Phase 1/2 Study of Switching to Fixed Dose Combination Dolutegravir/Rilpivirine Among Virologically Suppressed Children, 6 to Less Than 12 Years of Age, Living With HIV-1

The purpose of this study is to provide data on the pharmacokinetic (PK), safety, tolerability, efficacy and acceptability of this fixed dose combination (FDC) single tablet 2-drug regimen for virologically suppressed (HIV-1 RNA [Ribonucleic Acid] < 50 [cells per milliliter] c/mL) children 6 to less than 12 years of age, weighing at least 25 kilogram (kg).

开始日期2023-07-06

申办/合作机构

ViiV Healthcare Ltd.

[+1]

CTR20230945 / CompletedN/A

多替拉韦利匹韦林片的人体生物等效性研究

评估受试制剂多替拉韦利匹韦林片（规格：50mg/25mg，齐鲁制药有限公司生产）与参比制剂多替拉韦利匹韦林片（JULUCA®，规格：50mg/25mg，ViiV Healthcare BV持证）作用于空腹和餐后状态下健康成年受试者的生物等效性和安全性。

开始日期2023-04-24

申办/合作机构

齐鲁制药有限公司

NCT04867083 / Recruiting临床3期IIT

Randomized, Open-label and Multicentric Trial Evaluating the Non-inferiority of Antiretroviral Dual Therapy Taken 4 Consecutive Days Per Week Versus Antiretroviral Dual Therapy 7/7 Days Per Week in HIV-1 Infected Patients With Controlled Viral Load Under Antiretroviral Dual Therapy

The trial is an open-label, multicenter, prospective, randomized trial in 2 parallel groups, evaluating at W48 the non inferiority of antiretroviral dual therapy taken 4 consecutive days per week versus antiretroviral dual therapy 7/7 days per week in HIV-1 infected patients with controlled viral load under antiretroviral dual therapy.

开始日期2021-06-21

申办/合作机构

ANRS, Emerging Infectious Diseases

[+1]

100 项与多替拉韦利匹韦林相关的临床结果

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100 项与多替拉韦利匹韦林相关的转化医学

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100 项与多替拉韦利匹韦林相关的专利（医药）

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项与多替拉韦利匹韦林相关的文献（医药）

2023-05-04·The International journal of risk & safety in medicine

Two cases of drug induced hypersensitivity to dolutegravir-rilpivirine fixed-dose combination: A case report

Article

作者: Del Fabro, Giovanni ; Mileto, Palmiro ; Castelli, Francesco ; Quiros-Roldan, Eugenia

BACKGROUND: Two-drug regimens antiretroviral therapies are increasingly prescribed to HIV patients, as they are recommended by international guidelines, and they show an excellent efficacy, safety, and tolerability profile. Regimens administered as single tablets (STRs) are usually preferred by patients and they are associated with higher adherence. CASE REPORT: We report two cases of drug-induced hypersensitivity (DIH) that occurred after switching from dolutegravir (DTG) plus rilpivirine (RPV) in separate pills to a fixed dose combination containing the same molecules (DTG/RPV; Juluca®). Following the DIH event, DTG/RPV coformulation was discontinued. At symptomatic resolution, they continued to receive DTG plus RPV in separate pills uneventfully. The component present only in the DTG/RPV coformulation was iron oxide red (E172), contained in the film-coating. Iron oxide red is an approved colorant, used as drug excipient. Patch test with DTG/RV coformulation performed several months after the DIH event was negative. Drug allergy to excipients remains underappreciated and underreported and frequently leads to inappropriate medication discontinuation. CONCLUSION: Our case underscores the role of meticulous medication allergy history in differentiating true medication allergy from excipient allergy. This observation may be useful in the era of antiretroviral simplification to two-drug regimens.

