New data at CROI 2025 show zero cases of HIV acquisition reported with

CROI 2025上的新数据显示零例HIV感染报告

Apretude

阿普雷特уд

(cabotegravir long-acting (CAB LA) for PrEP) in varied clinical settings and populations in two implementation studies in the U.S. and Brazil

在美国和巴西的两项实施研究中，不同临床环境和人群中的（cabotegravir 长效制剂 (CAB LA) 用于 PrEP）

Data for

数据为

Cabenuva

卡贝努瓦

(cabotegravir + rilpivirine long-acting (CAB+RPV LA)), the only complete long-acting injectable approved for HIV treatment, show high effectiveness in two, large real-world studies

（卡博特韦＋利匹韦林长效注射剂（CAB+RPV LA））是唯一获批用于HIV治疗的完整长效注射疗法，在两项大型真实世界研究中显示出高效性。

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced new data from two implementation studies showing zero cases of HIV acquisition for

ViiV Healthcare是一家由GSK控股、辉瑞和盐野义制药参股的全球专业HIV公司，今天宣布了两项实施研究的新数据，数据显示零例HIV感染。

Apretude

阿普雷特уд

, the only long-acting injectable approved for HIV prevention. Real-world data were also presented for

，唯一获准用于预防艾滋病的长效注射剂。还提供了真实世界的数据

Cabenuva,

卡贝努瓦，

the only approved, complete long-acting injectable treatment regimen, showing its effectiveness in the three years since it has been available.

唯一获批的完整长效注射治疗方案，展示了其自三年前上市以来的有效性。

These data were presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), in San Francisco, U.S.

这些数据是在美国旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上发表的。

Harmony P. Garges, M.D. MPH., Chief Medical Officer at ViiV Healthcare, said:

ViiV Healthcare的首席医疗官Harmony P. Garges医学博士、公共卫生硕士表示：

“As the leaders in long-acting injectables for HIV, we’re committed to collecting data to understand the effectiveness of these first-in-class medicines in real-world settings. Our ongoing, real-world and implementation studies for

“作为HIV长效注射剂的领导者，我们致力于收集数据，以了解这些首创药物在真实世界环境中的有效性。我们正在进行的真实世界和实施研究对于...”

Apretude

阿普特鲁德

show effectiveness of HIV prevention of more than 99% in nearly 4,000 people; and we have real-world experience in more than 15,000 people receiving

在近4000人中显示出超过99%的HIV预防效果；并且我们在超过15000人中拥有实际应用经验。

Cabenuva

卡贝努瓦

for HIV treatment showing continued high effectiveness up to two years. Our data at CROI 2025 reinforce that, across a broad range of settings and populations, our long-acting injectables provide a highly effective option for both HIV treatment and prevention, that remove the need for daily pills.”.

在长达两年的时间里，HIV治疗显示出持续的高效性。我们在2025年逆转录病毒和机会性感染会议（CROI）上的数据进一步证实，在广泛的环境和人群中，我们的长效注射剂为HIV治疗和预防提供了一个高效的选择，避免了每日服用药片的需要。

Ricky Hsu, M.D., Department of Medicine, NYU Grossman School of Medicine and Medical Director, AHF Healthcare Center, said:

纽约大学格罗斯曼医学院医学系及AHF医疗中心医务主任徐瑞奇医生表示：

“While randomised clinical trials are the gold standard for testing the safety and efficacy of medicines, real-world evidence can provide a fuller understanding of the safety and effectiveness of a therapy over time. Since ViiV Healthcare’s introduction of long-acting injectables, generating these valuable insights is more important than ever to help providers decide who could benefit from particular medicines and better understand how they address the everyday needs of people impacted by HIV.'.

