LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced 48-week findings from the DOLCE study, sponsored by Fundación Huésped and the Bahiana Foundation of Infectiology, showing the 2-drug regimen Dovato (dolutegravir/lamivudine [DTG/3TC]) achieved similar results to 3-drug therapy in viral suppression in a population of adults with advanced HIV.

伦敦——（商业新闻短讯）——由葛兰素史克（GSK）控股、辉瑞（Pfizer）和Shionogi（Shionogi）为股东的全球艾滋病专家公司ViiV Healthcare今天宣布了由Fundación Huésped和Bahiana Foundation of Infectiology赞助的DOLCE研究为期48周的结果，该研究显示，在晚期HIV感染人群中，双药方案Dovato（dolutegravir/拉米夫定[DTG/3TC]）在病毒抑制方面取得了与三药疗法相似的结果。

A post-hoc analysis of the study showed DTG/3TC was non-inferior to 3-drug therapy regardless of the participant’s baseline viral load. These data were presented at HIV Glasgow 2024, being held in Glasgow, Scotland from 10 – 13 November..

该研究的事后分析显示，无论参与者的基线病毒载量如何，DTG/3TC都不逊于3种药物治疗。这些数据于11月10日至13日在苏格兰格拉斯哥举行的2024年格拉斯哥艾滋病毒会议上公布。。

Harmony P. Garges, M.D., Chief Medical Officer, at ViiV Healthcare, said: “We know taking fewer medicines is an important consideration for many in the HIV community, and these new data continue to reinforce the efficacy and safety of Dovato, a 2-drug regimen. The findings from the DOLCE study build on the robust body of evidence supporting its use in treatment-naïve adults living with HIV and shows comparable efficacy to a 3-drug regimen, even in people with low CD4 counts and high viral loads.”.

ViiV Healthcare首席医疗官Harmony P.Garges医学博士说：“我们知道减少服用药物是艾滋病毒社区许多人的一个重要考虑因素，这些新数据继续增强了Dovato（一种双药治疗方案）的疗效和安全性。DOLCE研究的结果建立在强有力的证据基础上，支持其用于治疗未经治疗的艾滋病毒感染者，并且显示出与三药治疗方案相当的疗效，即使在CD4计数低和病毒载量高的人群中也是如此。”。

DOLCE is a randomised, open-label, multicentre study assessing the efficacy and safety of DTG/3TC in 230 antiretroviral treatment (ART)-naïve people with advanced HIV (low CD4 counts [≤200 cells/mL]).1 In the clinical trial, participants were randomised in a 2:1 ratio to receive DTG/3TC (n=152) or DTG+TDF/XTC (n=77).

DOLCE是一项随机，开放标签，多中心研究，评估DTG/3TC在230例抗逆转录病毒治疗（ART）初治的晚期HIV患者（低CD4计数[≤200个细胞/mL]）中的疗效和安全性。在临床试验中，参与者以2:1的比例随机接受DTG/3TC（n=152）或DTG+TDF/XTC（n=77）。

The baseline characteristics of the participants were similar between the two treatment groups and represented a population of people with severe immunosuppression – 43% of participants having baseline CD4 counts less than 100 cells/mL, 69% having baseline viral load (VL) greater than 100,000 copies (c)/mL, and 23% having a very high baseline VL, greater than 500,000 copies (c)/mL..

两个治疗组参与者的基线特征相似，代表了严重免疫抑制的人群-43%的参与者基线CD4计数低于100个细胞/mL，69%的参与者基线病毒载量（VL）大于100000拷贝（c）/mL，23%的参与者基线VL非常高，大于500000拷贝（c）/mL。。

The primary endpoint of the study was the proportion of subjects with VL <50 copies/ml at week 48. At week 48 comparable efficacy was observed, with 82% of individuals in the DTG/3TC group and 80% in the 3-drug regimen group achieving a VL<50. Furthermore, a post-hoc analysis showed that Dovato was non-inferior to the 3-drug regimen in achieving a VL<50..

该研究的主要终点是第48周VL<50拷贝/ml的受试者比例。在第48周观察到可比较的疗效，DTG/3TC组中82%的个体和3药方案组中80%的个体达到VL<50。此外，事后分析表明，Dovato在达到VL<50方面并不劣于3药方案。。

Prof. Pedro Cahn, Scientific Director of Fundación Huésped study investigator of the DOLCE study, said: “It’s encouraging to see additional new data that continue to support the efficacy and safety of 2-drug regimens compared to traditional 3-drug regimens. The results from DOLCE provide healthcare providers with further confidence in prescribing DTG/3TC and are important findings for people living with HIV taking medicines to suppress their virus.”.

DOLCE研究的Fundación Huésped研究研究员佩德罗·卡恩（Pedro Cahn）教授说：“与传统的3种药物治疗方案相比，看到更多的新数据继续支持2种药物治疗方案的有效性和安全性，这令人鼓舞。DOLCE的结果为医疗保健提供者开处方DTG/3TC提供了进一步的信心，也是艾滋病毒感染者服用药物抑制病毒的重要发现。”。

A post-hoc analysis reported that DTG/3TC was non-inferior to 3-drug therapy (adjusted risk difference of 2.0%, 95% CI -8.6; 12.8%).1 The study also showed that secondary efficacy measures of viral load decline, time to viral suppression, and CD4 recovery were similar between arms. Efficacy by baseline viral load categories was similar across both arms, including those with baseline viral load greater than 500,000 copies with 74% in the DTG/3TC arm, and 67% in the DTG+TDF/XTC arm achieving virologic success.

