednesday, 24 July

提交日期:7月24日,星期三

Time of presentation: 12:00-13:00 CEST

演讲时间:CEST 12:00-13:00

Above Brand

以上品牌

Detailed modelling of viremia exposure does not independently predict cardiovascular disease in people with HIV

病毒血症暴露的详细模型不能独立预测艾滋病毒感染者的心血管疾病

O. Elvstam

O.埃尔夫斯塔姆

OAB34

OAB34

Oral

口头

Session date: Friday, 26 July 2024

会议日期:2024年7月26日,星期五

Session time: 10:30-11:30 CEST

会议时间:CEST 10:30-11:30

About Dovato

关于Dovato

Dovato is indicated as a complete regimen to treat HIV-1 infection in adults with no antiretroviral (ARV) treatment history or to replace the current ARV regimen in those who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable ARV regimen with no history of treatment failure and no known resistance to any component of Dovato..

Dovato被认为是一种完整的治疗方案,用于治疗无抗逆转录病毒(ARV)治疗史的成年人的HIV-1感染,或替代目前的ARV治疗方案,用于病毒学抑制(HIV-1 RNA<50拷贝/mL)的稳定ARV治疗方案,无治疗失败史,对Dovato的任何成分均无已知耐药性。。

Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets.

有关所有安全信息,请参阅产品特性的完整摘要:Dovato 50 mg/300 mg薄膜包衣片。

About Vocabria

关于Vocabria

Vocabria (cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the non-nucleoside reverse transcriptase inhibitors (NNRTI) and integrase inhibitor (INI) class..

Vocabria(cabotegravir)注射液与利匹韦林注射液联合使用,用于治疗在稳定的抗逆转录病毒治疗方案中被病毒学抑制(HIV-1 RNA<50拷贝/mL)的成年人中的人类免疫缺陷病毒1型(HIV-1)感染,目前或过去没有病毒耐药性的证据,并且之前没有使用非核苷逆转录酶抑制剂(NNRTI)和整合酶抑制剂(INI)类药物的病毒学失败。。

Vocabria tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA <50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with agents of the NNRTI and INI class for:.

Vocabria片剂与利匹韦林片剂联合使用,用于短期治疗在稳定的抗逆转录病毒治疗方案中被病毒学抑制(HIV-1 RNA<50拷贝/mL)的成年人的HIV-1感染,目前或过去没有病毒耐药性的证据,并且之前没有NNRTI和INI类药物的病毒学失败:。

oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection.

在服用长效奥卡布里亚注射液加长效利匹韦林注射液之前,口服铅以评估奥卡布里亚和利匹韦林的耐受性。

oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection.

口服治疗将错过Vocabria注射液加利匹韦林注射液计划剂量的成年人。

Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant tablets should also be consulted for recommended dosing.

Vocabria片剂仅适用于与利匹韦林片剂联合治疗HIV-1,因此,还应参考Edurant片剂的处方信息以获得推荐剂量。

Please consult the full Summary of Product Characteristics for all the safety information: Vocabria 400mg/600 mg prolonged-release suspension for injection and Vocabria 30 mg film-coated tablets

有关所有安全信息,请参阅产品特性的完整摘要:注射用Vocabria 400mg/600 mg缓释混悬液和Vocabria 30 mg薄膜包衣片

About Rekambys

关于[UNK]Rekambys

Rekambys is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults who are virologically suppressed (HIV-1 RNA < 50 copies/mL) on a stable antiretroviral regimen without present or past evidence of viral resistance to, and no prior virological failure with, agents of the NNRTI and INI class..

Rekambys与卡博特格雷韦注射液联合用于治疗在稳定的抗逆转录病毒治疗方案中病毒学抑制(HIV-1 RNA<50拷贝/mL)的成年人的HIV-1感染,目前或过去没有证据表明病毒对NNRTI和INI类药物有抗药性,也没有先前的病毒学失败。。

Rekambys should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing. Rekambys may be initiated with oral lead-in or without (direct to injection).

Rekambys应始终与卡博格雷韦注射液共同给药。建议的剂量应参考卡博特格雷韦注射液的处方信息。Rekambys可以口服导入或不口服(直接注射)。

Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection

有关所有安全信息,请参阅产品特性的完整摘要:注射用Rekambys 600mg/900 mg缓释混悬液

About Apretude

关于欣赏

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..