“虽然随机临床试验是测试药物安全性和有效性的黄金标准，但真实世界证据可以提供对疗法安全性和有效性更全面的理解。自从ViiV Healthcare推出长效注射剂以来，生成这些有价值的见解比以往任何时候都更重要，以帮助医疗提供者决定谁可能从特定药物中受益，并更好地了解这些药物如何满足受HIV影响人群的日常需求。”

Highlights from ViiV Healthcare and partner real-world and implementation studies for long-acting injectables

来自ViiV Healthcare及其合作伙伴关于长效注射剂的真实世界和实施研究亮点

Apretude

阿普雷特уд

(prevention) and

（预防）和

Cabenuva

卡贝努瓦

(treatment):

（治疗）：

PILLAR 12-month clinical results: zero HIV acquisition and high persistence with CAB LA for PrEP

PILLAR 12个月临床结果：使用CAB LA进行PrEP，HIV感染率为零且持久性高

1

1

New 12-month findings from the PILLAR study explore effectiveness, diagnostic testing, persistence (time that an individual continued to receive injections), safety and tolerability of CAB LA in 201 participants. PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S.

PILLAR 研究的最新 12 个月研究结果对 201 名参与者中 CAB LA 的有效性、诊断测试、持续性（个体继续接受注射的时间）、安全性和耐受性进行了探讨。PILLAR 是一项 IV 期实施试验，评估在美国 17 家诊所中整合 CAB LA 用于 PrEP 的情况。

among a diverse population of men having sex with men and transgender men, 26% of whom were Black and 38% Hispanic/Latino..

在与男性发生性关系的男性以及跨性别男性的人群中，其中26%为黑人，38%为西班牙裔/拉丁裔。

No cases of HIV acquisition were observed through 12 months. Persistence on CAB LA was high, at 85% (n=171/201) at six months and 72% (n=142/196) at 12 months; excluding five participants who completed the study post-data cutoff. Five participants missed an injection and received either oral CAB or alternative PrEP..

在12个月内未观察到HIV感染病例。CAB LA的持续使用率较高，在六个月时为85%（n=171/201），12个月时为72%（n=142/196）；排除了数据截止后完成研究的五名参与者。五名参与者错过了注射，接受了口服CAB或替代PrEP。

Adverse events (AEs) related to CAB LA were uncommon, with injection site pain the most frequently reported (3%, n=6). Five percent of participants (n=11) had AEs leading to discontinuation, most commonly due to injection site pain.

与CAB LA相关的不良事件（AEs）较少见，其中注射部位疼痛是最常报告的（3%，n=6）。5%的参与者（n=11）因不良事件导致停药，最常见的原因也是注射部位疼痛。

This implementation study data - obtained from a diverse population - supports CAB LA as an effective PrEP option associated with high persistence.

这项实施研究数据——来自不同人群——支持CAB LA作为一种与高持久性相关的有效PrEP选项。

ImPrEP CAB Brazil implementation study data shows significantly improved PrEP coverage and protection with CAB LA

ImPrEP CAB巴西实施研究数据显示，使用CAB LA显著提高了PrEP的覆盖率和保护效果。

2

2

The ImPrEP CAB Brazil study (The Choice Cohort) assessed PrEP coverage and HIV incidence among 1,447 participants who were given the choice of CAB LA or oral PrEP (TDF/FTC) for HIV prevention. The Choice Cohort included PrEP-naïve, cisgender men who have sex with men, non-binary and trans people aged 18 to 30.

ImPrEP CAB 巴西研究（选择队列）评估了1,447名参与者中CAB LA或口服PrEP（TDF/FTC）的覆盖范围和HIV发生率，这些参与者被给予选择CAB LA或口服PrEP（TDF/FTC）用于HIV预防。选择队列包括PrEP初用者、顺性别男同性恋者、非二元性别者和18至30岁的跨性别者。

As a comparison group, the study assessed 2,263 people of a similar demographic, initiating oral PrEP through the Brazilian public health system during the same period..