2022-10-21·Cureus

Effect of Dolutegravir on Plasma Glucose Among Human Immunodeficiency Virus Patients in a Community Health Center Setting

Article

作者: Bahamdain, Foud

Background Dolutegravir has become one of the initial backbones in antiretroviral therapy regimens for most patients with HIV in several recent clinical guidelines. However, dolutegravir has been associated with severe cases of hyperglycemia and the new-onset of diabetes in multiple case reports and clinical trials. A community health center noticed an increasing number of new-onset hyperglycemia incidences in patients on dolutegravir. Method Retrospective chart review of patients who started on dolutegravir or dolutegravir combination regimen (Triumreq®, Juluca®, GlaxoSmithKline (GSK), Research Triangle Park, NC) between the dates of January 1st, 2013 and January 1st, 2018 who have been treated in community healthcare centers. Baseline blood sugar and/or hemoglobin A1C before starting dolutegravir, at three to six months of treatment, and at the end of the study were compared between subjects. Four hundred twenty-two subjects were enrolled. Results Dolutegravir had little effect on plasma glucose among 72% of the subjects (n=305). However, 7% of the subjects (n=28) on dolutegravir treatment with no glucose intolerance met the criteria for prediabetes at three to six months of therapy. One of the subjects had developed diabetes three to six months after dolutegravir was initiated. In addition, at the end of the study, 13% of patients developed prediabetes (n=56) and 1.4% developed diabetes (n=6). Among the 24 subjects that had diabetes before dolutegravir was initiated, 83% required intensification of their diabetes regimen. Conclusion Dolutegravir may cause a moderate increase in plasma sugar after three to six months of therapy. Further increases in plasma sugar have been noticed in up to 13% of subjects meeting the criteria for prediabetes. Due to the existence of confounding variables, patients with diabetes should not be switched from dolutegravir.

2021-05-01·Value in health regional issues

Cost-Effectiveness of Juluca for Human Immunodeficiency Virus Infection Treatment in Virologically Suppressed Adults in Taiwan

Article

作者: Lopes, Sara ; Ou, Huang-Tz ; Anderson, Sarah-Jane ; Yang, Chun-Ting ; Ko, Nai-Ying ; Hsu, Chiung-Yuan

OBJECTIVES:

Although the efficacy of traditional 3-drug regimens for the treatment of HIV is well established, tolerability and toxicity concerns remain. New 2-drug regimens such as Juluca (dolutegravir [DTG]/rilpivirine [RPV]) offer noninferior efficacy versus 3-drug regimens (SWORD-1 and SWORD-2 studies), while reducing cumulative drug exposure and potentially long-term toxicities and drug-drug interactions. Here, we assess the cost-effectiveness of DTG/RPV for the treatment of HIV-1 for virologically suppressed adults in Taiwan.

METHODS:

A hybrid decision tree and Markov cohort state transition model was used to evaluate the expected economic costs and clinical outcomes associated with DTG/RPV and comparators. Model health states were defined by viral load and CD4 cell count. Efficacy and safety data were informed from SWORD-1 and SWORD-2 studies and the literature. The risk of long-term toxicities (cardiovascular disease, bone fractures, and chronic kidney disease) were included. Current branded drug acquisition prices were included, and healthcare costs informed by a bespoke costing study using National Health Insurance Research Database data. Incremental cost-effectiveness ratios were calculated and compared with a willingness-to-pay threshold of 2 times Taiwan's gross domestic product (NT$1 550 000).

RESULTS:

DTG/RPV was found to be a cost-saving regimen compared to 3 comparators (rilpivirine [RPV]/emtricitabine [FTC]/tenofovir disoproxil fumarate [TDF], dolutegravir [DTG]/abacavir [ABC]/lamivudine [3TC], and elvitegravir [EVG]/cobicistat [c]/emtricitabine [FTC]/tenofovir alafenamide [TAF]) and fell in the southwest quadrant of the cost-effectiveness plane where it is generating significant savings with a small decrement in lifetime quality-adjusted life-years (-0.005). It was, however, more expensive than efavirenz [EFV]/emtricitabine [FTC]/ tenofovir disoproxil fumarate [TDF].