Apretude是一种用于预防性传播HIV-1感染(暴露前预防或PrEP)的药物,用于预防体重至少35公斤且感染风险高的成年人和青少年。它应该与更安全的性行为相结合,例如使用避孕套。Apretude含有活性物质cabotegravir。。

Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection

有关所有安全信息,请参阅产品特性的完整摘要:注射用600 mg缓释混悬液

About ViiV Healthcare

关于ViiV医疗

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 are at risk of acquiring HIV. Shionogi became a ViiV shareholder in October 2012.

ViiV Healthcare是由葛兰素史克(LSE:GSK)和辉瑞(NYSE:PFE)于2009年11月成立的一家全球专业HIV公司,致力于为艾滋病毒感染者和有感染艾滋病毒风险的人提供治疗和护理方面的进步。Shionogi于2012年10月成为ViiV股东。

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..

该公司的目标是比以往任何公司都对艾滋病毒和艾滋病产生更深入和更广泛的兴趣,并采取新的方法提供有效和创新的艾滋病毒治疗和预防药物,以及支持受艾滋病毒影响的社区。有关公司、管理层、投资组合、渠道和承诺的更多信息,请访问viivhealthcare.com。。

About SEIMC-GeSIDA Foundation (FSG)

关于SEIMC GeSIDA基金会(FSG)

The SEIMC-GeSIDA Foundation (FSG) was founded by the Spanish Society of Clinical Microbiology and Infectious Diseases as a tool to promote high-quality investigation in the field of HIV infection and other infectious diseases. The Foundation is composed of qualified professionals with experience in the field of clinical trials and multicentre studies.

SEIMC GeSIDA基金会(FSG)由西班牙临床微生物学和传染病学会成立,作为促进艾滋病毒感染和其他传染病领域高质量调查的工具。该基金会由具有临床试验和多中心研究领域经验的合格专业人员组成。

Its streamlined infrastructure facilitates performance of clinical studies and responds to the needs of investigators in terms of methodology/statistical analysis and of logistics and management of trials and other multicentre studies. For more information on the SEIMC-GeSIDA Foundation (FSG), please visit https://fundacionseimcgesida.org/en/quienes-somos/.

其精简的基础设施有助于临床研究的开展,并在方法/统计分析以及试验和其他多中心研究的后勤和管理方面满足研究人员的需求。有关SEIMC GeSIDA基金会(FSG)的更多信息,请访问https://fundacionseimcgesida.org/en/quienes-somos/.

About GSK

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.

葛兰素史克是一家全球性生物制药公司,旨在将科学、技术和人才团结起来,共同战胜疾病。更多信息请访问gsk.com。

Cautionary statement regarding forward-looking statements

关于前瞻性声明的警示声明

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 under Item 3.D “Risk factors” in GSK’s Annual Report on Form 20-F for 2023, and GSK’s Q1 Results for 2024..

葛兰素史克提醒投资者,葛兰素史克所作的任何前瞻性陈述或预测,包括本公告中所作的前瞻性陈述或预测,都存在风险和不确定性,可能导致实际结果与预测结果存在重大差异。这些因素包括但不限于葛兰素史克2023年20-F表年度报告第3.D项“风险因素”中所述的因素,以及葛兰素史克2024年第一季度的业绩。。

References

参考文献

P. Ryan, et al. Non-inferior efficacy and less weight gain when switching to DTG/3TC than when switching to BIC/FTC/TAF in virologically suppressed people with HIV (PWH): the PASODOBLE (GeSIDA 11720) randomized clinical trial. Presented at the 25th International AIDS Conference. July 2024.

P、 Ryan等人。在病毒学抑制的HIV感染者(PWH)中,改用DTG/3TC比改用BIC/FTC/TAF时,疗效不差,体重增加更少:PASODOBLE(GeSIDA 11720)随机临床试验。在第25届国际艾滋病会议上发表。2024年7月。

C.P. Rolle, et al. Efficacy, safety and tolerability of switching to dolutegravir/lamivudine in virologically suppressed adults living with HIV on bictegravir/emtricitabine/tenofovir alafenamide - 48-week results from the DYAD study. Presented at the 25th International AIDS Conference. July 2024.

