Dolutegravir Plus Lamivudine (DTG/3TC) Dual Therapy Versus Dolutegravir With TDF-lamivudine (DTG + TDF/3TC) Among Antiretroviral naïve People With HIV and TB Receiving Rifampin-based TB Treatment

This will be a Phase IIIb Clinical Trial, an international multicenter, randomized, three-arm, non-comparative trial of efficacy, safety, and tolerability of the dual therapy regimen dolutegravir plus lamivudine either twice daily or DTG/3TC ( Dovato) in the morning +dolutegravir (DTG) in the evening, versus standard of care (SOC) twice-daily dolutegravir plus 2 once-daily Nucleoside reverse-transcriptase inhibitors (NRTIs) tenofovir disoproxil fumarate /lamivudine (TDF/3TC), among antiretroviral therapy (ART)-nave individuals with HIV-1 receiving rifampin-based TB therapy

开始日期2025-09-18

申办/合作机构

The Johns Hopkins University

[+1]

NCT06967753

/ Recruiting临床4期IIT

Switch to Dolutegravir Plus Lamivudine Dual-therapy in Transgender Women Living With HIV on Virologically Suppressive Antiretroviral Therapy (TRANS-SWITCH)

This single-arm, open label study is aimed to assess efficacy and safety of dolutegravir plus lamivudine as a switch strategy among TGW with HIV receiving suppresive antiretroviral therapy.

开始日期2025-07-31

申办/合作机构

ViiV Healthcare Ltd.

[+1]

CTR20252339

/ CompletedN/A

拉米夫定多替拉韦片（300mg/50mg）在健康受试者中随机、开放、两制剂、单次给药、两周期、两序列空腹状态下的生物等效性试验

主要目的：以海南林依生物科技有限公司的拉米夫定多替拉韦片（规格：拉米夫定300mg/多替拉韦钠50mg（以多替拉韦计））为受试制剂，按生物等效性试验的有关规定，与持证商ViiV Healthcare BV公司的拉米夫定多替拉韦片（规格：拉米夫定300mg/多替拉韦钠50mg（以多替拉韦计），商品名：多伟托®）对比空腹状态下在健康人体内的吸收速度及吸收程度，考察两制剂的人体生物等效性。次要目的：观察空腹状态下受试制剂拉米夫定多替拉韦片（300mg/50mg）和参比制剂拉米夫定多替拉韦片（300mg/50mg）（商品名：多伟托®）在健康受试者中的安全性。

开始日期2025-06-30

申办/合作机构

海南林依生物科技有限公司

100 项与多替拉韦钠/拉米夫定相关的临床结果

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100 项与多替拉韦钠/拉米夫定相关的转化医学

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100 项与多替拉韦钠/拉米夫定相关的专利（医药）

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项与多替拉韦钠/拉米夫定相关的文献（医药）

2025-10-01·Therapeutic Advances in Infectious Disease

Patient-reported outcomes among people living with HIV switching to dual therapy with dolutegravir/lamivudine: results from the PROBI study

Article

作者: Marcellin, Fabienne ; Chassany, Olivier ; Brown Hajdukova, Eva ; Alain, Tristan ; Duracinsky, Martin ; Hocqueloux, Laurent ; Rousset Torrente, Olivia ; Zucman, David ; Allavena, Clotilde

Background::

Simplification of antiretroviral regimens has the potential to improve both patient-reported outcomes (PROs) and therapeutic adherence in people living with HIV (PLWH). Dual therapy with dolutegravir (DTG) plus lamivudine (3TC) demonstrated good safety and efficacy, but its impact on PROs remains to be documented.

Objectives::

To evaluate PROs among adult PLWH switching from standard multi-drug therapy to the DTG/3TC combined therapy Dovato ® .

Design::

A non-comparative, 6-month observational study in 25 French medical centers.

Methods::

Sociodemographic and biomedical data were collected from medical records and PROs from self-administered questionnaires at treatment switch (Day, D0) and at months (M) 1 and 6. Primary endpoints included changes between D0 and M6 in perceived toxicity, treatment acceptability, PLWH’s preferences, and the score value of the treatment impact dimension of health-related quality of life (HRQL) (PROQOL-HIV) during follow-up. Secondary endpoints encompassed scores in other HRQL dimensions and self-reported symptoms. Multivariable standard and mixed-effects linear regression models were used to identify factors associated with PRO values and changes over time. Additionally, binary logistic regression was used to identify factors associated with the discontinuation of combined DTG/3TC regimen.

Results::

In the study population (260 PLWH, 64.6% male, mean ± SD age: 51 ± 12 years, 16 ± 10 years since HIV diagnosis), 20 individuals stopped treatment during follow-up, without resumption. Men, individuals previously receiving abacavir/3TC/DTG, and those with better daily comfort and perceived treatment efficacy were less likely to stop treatment. Treatment impact-related HRQL, acceptability of treatment, and number of self-reported symptoms significantly improved at M1 and M6. Mental and cognitive HRQL improved at M6.

Conclusion::

Dolutegravir and lamivudine dual oral therapy improved several dimensions in HRQL and delivered a simplified treatment regimen designed for eligible patients, supporting a patient-centered approach to managing HIV care. Attention should be maintained on the reasons for treatment discontinuation, especially among women.

Trial registration::

Patient-Reported Outcomes HV BItherapy (PROBI) was registered as number NCT04788784 on https://clinicaltrials.gov/study/NCT04788784?term=PROBI&rank=2 .

2025-04-21·Cureus Journal of Medical Science

A Stable Switch From Bictegravir/Emtricitabine/Tenofovir Alafenamide (B/FTC/TAF) to Dolutegravir/Lamivudine (DTG/3TC) in the Absence of Historical Resistance Records: Results From the Switch to Dovato in Patients Suppressed on Biktarvy (SOUND) Cohort

Article

作者: Fallon, James P ; Borsi, Rebecca A ; Touza, Masara ; Slim, Jihad ; Bellafiore, Paul

OBJECTIVE:

This article aims to examine the safety and efficacy of switching from bictegravir/emtricitabine/tenofovir alafenamide (B/FTC/TAF) to dolutegravir and lamivudine (DTG/3TC) in the absence of prior resistance records.

DESIGN:

Switch to Dovato in patients suppressed on Biktarvy (SOUND) is an open-label, single-arm, pilot study of adult people with HIV who were virologically suppressed (HIV-1 <50 copies/mL) on B/FTC/TAF for >24 weeks, and switched to DTG/3TC in the absence of available resistance records.

METHODS:

The primary endpoint was the percentage of participants with HIV viral load (VL) ≥50 c/mL at week 48. Secondary endpoints at weeks 48 and 96 included the percentage of participants with HIV-VL <50 c/mL, incidence and severity of adverse events, laboratory abnormalities, change in baseline CD4 cell count, and retrospective proviral DNA resistance testing on banked baseline samples.

RESULTS:

Of the 40 individuals enrolled, 0% had VL ≥50 c/mL at week 48. No participants discontinued due to laboratory abnormalities or safety-related concerns. Three participants withdrew from the study while virologically suppressed. Among the 32 baseline samples available for retrospective proviral DNA resistance testing, six (19%) had nucleoside reverse transcriptase inhibitor resistance-associated mutations (RAMs), all with M184V. Two (6%) participants had integrase strand transfer inhibitor RAMs at baseline (S147S/G and Q148Q/R); neither conferred resistance to DTG. Nonnucleoside reverse transcriptase inhibitor and protease inhibitor RAMs were observed in eight (25%) and three (9%) participants, respectively. A significant decrease in weight was observed over the study period.

