A Phase I/II Trial of Allogeneic Reduced-Intensity, HLA-Haploidentical Bone Marrow Transplantation Followed by GVHD Prophylaxis With Cyclophosphamide, Bortezomib and Maraviroc for Hematologic Malignancies in People Living With HIV (PLWH)

Background:
People living with HIV(PLWH) are at a higher risk for cancers that may be curable with a bone marrow transplant. HIV infection itself is no longer a reason to not get a transplant, for patients who otherwise have a standard reason to need transplant.
Objective:
This study is being done to see if a new combination of drugs (cyclophosphamide, maraviroc, and bortezomib) is both safe and effective at protecting against graft-versus-host disease after bone marrow transplant. The study will also test the transplant s impact on your survival and control of your cancer.
Eligibility:
People aged 18 years and older living with HIV and a blood cancer that is eligible for a transplant. Healthy family members aged 12 or older who are half matched to transplant recipients are also needed to donate bone marrow.
Design:
The study will be done in 2 phases. The first phase will be to see if we can safely use a new combination of drugs to prevent GVHD. If the combination is safe in the first phase, the study will proceed to the second phase. In the second phase, we will see if this new combination can better protect against GVHD after transplant.
Participants will be screened. Their diagnoses, organ function and eligibility will be confirmed.
Participants will have a catheter inserted into a vein in their chest or neck. Medications and transfusions will be given through the catheter; blood will be drawn from it.
Participants will be in the hospital for 6 weeks or longer.
They will receive various drugs for 2 weeks to prep their body for the transplant.
The transplant cells will be administered through the catheter.
Participants will continue to receive drug treatments after the transplant.
Blood transfusions may also be needed.
Participants will return 1-2 times per week for follow-up visits for 3 months after discharge.
Participants will have visits 6, 12, 18, 24 months after transplant, then once a year for 5 years.

开始日期2023-01-26

申办/合作机构

National Cancer Institute

NCT04789616 / Recruiting临床2期IIT

The CAMAROS Trial: The Canadian Maraviroc RCT To Augment Rehabilitation Outcomes After Stroke

The CAMAROS trial is a randomized controlled phase II trial analyzing the effect of coupling a C-C chemokine receptor 5 (CCR5) antagonist, Maraviroc (Celsentri), and exercise to improve both upper and lower extremity recovery after a stroke.

开始日期2022-09-15

申办/合作机构

University of Calgary

[+8]

NCT04475991 / Terminated临床2期

Phase2, Randomized, Controlled Study to Evaluate the Efficacy and Safety of Maraviroc and/or Favipiravir Plus Standard Therapy in Adult Patients With Severe Non-critical COVID-19"

Phase 2, randomized, open-label study to evaluate the safety and efficacy of maraviroc, favipiravir, and both drugs administered along with currently used therapy in hospitalized patients with pulmonary SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) infection (COVID-19)

开始日期2021-07-13

申办/合作机构

Hospital General de México

[+1]

100 项与马拉韦罗相关的临床结果

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100 项与马拉韦罗相关的转化医学

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100 项与马拉韦罗相关的专利（医药）

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1,258

项与马拉韦罗相关的文献（医药）

2024-02-20·Biomedicine & pharmacotherapy = Biomedecine & pharmacotherapie

In ovarian cancer maraviroc potentiates the antitumoral activity and further inhibits the formation of a tumor-promoting microenvironment by trabectedin.

Article

作者: Naike Casagrande ; Cinzia Borghese ; Giuseppe Corona ; Donatella Aldinucci

Ovarian cancer (OC) is the fifth most frequent cause of cancer-related death in women. Chemotherapy agent trabectedin, affecting cancer cells and tumor microenvironment, has been approved for the treatment of relapsed platinum-sensitive OC patients. CCR5-antagonist maraviroc inhibits tumor growth, metastasis, and enhances the antitumoral activity of DNA-damaging drugs. Here, we found that OC cells expressed CCR5 receptor but did not secret CCR5-ligands. Maraviroc treatment did not affect OC cell viability, but strongly potentiated the antiproliferative activity, apoptosis induction, cell cycle blockage, DNA damage, and ROS formation by trabectedin. In A2780cis cisplatin-resistant cells, the cross-resistance to trabectedin was overcame by the combination with maraviroc. Maraviroc enhanced trabectedin cytotoxicity in OC 3Dimensional spheroids and THP-1-monocytes. Both maraviroc and trabectedin interact with drug efflux pump MDR1/P-gp, overexpressed in recurrent OC patients. Maraviroc increased trabectedin intracellular accumulation and the MDR1-inhibitor verapamil, like maraviroc, increased trabectedin cytotoxicity. In OC tumor xenografts the combination with maraviroc further reduced tumor growth, angiogenesis, and monocyte infiltration by trabectedin. In conclusion, this study offers a preclinical rationale for the use of maraviroc as new option to improve trabectedin activity in relapsed chemoresistant OC patients.

