Peer Behavioral Activation Utilization to Address Structural Racism and Discrimination and Improve HIV Outcomes in High-Risk, Substance-Using Populations

This randomized Type 1 hybrid effectiveness-implementation trial (N=186) will evaluate the effectiveness and implementation of a peer-delivered problem solving and behavioral activation intervention for adherence to LAI-PrEP/ART ("Peer Activate-LAI") compared to enhanced treatment as usual (ETAU) for a largely Black, substance-using population living with or at high risk for HIV. Specific aims are to:
Aim 1: Evaluate the effectiveness of Peer Activate-LAI over 12-months on: a) LAI-PrEP/ART adherence (primary; receipt of all 6 maintenance injections within 7-day window); and b) substance use (secondary; WHOASSIST, urine toxicology); and c) Explore the moderating role of SRD-related factors (exploratory)
Aim 2: To evaluate the implementation of Peer Activate-LAI including feasibility, acceptability, fidelity, and adoption guided by RE-AIM and Proctor's model,12,13 assessed using mixed methods, including a rapid ethnographic assessment of how SRD-related factors may affect implementation.
Aim 3: To evaluate the economic viability of Peer Activate-LAI, including a) cost of implementation and sustainment, and b) cost-effectiveness from multiple stakeholder perspectives.
This study will inform a potentially scalable, cost-effective model for facilitating effective adherence to LAI formulations of PrEP/ART within Black, substance-using populations with multiple minority identities who to date have had limited support for improving LAI adherence for HIV treatment and prevention.

开始日期2025-01-01

申办/合作机构

University of Maryland Baltimore

NCT06468995 / Not yet recruiting临床3期IIT

Antiviral Long Acting Drugs Landing in People Living With HIV (ALADDIN): Prospective, Double-arm, Randomized, Open-label, Implementation-effectiveness Hybrid Type III Study

This is a monocentric, prospective, double-arm, randomized, open-label, implementation-effectiveness hybrid type III study aimed at comparing hospital-based and home-based administration of CAB LA + RPV LA treatment for HIV-1-infected patients.
Study participants receiving IM CAB + RPV will complete various questionnaires and scales, including FIM, AIM, IAM, EQ-5D-5L, HAT-QoL, and HIVTSQ, throughout the study. HCPs will also complete FIM, AIM, IAM, and a Likert scale.

开始日期2024-09-01

申办/合作机构

GSK Plc

NCT06411223 / Recruiting临床2期IIT

Project Tara: Pharmacist-led Intervention for Injectable HIV Treatment for Women With Health-related Social Needs

This study addresses real-world use of long-acting injectable cabotegravir/rilpivirine (CAB/RPV LA) by evaluating implementation and clinical outcomes of a pharmacist-led collaborative drug therapy management model (CDTM+) that will be expanded for telehealth outreach to women with health-related social needs (HRSN).

开始日期2024-08-01

申办/合作机构

Yale University

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100 项与卡博特韦/利匹韦林相关的临床结果

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100 项与卡博特韦/利匹韦林相关的转化医学

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100 项与卡博特韦/利匹韦林相关的专利（医药）

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项与卡博特韦/利匹韦林相关的文献（医药）

2022-08-03·Expert Review of Anti-infective Therapy

Cabotegravir/Rilpivirine: the last FDA-approved drug to treat HIV

Review

作者: Soleimani, Faezeh ; Ghahramanpour, Hossein ; Heidary, Mohsen ; Asadi, Arezoo ; Namvar, Ali ; Taki, Elahe