CONCLUSIONS:

DTG/RPV is cost-saving compared to RPV/FTC/TDF, DTG/ABC/3TC, and EVG/c/FTC/TAF, and provides comparable efficacy with reduced cumulative drug exposure.

项与多替拉韦利匹韦林相关的新闻（医药）

2024-03-21

·BiG生物创新社

全球最畅销的十款小分子药物！

作者｜betaloc小分子药物已过时？显然没有！随着抗体、基因疗法、细胞疗法等新兴药物模式的兴起，小分子药物一度被认为即将过时，事实上，小分子药物仍有其不可替代性，相对生物制剂来说，小分子在生产制造、运输、患者依从性、可用靶点范围、免疫原性等方面仍具有明显优势。在全球范围内的上市药物中，小分子药物的占比仍然高达近90%。而在2023年前三季度FDA批准的40个新药中，也有21个小分子。下面就让我们一起盘点小分子药物中的优等生，看看在销售榜单中的top 10都有哪些明星分子。根据Arizona大学Jon Njardarson课题组的统计，2022年前十大销售额的小分子药物总计销售超966亿美元，治疗领域涵盖病毒感染、心血管、肿瘤等。从公司来看，辉瑞不愧为小分子药物开发先驱，共有4款药物入围前十，其次是BMS，有阿哌沙班、来那度胺两款小分子药进入前十，合计贡献217亿美元营收。表1, 2022销售额 top 10小分子药物 01 奈玛特韦（Paxlovid，Nirmatrelvir）由辉瑞研发的一款3CL蛋白酶抑制剂，可以抑制3CL蛋白酶的作用，从而阻止新冠病毒后续的一系列复制活动。在临床试验中，Paxlovid可将新冠肺炎非住院患者的住院或死亡率降低89%。该药于2021年12月成为首款获得FDA紧急批准的新冠口服药，上市第一年，销售额便达到了189亿美元，一举超越阿哌沙班成为最畅销小分子药物。奈玛特韦是在先前开发的针对非典（SARS）的特效药PF-00835231基础上改造得来，辉瑞的研究人员发现，PF-00835231与SARS-CoV的结合位点，同样存在于新冠病原SARS-CoV-2，这意味着PF-00835231也许对新冠病毒同样有效，经测试证明确实如此，但静脉注射剂型太过繁琐，辉瑞便对PF-00835231进行结构优化并引入三氟乙酰胺基团，提高了生物利用度，使其可通过口服吸收。图1，由SARS特效药改造得到SARS-CoV-2特效药Paxlovid 02 阿哌沙班（Eliquis，apixaban）由BMS和辉瑞公司联合研发的一种新型凝血因子Xa（Factor Xa）抑制剂，分别于2011和2012年在欧洲和美国上市，用于患者术后静脉血栓栓塞症（VTE）预防及房颤患者脑卒中预防。虽然专利还未到期（2026年），但2022年销售额同比2021年仍降低了约30%，为117亿美元。阿哌沙班由BMS经过高通量筛选优化得到，对人FXa的Ki 0.08 nM，对 FXa 的选择性比其他人凝血蛋白酶高 30000 倍以上。与维生素K拮抗剂华法林等相比，阿哌沙班具有疗效更好，安全性更高的特点。图2, 阿哌沙班的结构优化过程 03 必妥维（Biktarvy）由吉利德科学公司研发，于2018年获FDA批准上市的用于治疗HIV的三合一复方新药，含有比克替拉韦（bictegravir）50mg/恩曲他滨（emtricitabine）200mg/丙酚替诺福韦（tenofovir alafenamide）25mg，bictegravir是HIV-1整合酶抑制剂，emtricitabine和tenofovir alafenamide都是核苷类似物，用作逆转录酶抑制剂。2020/2021/2022年的销售额分别为72.59亿、86.24亿、103亿美元，放量十分迅速。恩曲他滨和丙酚替诺福韦在2003和2015年就已经上市，只有比克替拉韦为Biktarvy复方新药中的NME成分，其化学结构与多替拉韦（Dolutegravir， GSK开发的HIV药物）类似，同为整合酶抑制剂，但Biktarvy安全性更佳。图3, Bictegravir（BIC）和Dolutegravir（DTG） 04 来那度胺（Revlimid, Lenalidomide）来那度胺由新基制药开发，是老药新用的经典案例，前身是臭名昭著的“反应停“沙利度胺。