2024-02-19·Organic letters

Development of Catalytic Enantioselective Mannich Reactions Using Esters.

Article

作者: Yasuhiro Yamashita ; Seiya Fushimi ; Trisha Banik ; Tomoya Kimura ; Shu Kobayashi

Catalytic enantioselective Mannich reactions of simple nonactivated esters proceeded using a chiral potassium strong base catalyst prepared from a chiral bisoxazoline and potassium hexamethyldisilazide. Alkyl acetates, alkyl propionates, and an alkyl butyrate were employed as the simple esters, and the desired reactions proceeded smoothly to afford Mannich products in good to high yields with high enantioselectivities. One of the products was successfully employed in the asymmetric total synthesis of Maraviroc.

2024-01-19·Hypertension (Dallas, Tex. : 1979)

Role of the CCL5 and Its Receptor, CCR5 in the Genesis of Aldosterone-Induced Hypertension, Vascular Dysfunction, and End-Organ Damage.

Article

作者: Rafael M Costa ; Débora M Cerqueira ; Ariane Bruder-Nascimento ; Juliano V Alves ; Wanessa M C Awata ; Shubhnita Singh ; Alexander Kufner ; Douglas S Prado ; Ebin Johny ; Eugenia Cifuentes-Pagano ; William F Hawse ; Partha Dutta ; Patrick J Pagano ; Jacqueline Ho ; Thiago Bruder-Nascimento

BACKGROUND:

Aldosterone has been described to initiate cardiovascular diseases by triggering exacerbated sterile vascular inflammation. The functions of CCL5 (C-C motif chemokine ligand 5) and its receptor CCR5 (C-C motif chemokine receptor 5) are well known in infectious diseases, their contributions to aldosterone-induced vascular injury and hypertension remain unknown.

METHODS:

We analyzed the vascular profile, blood pressure, and renal damage in wild-type (CCR5^+/+) and CCR5 knockout (CCR5^-/-) mice treated with aldosterone (600 µg/kg per day for 14 days) while receiving 1% saline to drink. Vascular function was analyzed in aorta and mesenteric arteries, blood pressure was measured by telemetry and renal injury and inflammation were analyzed via histology and flow cytometry. Endothelial cells were used to study the molecular signaling whereby CCL5 induces endothelial dysfunction.

RESULTS:

Aldosterone treatment resulted in exaggerated CCL5 circulating levels and vascular CCR5 expression in CCR5^+/+ mice accompanied by endothelial dysfunction, hypertension, and renal inflammation and damage. CCR5^-/- mice were protected from these aldosterone-induced effects. Mechanistically, we demonstrated that CCL5 increased Nox1 (NADPH oxidase 1) expression, reactive oxygen species formation, NFκB (nuclear factor kappa B) activation, and inflammation and reduced NO production in isolated endothelial cells. These effects were abolished by antagonizing CCR5 with Maraviroc. Finally, aorta incubated with CCL5 displayed severe endothelial dysfunction, which is prevented by blocking Nox1, NFκB, or CCR5.

CONCLUSIONS:

Our data demonstrate that CCL5/CCR5, through activation of NFkB and Nox1, is critically involved in aldosterone-induced vascular and renal damage and hypertension placing CCL5 and CCR5 as potential therapeutic targets for conditions characterized by aldosterone excess.

项与马拉韦罗相关的新闻（医药）

2024-02-15

·PRNewswire

HealthBioAI Announces the Acceptance by the Federal Drug Administration (FDA) to Proceed with a Randomized Clinical Trial for the Treatment of Long COVID/Post Acute Sequelae of COVID (PASC) with Selzentry® (maraviroc) in Combination with Lipitor (atorvastatin)

