Phase I/II Study of the Pharmacokinetics and Safety of Long-Acting Injectable Cabotegravir and Rilpivirine in Pregnant and Postpartum Adults With HIV-1

This is a Phase I/II, multicenter, open-label, non-randomized study with four groups to characterize the pharmacokinetics and safety of Cabotegravir (CAB) and Rilpivirine (RPV) long-acting injectable (LA) during pregnancy and postpartum among people with HIV-1 viral suppression and their infants.

开始日期2024-09-24

申办/合作机构

National Institute of Allergy & Infectious Diseases

PACTR202404510501536 / Suspended临床3期

Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

开始日期2024-05-31

申办/合作机构

ViiV Healthcare UK Ltd.

NCT06134362 / Not yet recruiting临床3期

A Phase IIIB, Long-Term Follow-Up of CAB LA for Participants in HPTN 083 and HPTN 084 CAB PrEP Studies at Risk of HIV Acquisition

The purpose of this study is long-term evaluation of long-acting injectable cabotegravir (CAB LA) for HIV pre-exposure prophylaxis (PrEP) in eligible participants who have completed DAIDS (Division of AIDS) sponsored studies HPTN 083 and HPTN 084 and associated sub-studies. Participants will continue receiving CAB LA and be followed for new HIV diagnosis, SAEs (serious adverse events), Grade 3 and Grade 4 ISRs (injection site reactions), and AEs (adverse events) leading to withdrawal.

开始日期2024-04-01

申办/合作机构

ViiV Healthcare Ltd.

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100 项与卡替拉韦钠相关的临床结果

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100 项与卡替拉韦钠相关的转化医学

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100 项与卡替拉韦钠相关的专利（医药）

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452

项与卡替拉韦钠相关的文献（医药）

2024-04-01·The Lancet HIV

Safety and pharmacokinetics of oral and long-acting injectable cabotegravir or long-acting injectable rilpivirine in virologically suppressed adolescents with HIV (IMPAACT 2017/MOCHA): a phase 1/2, multicentre, open-label, non-comparative, dose-finding study

Article

作者: Samson, Pearl ; Ounchanum, Pradthana ; Baltrusaitis, Kristin ; Van Solingen-Ristea, Rodica M ; Huang, Jenny ; Calabrese, Katherine ; Moye, John H ; Mathiba, Sisinyana Ruth ; Marzinke, Mark A ; Kneebone, Jared L ; Crauwels, Herta ; Heckman, Barbara ; Smith-Anderson, Christiana ; Camacho-Gonzalez, Andres ; Agwu, Allison L ; Adeyeye, Adeola ; Vandermeulen, Kati ; Bolton Moore, Carolyn ; Best, Brookie M ; Lowenthal, Elizabeth D ; McCoig, Cynthia ; Gaur, Aditya H ; Capparelli, Edmund V ; Ward, Shawn ; Townley, Ellen ; Harrington, Conn M ; Ford, Susan L ; Milligan, Ryan