CONCLUSIONS:

Results from SOUND support the efficacy and safety of switching to DTG/3TC for people living with HIV-1 who are virologically suppressed on B/FTC/TAF with unknown resistance history and may confer a weight advantage.

2024-12-01·LIFE SCIENCES

Clinical efficacy and safety of new compound single tablet antiviral drugs in the treatment of HIV/AIDS

Article

作者: Li, Xin ; Zhu, Na ; Lin, Yingying ; Yi, Yunyun ; Cui, Xinyu

AIMS:

Genvoya, Biktarvy and Dovato are novel single-tablet antiretroviral therapy(ART). The aim of this study is to explore the therapeutic effects of these novel drugs on HIV/AIDS.

MAIN METHODS:

This retrospective cohort study, conducted at a single center, included a total of 200 HIV-treated patients who transitioned to these new antiretroviral drugs from July 2021 to August 2023. Data were extracted from electronic medical records at Ditan Hospital. The Genvoya group comprised 22 patients, and all subsequent switches in this group were to Biktarvy. The primary HAART group consisted of 178 patients initially treated with a first-line triple Highly Active Antiretroviral Therapy (HAART) regimen during the same period. This group was further subdivided into HAART+Dovato, HAART+Biktarvy, and HAART+Genvoya groups based on the switching regimen. The primary outcomes focused on changes in viral load and immune efficacy, while secondary safety indicators included blood/liver function, lipid parameters, renal function, blood glucose, blood uric acid, etc. KEY FINDINGS: The viral suppression rate was 100 % after the drug change treatment, and CD4+ T cell counts increased significantly across all four groups. Over the 6-month treatment period, there were increases in creatinine (Cr), low-density lipoprotein (LDL), high-density lipoprotein (HDL), erythrocyte count, and glomerular filtration rate (eGFR). Conversely, Alanine transaminase (ALT), Aspartate aminotransferase (AST), C-reactive protein (CRP), albumin (ALB), and blood glucose (Glu) levels decreased.

SIGNIFICANCE:

Genvoya, Biktarvy and Dovato are recommended for the treatment of HIV/AIDS and have a good safety profile.