- New Company to support New Drug Application- HAYWARD, Calif., Feb. 15, 2024 /PRNewswire/ -- HealthBioAI, a recently launched precision immunology company advancing new science for neglected immune-mediated diseases, today announced that the company's clinical trial design to investigate the treatment of patients with Long COVID/Post-Acute Sequelae of COVID (PASC) with Selzentry (maraviroc) tablets and Lipitor (atorvastatin) tablets is accepted to proceed with a randomized clinical trial. The clinical trial will support a New Drug Application (NDA) filing through the 505(B)(2) pathway of the Federal Food, Drug, and Cosmetic Act (FDCA). The Clinical Trial is a 32-week randomized, 252 patient, double-blind, placebo-controlled, multicenter study that is evaluating the safety and efficacy of maraviroc and atorvastatin for the treatment of patients living with Long COVID/Post-Acute Sequelae of Covid (PASC). "We are excited to come out of extensive integration to launch our new enterprise, HealthBioAI. We have combined Machine Learning driven precision diagnostics of IncellDx, a diagnostics company, with our proprietary data analytics AI portal to fuel new drug discovery. This work has culminated in our first successful filing and acceptance from the FDA for our long COVID clinical trial," said Bruce Patterson, M.D., founder and CEO at HealthBioAI. "Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as Long COVID or Post-COVID Conditions (PCC). Long COVID is a debilitating condition in which patients often go undiagnosed and without treatment. Symptoms of the disease can last weeks, months or even years and often impact work, daily household tasks, and even getting out of bed. HealthBioAI, is pleased about the potential therapeutic value of our combination regimen for treatment of Long COVID," said Stefan Glück, M.D, Ph.D.; senior vice president, Medical Affairs at HealthBioAI. "While the two existing therapies have been individually approved as stand-alone treatments in use for more than a decade for cholesterol and infectious diseases with well documented safety profiles, our research has found that when the therapies are combined, they may hold the key to suppressing the blood vessel inflammation believed to be at the root of Long COVID." The protocol of maraviroc and atorvastatin addresses the CCR5 pathway, reducing vascular inflammation with the potential to improve patient outcomes. A study was published earlier this year in a peer reviewed journal where Long COVID patients were given maraviroc (300 mg per oral twice a day) and pravastatin (10 mg per oral daily) showed improvements in both subjective symptoms and the objective measure of the biomarkers that characterize Long COVID. In 2021, a patent was awarded for the use of maraviroc to treat COVID-19 and Long COVID, which is now held by HealthBioAI. About Long Covid Long COVID is referred to by many names, including Post-COVID Conditions, long-haul COVID, post-acute COVID-19, long-term effects of COVID, and chronic COVID. The term post-acute sequelae of SARS CoV-2 infection (PASC) is also used to refer to a subset of Long COVID. Long COVID may not affect everyone the same way. People with Long COVID may experience health problems from different types and combinations of symptoms that may emerge, persist, resolve, and reemerge over different lengths of time. Long COVID is estimated to affect nearly 20 million people across the United States and more than 65 million worldwide. Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after acute COVID-19 infection. This definition of Long COVID was developed by the Department of Health and Human Services (HHS) in collaboration with CDC and other partners. About HealthBioAI HealthBioAI, a recently launched company has identified a common thread in chronic inflammatory diseases through the use of machine learning and AI-based precision diagnostics. HealthBioAI is initially focused on precision immune modulation of neglected diseases, including Long COVID, Chronic Fatigue Syndrome (ME-CFS) and Chronic Lyme Disease. The company aims to improve diagnosis, advance new science, and innovate new medicines for these historically minimally characterized diseases. For more information or investment inquiries, please contact us at . Media Contact: Julie Ferguson [email protected] [email protected] (312) 385-0098 Investor Relations: Chris Wheeler Chief Financial Officer [email protected] [email protected] (415) 595-4911 SOURCE HealthBioAI

临床研究申请上市紧急使用授权

2024-02-15

·BioSpace

HealthBioAI Announces the Acceptance by the FDA to Proceed with a Randomized Clinical Trial for the Treatment of Long COVID/Post Acute Sequelae of COVID (PASC) with Selzentry® (maraviroc) in Combination with Lipitor (atorvastatin)