C、 P.Rolle等人。双格拉韦/恩曲他滨/替诺福韦-阿拉芬胺对病毒学抑制的HIV感染者改用dolutegravir/拉米夫定的疗效,安全性和耐受性-来自二元研究的48周结果。在第25届国际艾滋病会议上发表。2024年7月。

J. Slim, et al. Switch to dolutegravir/lamivudine (DTG/3TC) in people living with HIV-1 suppressed on bictegravir/emtricitabine/tenofovir alafenamide (B/F/TAF): 96-week final analysis from the SOUND study. Presented at the 25th International AIDS Conference. July 2024.

J、 Slim等人在双替格韦/恩曲他滨/替诺福韦-阿拉芬胺(B/F/TAF)抑制的HIV-1感染者中改用dolutegravir/拉米夫定(DTG/3TC):SOUND研究的96周最终分析。在第25届国际艾滋病会议上发表。2024年7月。

S. Delany-Moretlwe, et al. Initial evaluation of CAB-LA Safety during pregnancy in the HPTN 084 open-label extension. Presented at the 25th International AIDS Conference. July 2024.

S、 Delany Moretlwe等人。HPTN 084开放标签扩展中怀孕期间CAB-LA安全性的初步评估。在第25届国际艾滋病会议上发表。2024年7月。

M. Marzinke, et al. Evaluation of Long-Acting Cabotegravir (CAB-LA) Pharmacokinetics During Pregnancy: A Sub-Study Analysis of the HPTN 084 Open Label Extension. Presented at the 25th International AIDS Conference. July 2024.

M、 Marzinke等人。妊娠期长效卡博特格雷韦(CAB-LA)药代动力学的评估:HPTN 084开放标签扩展的子研究分析。在第25届国际艾滋病会议上发表。2024年7月。

L. Rogg, et al. Phase 1 study of VH4524184 (VH-184), a new third-generation integrase strand transfer inhibitor (INSTI) with a unique resistance profile. Presented at the 25th International AIDS Conference. July 2024.

五十、 Rogg等人。VH4524184(VH-184)的第一阶段研究,VH4524184是一种新的第三代整合酶链转移抑制剂(INSTI),具有独特的抗性特征。在第25届国际艾滋病会议上发表。2024年7月。

S. Schneider, et al. Clinical outcomes at Month 12 after initiation of cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.

S、 Schneider等人在一项观察性现实世界研究(BEYOND)中开始使用卡博特格雷韦和利匹韦林长效(CAB+RPV-LA)后第12个月的临床结果。在第25届国际艾滋病会议上发表。2024年7月。

W. Valenti, et al. Perspectives of people with HIV (PWH) 12 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the 25th International AIDS Conference. July 2024.

W、 Valenti等人在美国一项观察性现实世界研究(BEYOND)中,对艾滋病毒感染者(PWH)改用卡博特格雷韦和利匹韦林长效(CAB+RPV-LA)12个月后的观点。在第25届国际艾滋病会议上发表。2024年7月。

CJ. Oldenbüttel, et al. 12-Month outcomes of cabotegravir plus rilpivirine long-acting every 2 months in a real-world setting: effectiveness, adherence to injections, and patient-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the 25th International AIDS Conference.

希杰。Oldenbüttel等人。在现实世界中,每2个月卡博格雷韦联合利匹韦林长效治疗12个月的结果:德国卡洛斯队列中HIV-1感染者的有效性,坚持注射以及患者报告的结果。在第25届国际艾滋病会议上发表。

July 2024..

2024年7月。。

A. Pozniak, et al. Real-world utilization and effectiveness of long-acting cabotegravir + rilpivirine in virologically suppressed treatment experienced individuals in Europe: data from COMBINE-2 cohort study. Presented at the 25th International AIDS Conference. July 2024.

A、 Pozniak等人。长效卡博特格雷韦+利匹韦林在欧洲病毒学抑制治疗经验丰富的个体中的实际应用和有效性:来自COMBINE-2队列研究的数据。在第25届国际艾滋病会议上发表。2024年7月。