上世纪90年代，科学家发现沙利度胺有抗癌疗效，对其进行分子改造后得到来那度胺，后者于2005年获批上市，用于治疗多发性骨髓瘤（MM）、骨髓瘤增生异常综合征（MDS）等疾病。该药2020/2021/2022年的销售额分别为121亿、129亿、100亿美元，2023年进一步降至61亿美元，但上市至今累计销售额已达1050亿美元。图4, 沙利度胺与来那度胺后来，经过更广泛的研究，科学家发现来那度胺是通过分子胶水的机制诱导E3连接酶Cereblon (CRBN) 降解靶蛋白来发挥治疗作用，由此开发出了一项全新的小分子药物技术—蛋白水解靶向嵌合体（PROTAC），其能够弥补传统小分子药物难以靶向不可成药靶点的缺陷，诱导致病蛋白的降解。 05 恩格列净（Jardiance, Empagliflozin）由勃林格殷格翰公司研发的钠-葡萄糖协同转运蛋白-2 (SGLT2)抑制剂，于2014年8月获FDA批准上市，用于控制2型糖尿病成人患者的血糖和降低患者的心血管风险。SGLT2主要在肾脏表达，负责从肾小管腔重吸收过滤后的葡萄糖和钠，当SGLT2被抑制后，肾脏对葡萄糖和钠的重吸收都会减少，降低体内血糖浓度。该药2020/2021/2022年销售额为41.08亿、58.29亿、82.15亿美元。图5, 恩格列净作用机制 06 伊布替尼（Imbruvica，Ibrutinib）该药于2013年在美国上市，是全球首个BTK共价抑制剂，用于治疗套细胞淋巴瘤（MCL）、慢性淋巴细胞白血病/小淋巴细胞淋巴瘤（CLL/SLL）和华氏巨球蛋白血症（WM）等血液肿瘤。然而，伊布替尼作为一代抑制剂，对BTK选择性不够好，存在脱靶效应，并可能抑制其他具有相同保守的Cys残基的激酶从而导致过敏和腹泻等不良反应。图6, 已上市的BTK抑制剂结构该药2020/2021/2022年销售额为94.42亿、97.77亿、83亿美元，核心专利将于2026年到期，但由于泽布替尼和其他后来者的强力竞争，伊布替尼的市场急剧下滑，2023年销售额仅为36亿美元。而2022年刚获FDA批准的泽布替尼，2023年销售额已达到13亿美元。 07 多替拉韦（Tivicay，Dolutegravir）由GSK和ViiV Healthcare共同研发，与bictegravir一样，是HIV整合酶抑制剂，阻断HIV病毒DNA整合来限制HIV的复制，于2013年8月获FDA批准上市。多替拉韦还是GSK其他三款HIV产品——Triumeq(多替拉韦/阿巴卡韦/拉米夫定)、Juluca(多替拉韦/利匹韦林）和Dovato（多替拉韦/拉米夫定)的成分之一，该药2022年销售额达到了81亿美元。在dolutegravir之前，已经有raltegravir、elvitegravir等整合酶抑制剂上市，对整合酶药物结合口袋的构效关系研究也已经比较清楚，于是盐野义和GSK的研究人员在总结前期发表的分子结构基础上引入氧原子设计了化合物5，以增强化何物对整合酶的结合能力，之后又对生物利用度、半衰期和突变体结合活性进行了优化，得到了dolutegravir，半衰期为6 h，生物利用度达到了34%。图7, Dolutegravir（3）结构优化历程 08 Trikafta (Elexacaftor, Tezacaftor, Ivacaftor)由福泰制药研发，于2019年10月获FDA批准上市，用于治疗6岁及以上囊性纤维化跨膜电导调节蛋白（CFTR）的基因至少有一个F508del突变或其它有效突变的囊性纤维化（cystic fibrosis, CF）患者。Trikafta由三个小分子复方组成，他们同时结合致病的CFTR突变蛋白，彼此之间有协同作用，elexacaftor是新一代CFTR蛋白校正剂，帮助恢复携带F508del突变的CFTR蛋白的功能；tezacaftor帮助组装和运输CFTR蛋白至细胞表面来增强它的功能，ivacaftor则通过增加位于细胞表面CFTR通道的开放率（门控通道），提高CFTR蛋白的活性，增加氯化物的转运。三种分子联合应用能增加CFTR蛋白的数量并增强蛋白的功能。图8，Trikafta含有的三个小分子结构及其作用机制囊性纤维化是一种遗传性疾病，由CFTR的基因突变引起，在美国有3万多名囊性纤维化患者，全世界约有7万名患者。