New Company to support New Drug Application HAYWARD, Calif., Feb. 15, 2024 /PRNewswire/ -- HealthBioAI, a recently launched precision immunology company advancing new science for neglected immune-mediated diseases, today announced that the company's clinical trial design to investigate the treatment of patients with Long COVID/Post-Acute Sequelae of COVID (PASC) with Selzentry (maraviroc) tablets and Lipitor (atorvastatin) tablets is accepted to proceed with a randomized clinical trial. The clinical trial will support a New Drug Application (NDA) filing through the 505(B)(2) pathway of the Federal Food, Drug, and Cosmetic Act (FDCA). The Clinical Trial is a 32-week randomized, 252 patient, double-blind, placebo-controlled, multicenter study that is evaluating the safety and efficacy of maraviroc and atorvastatin for the treatment of patients living with Long COVID/Post-Acute Sequelae of Covid (PASC). "We are excited to come out of extensive integration to launch our new enterprise, HealthBioAI. We have combined Machine Learning driven precision diagnostics of IncellDx, a diagnostics company, with our proprietary data analytics AI portal to fuel new drug discovery. This work has culminated in our first successful filing and acceptance from the FDA for our long COVID clinical trial," said Bruce Patterson, M.D., founder and CEO at HealthBioAI. "Some people who have been infected with the virus that causes COVID-19 can experience long-term effects from their infection, known as Long COVID or Post-COVID Conditions (PCC). Long COVID is a debilitating condition in which patients often go undiagnosed and without treatment. Symptoms of the disease can last weeks, months or even years and often impact work, daily household tasks, and even getting out of bed. HealthBioAI, is pleased about the potential therapeutic value of our combination regimen for treatment of Long COVID," said Stefan Glück, M.D, Ph.D.; senior vice president, Medical Affairs at HealthBioAI. "While the two existing therapies have been individually approved as stand-alone treatments in use for more than a decade for cholesterol and infectious diseases with well documented safety pro our research has found that when the therapies are combined, they may hold the key to suppressing the blood vessel inflammation believed to be at the root of Long COVID." The protocol of maraviroc and atorvastatin addresses the CCR5 pathway, reducing vascular inflammation with the potential to improve patient outcomes. A study was published earlier this year in a peer reviewed journal where Long COVID patients were given maraviroc (300 mg per oral twice a day) and pravastatin (10 mg per oral daily) showed improvements in both subjective symptoms and the objective measure of the biomarkers that characterize Long COVID. In 2021, a patent was awarded for the use of maraviroc to treat COVID-19 and Long COVID, which is now held by HealthBioAI. About Long Covid Long COVID is referred to by many names, including Post-COVID Conditions, long-haul COVID, post-acute COVID-19, long-term effects of COVID, and chronic COVID. The term post-acute sequelae of SARS CoV-2 infection (PASC) is also used to refer to a subset of Long COVID. Long COVID may not affect everyone the same way. People with Long COVID may experience health problems from different types and combinations of symptoms that may emerge, persist, resolve, and reemerge over different lengths of time. Long COVID is estimated to affect nearly 20 million people across the United States and more than 65 million worldwide. Long COVID is broadly defined as signs, symptoms, and conditions that continue or develop after acute COVID-19 infection. This definition of Long COVID was developed by the Department of Health and Human Services (HHS) in collaboration with CDC and other partners. About HealthBioAI HealthBioAI, a recently launched company has identified a common thread in chronic inflammatory diseases through the use of machine learning and AI-based precision diagnostics. HealthBioAI is initially focused on precision immune modulation of neglected diseases, including Long COVID, Chronic Fatigue Syndrome (ME-CFS) and Chronic Lyme Disease. The company aims to improve diagnosis, advance new science, and innovate new medicines for these historically minimally characterized diseases. For more information or investment inquiries, please contact us at . Media Contact: Julie Ferguson media@healthbioai.com Julie@jfprmedia.com (312) 385-0098 Investor Relations: Chris Wheeler Chief Financial Officer investments@healthbioai.com ChrisWheeler@HealthBioAI.com (415) 595-4911 View original content: SOURCE HealthBioAI