作为对照组，该研究评估了2263名具有相似人口统计特征的人，他们在同一时期通过巴西公共卫生系统开始服用口服PrEP。

The results show that offering CAB LA injections significantly improved PrEP coverage and HIV prevention for young key populations, reinforcing the role of CAB LA in addressing adherence challenges some people face with oral PrEP.

结果表明，提供CAB LA注射显著提高了年轻重点人群的PrEP覆盖范围和HIV预防效果，进一步巩固了CAB LA在解决部分人对口服PrEP依从性挑战方面的作用。

Eighty-three percent of the 1,447 participants who were free to choose either CAB LA or oral PrEP chose CAB LA (1,200 participants) and there were zero HIV acquisitions reported over 798.4 person-years in The Choice Cohort. There were eight HIV acquisitions over 408.52 person-years reported in the comparison group (incidence rate 1.96 [95% CI 0.98-3.92] per 100 person-years). .

在1,447名可自由选择使用CAB LA或口服PrEP的参与者中，有83%选择了CAB LA（1,200名参与者），在The Choice队列中，经过798.4人年观察未报告任何HIV感染。而在对照组中，报告了在408.52人年中发生了8例HIV感染（发生率为每100人年1.96例 [95% CI 0.98-3.92]）。

The proportion of individuals covered by PrEP during follow-up was highest in the CAB LA group (96.2%, 221,273/ 229,951 days), followed by the oral PrEP group within The Choice Cohort (64.1%, 32,272/ 50,310 days) and lowest in the comparison group (47.4%, 191,765/ 404,781 days).

在随访期间，CAB LA组中使用PrEP的个体比例最高（96.2%，221,273/229,951天），其次是The Choice队列中的口服PrEP组（64.1%，32,272/50,310天），而在对照组中最低（47.4%，191,765/404,781天）。

The study is sponsored by the Evandro Chagas National Institute of Infectious Diseases at the Oswaldo Cruz Foundation, Brazil, and funded by Unitaid.

该研究由巴西奥斯瓦尔多·克鲁兹基金会的埃万德罗·查加斯国家传染病研究所赞助，并由Unitaid资助。

Real-world data from OPERA show high effectiveness of CAB + RPV LA in broad populations

来自OPERA的真实数据显示，CAB + RPV LA在广泛人群中具有很高的有效性

3,4

3，4

The first of two OPERA analyses looked at long-term effectiveness in diverse virologically suppressed individuals on CAB+RPV LA - 42% of whom are Black and 30% Hispanic - through two years.

两项 OPERA 分析中的第一项通过两年时间，研究了在使用 CAB+RPV LA 的病毒学抑制效果显著的不同人群中的长期有效性，其中 42% 为黑人，30% 为西班牙裔。

In this large (n=2,485) U.S. cohort of individuals who switched to CAB + RPV LA, with a median follow-up time of 11 months (IQR: 6-18), 95% maintained virological suppression (<50c/ml at last Viral Load (VL) and 1% (n=21) experienced confirmed virologic failure (CVF) after a median of seven months. Outcomes were consistent over time through 24 months and across BMI categories (<30 kg/m.

在这个大型（n=2,485）的美国队列中，参与者转换为使用CAB + RPV LA治疗，中位随访时间为11个月（IQR：6-18），其中95%的个体维持了病毒学抑制（最后一次病毒载量（VL）<50拷贝/毫升），1%（n=21）在中位7个月后出现确认的病毒学失败（CVF）。在长达24个月的时间内以及不同BMI类别（<30 kg/m²）中，结果保持一致。

2

2

, ≥30 kg/m

，≥30 kg/m

2

2

).

）。

iii

iii

In a second analysis among a diverse group of 381 virologically suppressed women with HIV, with a median follow-up time of 12 months (IQR:7-19), 94% maintained suppression at their last viral load and CVF was ≤1.3% (n≤5).