INTRODUCTIONThe development of long-acting (LA) drugs has changed the management of common medical conditions for human replication immunodeficiency virus (HIV). Cabenuva (cabotegravir/Rilpivirine) is the first LA antiretroviral injectable drug composed of nano-formulation of cabotegravir (CAB) and rilpivirine (RPV).AREAS COVEREDIn this review article, we aim to have a brief overview of results of major clinical trials that administrated Cabotegravir/Rilpivirine for patients considering the efficacy and safety profiles. Moreover, we discuss about CAB and RPV chemical structure, mechanism of action, ‎activity against drug-sensitive and -resistant HIV, and pharmacodynamics/pharmacokinetics properties.EXPERT OPINIONBased on the results of the ATLAS and FLAIR trials, Cabotegravir/Rilpivirine regimen once-monthly has shown equal effectivity to oral combination antiretroviral therapy (cART) in maintaining HIV-1 suppression in patients. Furthermore, ATLAS-2 M study revealed the non-inferiority of Cabotegravir/Rilpivirine regimen every 8 weeks compared to every 4 weeks. The injectable LA ART reduces the number of treatment intake as well as increases adherence, especially in patients with HIV-related stigma. Administration of extended-release agents probably minimize the risk of treatment-related toxicity and resistance related to sub-optimal adherence to oral ART, so Cabotegravir/Rilpivirine can be suggested as a suitable alternative for HIV infection control in current era.

2022-08-01·AIDS

Cabotegravir–rilpivirine treatment initiation in a nonvirologically suppressed patient

Article

作者: Barnett, Steven K. ; Riedel, David J. ; Armas-Kolostroubis, Laura ; Sension, Michael

Currently, there is a single option for a complete parenteral HIV antiretroviral therapy (ART) regimen.Cabotegravir rilpivirine is a complete HIV ART regimen combining an extended-release injectable integrase strand inhibitor (INSTI) solution (cabotegravir) with an extended-release injectable nonnucleoside reverse transcriptase inhibitor (NNRTI) solution (rilpivirine), which allows for once-amonth dosing.We describe a patient who had failed four different traditional oral HIV ART regimens and had no ART resistance who was initiated on a once-monthly injection of cabotegravir-rilpivirine to circumvent poor pill adherence and gastrointestinal concerns.

2021-08-01·Saudi Pharmaceutical Journal3区 · 医学

Cabenuva®: Differentiated service delivery and the community Pharmacists’ roles in achieving UNAIDS 2030 target in Nigeria

3区 · 医学

ArticleOA

作者: Rasaq Kayode, Oladapo ; Afeez Babatunde, Oyetola

The approval of the novel long-acting HIV injection; Cabenuva®- Cabotegravir and Rilpivirine injectable formulation) and the recent call by the World Health Organization for promoting community-based ART management, underscore the remarkable progress towards meeting the Joint United Nations Programme on HIV/AIDS (UNAIDS) 95-95-95 targets by 2030. As the availability of antiretroviral therapy (ART) for the treatment of HIV/AIDS has increased in resource-limited settings, there has been a move to develop and implement alternative treatment delivery models such as Differentiated Service Delivery (DSD) in high prevalence countries to meet the global targets for HIV treatment while maintaining the quality of care. However, there is limited data on the involvement of community pharmacies in the delivery of ART within the community. Although, in western countries, several studies have documented the different roles community pharmacists can play in the management of HIV/AIDS. Community pharmacists are the most accessible and first points of health care for most clients. They are trusted, highly trained health care professionals. They should be incorporated and allowed to administer the Cabenuva® injection if the battle against the HIV pandemic is to be totally won. In this paper, we, therefore, aim to explore how the community pharmacist can be positioned in HIV service delivery regarding the administration of the Novel long-acting Cabenuva® injection formulation. It is therefore recommended that the Nigerian government embrace community pharmacy-led drug administration initiatives and embark on accredited training programmes for the profession in line with drug administration services. The government should also put in place necessary funding mechanisms for community pharmacists for the extra workload placed on them in administering injection drug formulation in their respective pharmacies.

