Vocabria

词汇

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Rekambys

促销

(cabotegravir + rilpivirine) is the first and only complete long-acting injectable for the treatment of HIV

（cabotegravir+rilpivirine）是第一种也是唯一一种用于治疗HIV的完全长效注射剂

Ninety-nine percent of adolescents living with HIV preferred the long-acting injectable to a daily oral regimen when given the option due to convenience and pill burden reduction

由于方便和减轻药丸负担，99%的艾滋病毒感染青少年更喜欢长效注射剂而不是每日口服方案

This Marketing Authorisation builds on company legacy of expanding access to medicines for children and young people

这项上市授权建立在公司扩大儿童和年轻人获得药物的传统基础上

GSK plc (LSE/NYSE: GSK) announced that ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, has today announced that the European Commission has authorised

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，辉瑞和Shionogi为股东，今天宣布欧盟委员会已授权

Vocabria

词汇

(cabotegravir long-acting injections) in combination with Johnson & Johnson’s

（cabotegravir长效注射剂）与强生公司联合使用

Rekambys

促销

(rilpivirine long-acting injections) for the treatment of HIV-1 infection in adolescents 12 years of age and older and weighing at least 35 kg who are virologically suppressed.

（利匹韦林长效注射剂）用于治疗12岁及以上，体重至少35公斤，病毒学受到抑制的青少年的HIV-1感染。

As of 2023, there were 1.55 million people aged 10 to 19 around the world living with HIV; people in this age bracket typically have lower reported treatment coverage, adherence to treatment and viral suppression rates than older age groups.

截至2023年，全世界有155万10至19岁的艾滋病毒感染者；与年龄较大的人群相比，这个年龄段的人群通常报告的治疗覆盖率，坚持治疗和病毒抑制率较低。

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Cabotegravir and rilpivirine long-acting reduces the number of doses needed for effective HIV treatment from 365 daily pills to as few as six injectable treatments per year and helps alleviate challenges with daily oral treatments, including stigma and adherence-related stress, in clinical trials and observed in real-world studies..

卡博特格雷韦和利匹韦林长效将有效治疗艾滋病毒所需的剂量从每天365粒减少到每年少至6次注射治疗，并有助于缓解临床试验和现实世界研究中观察到的日常口服治疗挑战，包括耻辱感和依从性相关压力。。

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

ViiV Healthcare首席医疗官Harmony P.Garges医学博士表示：

'This authorisation for

“本授权书

Vocabria

词汇

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Rekambys

促销

is an important milestone for adolescents living with HIV across Europe who may prefer a long-acting HIV treatment that could address challenges with taking daily oral regimens and could better suit their individual needs. As the only global pharmaceutical company 100% dedicated to HIV, we are committed to ensuring no person living with HIV – regardless of their age – is left behind, and today’s announcement is one more step towards realising this mission.”.

对于整个欧洲感染艾滋病毒的青少年来说，这是一个重要的里程碑，他们可能更喜欢长效艾滋病毒治疗，这种治疗可以应对日常口服方案的挑战，并且可以更好地满足他们的个人需求。作为唯一一家百分之百致力于艾滋病毒的全球制药公司，我们致力于确保艾滋病毒感染者无论年龄大小都不会落后，今天的宣布是实现这一使命的又一步。”。

The Marketing Authorisations are supported by week 24 data from the MOCHA study, (IMPAACT 2017, Study 208580), an ongoing Phase I/II multicentre, open-label, non-comparative study of the safety, tolerability and pharmacokinetics of cabotegravir and rilpivirine long-acting. Based on data from the study in 144 adolescents (aged at least 12 years and weighing 35kg or more), no new safety concerns were identified and 139 of 144 participants (96.5%) remained virologically suppressed (plasma HIV-1 RNA value <50 c/mL)..

MOCHA研究（IMPAACT 2017，研究208580）的第24周数据支持了上市授权，这是一项正在进行的I/II期多中心，开放标签，非比较研究，涉及卡博格雷韦和利匹韦林长效的安全性，耐受性和药代动力学。根据144名青少年（年龄至少12岁，体重35公斤或以上）的研究数据，没有发现新的安全问题，144名参与者中有139名（96.5%）仍然受到病毒学抑制（血浆HIV-1 RNA值<50 c/mL）。。

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Ninety-nine percent of the MOCHA study participants (139/141) stated that they preferred injectable long-acting medicines over daily orals, mainly for the convenience and pill burden reduction; the most prominent components of pill burden reduction were decrease in adherence-related stress and increased privacy..

99%的摩卡研究参与者（139/141）表示，他们喜欢注射长效药物而不是每日口服，主要是为了方便和减轻药丸负担；减少药丸负担最突出的组成部分是减少依从性相关的压力和增加隐私。。

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Cabotegravir and rilpivirine long-acting, under the brand name

Cabotegravir和rilpivirine长效，品牌名称

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Rekambys

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, was approved by the EMA for the treatment of HIV-1 in adults who are virologically suppressed in December 2020.

，于2020年12月被EMA批准用于治疗被病毒学抑制的成年人的HIV-1。

About

关于

Vocabria

词汇

Vocabria

词汇

(cabotegravir) injection is indicated - in combination with rilpivirine injection - for the treatment of Human Immunodeficiency Virus type 1 (HIV-1) infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) 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..

（卡博特格雷韦）注射液与利匹韦林注射液联合使用，用于治疗成人和青少年（至少12岁，体重至少35kg）的人类免疫缺陷病毒1型（HIV-1）感染，这些人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），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

词汇

tablets are indicated - in combination with rilpivirine tablets - for the short-term treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) 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:.

