Dolutegravir Sodium/Lamivudine

LONDON--(BUSINESS WIRE)--ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi as shareholders, today announced data from the phase IIIb VOLITION study demonstrating that 89% (n=129/145) of eligible treatment-naïve people living with HIV opted to switch to long-acting injectable Vocabria + Rekambys (branded as Cabenuva in the US Canada and Australia) following rapid viral suppression with daily Dovato (dolutegravir/lamivudine (DTG/3TC)). Additional real-world data from other studies reinforce CAB+RPV LA’s effectiveness across a broad range of populations. Jean van Wyk, MBChB, MFPM, Chief Medical Officer at ViiV Healthcare, said: “Data from the VOLITION study highlight how providing choice in HIV care empowers individuals to choose medicines that meet their evolving everyday needs. ViiV pioneered long-acting injectables for HIV, and we now have over three years of robust real-world evidence demonstrating the impact our portfolio is having today across a broad range of settings and populations. Long-acting injectables provide options that can offer high effectiveness and tolerability, improved adherence, and a preferred dosing schedule compared with daily oral pills. We believe they are a key part of HIV treatment and prevention and will play a critical role in achieving our ambition of ending HIV and AIDS.” Data summary from ViiV Healthcare and partner studies at IAS 2025: Empowering choice: 89% of treatment-naïve people with HIV opt for CAB+RPV LA after achieving rapid viral suppression: These new data from the phase IIIb VOLITION study evaluate the experience of treatment-naïve individuals who initiated treatment with daily DTG/3TC pills and were subsequently offered the choice to switch to CAB+RPV LA after achieving viral suppression. Study results showed that participants achieved rapid viral suppression with DTG/3TC (median time to suppression: 4.14 weeks), following which they were offered to switch. At the immediate next study visit (Day of Choice), 89% (n=129/145) of eligible participants chose to switch to CAB+RPV LA, while 11% (n=16) opted to continue DTG/3TC. The most common reasons cited for choosing CAB+RPV LA were not having to worry about missing a dose each day (80%) and not having to carry medication (68%).These findings underscore the efficacy and tolerability of DTG/3TC as a rapid suppression option, and demonstrate the value of offering CAB+RPV LA as a treatment option to meet individual needs and preferences.1 CAB+RPV LA delivers sustained effectiveness and enhanced patient experience in real-world settings: Data from multiple real-world observational studies, including the two-year BEYOND study in the US, the CARLOS study in Germany, the COMBINE-2 cohort across seven European countries, and the OPERA study, consistently reinforce the high effectiveness, favourable outcomes and patient satisfaction associated with CAB+RPV LA.2,3,4,5,6,7 BEYOND is a two-year prospective observational study enrolling people with HIV following the decision to switch to CAB+RPV LA across 27 U.S. sites.2 Among the 308 participants, 97% maintained virologic suppression at Month 24 (at most recent viral load of <50 copies/ml), with infrequent discontinuations due to injection reactions and no new confirmed virologic failures after Month 6. Participants reported reduced stigma and improved treatment satisfaction.3 Similarly, the real-world CARLOS study of 351 participants in Germany, showed 77.5% virologic suppression at Month 24, with high adherence (94.2% on-time