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项与卡博特韦/利匹韦林相关的新闻（医药）

2024-10-31

·生物制品圈

RSV疫苗销售额暴跌74%！GSK公布2024Q3业绩，二度下调年度疫苗收入指引

2024年10月30日，葛兰素史克（GSK）发布了2024Q3季度财报，公司第三季度收入达80.12亿英镑（约合104.96亿美元），同比增长2%（按固定汇率计算，下同）。前三季度销售额为232.59 亿英镑（约合304.69 亿美元），同比增长8%。其中，疫苗销售额下降了15%，而专科药品（包括肿瘤、HIV、呼吸/免疫板块）和普通药品的销售额分别增长了19%和7%。据GSK首席执行官Emma Walmsley表示，第三季度对该制药公司而言“充满挑战”。这些挑战导致公司备受瞩目的呼吸道合胞病毒（RSV）疫苗Arexvy销售额急剧下降。 Arexvy在去年获批上市后，其便一跃成为重磅炸弹产品，然而该产品却在今年迅速回落。第三季度，该疫苗的销售额同比暴跌74%至1.88亿英镑（2.44亿美元）。不仅如此，GSK的旗舰产品带状疱疹疫苗Shingrix在第三季度的销售额也下降了10%，至7.39亿英镑（9.56亿美元）。这一数字比分析师的预期低了13%。由于业绩不佳，GSK今年第二次下调了其年度疫苗收入指引。现在，该公司预计与2023年相比，疫苗板块收入将出现个位数的低百分比下降。而在今年7月，GSK曾预计其2024年的疫苗板块销售额将实现个位数的低至中百分比增长，这一预测已经低于公司最初设定的高个位数至低双位数的增长目标。 GSK首席商务官Luke Miels在周三的投资者电话会议上表示，Arexvy遭遇了三重打击。一个显而易见的因素是美国疾病控制与预防中心（CDC）缩窄了免疫接种建议。此外，许多美国人开始优先接种新冠疫苗，另外RSV的季节性低发病率也起到了阻碍的作用。 Miels还表示，去年的第三季度也是一个艰难的对比基准，因为当时2/3的销售额与备受期待的RSV疫苗首次接种的库存备货有关。与其竞争对手辉瑞的RSV疫苗Abrsyvo同时出现的第三季度销售额下降相比，Arexvy的下滑对GSK的影响要大得多。Abrysvo第三季度的销售额仅下降5%至3.56亿美元。在美国，辉瑞的RSV疫苗的销售额下降15%至3.18亿美元。现在，GSK正在采纳Walmsley所谓的“保守”假设，即美国疾病控制与预防中心（CDC）的免疫咨询委员会不会在2025年改变其RSV指南。因此，该公司预计其疫苗部门明年将实现“有限增长”。不过，GSK高管在周三的电话会议上向投资者保证，他们对Arexvy最终能实现超过30亿英镑的峰值销售额充满信心。 “2025年以后，对于Arexvy，我们预计将进一步成功推广，并且鉴于患者的需求和该疫苗能提供的针对RSV的保护，公共卫生部门将确认扩大接种人群和重新接种的建议，同时推动国际市场的渗透，”Miels说。 Walmsley指出，在美国，CDC建议接RSV疫苗的人群中约有80%尚未接种疫苗。尽管如此，GSK在每个RSV季节可能每年都面临与新冠疫苗接种的冲突。为了应对这一问题，GSK正在研究Arexvy与其他疫苗的联合接种，并审查可能Arexvy “去季节性”接种的选项。 “这就是药剂师告诉我们他们想要的，就管理他们的工作流程、人员配备水平而言，”Miels 说。“所以我认为这款疫苗将在中长期内实现这一目标。” 在美国以外，今年早些时候，英国政府选择了辉瑞在未来两年内向该国供应500万剂RSV疫苗。在德国，一个名为STIKO的独立疫苗咨询小组在8月份支持为75岁及以上人群接种辉瑞的Abrysvo和GSK的Arexvy。 Miels表示，在与世界不同地区的各种权威机构打交道后，GSK对Arexvy的定价点“有了很好的了解”。尽管最近投资者的大部分注意力都集中在GSK疫苗板块的疲软上，但该公司包括HIV、免疫学和肿瘤学药物在内的专科药物板块已经比疫苗板块成为了一个更大的特许经营业务。然而，该板块在第三季度也有自己的问题。GSK的两种HIV长效产品Cabenuva和Apretude的销售额均低于分析师的预期。尽管疫苗的销售令人失望，但由于专科药品的表现相对较好，GSK维持了其2024年的销售预测。其中肿瘤学是亮点，按固定汇率计算，第三季度的销售额同比增长94%，营收3.73亿英镑，比市场普遍估计高出3%。参考资料： [1]GSK tries to steady the ship as Arexvy sales plummet in wake of CDC guidance changes.By Angus Liu.Oct 30, 2024 10:41am. [2]GSK公布2024Q3业绩：疫苗收入下降15%，肿瘤和HIV领域强势“补位”！.猎药人俱乐部.2024年10月30日. [3]GSK 2024Q3季度财报材料. 识别微信二维码，添加生物制品圈小编，符合条件者即可加入生物制品微信群！请注明：姓名+研究方向！版权声明本公众号所有转载文章系出于传递更多信息之目的，且明确注明来源和作者，不希望被转载的媒体或个人可与我们联系(cbplib@163.com)，我们将立即进行删除处理。所有文章仅代表作者观点，不代表本站立场。