项与多替拉韦钠/拉米夫定相关的新闻（医药）

2025-10-26

·同写意

GSK要大干一场了

11月28日-30日泰州医博会期间，同写意将组织30+场交流对接活动，邀请300+展商前来展览展示，欢迎报名演讲，设展。一纸CEO更替公告，让全球目光再次聚焦葛兰素史克（GSK）。近日，GSK宣布重磅人事安排，任命Luke Miels为CEO候选人。他将于2026年1月1日全面履行首席执行官职责并加入董事会。消息公布后，资本市场给出了积极反馈，GSK股价连续3个交易日大涨，累计涨幅超13%。不过，积极乐观的背后是残酷的现实：由于核心的疫苗业务遭遇下滑，GSK在2024年跌出了全球制药企业营收十强行列。新帅上任，不仅要直面收入规模增长放缓的困境，还肩负着让GSK到2031年总销售额突破400亿英镑的重任。2024年，GSK总营收同比仅增长3%至313.76亿英镑。想要达成高目标，未来GSK需要找到新的战略增长点，破局之路在何方？ TONACEA 01 “三驾马车”并进回看GSK过去九年的发展，离不开现任首席执行官Emma Walmsley的领航。 2016年9月20日，GSK宣布任命Emma Walmsley为新一任CEO。直到此次GSK宣布换帅，由Luke Miels接替Emma Walmsley成为下一任掌门人，后者将于2025年12月31日正式卸任GSK董事会职务。在九年任期内，Emma Walmsley为GSK带来了许多新变化：成功分拆了消费者保健业务，将公司业务来源分为特药、疫苗、普药三大块，并优先发展特药和疫苗，带来了多款重要的新产品，包括呼吸道合胞病毒（RSV）疫苗等，还让GSK研发端重新焕发活力，15个重要管线将在2025年-2031年上市。简而言之，Emma Walmsley推动GSK完成了从“综合药企”到“专注生物制药”的战略聚焦。对于Emma Walmsley做出的重要贡献，资本市场反馈也比较积极：自2016年9月20日至2025年9月30日收盘，GSK股价累计涨幅达到25.66%。从经营情况看，近年来GSK业绩表现起起伏伏。 2019年至2021年，由于成熟药品销售额持续缓慢下降，新产品尚未成长为重磅炸弹，GSK总收入规模持续3年基本持平。直到2022年完成消费健康业务的分拆，GSK实现总收入同比增长19%至293.24亿英镑，其中特药、疫苗、普药三大板块分别同比增长37%、17%、5%，占公司总收入比重分别为38.4%、27.07%、34.5%。 2023年，GSK实现总收入为303.28亿英镑，同比增长5%（不计新冠肺炎相关业务影响，为+14%），其中疫苗板块收入同比增长25%（排除新冠产品增长24%）。不过，到了2024年，由于核心的疫苗业务遭遇下滑，导致GSK总收入同比仅增长3%至313.76亿英镑，还跌出了全球制药企业营收TOP10行列。而且，普药板块收入表现也不稳定，2024年、2025年上半年实现营收同比增长分别为+6%、-3%。图片来源：国盛证券研报相较之下，特药板块增长最为强劲。2024年、2025年上半年，特药板块贡献收入分别为118.1亿英镑、62.6亿英镑，同比增长19%、16%，而且占GSK总收入比重提升至40.38%，已成为GSK业绩发展的关键支柱。今年上半年，特药板块中的HIV、肿瘤、呼吸/免疫/炎症（RI&I）三大疾病领域均实现两位数增长，分别达到10%、47%、18%。值得一提的是，即将上任的新掌门人Luke Miels，在构建GSK的特色药物产品组合方面发挥了重要作用，尤其是在肿瘤和呼吸疾病领域。Luke Miels于2017年加入GSK，目前担任首席商务官，负责全球药品和疫苗业务。这或许预示着，未来GSK将在核心领域大干一场。 TONACEA 02 “冰与火”之歌如果用一句话来概括GSK的经营现状，那就是上演了一场“冰与火”之歌。从业绩表现来看，合计贡献近六成营收的疫苗和普药两大板块收入起伏不定。 2024年、2025年上半年，疫苗板块营收同比增长分别为-4%、+1%，其中带状疱疹疫苗Shingrix销售额均与上年基本持平，RSV疫苗Arexvy因美国疾病控制与预防中心收紧推荐接种年龄，导致销售额连续大幅下滑。当然，疫苗板块也有亮点之处。今年上半年，脑膜炎疫苗Meningiti（Bexsero和Menveo等）实现收入同比增长21%至7.29亿英镑。但一花独放不是春，疫苗业务的缺口亟需更多新产品填补。今年2月，GSK的五价脑膜炎球菌疫苗Penmenvy（脑膜炎球菌群A、B、C、W和Y疫苗）获美国FDA批准上市，适用于10-25岁人群。据Norstella的Evaluate Vantage预测，到2030年，Penmenvy的全球销售额将达到11亿美元。特药板块也是“喜忧参半”。一方面，HIV、肿瘤、呼吸/免疫领域保持稳健增长态势，成为GSK未来发展的“压舱石”，但另一方面，HIV领域存在“隐忧”。当前，GSK的HIV业务收入主要来源于多替拉韦产品组合，包括Tivicay、Triumeq、Juluca和Dovato。然而，作为这四款畅销药物核心成分的Dolutegravir（多替拉韦）的分子专利将于2027年到期（晶体专利2029年到期），即将面临仿制药竞争的压力。为了对抗专利悬崖和吉利德等强敌的竞争，GSK推出了更方便的长效注射HIV药物Cabenuva（卡替拉韦+利匹韦林）和Apretude（卡替拉韦），以及贡献不菲收入的口服复方制剂Dovato（多替拉韦+拉米夫定），目前这些药物均处于快速放量期。图片来源：GSK官网在特药板块中，肿瘤业务的增长势头最为迅猛，2024年、2025年上半年营收同比增长分别达到98%、47%，主要得益于PARP抑制剂Zejula（尼拉帕利）、PD-1单抗Jemperli、JAK1/JAK2/ACVR1抑制剂Ojjaara（莫洛昔尼）等产品的贡献。未来肿瘤业务的增长亮点，在于头对头击败强生达雷妥尤单抗的BCMA ADC药物Blenrep（玛贝兰妥单抗），GSK预计其销售峰值将超过30亿英镑。呼吸/免疫业务表现也十分出色，2025年上半年实现营收同比增长18%至17.67亿英镑，得益于两款重磅炸弹药物的贡献，包括每月注射一次的IL-5单抗Nucala（美泊利珠单抗）和BAFF单抗Benlysta（贝利尤单抗）。值得注意的是，GSK有一款销售额峰值预计超40亿英镑的大药已进入冲刺时刻——新一代超长效IL-5单抗Depemokimab（德莫奇单抗），每年仅需注射两次，已向FDA递交用于治疗哮喘和慢性鼻窦炎伴鼻息肉（CRSwNP）两项适应症的上市申请，PDUFA日期为2025年12月16日。 TONACEA 03 破局之战 GSK新帅Luke Miels的任务很明确，带领GSK实现“2031年总销售额超过400亿英镑”的目标。结合GSK当前的经营现状，可以说，这是一场突破增长瓶颈的破局之战。突破的关键，就在于找到新的增长引擎。基于此，GSK将布局重点放在了肿瘤学和呼吸/免疫/炎症（RI&I）领域上，这正是新帅Luke Miels做出过重要贡献的领域。例如，GSK在2024年10月以超8亿美元引进恩沐生物一款用于自免疾病的CD19/CD20/CD3三抗CMG1A46，又在12月以超10亿美元引进映恩生物开发的针对胃肠道（GI）癌症的潜在同类最佳ADC药物DB-1324。 2025年，GSK继续买买买，收购了IDRx、Boston Pharmaceuticals，还与恒瑞医药达成总金额高达120亿美元的合作，共同开发至多12款涵盖呼吸、自免和炎症、肿瘤治疗领域的创新药物，包括潜在同类最优PDE3/4抑制剂HRS-9821。具体来看，通过收购IDRx，GSK拿下了一种高度选择性的KIT酪氨酸激酶抑制剂IDRX-42。目前，该药正在开展一线和二线治疗胃肠道间质肿瘤（GIST）患者的临床试验。 GSK斥资20亿美元收购Boston Pharmaceuticals，主要是看中后者一种新型的、每月一次皮下注射的成纤维细胞生长因子21（FGF21）类似物Efimosfermin alfa。目前，Efimosfermin alfa已处于III期阶段，用于治疗脂肪变性肝病（SLD），包括代谢功能障碍相关脂肪性肝炎（MASH），包括肝硬化，以及未来可能出现的酒精性肝病（ALD），预计在2029年首次上市。ALD影响全球约2600万患者，与MASH一起是美国肝移植的主要原因。此前，GSK布局了一款用于SLD患者亚组的siRNA治疗药物GSK-990，而Efimosfermin alfa具有与GSK-990联合用药的潜力。值得一提的是，近期诺和诺德以52亿美元收购Akero Therapeutics，拿下一款已进入临床III期、治疗MASH的FGF21类似物Efruxifermin（EFX）。而且，盯上MASH领域的MNC巨头还有很多，这无疑为Efimosfermin alfa带来了巨大的想象空间。资料来源：灼识咨询另外，GSK从恒瑞医药引进的HRS-9821，是一款潜在的同类最佳PDE3/4抑制剂，目前处于临床Ⅰ期阶段，可用于治疗慢性阻塞性肺（COPD），作为辅助维持治疗，无需考虑既往治疗方案。在早期临床和临床前研究中，HRS-9821显示出强效的PDE3和PDE4抑制作用，从而增强支气管扩张和抗炎作用，并为开发便捷的干粉吸入器（DPI）制剂提供了机会。值得注意的是，PDE3/4抑制剂赛道极具潜力，目前全球仅一款药物获批上市，尚处于蓝海阶段。今年7月，默沙东豪掷100亿美元收购Verona Pharma，拿下了全球首款PDE3/4双重抑制剂Ohtuvayre（Ensifentrine，恩塞芬汀）。Ohtuvayre是20多年来首个用于治疗COPD的新型吸入机制药物，分析师预测其峰值销售额将达到40亿美元。 — 结语 — CEO更替标志着GSK进入新阶段，破局之路已清晰指向了深度创新与核心领域强化。通过“买买买”模式高效地填补研发管线的空白，预示着未来GSK将继续在全球范围内搜寻有潜力的资产，打造具有竞争力的产品组合，以支撑其400亿英镑的营收目标。未来的成败，将取决于这些创新管线能否成功兑现其巨大的市场潜力，并有效对冲疫苗、普药板块波动与HIV领域专利悬崖带来的风险。尤其是，未来几年的执行力，将直接决定GSK是能重返全球药企营收十强行列，还是被增长瓶颈所困。参考资料： 1.葛兰素史克的财报、公告、官微 2.《GSK 2025H1：肿瘤业务收入大涨，HIV业务保持强势，公司2031年目标锁定400亿+英镑》，医药魔方，2025年07月30日 3.国盛证券研报