Trikafta则是福泰制药的当家产品，该药在2020/2021/2022/2023年销售额分别为39亿、57亿、76亿、89亿美元，年均增长率达32%，在2023年更是贡献了福泰全年总营收的90%。 09 利伐沙班（Xarelto，Rivaroxaban）利伐沙班由拜耳制药开发，为首个上市的Factor Xa抑制剂（分别于2008和2011年在欧洲和美国获批），它通过抑制因子Xa可以中断凝血瀑布的内源性和外源性途径，抑制凝血酶的产生和血栓形成。Bayer于1998年便启动了直接抑制FXa小分子抗凝药物研发项目，经过高通量筛选20万化合物后得到了一个IC50为70 nM、选择性抑制FXa体外酶活的苗头化合物，并对其进行结构优化以提升抑制活性和口服生物利用度，最终优化得到含有吡咯烷酮结构的利伐沙班，IC50为0.7 nM，口服生物利用度接近60%。图9，利伐沙班抗凝血机制 10 恩杂鲁胺（Xtandi, Enzalutamide）由美国Medivation公司研发，是一款成功的me-better的非甾体雄激素受体（androgen receptor，AR）抑制剂，于2012年获FDA批准上市，用于治疗去势性前列腺癌和转移性激素敏感性前列腺癌。最初的药化工作是由UCLA大学的Jung和Memorial Sloan-Kattering癌症中心的Sawyers合作进行, Jung等以药物尼鲁米特和雄激素激动剂RU59063为出发点, 试图优化得到AR拮抗剂，最终从合成的200多个化合物中优选出恩杂鲁胺。图10 恩杂鲁胺及其先导化合物结构恩杂鲁胺2020/2021/2022年销售额51亿、56.36、62亿，销售额仍处于稳定爬坡中。Ref：Wong PC, Pinto DJ, Zhang D. Preclinical discovery of apixaban, a direct and orally bioavailable factor Xa inhibitor. J Thromb Thrombolysis. 2011 May;31(4):478-92.Owen DR, Allerton CMN, Zhu Y. An oral SARS-CoV-2 Mpro inhibitor clinical candidate for the treatment of COVID-19. Science. 2021 Dec 24;374(6575):1586-1593.Liu J, Chen C, Wang D, Zhang J, Zhang T. Emerging small-molecule inhibitors of the Bruton's tyrosine kinase (BTK): Current development. Eur J Med Chem. 2021 May 5;217:113329.Perzborn, E., Roehrig, S., Straub, A.et al. The discovery and development of rivaroxaban, an oral, direct factor Xa inhibitor. Nat Rev Drug Discov 10, 61–75 (2011).https://www.xareltohcp.com/Fiedorczuk K, Chen J. Molecular structures reveal synergistic rescue of Δ508 CFTR by Trikafta modulators. Science. 2022 Oct 21;378(6617):284-290.Yoshiyuki Taoda, Shuichi Sugiyama & Takahiro Seki. (2023) New designs for HIV-1 integrase inhibitors: a patent review (2018-present). Expert Opinion on Therapeutic Patents 33:1, pages 51-66.共建Biomedical创新生态圈！如何加入BiG会员？