疫苗财报

2024-10-23

·医药观澜

超94%有效，吉利德/默沙东长效HIV口服疗法最新数据公布

日前，吉利德科学（Gilead Sciences）和默沙东（MSD）公司公布其长效HIV口服组合疗法islatravir（ISL）和lenacapavir（LEN）的2期临床试验最新结果。分析显示，在48周时，这一创新组合疗法保持了高比率（94.2%）HIV患者的病毒抑制（HIV-1 RNA <50拷贝/毫升）。研究详细数据公布于2024年感染性疾病周（IDWeek）会议上。目前该HIV口服组合疗法正在临床3期试验当中接受检视。新闻稿指出，这一创新组合具有成为首款每周一次治疗HIV口服组合疗法的潜力。数据显示，在2023年，全球共有近4000万艾滋病患者，其中有约130万新确诊患者，63万人因艾滋病相关疾病死亡。艾滋病是由于HIV病毒感染造成的传染性疾病。现代抗病毒药物的发展和抗病毒“鸡尾酒疗法”的兴起，已经让HIV感染患者能够长期控制病情，并且达到与正常人相当的预期寿命，这被认为是医学领域在过去25年中取得的最重要进展之一。目前已经有多种有效控制HIV病毒增殖的单片复方治疗方案，只要患者坚持每日服药，他们的寿命与健康人没有显著区别。然而，如果患者因为某些原因无法每日服药，体内的病毒不但可能卷土重来，产生耐药性的风险也会增加。在治愈性疗法诞生之前，每日服药对于很多HIV感染者来说仍然是一个负担。这次所公布的是一项开放标签、含活性对照的2期研究。正在接受每日口服抗病毒方案Biktarvy治疗并且病毒水平得到抑制的艾滋病成人患者，被以1：1的比例随机分配接受每周一次口服islatravir（2毫克）和lenacapavir（300毫克）组合疗法（n=52），或继续接受活性对照药物（n=52）治疗。两家公司在今年3月公布该试验主要终点的结果。主要终点是在第24周时测量HIV-1 RNA ≥50拷贝/毫升的患者人数，数据显示1位接受ISL+LEN治疗的受试者（1.9%）在第24周时病毒水平超过50拷贝/毫升；该受试者在第30周时病毒水平得到抑制。在活性对照药物组中，没有受试者在第24周时病毒水平超过50拷贝/毫升。试验的其中一项次要终点为第24周HIV-1 RNA <50拷贝/毫升的个体比例，结果显示转换至每周一次ISL+LEN组合疗法或继续活性对照药物治疗的受试者，在第24周均保持了相当高的HIV抑制率（94.2% vs. 94.2%）。试验的另一项次要终点是在第48周时HIV-1 RNA <50拷贝/毫升的个体比例。这次公布的结果显示，改用每周一次ISL+LEN组合疗法或继续使用活性对照药物治疗的受试者在第48周保持了相当高的HIV抑制率（分别为94.2%和92.3%）。此外，接受ISL+LEN或活性对照药物治疗的受试者在第48周时病毒载量均未达≥50拷贝/毫升，这是试验的另一个次要终点。安全性方面，ISL+LEN组中19.2%的受试者（n=10/52）出现了治疗相关不良事件（TRAE），最常见的是口干（n=2/52；3.8%）和恶心（n=2/52；3.8%）。活性对照药物组中5.8%的受试者（n=3/52）报告了TRAE。两个治疗组均未报告与研究药物相关的3级或4级TRAE。两名受试者（n=2/52；3.8%）因与药物无关的不良事件停止使用ISL+LEN。在第48周，治疗组之间的CD4+ T细胞计数或绝对淋巴细胞计数与基线相比的平均变化没有显著差异。没有受试者因CD4+ T细胞或淋巴细胞计数减少而停止治疗。这项每周口服ISL+LEN组合疗法正在两项3期研究中作为固定剂量联合方案接受评估，用于治疗病毒水平得到抑制的艾滋病成人患者。 