片剂与利匹韦林片剂联合使用，用于短期治疗成人和青少年（至少12岁，体重至少35公斤）的HIV-1感染，这些人在稳定的抗逆转录病毒治疗方案中受到病毒学抑制（HIV-1 RNA<50拷贝/毫升），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

口服铅以评估耐受性

Vocabria

词汇

and rilpivirine prior to administration of long acting

和利匹韦林在服用长效药物之前

Vocabria

词汇

injection plus long acting rilpivirine injection.

注射加长效利匹韦林注射液。

oral therapy for adults who will miss planned dosing with

口服治疗将错过计划剂量的成年人

Vocabria

词汇

injection plus rilpivirine injection.

注射加利匹韦林注射液。

Vocabria

词汇

tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for

片剂仅用于与利匹韦林片剂联合治疗HIV-1，因此

Edurant

Edurant公司

(rilpivirine) tablets should also be consulted for recommended dosing.

（利匹韦林）片剂也应咨询推荐剂量。

Please consult the full Summary of Product Characteristics for all the safety information:

有关所有安全信息，请参阅产品特性的完整摘要：

Vocabria

词汇

400mg/600 mg prolonged-release suspension for injection and

400mg/600 mg注射用缓释混悬液和

Vocabria

词汇

30 mg film-coated tablets

30毫克薄膜包衣片

About

关于

Rekambys

促销

Rekambys

填海工程

is indicated - in combination with cabotegravir injection - for the treatment of HIV-1 infection in adults and adolescents (at least 12 years of age and weighing at least 35kg) 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..

与卡博特格雷韦注射液联合用于治疗成人和青少年（至少12岁，体重至少35公斤）的HIV-1感染，这些人在稳定的抗逆转录病毒治疗方案中受到病毒学抑制（HIV-1 RNA<50拷贝/mL），目前或过去没有对NNRTI和INI类药物产生病毒耐药性的证据，也没有先前的病毒学失败。。

Rekambys

促销

should always be co-administered with a cabotegravir injection. The prescribing information for cabotegravir injection should be consulted for recommended dosing.

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

促销

may be initiated with oral lead-in or without (direct to injection).

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:

有关所有安全信息，请参阅产品特性的完整摘要：

Rekambys

填海工程

600mg/900 mg prolonged-release suspension for injection

600mg/900 mg注射用缓释混悬液

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

商标由ViiV Healthcare group of Companys拥有或授权。

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 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前任何一家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。。

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.

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 Q3 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产生重大差异。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年第三季度的业绩。。

References

参考文献

Adolescent HIV treatment. Available at: https://data.unicef.org/topic/hivaids/adolescent-hiv-treatment. Last accessed December 2024.

青少年艾滋病毒治疗。网址：https://data.unicef.org/topic/hivaids/adolescent-hiv-treatment.上次访问时间为2024年12月。

Ramgopal MN, et al. Efficacy, safety, and tolerability of switching to long-acting cabotegravir plus rilpivirine versus continuing fixed-dose bictegravir, emtricitabine, and tenofovir alafenamide in virologically suppressed adults with HIV, 12-month results (SOLAR): a randomised, open-label, phase 3b, non-inferiority trial.

Ramgopal MN等人。在病毒学抑制的HIV成人中，改用长效卡博格雷韦加利匹韦林与持续固定剂量的比格拉韦，恩曲他滨和替诺福韦-阿拉芬胺的疗效，安全性和耐受性，12个月的结果（SOLAR）：一项随机，开放标签，3b期，非劣效性试验。

Lancet HIV 2023;10(9):e566-e577.

柳叶刀HIV 2023；10（9）：e566-e577。

Scherzer J, et al. Perceptions of cabotegravir + rilpivirine long-acting (CAB+RPV LA) from people living with HIV (PLHIV) in the CARLOS study. IAS 2023, poster EPE0863.

在CARLOS研究中，Scherzer J等人对HIV感染者（PLHIV）对cabotegravir+rilpivirine长效（CAB+RPV-LA）的看法。IAS 2023，海报EPE0863。

Gaur A et al. Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study. CROI 2024, abstract 188. Available at:

Gaur A等人，《艾滋病青少年中的长效卡博特格雷韦联合利匹韦林：2017年第24周IMPAACT（MOCHA）研究》。CROI 2024，摘要188。网址：

Long-Acting Cabotegravir Plus Rilpivirine In Adolescents With HIV: Week 24 IMPAACT 2017(MOCHA) Study - CROI Conference

长效卡博特格雷韦联合利匹韦林治疗青少年艾滋病毒感染者：2017年第24周IMPAACT（摩卡）研究-CROI会议

. Last accessed January 2025.

.上次访问时间为2025年1月。

Lowenthal ED et al. IMPAACT 2017 Adolescent/Parent Experiences With LA Cabotegravir Plus Rilpivirine for HIV Treatment. CROI 2024, abstract 949. Available at: https://www.croiconference.org/abstract/impaact-2017-adolescent-parent-experiences-with-la-cabotegravir-plus-rilpivirine-for-hiv-treatment. Last accessed January 2025..

Lowenthal ED等人，IMPAACT 2017青少年/父母使用LA Cabotegravir加Rilpivirine治疗艾滋病毒的经验。CROI 2024，摘要949。网址：https://www.croiconference.org/abstract/impaact-2017-adolescent-parent-experiences-with-la-cabotegravir-plus-rilpivirine-for-hiv-treatment.上次访问时间为2025年1月。。