上市批准专利到期细胞疗法基因疗法

2024-01-26

·药融圈

大卖5亿美元！传奇生物2023年 CAR-T销售出炉

▲3月7-8日成都生物医药创新者峰会 · 点击立即报名注：本文不构成任何投资意见和建议，以官方/公司公告为准；本文仅作医疗健康相关药物介绍，非治疗方案推荐（若涉及），不代表平台立场。任何文章转载需得到授权。2024年1月23日，强生发布了2023年全年业绩：2023财年全年销售额达到852亿美元，同比增长6.5%，主要由Darzalex、Stelara、Erleada、Carvykti等创新药物强劲销售驱动的；研发费用150.85亿美元，同比增长6.7%；其中2023 Q4销售额214亿美元，同比增长7.3%。从具体业务划分来看，2023年全年制药业务营收547.59亿美元，同比增长4.2%。医疗设备部门业务营收304亿美元，同比增长10.8%。强生财报中，与传奇生物合作的BCMA CAR-T疗法Carvykti 的销售成绩也是一大亮点。Carvykti 2023 Q4销售额约1.59亿美元，较2022年大增194%；2023全年总销售额为5亿美元，同比增长276%，明年有望突破10亿美元（目前仅美国、欧盟、日本上市）。CARVYKTI®（ciltacabtagene autoleucel）是一种针对 BCMA 的基因修饰自体 T 细胞免疫疗法，适用于治疗经过四线或更多线的治疗（包括蛋白酶体抑制剂、免疫调节剂和抗 CD38单克隆抗体）的复发或难治性多发性骨髓瘤成年患者。2023年Carvykti在CARTITUE-4试验中，在二线至四线患者中使用时显示出巨大的无进展生存期（PFS）获益。2017年12月，传奇生物与强生制药就Carvykti以3.5亿美元首付款签订合作协议，共同负责全球范围的药物开发、临床试验、生产及商业化；中国分成：传奇生物70%、强生30%；其他地区分成：各按50%。2023年强生多款新药实现新进展：例如在研TAR-200获得美国FDA突破性疗法认定，用于治疗高风险非肌肉浸润性膀胱癌；向欧洲药品管理局提交 RYBREVANT（amivantamab）联合化疗治疗既往治疗失败后患有晚期 EGFR 突变非小细胞肺癌成年患者的申请等等。迄今为止强生确定了多项战略伙伴关系、合作与许可协议：在免疫领域与Merck和田边三菱制药（Mitsubishi Tanabe Pharma）进行免疫学产品Remicade（英夫利昔单抗）和Simponi/ Simponi Aria（戈利木单抗）的市场合作；强生与Protagonist合作开发口服多肽JNJ2113。在传染病领域，与吉利德科学公司合作开发HIV药物PREZCOBIX/REZOLSTA固定剂量组合、SYMTUZA和ODEFSEY；与ViiV Healthcare公司合作开发JULUCA和CABENUVA，等等。参考资料：公司公告版权声明：本文转自细胞基因治疗前沿，如不希望被转载的媒体或个人可与我们联系，我们将立即删除活动推荐 3月 • NDC x 2024新药创新者峰会关键词： ADC，改良型新药，小分子新药，GLP-1药物（点击下方图片查看详情）▼【关于药融圈】药融圈PRHub旨在帮助生物医药科技型企业进行品牌推广及商务拓展服务，针对客户的真实需求制定系统化解决方案，通过“翻译-降维-场景化”将客户的品牌信息以直白易懂的方式被公众知悉，同时在流量渠道覆盖100万+垂直用户基础上实现合作目的，帮助合作伙伴完成从品牌开始到商务为终的闭环营销服务。我们已经完成了数十场线下1000人规模的生物医药研发类会议，涵盖小分子新药，大分子新药，改良型新药，BD跨境交易等多个领域，服务了百余家上市/独角兽/生物技术/制药企业。