疫苗高管变更财报

2025-10-17

·CPHI制药在线

2025年畅销传染病药物TOP20

关注并星标CPHI制药在线随着全球注意力继续集中在大流行防范、抗菌素耐药性和疫苗驱动的疾病预防上，传染病疗法仍然处于药物创新和商业成功的前沿。 2024年，吉利德、辉瑞、默沙东和葛兰素史克（GSK）等领先制药商从针对 HIV、COVID-19、HPV、RSV、带状疱疹、肺炎和其他严重感染的疫苗和抗病毒药物中获得了数十亿美元的收入。虽然一些疗法，如 HIV 领跑者 Biktarvy 和 HPV 疫苗 Gardasil，保持了强劲的势头，但其他疗法，即 Paxlovid 和 Veklury 等 COVID-19 疗法，由于大流行时期的需求下降而面临阻力。在这里，我们重点介绍了 2024 年20种最畅销的传染病药物，分析了它们的财务业绩以及 2025年的预期。 1. Biktarvy（比克替拉韦/恩曲他滨/替诺福韦艾拉酚胺）适应症：艾滋病毒企业：吉利德 2024 年销售额：134.2 亿美元图1.Biktarvy组成结构图片来源：参考资料[1] 2025年展望：吉利德旗下的 HIV 治疗药物 Biktarvy 是 2024 年全球销量最高的传染病药物，全球销售额约为 134.2 亿美元，同比增长 13%，占吉利德 HIV 收入的一半以上。仅在第四季度，Biktarvy 的销售额就增长了 21%，达到 38 亿美元，巩固了其作为美国和其他主要市场领先的 HIV 治疗方案的地位。这一激增主要是由需求增加、有利的库存动态和更高的平均实现价格推动的。2025年上半年该药物的全球销售额已达到66.8亿美元。同比增长8.1%，极大地促进了吉利德的艾滋病毒产品总销售额。 2. Gardasil（Gardasil 9，HPV疫苗）适应症：HPV 企业：默沙东 2024 年销售额：85.8 亿美元图2.Gardasil组成结构图片来源：参考资料[1] 2025年展望：默沙东的 HPV 疫苗 Gardasil/Gardasil 9 在 2024 年创造了 86 亿美元的全球销售额，由于中国需求疲软，同比下降 ~2%。因此，默沙东在第四季度暂停了 Gardasil 对中国的发货，以实现库存正常化。尽管中国经济不景气，但 Gardasil 在大多数其他地区的销售额仍以两位数的速度增长。对于 2025年，由于中国的不确定性和更广泛的消费者疲软，默沙东公司暂停了对 Gardasil 的 110 亿美元长期销售目标，并发出了更温和的增长预期。尽管存在不确定性，Gardasil 仍然是默沙东的第二大创收产品。2025年 1 月，默沙东还获得了 Gardasil 在中国的扩大批准，用于 9 至 26 岁的男性，使其成为中国批准的第一个针对该群体的 HPV 疫苗，这可能会重振该国的一些需求。 3. Comirnaty（托齐那旋）适应症：新冠肺炎（COVID-19）企业：辉瑞/BioNTech 2024 年销售额：77.9 亿美元图3.Comirnaty剂型示意图图片来源：参考资料[1] 2025年展望：2024年，辉瑞与BioNTech联合研发的COVID-19疫苗Comirnaty在全球销售额约为77.9亿美元，辉瑞的份额达53.5亿美元。尽管受疫苗接种率大幅下降和合同销量下降的影响，第四季度运营下降了 38%，年销售额比上一年下降了 53%，但Comirnaty仍然是辉瑞产品组合的重要贡献者。BioNTech 报告称，2024 年总收入为 27.5 亿欧元（29.8 亿美元），比上年下降 27%，原因是对其唯一商业产品疫苗的需求下降。库存减记和与辉瑞合作的毛利润份额减少加剧了这一下降，导致 BioNTech 自 2019 年以来首次出现年度净亏损。总体而言，辉瑞预计 2025年Comirnaty的销售额将相对于 2024 年普遍低迷，这反映出与 COVID 相关的免疫需求的稳定。 4. Prevnar 家族（肺炎球菌结合疫苗）适应症：肺炎企业：辉瑞 2024 年销售额：64.1 亿美元图4.Prevnar 家族结构示意图图片来源：参考资料[1] 2025年展望：2024 年，包括 Prevnar 20/Apexxnar 和 Prevnar 13 在内的更广泛的 Prevnar 系列创造了约 64.1 亿美元的疫苗收入，同比增长约 7%，这得益于美国儿科采用率的提高和国际市场成人采用率的提高。这些疫苗可预防所有年龄组的肺炎球菌疾病，并构成全球免疫计划的核心部分。虽然辉瑞没有披露 Prevnar 20 的特定收入，但 20 价疫苗在这一增长中发挥了核心作用，特别是在扩大成人免疫计划方面。 5. Paxlovid（尼马曲韦/利托那韦）适应症：新冠肺炎（COVID-19）企业：辉瑞 2024 年销售额：57.2 亿美元图5.Paxlovid组成结构图片来源：参考资料[1] 2025年展望：2024 年，辉瑞的 COVID-19 抗病毒药物 Paxlovid 产生了约 57.2 亿美元的收入，约占公司总收入的 9%，并被列为该公司年度第三大销量产品。辉瑞预计，2025年，包括 Paxlovid 在内的 COVID-19 产品收入在运营上将基本持平。由于 COVID-19 需求减弱和政府采购减少，Paxlovid 的销售额预计将同比下降约25%。尽管如此，该药物仍然是辉瑞产品组合的重要贡献者，尽管其相对份额预计将下降。 6. Shingrix（带状疱疹疫苗）适应症：带状疱疹企业： GSK 2024 年销售额：43.0 亿美元图6.Shingrix剂型示意图图片来源：参考资料[1] 2025年展望：2024 年，葛兰素史克的带状疱疹疫苗 Shingrix 的收入约为43 亿美元，同比小幅增长 1%。增长主要是由强劲的国际需求推动的，尤其是在欧洲和澳大利亚。2024 年，Shingrix 在 52 个国家推出后，美国以外的市场占 Shingrix 全球销售额的 56%，高于 2023 年的 45%。葛兰素史克还在研究 Shingrix 与其他疫苗的联合给药，包括季节性流感及其 RSV 疫苗 Arexvy，以评估与肺炎球菌疫苗的联合给药。2025年，葛兰素史克预计整体疫苗销量将小幅下降，但由于 Shingrix 在现有成人免疫计划中的高渗透率以及在美国以外市场的持续采用，Shingrix 可能会保持相对稳定。 7. Dovato（多替拉韦/拉米夫定）适应症：艾滋病毒企业： ViiV Healthcare，GSK与辉瑞（Pfizer）和盐野义（Shionogi）共同拥有多数股权的合资企业 2024 年销售额：27.9 亿美元图7. Dovato组成结构图片来源：参考资料[1] 2025年展望：Dovato 仍然是 ViiV HIV 产品组合中最大的产品，这得益于强劲的需求和良好的市场表现。ViiV 在全球 HIV 治疗市场中占据第二大份额，约为 32%，仅次于吉利德，后者以 51% 的 Biktarvy 占据主导地位。Dovato 是 HIV 治疗领域领先的双药方案，ViiV 预计其口服双药产品组合将持续增长，同时扩大其长效治疗产品。 8. ProQuad（麻疹、腮腺炎、风疹和水痘病毒疫苗）适应症：主动免疫预防儿童麻疹、腮腺炎、风疹和水痘企业：默沙东 2024 年销售额：24.9 亿美元图8.ProQuad剂型示意图图片来源：参考资料[1] 2025年展望：尽管最近的销量有所下降，但 ProQuad 继续在儿科免疫接种中发挥关键作用。ProQuad 在 2025年第一季度产生了约 5.39 亿美元的收入，同比下降了5%，这主要归因于美国在麻疹爆发期间使用其儿科疫苗库存。单价水痘疫苗在水痘市场中占据主导地位，到 2024 年，水痘市场价值为 34 亿美元，并因其成本效益和公共项目采购的便利性而受到青睐。像 ProQuad 这样的联合疫苗不太普遍。 9. Beyfortus（尼塞韦单抗）适应症：呼吸道合胞病毒企业：阿斯利康和赛诺菲 2024 年销售额：22.8 亿美元图9.Beyfortus作用机制示意图图片来源：参考资料[1] 2025年展望：Beyfortus 是一种长效单克隆抗体（LAAB），由阿斯利康开发并与赛诺菲合作商业化。自 2023 年 7 月获得批准以来，Beyfortus 上市的第一个完整年度就以超过 20 亿美元的全球销售额取得了轰动一时的地位。在 2025-2026 年呼吸道合胞病毒（RSV）的流行季节之前，制造能力的提高和全球分销的加速支持下，预计将持续增长。 10. Descovy（恩曲他滨/替诺福韦艾拉酚胺）适应症：艾滋病毒企业：吉利德 2024 年销售额：21.1 亿美元图10. Descovy组成结构图片来源：参考资料[1] 2025年展望： 2024 年，Descovy 的销售额约为 21 亿美元，比 2023 年增长约 6%，受需求增加的推动，但被略低的平均实现价格所抵消。