事后分析报道，DTG/3TC不逊于3种药物治疗（调整后的风险差异为2.0%，95%可信区间为8.6；12.8%）。1该研究还表明，病毒载量下降，病毒抑制时间和CD4恢复的次要疗效指标在两组之间相似。基线病毒载量类别的疗效在两组中相似，包括基线病毒载量大于500000拷贝的那些，DTG/3TC组为74%，DTG+TDF/XTC组为67%，取得病毒学成功。

The change in median CD4 count from baseline to Week 48 showed an increase of 200 cells/mL in the DTG/3TC arm and an increase of 177 cells/mL in the triple therapy arm..

从基线到第48周，CD4中位数的变化显示DTG/3TC组增加了200个细胞/mL，三联疗法组增加了177个细胞/mL。。

Safety through Week 48 was comparable across both arms and consistent with known safety profiles and showed similar rates of serious adverse events (SAEs) and immune reconstitution inflammatory syndrome across arms. The rate of discontinuation in both arms was also similar (DTG/3TC = 12.8%; DTG+TDF/XTC = 6.8%)..

第48周的安全性在两组之间具有可比性，并且与已知的安全性特征一致，并且显示出相似的严重不良事件（SAE）和免疫重建炎症综合征的发生率。两组的停药率也相似（DTG/3TC=12.8%；DTG+TDF/XTC=6.8%）。。

About DOLCE

关于DOLCE

The DOLCE (NCT04880395) randomised clinical trial is a phase IV, open-label, multicentre clinical trial assessing the efficacy of DTG/3TC for the treatment of HIV-1 in treatment-naïve adults 18 years or older with CD4+ T-cell count ≤200 c/mm3 and HIV-1 RNA >1,000 copies/mL with no known ART-resistance or HBV co-infection, conducted in 11 sites across Argentina and Brazil.

DOLCE（NCT04880395）随机临床试验是一项IV期，开放标签，多中心临床试验，评估DTG/3TC治疗18岁或以上未接受治疗的成年人中HIV-1的疗效，CD4+T细胞计数≤200 c/mm3，HIV-1 RNA>1000拷贝/mL，无已知的ART耐药性或HBV合并感染，在阿根廷和巴西的11个地点进行。

The primary endpoint was the proportion of participants with plasma HIV-1 RNA <50 c/mL at Week 48 (FDA snapshot for ITT-E population) and secondary outcomes included, among others, efficacy, resistance, safety, and tolerability..

主要终点是第48周血浆HIV-1 RNA<50 c/mL的参与者比例（ITT-E人群的FDA快照），次要结果包括疗效，耐药性，安全性和耐受性。。

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。。

Dovato is approved in the US, Europe, Japan, Australia, and other countries worldwide.

Dovato在美国、欧洲、日本、澳大利亚和全球其他国家获得批准。

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。

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 Fundación Huésped

关于宿主基金会

Fundación Huésped is an Argentine organisation with a regional reach that has been working in public health since 1989, aiming to ensure the right to health and the control of diseases are guaranteed. Our comprehensive approach includes the development of research, practical solutions, and communications related to public health policies in our country and the region.

Huésped基金会（Fundación Huésped）是一个阿根廷组织，自1989年以来一直致力于公共卫生领域，旨在确保健康权和疾病控制得到保障。我们的综合方法包括开发与我国和该地区公共卫生政策相关的研究，实用解决方案和沟通。

Our mission is to conduct scientific research and implement preventive actions and rights-promotion initiatives to ensure access to healthcare and reduce the impact of diseases, with a focus on HIV/AIDS, viral hepatitis, vaccine-preventable diseases, and other transmissible diseases, as well as sexual and reproductive health..

我们的使命是进行科学研究，实施预防行动和权利促进举措，以确保获得医疗保健并减少疾病的影响，重点是艾滋病毒/艾滋病、病毒性肝炎、疫苗可预防疾病和其他传播疾病，以及性健康和生殖健康。。

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GSK（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..

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。。

For more information on the company, its management, portfolio, pipeline, and commitment, please visit viivhealthcare.com.

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 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的生物制药公司，旨在联合科学、技术和人才共同战胜疾病。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。。

Registered in England & Wales:

在英格兰和威尔士注册：

GSK plc

葛兰素史克公司

ViiV Healthcare Limited

ViiV医疗保健有限公司

No. 3888792

编号3888792

No. 06876960

编号：06876960

Registered Office:

注册办事处：

79 New Oxford Street

新牛津街79号

ViiV Healthcare Limited

ViiV医疗保健有限公司

London

伦敦

GSK Medicines Research Centre

葛兰素史克药物研究中心

WC1A 1DG

WC1A 1DG

Gunnels Wood Road, Stevenage

Stevenage Gunnels Wood路

United Kingdom

英国

SG1 2NY

SG1 2NY

References

参考文献

1M. I. Figueroa, et al. Comparable efficacy and safety of dolutegravir / lamivudine to a three drug regimen amongst ARV naive people living with HIV with CD4 <200/mm3: the DOLCE study. Presented at HIV Glasgow 2024, 10 – 13 November, Glasgow, Scotland.

1米。一、 Figueroa等人。dolutegravir/拉米夫定与三药方案在CD4<200/mm3的ARV初治HIV感染者中的疗效和安全性相当：DOLCE研究。于2024年11月10日至13日在苏格兰格拉斯哥举行的艾滋病毒格拉斯哥会议上发表。

For media and investors only

仅供媒体和投资者使用