Islatravir（MK-8591）是默沙东开发的创新核苷类逆转录酶易位抑制剂（NRTTI），临床前研究表明它能够通过多种机制抑制HIV逆转录酶的功能，它的作用机制有别于目前获批的抗HIV疗法和传统的核苷类逆转录酶抑制剂（NRTIs）。目前，默沙东已经开展多项临床试验，检验它作为单药暴露前预防疗法（PrEP）疗法，和与其它抗病毒疗法联用治疗HIV感染的效果。 Lenacapavir是一种“first-in-class”长效HIV衣壳抑制剂，适用于与其他抗逆转录病毒药物联合治疗多药耐药HIV感染的成人患者，该疗法可以干扰HIV病毒衣壳蛋白的组装和拆卸，在HIV-1生命周期的多个阶段发挥作用。它已经在多个国家和地区获得监管批准。Lenacapavir曾在2019年获得美国FDA授予的突破性疗法认定，用于联合其他抗逆转录病毒药物治疗多重耐药的重度经治HIV-1感染者。Lenacapavir注射液和片剂在2022年12月获得FDA的上市许可（商品名Sunlenca），用于联合其他抗逆转录病毒药物治疗多重耐药HIV感染的成人患者。根据新闻稿，该疗法是首个基于衣壳抑制剂的HIV治疗选项，此“first-in-class”药物向HIV患者提供了一种新的、一年两次的治疗选择。延长给药间隔、提高服药依从性是艾滋病疗法的开发趋势。除了ISL+LEN组合疗法外，近年所开发的长效艾滋病疗法还包含由ViiV Healthcare开发的长效注射型抗逆转录病毒疗法Cabenuva。Cabenuva是FDA批准的首款用于HIV感染成人患者的完整注射方案，批准方案为每个月给药一次。该药由利匹韦林和卡博特韦组成。今年2月所公布的临床3期结果显示，对于过去药物依从性较差的患者，Cabenuva与每日口服治疗相比，能更好地维持病毒载量的抑制。此外，Immunocore公司也在去年12月公布其双特异性的在研可溶性TCR疗法IMC-M113V用于治疗HIV病毒感染者的临床数据。结果显示，所有的剂量都有良好的耐受性，没有严重的不良事件，没有血液学或化学方面的明显变化，也没有出现细胞因子释放综合征或神经毒性。新闻稿指出，这种疗法旨在消灭被HIV病毒感染的细胞“储库”，以实现功能性治愈。参考资料： [1] GILEAD AND MERCK ANNOUNCE PHASE 2 DATA SHOWING A TREATMENT SWITCH TO AN INVESTIGATIONAL ORAL ONCE-WEEKLY COMBINATION REGIMEN OF ISLATRAVIR AND LENACAPAVIR MAINTAINED VIRAL SUPPRESSION IN ADULTS AT WEEK 48. Retrieved October 21, 2024 from https://www.merck.com/news/gilead-and-merck-announce-phase-2-data-showing-a-treatment-switch-to-an-investigational-oral-once-weekly-combination-regimen-of-islatravir-and-lenacapavir-maintained-viral-suppression-in-adults-at-wee/ [2] slatravir Clinical Program Overview. Retrieved July 20, 2021, from https://www.merck.com/wp-content/uploads/sites/5/2021/07/ISL-Pipeline-Document-7-7-21.pdf 内容来源于网络，如有侵权，请联系删除。