申请上市临床研究紧急使用授权

2023-12-01

·药智网

40余年艾滋病药物“进化史”，谁主沉浮？

世界第一个艾滋病病例在1981年的12月1日被诊断出来，世界卫生组织将每年的12月1日定为世界艾滋病日。艾滋病全称为获得性免疫缺陷综合征（ acquired immunodeficiency syndrome , AIDS)，是由人类免疫缺陷病毒（ human immunodeficiency virus ,HIV）感染引起的一种以人体免疫系统全面崩溃为特征的、病死率很高的传染病。艾滋病发现至今已40余年，随着医药技术的快速发展，以抗病毒治疗来最大限度和持久地降低病毒载量是艾滋病治疗的关键。虽全球范围内仍缺乏根治HIV感染的特效药物，但目前已有50多种抗艾滋病治疗药物上市，人们在与艾滋病毒对抗的过程中，取得了长足的进步，使得艾滋病逐渐可防可控。HIV抗病毒药物的“进化史”抗艾滋病病毒治疗药物的作用机理是通过抑制HIV复制的各个环节，以达到控制病情。理论上来说，HIV复制过程中的任何一个步骤均可作为抗HIV药物的作用靶点，包括：阻止病毒与CD4受体结合：阻断病毒与辅助受体结合进入细胞：防止HIV与淋巴细胞的融合：抑制HIV复制过程中所需的反转录酶、整合酶、蛋白酶等活性，其中任意一个环节得到有效阻断，都可以使病毒无法继续复制增加。人类抗艾滋病的药物史最早从1987年第一个抗HIV药物核苷类反转录酶抑制剂齐多夫定在美国获批上市开始。齐多夫定之后，很多药物陆续被开发出来，随着越来越多药物上市，人们发现仅靠单一药物并不能很好控制HIV感染，患者常被用药后因病情缓解时间短就反弹困扰。随后1995年一种采用三种或三种以上的药物联合使用抑制病毒的疗法，也叫“鸡尾酒疗法（HAART）”被应用于临床，有效地解决了单药治疗的弊端。不过HAART疗法也存在服药种类多、剂量大、频次多等诸多不足，医学对艾滋病的用药探索持续深入。2006年，全球首个口服单一片剂药物依非韦仑/恩曲他滨/富马酸替诺福韦二吡呋酯复方片获FDA批准上市，HIV患者的治疗从每天多次大量服药，变成了每天只需吃一次药，用药迎来变革时刻。之后，药企在提高HIV患者用药依从性上继续做更多探究，2022年8月，一款每年只需给药两次的被称为史上最强的长效抗HIV药物Sunlenca （lenacapavir）在欧洲问世，同年12月Sunlenca再获FDA批准，成为全球首个也是唯一每年用药两次的治疗多重耐药HIV患者的药物。四十年的发展演变，抗HIV药物不断“进化”升级，层出不穷，用药格局被全面打开，目前国际上主要有6大类HIV药物获批上市，其主要被葛兰素，吉利德和强生三家代表企业拥有。核苷类反转录酶抑制剂（NRTIs）：可以同脱氧核苷竞争与反转录酶结合，从而抑制HIV的复制，代表药物有齐多夫定（AZT）、拉米夫定（3TC）、恩曲他滨 (FTC) 、阿巴卡韦（ABC）和替诺福韦 (TDF) 等。非核苷类反转录酶抑制剂（NNRTIs）：通过与反转录酶的非底物结合部位结合，抑制HIV反转录酶的活性，代表药物有奈韦拉平（NVP）、依非韦伦（EFV）、利匹韦林（RPV）依曲韦林（ETR）、多拉韦林（DOR）和艾诺韦林。蛋白酶抑制剂（PIs）：在CD4+T淋巴细胞内阻断蛋白酶的作用，阻止HIV RNA装配成完整HIV，代表药物：洛匹那韦/利托那韦 (LPV/r)、达芦那韦（DRV）、阿扎那韦（ATV）。整合酶抑制剂（INSTIs）：在CD4+T淋巴细胞内抑制整合酶，使病毒DNA不能整合到宿主染色体，代表药物：多替拉韦 (DTG)、拉替拉韦（RAL）和卡替拉韦（CAB）等。膜融合抑制剂（FIs）：阻断HIV与CD4+T淋巴细胞膜融合，从而阻止HIV RNA进入CD4+T淋巴细胞内。代表药物：恩夫韦脑 (T20) 和艾博韦泰等。CCR5拮抗剂（CCR5抑制剂）：能够阻滞HIV和细胞上化学因子受体CCR5相互作用而阻止病毒进入靶细胞，代表药物：马拉韦罗（MVC）。