在对381名病毒学抑制的HIV女性进行的第二次分析中，这些女性具有多样性，中位随访时间为12个月（四分位距：7-19），94%的女性在最后一次病毒载量检测时仍保持抑制，CVF ≤1.3%（n≤5）。

iv

四

High rates of viral suppression observed in Trio Health cohort

Trio Health队列中观察到较高的病毒抑制率

5

5

The Trio Health cohort followed 928 virologically suppressed individuals initiating CAB + RPV LA in real-world settings in the U.S. The median (IQR) follow-up time after the first injection was 12 months (5-19) and 89% of injections (6176/6934) were administered without delay (<7 days after the target dosing date).

Trio Health队列跟踪了在美国真实世界环境中开始使用CAB + RPV LA的928名病毒学抑制个体。第一次注射后的中位（四分位距）随访时间为12个月（5-19），并且89%的注射（6176/6934）按时进行（在目标给药日期后<7天内）。

Ninety-five percent of individuals on CAB+RPV LA maintained viral suppression (last VL <50 cp/mL) and 1.6% (n=15) experienced CVF..

百分之九十五的使用CAB+RPV LA的个体维持了病毒抑制（最近病毒载量<50拷贝/毫升），1.6%（n=15）经历了CVF。

These studies add to the real-world evidence supporting CAB+RPV LA’s high effectiveness in a broad range of populations.

这些研究增加了真实世界证据，支持CAB+RPV LA在广泛人群中具有高效性。

About

关于

Apretude

阿普雷特уд

Apretude

阿普雷特уд

is a medicine used for preventing sexually transmitted HIV-1 infection (pre-exposure prophylaxis or PrEP) in adults and adolescents weighing at least 35kg who are at high risk of being infected. Individuals must have a negative HIV-1 test prior to initiating

是一种用于预防成年人和体重至少35公斤的青少年性传播HIV-1感染（暴露前预防或PrEP）的药物，这些人群感染的风险较高。在开始使用前，个人必须进行HIV-1阴性测试。

Apretude

阿普雷特уд

(with or without an oral lead-in with oral cabotegravir) for HIV-1 PrEP. It should be used in combination with safer sex practices, such as using condoms.

（无论是否使用口服卡博特韦作为前导）用于HIV-1的PrEP。应与安全性行为实践（例如使用避孕套）结合使用。

Apretude

阿普雷特уд

contains the active substance cabotegravir.

包含活性物质卡博特韦。

Please consult the full Prescribing Information

请查阅完整的处方信息

here

这里

.

。

About

关于

Cabenuva

卡贝努瓦

(cabotegravir + rilpivirine)

（卡博特韦 + 利匹韦林）

Cabenuva

卡贝努瓦

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 35kg 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..

被指定为用于治疗12岁及以上且体重至少35公斤的成人和青少年HIV-1感染的完整方案，用于替代当前的抗逆转录病毒治疗方案，适用于那些在稳定的抗逆转录病毒治疗方案下病毒学抑制（HIV-1 RNA <50拷贝/毫升）的患者，这些患者没有治疗失败史，并且对卡博特韦或利匹韦林均无已知或疑似耐药性。

The complete regimen combines the integrase strand transfer inhibitor (INSTI) cabotegravir, developed by ViiV Healthcare, with rilpivirine, a non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Janssen Sciences Ireland Unlimited Company. Rilpivirine tablets are approved in the U.S. 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 35kg 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..

完整的治疗方案结合了由ViiV Healthcare开发的整合酶链转移抑制剂（INSTI）卡博特韦和由Janssen Sciences Ireland Unlimited Company开发的非核苷逆转录酶抑制剂（NNRTI）利匹韦林。利匹韦林片在美国已获批准，与卡博特韦联合使用时，适用于短期治疗HIV-1感染，针对12岁及以上且体重至少35公斤的成人和青少年，这些患者在稳定的治疗方案下病毒受到抑制（HIV-1 RNA小于50拷贝/mL），无治疗失败史，并且对卡博特韦或利匹韦林均无已知或怀疑的耐药性。

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..