临床结果

2024-10-22

·Pharmaceutical Technology

Gilead and MSD to advance once-weekly HIV treatment to Phase III

The treatment combines MSD’s islatravir with Gilead’s lenacapavir. Credit: Ground Picture via Shutterstock. Gilead Sciences and MSD are advancing their once-weekly HIV treatment regimen to Phase II trials, following promising results from a 48-week study. The treatment combines MSD’s islatravir, an experimental nucleoside reverse transcriptase inhibitor, with Gilead’s lenacapavir, marketed as Sunlenca for use in combination with other antiretroviral drugs to treat people with multidrug-resistant HIV infection. In contrast to currently available daily HIV medications, such as Gilead’s Biktarvy (bictegravir 50mg/emtricitabine 200mg/tenofovir alafenamide 25mg), this new option could offer a long-acting alternative for people living with HIV. In the Phase II trial (NCT05052996), 104 virologically suppressed adults on Biktarvy were randomly assigned to either continue their daily regimen or switch to the once-weekly islatravir/lenacapavir combination. At the 24-week mark, 94.2% of patients on the experimental treatment maintained viral loads below 50 copies m/L – a key threshold for HIV suppression – matching the Biktarvy group. By week 48, the new regimen continued to demonstrate non-inferior efficacy, with 94.2% of participants achieving sustained viral suppression, compared to 92.4% of those who remained on Biktarvy. These results suggest that the once-weekly combination could provide a more convenient option for patients, potentially reducing the burden of daily medication. Currently, the only long-acting HIV treatment available in the US is Viiv Healthcare’s Cabenuva, which is administered as a monthly or bi-monthly injection. This could make Gilead and MSD’s new pill an attractive alternative to those seeking a less frequent oral regimen. See Also: Editas and Genevant team up to develop gene editing therapies World Osteoporosis Day calls for urgent action to prevent fragility fractures Biktarvy is approved as a once-daily pill to treat patients living with certain types of HIV. The drug generated $11.9bn in global sales in 2023, as per Gilead’s financials. According to GlobalData’s Pharma Intelligence Center, Biktarvy will generate $15.3bn in sales in 2030. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the results, Elizabeth Rhee, vice president of global clinical development of Merck Research Laboratories said: “Daily single-tablet regimens have helped to transform HIV care but can be challenging for some people to maintain. Novel HIV treatment options that allow for less frequent oral dosing have the potential to help support adherence, and address stigma faced by some individuals taking daily oral therapy.” MSD previously tried to develop a higher dose of islatravir, however it had to pause development after it led to a drop in counts of lymphocytes and CD4+ T cells in clinical trials in 2021. In MSD and Gilead’s Phase II study, there were no differences in immune cell count changes between the Biktarvy and experimental groups. Additionally, no participants discontinued because of a decrease in CD4+ T-cell or lymphocyte counts. Encouraged by these results, Gilead and MSD are now advancing the treatment in Phase III trials. Gilead is also advancing lenacapavir as a PrEP medication, a group of drugs that HIV-negative people can take to minimise the risk of contracting HIV. The company plans to use the data from two Phase III clinical trials – PURPOSE-1 (NCT04994509) and PURPOSE-2 (NCT04925752) – to support a series of global regulatory filings for lenacapavir for PrEP that will begin by the end of 2024.