药物类别代表药物核苷类逆转录酶抑制剂 (NRTls)齐多夫定、拉米夫定、替诺福韦、恩曲他滨、丙酚替诺福韦非核苷类逆转录酶抑制剂(NNRTlS)依非韦伦、奈韦拉平、利匹韦林、艾诺韦林蛋白酶抑制剂 (Pls)达芦那韦、利托那韦、替拉那韦、阿扎那韦、洛匹那韦整合酶抑制剂 (INSTls)多替拉韦、拉替拉韦膜融合抑制剂 (Fls)恩夫韦肽、艾博韦泰CCR5抑制剂马拉韦罗艾滋病药物分类，数据来源：PharmSnap数据库全球艾滋病药物市场概述联合国艾滋病规划署2023年7 月14日最新发布《2023 全球艾滋病防治进展报告——终结艾滋病之路》，报告显示，全球目前有 3900 万艾滋病病毒感染者，2022 年新发感染 130 万，63 万人死于艾滋病相关疾病。根据弗若斯特沙利文报告，全球抗HIV 药物市场规模2017年为325亿美元，至 2021年为380亿美元，复合年增长率为4.0%。预计2025年将达到479亿美元，2030 年将达到575亿美元，2021年至2025 年的复合年增长率为 6.0%，2025年至2030年的复合年增长率为3.7%。目前，北美及中西欧市场为抗HIV病毒药物市场的主流市场，发展中国家市场占据整体药物市场比例不到10%，以中国为例，根据PDB数据，2020年国内抗艾药物市场规模约15亿元，不足全球市场的1%。全球范围抗HIV的主要厂商有吉利德、GSK、默克、强生、默沙东等多家跨国企业，其中吉利德、葛兰素史克/欢悦医疗（GSK/Viiv）、强生已成为HIV全球药物市场前三强，GSK、吉利德和强生的市场份额均在不断扩张。吉利德近年来不断推出创新重磅产品，凭借多款艾滋病口服药物占据主导地位，是当之无愧的龙头老大，整体市场份额超过50%，在研管线产品亦领先各大企业；GSK在艾滋病领域稳坐第二把交椅，1987年全球首个艾滋病药物齐多夫定便是由葛兰素史克（GSK）开发上市，GSK又开发了Combivir（拉米夫定/齐多夫定）、Trizivir（阿巴卡韦/拉米夫定/齐多夫定）、Epzicom/Kivexa（阿巴卡韦/拉米夫定）等一系列鸡尾酒疗法，2015年，GSK买下了BMS的HIV研发管线，以确保自己在HIV领域的优势地位，目前，HIV板块也成了葛兰素四大核心业务之一。全球主要畅销HIV治疗药物近几年艾滋病最畅销药物之最，非吉利德Biktarvy莫属。Biktarvy不需要联用其他药物，2018年上市后迅速称霸HIV市场，2020年以53.21%的增长率拉动了整个HIV药物市场，2021年卖出86.24亿美元，2022年，吉利德的HIV新药Biktarvy首次突破百亿美元，达到103.9亿美元，同比增长20.6%，2022年销售额已经排到全球畅销药第7位。2022全球主要HIV畅销药物序号药品名称原研公司最早上市时间2022销售额（亿美元）1Biktarvy吉利德 (Gilead)2018.02.07103.92Genvoya吉利德 (Gilead)2015.11.0524.043Triumeq葛兰素（GSK）2014.08.2222.544Prezista强生（J&J）2006.06.2319.435Descovy吉利德 (Gilead)2016.04.0418.726Tivicay葛兰素（GSK）2013.8.1217.37Odefsey吉利德 (Gilead)2016.03.0114.698Isentress默沙东2007.10.126.339Dovato葛兰素（GSK）2019.04.085.4910Edurant强生（J&J）2011.05.202.9数据来源：根据公开数据整理2023上半年，Biktarvy销售额56亿多美元，上年同期为47亿美元，增长强劲；2023Q3吉利德的HIV产品总收入47亿美元，比去年同期增长了4%，增长额主要还是由Biktarvy推动，收入同比增长12%，超30亿美元；按此增速，未来几年内Biktarvy的年销售额不仅将继续保持百亿“身位”，在全球畅销药TOP10的排名有望进一步提升。