免疫疗法细胞疗法引进/卖出抗体药物偶联物财报

2023-09-29

·BioSpace

GSK Raises HIV Business Forecast on Projected Growth of Long-Acting Antiretroviral

Pictured: GSK building in Poland/iStock, Wirestock GlaxoSmithKline is boosting the medium-term forecast for its HIV business, based on the success of GSK’s long-acting antiretroviral therapy Cabenuva, according to multiple media outlets. GSK is forecasting sales growth of between 6% and 8% for its HIV business, reaching £7 billion ($8.5 billion) by 2026, up from “mid-single-digit” percentage growth. However, ODDO BHF analysts already bumped up the valuation for GSK’s HIV business by the same amount in late 2022, while estimating that Cabenuva alone could reach £3 billion in sales by 2030. By comparison, the company recorded £5.7 billion in HIV drug sales in 2022, a 12% increase from 2021 at constant currencies. Deborah Waterhouse, CEO of GSK’s specialist HIV company ViiV Healthcare, said during Thursday’s capital markets day that the strong performance of Cabenuva partly drove the new projection, and that the long-acting regimen will likely make up a third of GSK’s HIV revenue by 2026. The company also said its Apretude injection to prevent infection is gaining acceptance among the at-risk population, and demand for its shingles vaccine is also continuing to grow. Waterhouse also noted that an older-generation drug, dolutegravir, will be losing patent protections by the end of the decade, and that the strong performance of new-generation drugs like Cabenuva will help bolster GSK. The core composition patent for dolutegravir expires in 2028, while its formulation patents for Dovato and Juluca expire in 2029 and 2030, respectively. Much of the projected growth is being driven by growing demand for long-acting HIV regimens. Traditional doses are given orally daily, which means that missing a single day can be significant for patients. Longer-acting doses give patients more freedom, Waterhouse said. First approved by the FDA in January 2021, Cabenuva drastically simplified HIV-1 treatment regimens. Instead of taking antiviral drugs daily, patients only had to get injections once per month or 12 times a year. Cabenuva was later approved by the FDA in February 2022 for use every two months, cutting dosing in half. However, Waterhouse acknowledged that patients having to go to a clinic to receive an injectable dose six times per year can be onerous, which is why the company is working on ultra-long-acting drugs, as well as self-administered treatments. GSK is looking to have selected a long-acting, self-administered drug candidate by next year, with the goal of winning approval by 2030. The company is also looking to leverage cabotegravir, a Cabenuva component, into a twice-yearly formula by 2030. For now, daily pills such as Gilead Sciences’ Biktarvy remain the mainstay of HIV treatment. Gilead is developing a long-acting injectable HIV treatment, lenacapavir, that can be given every six months, and reported positive data from the Phase II/III CAPELLA trial in July 2023. In August 2022, Gilead scored the first regulatory approval for twice-yearly treatment when lenacapavir was awarded marketing authorization by the European Commission for adults living with multi-drug resistant HIV. Connor Lynch is a freelance writer based in Ottawa, Canada. Reach him at lynchjourno@gmail.com.

上市批准疫苗临床研究临床结果

100 项与多替拉韦利匹韦林相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	J05AR	-

研发状态

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
HIV感染	美国	ViiV Healthcare Co.	2017-11-21

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临床结果

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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


NCT03984838 (CTgov)	临床1期	HIV感染	16	DTG+FDC+RPV	壓淵襯餘範範選願鏇鏇(憲廠窪顧廠憲齋艱淵夢) = 獵齋餘襯鬱築繭鹽觸鏇遞鹽衊憲繭願餘繭齋獵 (醖網鏇窪觸簾艱壓網廠, 鹽廠醖廠壓網網齋範醖 ~ 蓋鏇遞膚醖餘積膚壓願) 更多	-	2020-07-14