第四季度，在有利的库存动态和定价趋势的支持下，它实现了约 6.16 亿美元的销售额，同比增长 21%。然而，在长效注射疗法和仿制药侵占的竞争压力下，预计其贡献将逐渐减弱。吉利德预计，到 2025年，艾滋病毒行业的收入总体上将保持相对停滞，Descovy 徘徊在 20 亿美元大关。 11. Veklury（瑞德西韦）适应症：新冠肺炎（COVID-19）企业：吉利德 2024 年销售额：18.0 亿美元图11. Veklury组成结构图片来源：参考资料[1] 2025年展望：2024 年，Veklury 销售额同比下降约 18% 至 18 亿美元，反映出随着疫苗接种和治疗选择的增加，全球 COVID-19 住院人数减少。仅在第四季度，销售额就与 2023 年第四季度相比暴跌 53% 至 3.37 亿美元，这是由于需求持续疲软。随着全球 COVID-19 住院率下降和治疗需求正常化，预计 2025年销售额将继续呈下降趋势。吉利德预计今年 Veklury 的收入约为 14 亿美元，反映出与大流行相关的采购减少以及替代抗病毒药物和预防措施的竞争加剧。 12. Genvoya（艾维替韦/考比司他/恩曲他滨/替诺福韦）适应症：艾滋病毒企业：吉利德 2024 年销售额：17.6 亿美元图12. Genvoya组成结构图片来源：参考资料[1] 2025年展望：Genvoya因其作为单片方案的便利性和改进的安全性仍然是 HIV 治疗的基石，然而，它面临着来自 Biktarvy 和 Descovy 等新代理商的日益激烈的竞争，2024 年的销售额从 2023 年的略高于 20 亿美元下降到 2024 年的 17.6 亿美元。定价压力、潜在的专利到期和不断变化的治疗指南将是其到 2025年发展轨迹的关键。 13. Prezista（达芦那韦/考比司他）适应症：艾滋病毒企业：杨森和吉利德 2024 年销售额：17.1 亿美元图13. Prezista组成结构图片来源：参考资料[1] 2025年展望：Prezista 是全球达芦那韦市场的重要组成部分，到 2024 年，该市场价值约为 18.9 亿美元，预计到 2030 年将增至约 23.4 亿美元，表明以 ~3.6% 的复合年增长率（CAGR）温和增长。销售额从 2023 年的 18.5 亿美元下降到 2024 年的 17.1 亿美元，下降了 7.7%。Amneal 和 Annora Pharma 最近分别于 2023 年底和 2025年初在美国批准了几种达芦那韦仿制药。随着专利到期和仿制药进入，Prezista 的销售可能会面临阻力。然而，其在二线治疗方案中的既定存在和作用可以维持整合酶抑制剂等替代品尚无法获得的市场的剩余需求。 14. Tivicay（多替拉韦）适应症：艾滋病毒企业： ViiV Healthcare，GSK与辉瑞（Pfizer）和盐野义（Shionogi）共同拥有多数股权的合资企业 2024 年销售额：16.8 亿美元图14. Tivicay组成结构图片来源：参考资料[1] 2025年展望：Tivicay 因其高疗效和耐受性仍是 HIV 治疗的基础方案。然而，随着双药方案越来越受欢迎，并从旧的三药方案中蚕食市场份额，其美国和全球的增长正面临越来越大的压力。随着 ViiV Healthcare 的 HIV 产品组合转向口服双药方案 Dovato 和 Juluca，目前占总销售额的 42%，Tivicay 的销售额在 2024 年下降。多替拉韦的核心专利预计将于 2027 年 10 月到期，相关形式专利将延长至 2029 年 12 月。随着仿制药进入的临近，ViiV 正在战略性地将患者转向将多替拉韦与其他药物捆绑在一起的更新制剂和联合疗法，以保持市场份额并减轻潜在的收入侵蚀。 15. Triumeq（阿巴卡韦/多替拉韦/拉米夫定）适应症：艾滋病毒企业： ViiV Healthcare，GSK与辉瑞（Pfizer）和盐野义（Shionogi）共同拥有多数股权的合资企业 2024 年销售额：16.5 亿美元图15. Triumeq组成结构图片来源：参考资料[1] 2025年展望：Triumeq 继续受益于全球对简化、有效的抗逆转录病毒疗法的需求。作为一种三药单片方案，Triumeq 仍然是一种高效的治疗和患者依从性促进剂。然而，其未来的增长可能会受到来自 Dovato 和 Juluca 等较新的双药方案的内部竞争的缓和，以及对耐受性或安全性有所改善的药物的偏好不断变化。Triumeq 的核心专利将于 2028 年 4 月到期，为仿制药打开了大门。与 2023 年相比，该药物的销售额下降了 11%。尽管如此，Triumeq 可能会在 2025年保持温和增长。然而，随着较新的方案越来越受欢迎，以及仿制药在专利到期后越来越近，增长可能会放缓。 16. Epclusa（索非布韦/维帕他韦）适应症：慢性丙型肝炎病毒（HCV）感染企业：吉利德 2024 年销售额：16.0 亿美元图16. Epclusa组成结构图片来源：参考资料[1] 2025年展望：在早些年达到超过 30 亿美元的峰值后，由于治疗饱和度增加以及主要市场未经治疗的 HCV 患者数量下降，Epclusa 的收入趋于稳定。预测表明，随着仿制药替代品的出现，2025年后成熟市场将呈下降趋势。尽管如此，在治疗渗透率较低、诊断率持续和新兴应用的地区，需求可能保持弹性。 17. NexGard（阿福拉纳）适应症：狗的跳蚤和蜱虫预防和治疗企业： Merial Animal Health，现隶属于勃林格殷格翰动物保健部门 2024 年销售额：15.3 亿美元图17. NexGard组成结构图片来源：参考资料[1] 2025年展望：NexGard 继续受益于不断增长的跳蚤和蜱虫预防产品市场的强劲需求。在宠物拥有量增加、气候变化和人畜共患风险意识提高的推动下，全球跳蚤和蜱虫产品市场预计将大幅增长，从 2024 年的 ~80.4 亿美元增加到 2032 年的超过 144 亿美元。北美仍然是异恶唑啉类药物（包括阿福拉纳）最大的区域市场。勃林格殷格翰称，其杀寄生虫剂产品组合表现强劲，并指出 NexGard 在 2025年上半年增长了 7.9%。NexGard 预计将在 2025年保持温和、稳定的增长。 18. Mavyret（格列卡普韦/匹布伦他韦）适应症：急性和慢性丙型肝炎病毒（HCV）企业：艾伯维 2024 年销售额：13.1 亿美元图18. Mavyret组成结构图片来源：参考资料[1] 2025年展望：Mavyret 2024 年的销售额为 13.1 亿美元，较 2023 年的 14.3 亿美元收入下降了 8.32%。由于 Mavyret 在前几年的广泛采用，导致许多成熟市场的患者群体饱和，因此面临收入压力。鉴于持续的治疗量和竞争，预计 Mavyret 在主要市场的表现将温和、持平至略有下降。 19. Odefsey（恩曲他滨/利匹韦林/替诺福韦艾拉酚胺）适应症：艾滋病毒企业：吉利德 2024 年销售额：12.9 亿美元图19. Odefsey组成结构图片来源：参考资料[1] 2025年展望：Odefsey 以 12.9 亿美元的销售额成为吉利德 2024 年第四大最畅销的 HIV 药物，略低于 2023 年的 13.5 亿美元总销售额。Odefsey 最早的仿制药预计要到 2033 年 2 月 15 日才能进入。这种长期的专利障碍降低了短期仿制药竞争风险，并支持了持续的排他性。到 2025年，医疗保险处方药覆盖范围的变化预计将使艾滋病毒药物收入减少约 9 亿美元至 11 亿美元。尽管 Odefsey 拥有专利护城河，但这种不利因素可能会间接限制 Odefsey 的增长。 20. Edurant（利匹韦林）适应症：艾滋病毒企业：杨森 2024 年销售额：12.7 亿美元图20. Edurant组成结构图片来源：参考资料[1] 2025年展望：预计 Edurant 将面临来自更新、更方便的 HIV 治疗方案的日益激烈的竞争，特别是 ViiV 的 Dovato 和 Juluca 等双药疗法。Edurant 的仿制药最早可能在 2025年 10 月 21 日进入美国市场，这可能会加速价格压力。随着专利保护的减弱和处方转向更新的组合，Edurant 的收入可能会出现中度至急剧下降。参考资料 [1] https://sites.arizona.edu/njardarson-lab/top200-posters/ [2] https://xtalks.com/ [3] 各公司财报及各种公开资料整理 END 智药研习社近期活动推荐来源：CPHI制药在线声明：本文仅代表作者观点，并不代表制药在线立场。本网站内容仅出于传递更多信息之目的。如需转载，请务必注明文章来源和作者。投稿邮箱：Kelly.Xiao@imsinoexpo.com ▼更多制药资讯，请关注CPHI制药在线▼ 点击阅读原文，进入智药研习社~