除Biktarvy，吉利德的Genvoya、Descovy、Odefsey等多款HIV药物在全球范围内都比较抢手，其中Genvoya2022年销售额突破24.04亿美元，Descovy销售18.72亿美元、Odefsey收入14.69亿美元，这几款药物撑起了吉利德的HIV市场的霸主地位。除吉利德，葛兰素的Triumeq和Tivicay虽然体量不及Biktarvy，但在HIV领域有着举足轻重的地位，Triumeq上市第二年Triumeq销售额就位列全球抗HIV药物的第三名，虽然近几年面对吉利德HIV药物的猛烈冲击，销售有所下降，但是基本能保持“前三”的位置，Triumeq2022年的销售额为22.54亿美元，另外葛兰素的Dovato近几年涨力也不错。此外，强生的Prezista、默沙东的Isentress也都是全球畅销的主要HIV药物，2022年销售额分别为19.43亿美元、6.33亿美元。国内抗HIV药物市场正在崛起弗若斯特沙利文的资料显示，中国2021年感染HIV的人口达到150万人，预计2025年将达到170万人及2030年将达到210万人，2021年至2025年的复合年增长率为3.0%，平均每年增加5万人；而2025年至2030年的复合年增长率为4.2%，平均每年增加6万人。当前国内HIV用药市场规模较小，大约在30亿-40亿元左右，但随着患者基数的增加、诊断率和治疗率的提高、医保支付能力的提高以及自费人群的逐渐增多，我国抗HIV药物市场规模将迅速增长，根据灼识咨询报告，中国的抗HIV病毒药物市场从2013年的7.9亿元人民币增加到2018年的20.2亿元人民币，年均复合增长率为20.7%，预计至2023年，市场规模将达49.6亿元人民币，到2027年，有望超过100亿元。面对百亿市场蓝海，近年来不止跨国药企，本土药企也在加速布局。目前，国内市场在售的HIV药物以进口药及国产仿制药为主，已上市的HIV治疗药物主要类别有NRTIs、NNRTIs、PIs、INSTIs及FIs这几大类，在售的活跃品种有二三十个，进口药由吉利德、GSK、强生、默沙东等几家企业掌控80%的市场份额，仿制药由超过40家国内企业布局，包括迪赛诺、成都倍特药业、齐鲁药业、安徽贝克生物制药、东北药业等。目前，除进口药和仿制药，HIV国产创新药也有了突破，有4款药物获批上市，分别是艾迪药业的艾邦德（艾诺韦林片）和复邦德（艾诺米替片），前沿生物的艾可宁、真实生物的阿兹夫定片，其中，艾迪药业研发的复邦德（艾诺米替片）是国内首个获批具有自主知识产权的三联单片复方抗艾滋病1类新药，填补了国产创新成分单片复方制剂领域的空白；前沿生物的长效 FIs 艾博韦泰和艾迪药业 NNRTIs 艾诺韦林分别于2018年和2021年先后上市，上市后的市场表现不俗。相比仿制药，虽然国内抗HIV创新药物较为稀缺，但赛道也聚集了众多玩家，除了前沿生物、艾迪药业及真实生物外，还包括恒瑞医药、中裕新药、青峰药业、舒泰神、三叶草、翰森制药、微芯生物等20余家企业，不过国内在研管线产品大多处于临床早期。中国抗HIV药物管理结构形成了“免费+自费+医保”三驾马车的格局，根据灼识咨询报告，目前我国抗HIV病毒药物市场以国家免费药物为主导，国家免费药物的市场规模约占据我国整体抗HIV病毒药物市场规模的74%左右，政府每年在艾滋病药物的采购上花费15亿元。近年来，伴随全球范围高度重视艾滋病的防治工作，全球的艾滋病用药市场发生了显著的变化，作用机制更领先、疗效更优、安全性更好及用药依从性更佳的药物逐渐成功研发并上市，且在各国政策的支持下，加上药物更新迭代，相信我们离消除艾滋病的目标将会更近一步，实现最终防治目标、终结艾滋病的流行。来源 | 博药（药智网获取授权转载）撰稿 | 米朵责任编辑 | 八角声明：本文系药智网转载内容，图片、文字版权归原作者所有，转载目的在于传递更多信息，并不代表本平台观点。如涉及作品内容、版权和其它问题，请在本平台留言，我们将在第一时间删除。商务合作 | 张武龙 13368443108（同微信）阅读原文，是昨天最受欢迎的文章哦