injections) and clinically meaningful improvements in treatment satisfaction.4 97.7% of participants maintained virologic suppression at last known viral load at Month 24 or at discontinuation. In Europe, the COMBINE-2 study, evaluating real-world outcomes for 956 virologically suppressed people with HIV initiating CAB+RPV LA across seven European countries, reported 99% virologic suppression at last measured viral load (median follow-up of 10.2 months), with low rates of confirmed virologic failure (0.5%) and high persistence (92% remaining on therapy).5 Real-world evidence focussed on the effectiveness of CAB+RPV LA outside the labelled indication in viraemic patients: The large-scale OPERA study further explored the effectiveness of CAB+RPV LA in treatment-experienced individuals initiating therapy with detectable viral loads and long-standing HIV. Among the 3,304 participants, 11% (368 individuals) initiated with baseline viremia (>50 copies/mL), of these, 88% achieved viral suppression to <50 copies/mL (of n=277/313 with ≥ 1 viral load during follow-up and VL<50 copies/mL at any point during follow-up). A separate analysis also showed that among a diverse group of 105 women initiating CAB+RPV LA with viremia, most achieved viral suppression (of 92 women with ≥1 VL at follow-up, 92% achieved VL <50 copies/mL at any point during follow up), with confirmed virologic failure being rare.6,7 Through these findings, CAB+RPV LA was shown to address challenges associated with daily oral pills, offering improved treatment satisfaction, high effectiveness and a patient-preferred treatment option that supports long-term virologic control. Implementation studies highlight CAB LA for PrEP is highly preferred and easy to implement for key prevention groups: The PILLAR and EBONI studies highlight the high acceptability and feasibility of CAB LA for PrEP for HIV prevention in broad populations, including men who have sex with men (MSM), transgender men (TGM), and Black women (BW).8,9 PILLAR is a phase IV implementation trial assessing the integration of CAB LA for PrEP across 17 clinics in the U.S. among a broad population of MSM and TGM (n=201).8 CAB LA for PrEP was rated highly acceptable (mean 4.6/5 at Month 12) and feasible (mean 4.4/5), with 95% of participants (n=131) who switched from oral PrEP reporting being happy with the choice and 98% recommending CAB LA for PrEP (n=140). Flexible scheduling, reminders, and educational tools supported adherence, while stigma concerns were significantly lower compared to oral PrEP users. Similarly, EBONI, an implementation study evaluating CAB LA for PrEP in Black cis and transgender women, among women’s health clinics, across 72 healthcare provider respondents at 15 clinics primary care and infectious disease clinics in the US. Data found CAB LA for PrEP highly appropriate (mean 4.5/5) and feasible (mean 4.4/5) for Black women.9 In addition, clinic capacity to accommodate CAB LA for PrEP tripled within a year without increasing staff or time commitment. The health benefits of two monthly visits included additional opportunities to screen for STIs, screening for comorbidities or providing other health or psychological care. These findings highlight Apretude’s potential to support broader PrEP implementation and improve outcomes in underserved populations who may benefit the most across varied clinical settings. Trademarks are owned by or licensed to the ViiV Healthcare group of companies. About Apretude (cabotegravir long-acting for PrEP) 