疫苗财报

2025-10-17

·Business Wire

ViiV Healthcare announces 96-week data reaffirming Dovato is as effective as Biktarvy in maintaining virological suppression of HIV-1 with significantly less weight gain

DURHAM, N.C.--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced 96-week findings from PASO DOBLE (GeSIDA 11720 study) showing that Dovato (dolutegravir/lamivudine [DTG/3TC]) is as effective as Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide fumarate [BIC/FTC/TAF]) in maintaining virological suppression in adults with HIV-1. Individuals taking Dovato also experienced statistically significant less weight gain and fewer drug-related adverse events over the two-year study period. Results will be presented at the European AIDS Clinical Society (EACS) annual congress, held in Paris, France (15-18 October). PASO DOBLE is the largest head-to-head, phase IV randomized clinical trial investigating the two-drug regimen Dovato compared to the three-drug regimen BIC/FTC/TAF for the treatment of HIV-1 in people who are virologically suppressed and could benefit from treatment optimization. Results at 96 weeks showed patients who switched to Dovato achieved non-inferior efficacy in maintaining viral suppression compared with switching to BIC/FTC/TAF.1,2 Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: "For people living with HIV, achieving and maintaining viral suppression remains the cornerstone of effective treatment. However, HIV treatment options have now advanced to where we can also look to other health metrics to help define success. The 96-week results from PASO DOBLE provide long-term findings that show Dovato continues to deliver robust viral control as effectively as a three-drug regimen, and people taking Dovato also experienced less weight gain compared to those taking Biktarvy. ViiV Healthcare remains committed to developing innovative, patient-centric treatment options that are not only effective with a good safety profile, but also address the needs of the community, beyond viral suppression." In the PASO DOBLE clinical trial, 553 people living with HIV who were virally suppressed switched treatment to either Dovato (n=277) or BIC/FTC/TAF (n=276).1 The study population included individuals who were on therapy that could be optimized, such as multiple tablet regimens, or those containing pharmacokinetic boosting agents or drugs with cumulative toxicity, such as efavirenz (EFV) or tenofovir disoproxil fumarate (TDF). The study met its primary endpoint, with Dovato demonstrating sustained non-inferior efficacy versus BIC/FTC/TAF based on the proportion of participants with HIV-1 RNA ≥50 copies/mL at 96 weeks using the FDA snapshot and a 4% non-inferiority margin in the exposed intention-to-treat population.1 Esteban Martínez, MD, PhD, Chief Executive Investigator of the PASO DOBLE study and Senior Consultant in Infectious Diseases at Hospital Clínic of Barcelona, Spain said: "This 96-week data from PASO DOBLE underscores a favorable profile for Dovato, particularly regarding weight gain, which is an important consideration for virologically suppressed adults that may be on treatment for decades. Longer-term data for a two-drug regimen is crucial for HCPs and people living with HIV as they work together to make informed treatment decisions, considering long-term health management, beyond just viral suppression.” At 96 weeks, Dovato was non-inferior to BIC/FTC/TAF (risk difference between Dovato [0.4%] minus BIC/FTC/TAF [1.1%] of –0.7%, 95% CI –2.1 to 0.7) in the maintenance of viral suppression. Three participants in the BIC/FTC/TAF arm and zero in the Dovato arm had protocol-defined virological failure through week 96 (HIV-1 RNA≥50 c/mL, followed by a second consecutive HIV-1 RNA assessment≥200 c/mL); no resistance was observed in any cases of virological failure.1 These findings showed an increase of two new virologic failures in the BIC/FTC/TAF arm since the initially reported 48-week findings.1,2 The trial was powered to assess weight gain as a key secondary endpoint. Data showed a statistically significant mean adjusted increase in weight gain with BIC/FTC/TAF (2.35kg, 95% CI 1.61–3.09) compared to Dovato (0.84kg, 95% CI 0.09–1.60) [difference: 1.52kg, 95% CI 0.74–2.29] through week 96.1 The findings also showed the mean adjusted weight gain difference between arms increased from 1.13kg at 48 weeks (95% CI 0.37-1.89) to 1.52kg at 96 weeks (95% CI 0.74-2.29).1,2 A significantly higher proportion of participants experienced a greater than 5% weight increase on BIC/FTC/TAF (34.8%) compared to Dovato (20.1%) (adjusted OR 2.05, 95% CI 1.37–3.07).1 The study also found that drug-related adverse events were less frequent with Dovato (7.6%) as compared to BIC/FTC/TAF (13.4%) (p=0.025). Six participants discontinued treatment due to adverse events, mainly neuropsychiatric (Dovato [n=2] vs BIC/FTC/TAF [n=4]), with no significant differences between arms (p=0.409).1 About PASO DOBLE The PASO DOBLE (NCT04884139) randomized clinical trial is a phase IV, open-label, randomized multicenter clinical trial evaluating the efficacy of DTG/3TC versus BIC/FTC/TAF for the maintenance of virologic suppression in people living with HIV-1, conducted in 30 sites across Spain. Virologically suppressed people living with HIV-1 on regimens containing ≥1 pill/day, boosters, or drugs with cumulative toxicity such as efavirenz or TDF were eligible and were randomized (1:1) to switch to either DTG/3TC or BIC/FTC/TAF. The primary endpoint was virologic suppressions in people living with HIV-1 with RNA ≥50 copies/mL at 48 weeks (FDA snapshot, 4% non-inferiority margin) in the intention-to-treat exposed population. Secondary outcomes measured included, among others, absolute weight gain, BMI change, and the proportion of participants with weight change greater than 5%. DOVATO (dolutegravir and lamivudine) tablets INDICATION DOVATO is indicated as a complete regimen for the treatment of HIV-1 infection in adults and adolescents 12 years of age and older and weighing at least 25 kg with no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies/mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to the individual components of DOVATO. IMPORTANT SAFETY INFORMATION BOXED WARNING: PATIENTS CO-INFECTED WITH HEPATITIS B VIRUS (HBV) AND HIV-1: EMERGENCE OF LAMIVUDINE-RESISTANT HBV AND EXACERBATIONS OF HBV All