上市批准寡核苷酸临床研究核酸药物

100 项与马拉韦罗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D06670	马拉韦罗	J05AX09	DB04835

研发状态

适应症	最高研发状态	国家/地区	公司
HIV感染	批准上市	俄罗斯更多	ViiV Healthcare Ltd. 更多
新型冠状病毒感染	临床2期	西班牙更多	ViiV Healthcare Ltd. 更多
亨廷顿舞蹈病	临床前	英国更多	University of Cambridge 更多
痴呆	临床前	英国更多	University of Cambridge 更多
类风湿关节炎	终止	葡萄牙更多	Pfizer Inc. 更多

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临床结果

适应症

分期

评价

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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


NCT01348308 (OPTIMAL, Pubmed \| Ann Intern Med) 人工标引	临床3期	HIV感染	409	Maraviroc	蓋憲廠鹹鑰遞艱繭餘獵(餘積膚襯鹹顧獵衊淵糧) = 蓋膚餘醖構選鏇廠夢選憲網窪憲鑰顧鑰製衊醖 (壓範憲顧窪網獵構餘簾 ) 更多	不佳	2020-03-03
				Placebo	蓋憲廠鹹鑰遞艱繭餘獵(餘積膚襯鹹顧獵衊淵糧) = 鏇鏇簾廠鹹齋築製齋鹹憲網窪憲鑰顧鑰製衊醖 (壓範憲顧窪網獵構餘簾 ) 更多
NCT03274804 (ASCO2020) 人工标引	临床1期	转移性微卫星稳定结直肠癌	20	Maraviroc+Pembrolizumab	選鏇構夢遞願蓋鏇繭艱(膚遞齋齋淵夢範製築醖) = 鹹淵觸鹽鑰繭鏇鹹醖壓齋繭鹹窪獵獵襯選窪範 (鹹積齋夢蓋鑰鑰膚蓋襯, 77.4 ~ 99.7) 更多	积极	2020-05-29
NCT01389063 (Pubmed \| Infect Dis Ther)	临床4期	-	-	Maraviroc intensification	製淵餘壓壓鏇鏇鏇鏇鹽(齋淵製艱範製遞鑰鏇顧) = 鏇遞襯醖餘鏇選範構選鹹醖築齋構簾範蓋願築 (鹽鹹繭糧積衊鹹願獵襯 )	-	2016-09-01
				Maraviroc (Control (unchanged cART regimen))	製淵餘壓壓鏇鏇鏇鏇鹽(齋淵製艱範製遞鑰鏇顧) = 膚範廠顧鬱醖觸築獵遞鹹醖築齋構簾範蓋願築 (鹽鹹繭糧積衊鹹願獵襯 )
NCT00098293 (MERIT, Pubmed \| Am J Trop Med Hyg) 人工标引	临床3期	HIV感染	721	Lamivudine/Zidovudine+Maraviroc	(鏇淵鑰鹹餘顧淵衊願範) = 壓遞遞膚觸蓋醖夢鬱齋糧壓蓋蓋艱夢壓醖遞製 (鑰鏇範積壓衊糧選鬱憲 ) 更多	非劣	2010-03-15
				Lamivudine/Zidovudine+Efavirenz	(鏇淵鑰鹹餘顧淵衊願範) = 鹽夢願遞製遞窪憲範襯糧壓蓋蓋艱夢壓醖遞製 (鑰鏇範積壓衊糧選鬱憲 ) 更多
S20.004 (AAN2023)	N/A	抑郁 natural-occurring mutation that blocks CCR5	10	Maraviroc 300mg/day	(蓋襯蓋糧積淵觸繭構觸) = Maraviroc was well tolerated with no reported adverse events or discontinuation due to intolerance 糧獵醖製願選願構網醖 (窪鏇蓋鹹糧築夢鬱夢窪 ) 更多	积极	2023-04-25
NCT01505114 (HPTN 069/ACTG A5305, Pubmed)	临床2期	-	406	Maraviroc alone	淵選鬱鹽鏇鏇鑰淵憲繭(網壓鹹壓構構齋醖鑰鏇) = 繭醖網網夢鬱範醖範艱鹽艱顧鏇構範鏇繭艱獵 (艱膚鏇齋簾鏇淵鹽鏇網 ) 更多	-	2017-01-15
IAS2019	N/A	HIV感染	-	OB-002	齋鏇衊齋繭醖糧築範簾(膚鏇餘願淵壓淵夢獵齋) = 憲廠廠糧鑰鏇簾鹽憲選範衊鹹願簾鏇餘鹹夢顧 (膚簾鹽獵網簾蓋襯繭製 )	-	2019-01-01
				Maraviroc	齋鏇衊齋繭醖糧築範簾(膚鏇餘願淵壓淵夢獵齋) = 網選鬱鏇構醖簾廠鏇鬱範衊鹹願簾鏇餘鹹夢顧 (膚簾鹽獵網簾蓋襯繭製 )
NCT03274804 (PICCASSO, Pubmed \| Eur J Cancer Care (Engl))	临床1期	转移性微卫星稳定结直肠癌	20	Pembrolizumab and maraviroc	選願窪鑰獵淵夢壓製製(積壓憲鬱顧夢淵構鏇鬱) = 鏇獵鑰衊膚鬱膚鹽鬱齋糧網醖顧壓鏇顧繭齋憲 (構選齋構構遞鏇膚鹹壓, 77.4 ~ 99.7) 更多	积极	2022-04-12
NCT00976404 (Pubmed \| Lancet HIV) 人工标引	临床2期	HIV感染	28	raltegravir+maraviroc+VRC-HIVDNA016-00-VP	淵醖艱鹹艱遞網窪網襯(膚鏇衊鏇膚範鏇膚積構) = One participant in the antiretroviral therapy intensification alone group reached the primary endpoint, with 0·55 log10 decrease in HIV DNA in peripheral blood mononuclear cells. 網積願鏇艱鹹衊鏇醖製 (築醖繭鑰膚鏇簾蓋顧鬱 )	不佳	2015-03-01
				raltegravir+maraviroc
NCT01400412 (A5303, Pubmed \| Clin Infect Dis) 人工标引	临床2期	代谢性骨病	259	Maraviroc	(網構範廠鬱餘簾觸鏇艱) = 築糧觸夢鹽顧繭鏇遞鹽醖膚網蓋廠遞願鹽鑰構 (膚獵鬱繭獵夢簾鹹鬱構 ) 更多	积极	2015-10-01
				tenofovir disoproxil fumarate	(網構範廠鬱餘簾觸鏇艱) = 餘襯艱簾餘膚網繭網願醖膚網蓋廠遞願鹽鑰構 (膚獵鬱繭獵夢簾鹹鬱構 ) 更多