整合酶抑制剂通过阻止病毒DNA整合到人体免疫细胞（T细胞）的遗传物质中来抑制HIV的复制。这一步骤在HIV复制周期中至关重要，也是导致慢性疾病形成的关键。利匹韦林是一种非核苷类逆转录酶抑制剂，通过干扰一种叫做逆转录酶的酶来发挥作用，从而阻止病毒的增殖。

Please consult the full Prescribing Information

请查阅完整的处方信息

here

这里

.

。

Trademarks are owned by or licensed to the ViiV Healthcare group of companies.

商标由ViiV Healthcare集团的公司拥有或许可。

About ViiV Healthcare

关于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.

ViiV Healthcare 是一家全球专业的艾滋病公司，由葛兰素史克（GSK，伦敦证交所代码：GSK）和辉瑞（Pfizer，纽约证交所代码：PFE）于2009年11月成立，致力于为艾滋病毒感染者以及可能受益于艾滋病预防的人们提供治疗和护理的进步。盐野义制药于2012年10月成为ViiV的股东。

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. .

该公司旨在比任何公司更深入、更广泛地关注艾滋病和艾滋病，并采取新的方法，为艾滋病治疗和预防提供有效且创新的药物，同时支持受艾滋病影响的社区。有关该公司、其管理层、产品组合、研发进展和承诺的更多信息，请访问 viivhealthcare.com。

About GSK

关于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.

GSK是一家全球生物制药公司，致力于联合科学、技术和人才，共同战胜疾病。欲了解更多信息，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 2024..

GSK提醒投资者，GSK所做的任何前瞻性声明或预测，包括本公告中所包含的内容，均受可能致使实际结果与预测结果存在重大差异的风险和不确定性影响。这些因素包括但不限于GSK 2024年Form 20-F年度报告中第3.D项“风险因素”下所述的内容。

References

参考文献

T Khan,

T可汗，

et al.

等人

PILLAR 12 Month Clinical Results: Zero HIV acquisition and High Persistance with CAB LA for PrEP. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

支柱12个月临床结果：使用CAB LA进行PrEP，零HIV感染且持久性高。于2025年3月9日至12日在加利福尼亚州旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上发布。

B Grinsztejn

B 格林斯兹恩

et al.

等。

ImPrEP CAB Brasil: Enhancing PrEP coverage with CAB LA in Young Key Populations. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

ImPrEP CAB 巴西：通过CAB LA提升年轻重点人群的PrEP覆盖率。在2025年逆转录病毒和机会性感染会议（CROI 2025）上展示，时间为3月9日至12日，地点为加利福尼亚州旧金山。

Sension M,

森西恩 M，

et al.

等。

Long-term CAB+RPV LA Effectiveness in Virologically Suppressed Individuals in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

在病毒学抑制的个体中，长效CAB+RPV在OPERA队列中的长期有效性。于2025年3月9日至12日在美国加利福尼亚州旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上发表。

Altamirano J,

阿尔塔米拉诺 J，

et al

等人

. Clinical outcomes Among Virologically Suppressed Women Receiving CAB+RPV LA in the OPERA Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

在OPERA队列中接受CAB+RPV LA治疗的病毒学抑制女性的临床结果。于2025年3月9日至12日在加利福尼亚州旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上发表。

Sax P,

萨克斯管，

et al

等人

. Outcomes on Cabotegravir + Rilpivirine in Suppressed People with HIV (PWH) in TRIO Health US Cohort. Presented at the Conference on Retroviruses and Opportunistic Infections (CROI 2025), 9-12 March, San Francisco, CA

. 在TRIO Health美国队列中，对接受Cabotegravir + Rilpivirine治疗的已抑制HIV感染者（PWH）的疗效结果。于2025年3月9日至12日在加利福尼亚州旧金山举行的逆转录病毒和机会性感染会议（CROI 2025）上展示。