patients with HIV-1 should be tested for the presence of HBV prior to or when initiating DOVATO. Emergence of lamivudine-resistant HBV variants associated with lamivudine-containing antiretroviral regimens has been reported. If DOVATO is used in patients co-infected with HIV-1 and HBV, additional treatment should be considered for appropriate treatment of chronic HBV; otherwise, consider an alternative regimen. Severe acute exacerbations of HBV have been reported in patients who are co-infected with HIV-1 and HBV and have discontinued lamivudine, a component of DOVATO. Closely monitor hepatic function in these patients and, if appropriate, initiate anti-HBV treatment. Contraindications Do not use DOVATO in patients with previous hypersensitivity reaction to dolutegravir or lamivudine Do not use DOVATO in patients receiving dofetilide Warnings and precautions Hypersensitivity Reactions: Hypersensitivity reactions have been reported with dolutegravir and were characterized by rash, constitutional findings, and sometimes organ dysfunction, including liver injury Discontinue DOVATO immediately if signs or symptoms of severe skin or hypersensitivity reactions develop, as a delay in stopping treatment may result in a life-threatening reaction. Clinical status, including liver aminotransferases, should be monitored and appropriate therapy initiated Hepatotoxicity: Hepatic adverse events have been reported, including cases of hepatic toxicity (elevated serum liver biochemistries, hepatitis, and acute liver failure), in patients receiving a dolutegravir-containing regimen without pre-existing hepatic disease or other identifiable risk factors Patients with underlying hepatitis B or C or marked elevations in transaminases prior to treatment may be at increased risk for worsening or development of transaminase elevations with use of DOVATO. In some cases, the elevations in transaminases were consistent with immune reconstitution syndrome or hepatitis B reactivation, particularly in the setting where anti-hepatitis therapy was withdrawn Monitoring for hepatotoxicity is recommended Lactic Acidosis and Severe Hepatomegaly With Steatosis: Fatal cases have been reported with the use of nucleoside analogs, including lamivudine. Discontinue DOVATO if clinical or laboratory findings suggestive of lactic acidosis or pronounced hepatotoxicity develop, including hepatomegaly and steatosis in the absence of marked transaminase elevations. Adverse Reactions or Loss of Virologic Response Due to Drug Interactions with concomitant use of DOVATO and other drugs may occur (see Contraindications and Drug interactions). Immune Reconstitution Syndrome, including the occurrence of autoimmune disorders with variable time to onset, has been reported with the use of DOVATO. Adverse reactions The most common adverse reactions (incidence ≥2%, all grades) with DOVATO were headache (3%), nausea (2%), diarrhea (2%), insomnia (2%), fatigue (2%), and anxiety (2%). Drug interactions Consult full Prescribing Information for DOVATO for more information on potentially significant drug interactions DOVATO is a complete regimen. Coadministration with other antiretroviral medications for the treatment of HIV-1 infection is not recommended Drugs that induce or inhibit CYP3A or UGT1A1 may affect the plasma concentrations of dolutegravir Administer DOVATO 2 hours before or 6 hours after taking polyvalent cation-containing antacids or laxatives, sucralfate, oral supplements containing iron or calcium, or buffered medications. Alternatively, DOVATO and supplements containing calcium or iron can be taken with food Use in specific populations Pregnancy: There are insufficient human data on the use of DOVATO during pregnancy to definitively assess a drug-associated risk for birth defects and miscarriage. An Antiretroviral Pregnancy Registry has been established. Lactation: Potential risks of breastfeeding include HIV-1 transmission, developing viral resistance in HIV-positive infants, and adverse reactions in a breastfed infant Renal Impairment: DOVATO is not recommended for patients with creatinine clearance <30 mL/min. Patients with a sustained creatinine clearance between 30 and 49 mL/min should be monitored for hematologic toxicities, which may require a dosage adjustment of lamivudine as an individual component Hepatic Impairment: DOVATO is not recommended in patients with severe hepatic impairment (Child-Pugh Score C) For more information, please see full US Prescribing Information for DOVATO: https://gskpro.com/content/dam/global/hcpportal/en_US/Prescribing_Information/Dovato/pdf/DOVATO-PI-PIL.PDF Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About SEIMC-GeSIDA Foundation (FSG) The SEIMC-GeSIDA Foundation (FSG) was created to encourage, promote, and support scientific and technical research and development, training, and publication of findings in the field of clinical microbiology and infectious diseases and associated conditions. FSG was founded by investigators from 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 also aims to respond to the scientific concerns of the group’s members. FSG is composed of qualified professionals with experience in the field of clinical trials and multicenter studies. 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 multicenter studies. We also provide staff to run events such as scientific meetings and conferences (national and international) and to organize courses, lectures, talks, seminars, round-table talks, and specialized workshops. For more information on the FSG, please visit https://fundacionseimcgesida.org/en/quienes-somos/ About 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. 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. 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 2024, and GSK’s Q2 Results for 2025. References M. Masia, et al. Virological non-inferiority and lower weight gain with DTG/3TC versus BIC/FTC/TAF: 96-week final results from the PASO-DOBLE (GeSIDA 11720) randomised, multicentre, open-label, non-inferiority trial. Presented at the European AIDS Clinical Society (EACS) annual conference. October 2025 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) randomised clinical trial. Presented at the 25th International AIDS Conference. July 2024

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适应症	国家/地区	公司	日期
HIV感染	美国	ViiV Healthcare Co.	2019-04-08