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. Individuals must have a negative HIV-1 test prior to initiating Apretude (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. Apretude contains the active substance cabotegravir. Please consult the full Summary of Product Characteristics for all the safety information: Apretude 600 mg prolonged-release suspension for injection About Vocabria (cabotegravir) Vocabria 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. Vocabria 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: oral lead in to assess tolerability of Vocabria and rilpivirine prior to administration of long acting Vocabria injection plus long acting rilpivirine injection. oral therapy for adults who will miss planned dosing with Vocabria injection plus rilpivirine injection. Vocabria tablets are only indicated for treatment of HIV-1 in combination with rilpivirine tablets, therefore, the prescribing information for Edurant (rilpivirine) tablets should also be consulted for recommended dosing. 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 About Rekambys (rilpivirine) Rekambys 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. 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). Please consult the full Summary of Product Characteristics for all the safety information: Rekambys 600mg/900 mg prolonged-release suspension for injection About Cabenuva (cabotegravir + rilpivirine) Cabenuva 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 35 kg 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. 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 US 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 35 kg 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. 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. Please consult the full Prescribing Information here. About Dovato (dolutegravir and lamivudine) Dovato is indicated as a complete regimen to treat HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40kg, in the EU, and weighing at least 25kg in the US, 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. Please consult the full Summary of Product Characteristics for all the safety information: Dovato 50 mg/300 mg film-coated tablets. 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 Q1 Results for 2025. Registered in England & Wales: GSK plc ViiV Healthcare Limited No. 3888792 No. 06876960 Registered Office: 79 New Oxford Street ViiV Healthcare Limited London GSK Medicines Research Centre WC1A 1DG Gunnels Wood Road, Stevenage United Kingdom SG1 2NY References 1 F. Felizarta, et al. The power of choice: strong preference for CAB+RPV LA following rapid suppression with DTG/3TC in treatment naive people living with HIV. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 2 F. Felizarta, et al. Perspectives of people living with HIV (PWH) 24 months following a switch to cabotegravir and rilpivirine long-acting (CAB+RPV LA) in an observational real-world US study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 3 G. Blick, et al. Clinical outcomes at month 24 after initiation of cabotegravir and rilpivirine long acting (CAB+RPV LA) in an observational real-world study (BEYOND). Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 4 C. Wyen, et al. 24-month outcomes of cabotegravir+rilpivirine long-acting every 2 months in a real‑world setting: effectiveness, adherence to injections, and participant-reported outcomes from people with HIV-1 in the German CARLOS cohort. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 5 A. Pozniak, et al. High virologic suppression and few virologic failures with Long-Acting Cabotegravir + Rilpivirine in Treatment Experienced Virologically Suppressed Individuals from COMBINE-2 cohort in Europe. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 6 R. Hsu, et al. Real-world effectiveness of CAB+RPV LA in individuals with HIV viremia at therapy initiation. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 7 J. Altamirano, et al. Clinical outcomes among women in the OPERA cohort initiating CAB+RPV LA with viral loads ≥ 50 copies/mL. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 8D. Dandachi, et al. One-year implementation outcomes of cabotegravir long-acting injectable PrEP in men who have sex with men (MSM) & transgender men (TGM): findings from the PILLAR study. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW. 9 Z. Tims-Cook, et al. Health care provider experiences after 12 months of implementing cabotegravir long-acting injectable PrEP (CAB LA) for Black women: EBONI study results. Presented at the International AIDS Society Conference (IAS 2025), 13-17 July, Kigali, RW.

成立于1878年的日本制药企业盐野义制药集团，拥有超过140年的历史。作为日本历史最悠久的药企之一，成立于日本大阪，创立之初主要贩卖汉方药材。后续研发青霉素，1948年推出首款国产抗生素，1950年开发的广谱抗生素「Keflex」（头孢菌素），全球销售额超10亿美元，成为"日本制药黄金时代"象征。一、2024财年营收情况2025年5月盐野义制药公布了2024财年（2024年4月-2025年3月）营收达4383亿日元（同比+0.7%），营业利润1566亿日元（同比+2.1%），连续三年创新高。关键增长点主要来自HIV业务，来自ViiV Healthcare的特许权收入增长22.8%（446亿日元），主要受益于长效注射剂Cabenuva及口服疗法（如Dovato）的强劲销售。海外业务收入同比增长18.4%（约92亿日元）。从2000年到如今，盐野义经历利润连跌的风波，2009年将整合酶抑制剂dolutegravir授权给GSK，换得ViiV合资公司20%股权。这是一场HIV的“豪赌”，ViiV的HIV药物2024年贡献2404亿日元特许权收入，占盐野义总营收55%。二、营运成本与费用情况2024财年盐野义制药的成本支出情况如下：总成出支出增加1490亿日元，主要来自三个部分，销售成本同比上一个财年增加了62亿日元增幅达10.8%，总金额达到6380亿日元；研发费用增加了60亿日元，增幅5.8%，研发费用总额1086亿日元；销售及行政费用增加了27亿日元，同比增长了2.6%，总额达到1061亿日元。盐野义制药2024财年的销售成本增加主要有三个方面的原因：自2022财年起，为应对抗生素等产品需求增长，持续扩大生产规模并增建生产设施、产品结构变化以及原材料与制造成本上升等。在销售管理与研发费用方面，主要由于新冠产品推广费用、感染药物研发投入以及全球研发布局美国研究中心扩建及后期开发项目的推进等等。尽管成本上升，但其通过严格的费用管控，经营利润仍实现增长。盐野义制药2025财年预计在营收方面较2024财年增长20.9%，目标预测5300亿日元，营业利润1750亿日元，同比增长11.7%的预期，归属母公司的净利润为1800亿日元目标，同比增长5.65%。其2025财年的主要增长引擎为并购了JT制药部门的收入，吞并日本烟草旗下百年药企——（原）田边制药，获得AI药物发现平台。另一个重要举措是其HIV/失眠药Quviviq的尺寸放量以及Zuranolone抗抑郁药的上市、ENDEAVORRIDE数字疗法业务拓展，希望能共同作用于企业的营收。三、研发进度及研发管线布局以下为盐野义制药2025财年的研发里程碑计划，从不同疾病领域来看：* 感染性疾病Ensitrelvir针对新冠治疗，处于提交阶段，2025上半财年（FY2025 1H）向欧盟提交；用于新冠暴露后预防（PEP），提交阶段，2025上半财年向美、欧提交，下半财年（FY2025 2H）争取日本获批；针对12岁以下儿童新冠治疗与预防，处于全球提交准备阶段，2025上半财年向日本提交。* S-268024：新冠JN.1疫苗，处于3期临床，2025上半财年出3期临床初步结果。* Cefiderocol：抗耐药菌（AMR）儿科感染（革兰氏阴性菌感染），3期临床，2025上半财年出3期初步结果，下半财年向美、欧提交。* 其他几项处于2期临床或1期临床阶段。生活质量相关疾病：* Zuranolone：抑郁症，提交阶段，2025上半财年争取日本获批。* Zatolmilast：脆性X综合征，2/3期临床，2025下半财年出2/3期初步结果。* SASS-001（S-600918+DrugX）：中枢性睡眠呼吸暂停，2期临床，2025下半财年出2期初步结果。* S-531011：实体瘤，1b/2期临床，2025下半财年出1b/2期初步结果。* S-606001：庞贝病，1期临床，2025上半财年出1期初步结果。* S-740792：多发性硬化相关步态障碍，1期临床，2025下半财年出1期初步结果。盐野义集团针对新冠药物，其意图或将新冠管线从“应急产品”转型为常态化呼吸感染防控组合。各类药物都在积极布局全球审批和申报，以拓展并布局全球市场。基于盐野义制药在2025财年研发里程碑计划，其管线布局呈现出战略聚焦、风险平衡以及全球化开发效率的三大特点。四、战略布局为了应对新冠冬峰低于预期以及Ensitrelvir美国III期试验未达终点两方面的外部挑战，以及其内部暂停慢性疼痛药S-151128（膝骨关节炎疗效未达标），资源倾斜晚期管线。盐野义为其制定全新的战略目标成为"全球小分子药物研发领导者"，专注感染性疾病和高质量生命（QOL）疾病领域。盐野义制药在最新的STS2030计划中将战略分为以下三部分：* Phase1(2020-2022)：转型基础建设* Phase2(2023-2025)：加速增长与投资* Phase3(2026-2030)：实现全球领导地位针对以上新战略，盐野义制药做出如下核心战略举措调整：-- 业务投资驱动的新增长模式，并购整合JT制药部门，Torii制药以及Akros Pharma，强化日本销售网络，增强研发管线，优化生产。-- 稳固现有的增长引擎：聚焦长效注射剂和口服双药方案，抢占全球长效治疗市场30%的份额为其2031年目标。并积极拓展海外业务，扩大美欧的销售覆盖范围，亚洲板块依托合作伙伴加速市场准入。-- 管线产品的加速开发：感染性疾病领域，Ensitrelvir（新冠药）加速全球申报（美国滚动提交，欧洲准备中）。多项药物积极驱动2/3期临床试验。在QOL疾病领域，2025年在日本上市首个快速抗抑郁药Zuranolone。盐野义聚焦感染病与高社会影响QOL疾病，稳步实现管线推进、海内外协同拓展市场，以研发转化与创新药上市巩固地位，应对行业变化向2030愿景迈进，积极布局突破挑战，重塑集团优势。药事纵横投稿须知：稿费已上调，欢迎投稿