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适应症	最高研发状态	国家/地区	公司	日期
肺结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
结核	临床3期	巴西	ViiV Healthcare Ltd.	2025-09-18
HIV血清阳性	临床3期	美国	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	日本	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	澳大利亚	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	比利时	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	加拿大	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	法国	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	德国	ViiV Healthcare Ltd.	2018-01-18
HIV血清阳性	临床3期	荷兰	ViiV Healthcare Ltd.	2018-01-18

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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


NCT04808973 (PREGNANCY, Pubmed)	-	HIV感染	20	拉米夫定+多替拉韦	齋觸遞糧顧蓋積夢積衊(糧選蓋齋選餘積憲糧廠) = 範壓糧鹹壓鏇選選觸觸憲襯餘鬱鑰艱壓鹽膚淵 (憲憲餘積築網鏇膚製壓 )	积极	2024-11-12
NCT04585737 (DYAD, CTgov)	临床4期	HIV感染	222	Dolutegravir / Lamivudine Pill (Treatment Group 1)	鏇網選齋顧淵遞範壓遞 = 鏇淵廠鏇鑰鑰壓觸願獵壓範選廠壓製憲製鏇糧 (憲構糧選繭鏇簾觸襯鑰, 蓋糧餘壓鬱膚醖願築鏇 ~ 餘積網遞衊製簾鏇憲範) 更多	-	2024-10-17
				Bictegravir / Emtricitabine / Tenofovir Alafenamide Pill (Treatment Group 2)	鏇網選齋顧淵遞範壓遞 = 網鏇製蓋鹹齋艱壓衊糧壓範選廠壓製憲製鏇糧 (憲構糧選繭鏇簾觸襯鑰, 繭醖製範範顧網壓構網 ~ 繭餘衊網艱餘衊製簾製) 更多
PASO DOBLE (NEWS) 人工标引	临床4期	HIV感染维持	-	Dovato (dolutegravir/lamivudine)	願願廠艱積願夢襯顧窪(壓糧網齋遞範網膚窪積) = Dovato demonstrating non-inferior efficacy in maintaining viral suppression after 48 weeks of treatment compared to Biktarvy. 襯製構壓鬱壓選襯蓋艱 (積淵糧簾鏇鹽顧鏇夢製 ) 达到	非劣	2024-07-24
				Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide)
NCT03446573 (TANGO, Pubmed \| Antimicrob Agents Chemother) 人工标引	临床3期	HIV感染	362	Dolutegravir/lamivudine FDC	鏇齋衊醖鏇壓鹽築廠鬱(鏇齋醖範餘襯選製願選) = 鏇選鹽衊衊淵壓顧齋願鹽醖顧構壓網憲鹽襯憲 (夢衊醖壓鏇醖觸憲構艱 ) 更多	积极	2024-04-08
NCT04707326 (DUALING, Pubmed \| Open Forum Infect Dis) 人工标引	N/A	HIV感染	2,040	Dolutegravir/lamivudine	築選齋膚獵艱鹽憲鹹顧(製醖艱襯壓範鑰觸觸鏇) = 膚顧製選鏇襯鹹獵窪夢蓋鬱鏇範範築遞繭觸齋 (顧網選蓋廠鏇壓餘網構 ) 更多	积极	2024-04-01
				Continuing triple-drug antiretroviral regimens	築選齋膚獵艱鹽憲鹹顧(製醖艱襯壓範鑰觸觸鏇) = 衊鏇壓顧願膚製齋憲窪蓋鬱鏇範範築遞繭觸齋 (顧網選蓋廠鏇壓餘網構 ) 更多
NCT04021290 \| NCT03446573 (SALSA, Pubmed) 人工标引	临床3期	HIV感染	1,234	Switch to dolutegravir/lamivudine (DTG/3TC)	顧積鏇製網構鑰網繭廠(窪願選膚遞蓋夢壓艱遞) = In the DTG/3TC group, incidence of adverse events (AEs) was similar across age groups. 醖襯獵壓鏇鬱廠繭製繭 (範網網製廠積糧積構鏇 ) 更多	积极	2024-03-21
				Continuing current antiretroviral regimen (CAR)
NCT04827134 (CTgov)	临床1期	HIV感染	33	TRIUMEQ+DTG+3TC+ABC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fed)	齋願構醖衊窪窪範蓋壓(觸蓋壓齋遞鹹窪築遞鬱) = 襯窪構憲鏇窪遞簾範鏇膚蓋衊醖窪鬱糧襯蓋獵 (鑰鏇齋鏇膚網積夢鏇鹹, 25.7) 更多	-	2023-06-05
				DTG+3TC+ABC (Cohort 1: TRIUMEQ (DTG/ABC/3TC) Fasted)	齋願構醖衊窪窪範蓋壓(觸蓋壓齋遞鹹窪築遞鬱) = 襯鬱鹹築鹹簾衊醖憲鹽膚蓋衊醖窪鬱糧襯蓋獵 (鑰鏇齋鏇膚網積夢鏇鹹, 24.0) 更多
NCT03682848 (CTgov)	临床3期	HIV感染	32	3TC FDC+DTG	鑰簾蓋齋膚鑰餘窪憲繭 = 膚獵簾積觸範艱積窪範鬱憲壓顧鑰鏇淵鹹夢繭 (鑰齋觸繭網齋鏇網鬱製, 蓋願鹽鏇廠繭夢艱鏇襯 ~ 鬱餘願繭鹹醖醖築壓膚) 更多	-	2022-08-08
NCT04021290 (SALSA, CTgov)	临床3期	HIV感染	493	3TC FDC+DTG (Randomized Phase-Participants Who Received DTG/3TC FDC)	築齋餘鏇餘範鏇願夢餘 = 夢繭艱醖鬱鏇選廠鹹獵艱憲鹹獵醖衊餘遞廠鑰 (憲獵餘鹹廠醖蓋夢壓簾, 醖鑰膚製襯夢壓鏇糧齋 ~ 鑰獵築構膚鏇廠鬱夢範) 更多	-	2022-07-01
				atazanavir (Randomized Phase-Participants Who Received CAR)	築齋餘鏇餘範鏇願夢餘 = 顧襯選觸襯構窪範窪窪艱憲鹹獵醖衊餘遞廠鑰 (憲獵餘鹹廠醖蓋夢壓簾, 齋顧鑰鹹簾淵夢衊壓齋 ~ 壓鑰選窪廠獵觸鏇廠夢) 更多
IAS2022	N/A	-	-	Dolutegravir/Lamivudine (D/L)	築壓簾窪鬱艱齋網齋鏇(繭壓鑰築獵鹽糧齋膚築) = 夢齋夢憲築憲觸艱鹹夢遞鏇廠餘淵齋壓構鹹壓 (鬱構顧願鹹鑰構獵構窪 ) 更多	-	2022-01-01
				Bictegravir/Emtricitabine/Tenofovir alafenamide (B/F/T)	築壓簾窪鬱艱齋網齋鏇(繭壓鑰築獵鹽糧齋膚築) = 艱繭願鹽衊廠壓鑰鏇築遞鏇廠餘淵齋壓構鹹壓 (鬱構顧願鹹鑰構獵構窪 ) 更多