BACKGROUNDCombined intramuscular long-acting cabotegravir and long-acting rilpivirine constitute the first long-acting combination antiretroviral therapy (ART) regimen approved for adults with HIV. The goal of the IMPAACT 2017 study (MOCHA [More Options for Children and Adolescents]) was to assess the safety and pharmacokinetics of these drugs in adolescents.METHODSIn this phase 1/2, multicentre, open-label, non-comparative, dose-finding study, virologically suppressed adolescents (aged 12-17 years; weight ≥35 kg; BMI ≤31·5 kg/m²) with HIV-1 on daily oral ART were enrolled at 15 centres in four countries (Botswana, South Africa, Thailand, and the USA). After 4-6 weeks of oral cabotegravir (cohort 1C) or rilpivirine (cohort 1R), participants received intramuscular long-acting cabotegravir or long-acting rilpivirine every 4 weeks or 8 weeks per the adult dosing regimens, while continuing pre-study ART. The primary outcomes were assessments of safety measures, including all adverse events, until week 4 for oral cabotegravir and until week 16 for long-acting cabotegravir and long-acting rilpivirine, and pharmacokinetic measures, including the area under the plasma concentration versus time curve during the dosing interval (AUC_0-tau) and drug concentrations, at week 2 for oral dosing of cabotegravir and at week 16 for intramuscular dosing of cabotegravir and rilpivirine. Enrolment into cohort 1C or cohort 1R was based on the participant's pre-study ART, meaning that masking was not done. For pharmacokinetic analyses, blood samples were drawn at weeks 2-4 after oral dosing and weeks 4-16 after intramuscular dosing. Safety outcome measures were summarised using frequencies, percentages, and exact 95% CIs; pharmacokinetic parameters were summarised using descriptive statistics. This trial is registered at ClinicalTrials.gov, NCT03497676, and is closed to enrolment.FINDINGSBetween March 19, 2019, and Nov 25, 2021, 55 participants were enrolled: 30 in cohort 1C and 25 in cohort 1R. At week 16, 28 (97%, 95% CI 82-100) of the 29 dose-evaluable participants in cohort 1C and 21 (91%; 72-99) of the 23 dose-evaluable participants in cohort 1R had reported at least one adverse event, with the most common being injection-site pain (nine [31%] in cohort 1C; nine [39%] in cohort 1R; none were severe). One (4%, 95% CI 0-22) participant in cohort 1R had an adverse event of grade 3 or higher, leading to treatment discontinuation, which was defined as acute rilpivirine-related allergic reaction (self-limiting generalised urticaria) after the first oral dose. No deaths or life-threatening events occurred. In cohort 1C, the week 2 median cabotegravir AUC_0-tau was 148·5 (range 37·2-433·1) μg·h/mL. The week 16 median concentrations for the every-4-weeks and every-8-weeks dosing was 3·11 μg/mL (range 1·22-6·19) and 1·15 μg/mL (<0·025-5·29) for cabotegravir and 52·9 ng/mL (31·9-148·0) and 39·1 ng/mL (27·2-81·3) for rilpivirine, respectively. These concentrations were similar to those in adults.INTERPRETATIONStudy data support using long-acting cabotegravir or long-acting rilpivirine, given every 4 weeks or 8 weeks, per the adult dosing regimens, in virologically suppressed adolescents aged 12 years and older and weighing at least 35 kg.FUNDINGThe National Institutes of Health and ViiV Healthcare.

2024-04-01·BMJ Open

Willingness and preferences for long-acting injectable PrEP among US men who have sex with men: a discrete choice experiment

Article

作者: Sarkar, Supriya ; Cole, Sam Wilson ; Rinehart, Alex ; Glick, Jennifer L ; Rawlings, Keith ; Sullivan, Patrick S ; Campoamor, Nicola B ; Vannappagari, Vani ; Sanchez, Travis H ; Bridges, John F P

IntroductionCabotegravir long-acting injectable HIV pre-exposure prophylaxis (LA-PrEP) was shown to be safe and effective in multiple clinical trials. Increasing uptake and persistence among populations with elevated risk for HIV acquisition, especially among men who have sex with men (MSM), is critical to HIV prevention.ObjectiveThis analysis aims to understand potential users’ preferences for LA-PrEP, with audience segmentation.DesignWillingness to use and preferences for LA-PrEP were measured in HIV-negative, sexually active MSM in the 2020 American Men’s Internet Survey. Respondents answered a discrete choice experiment with paired profiles of hypothetical LA-PrEP characteristics with an opt-out option (no LA-PrEP). Conditional and mixed logit models were run; the final model was a dummy-coded mixed logit that interacted with the opt-out.SettingUS national online sample.ResultsAmong 2506 MSM respondents, most (75%) indicated a willingness to use LA-PrEP versus daily oral PrEP versus no PrEP. Respondents were averse to side effects and increasing costs and preferred increasing levels of protection. Respondents preferred a 2-hour time to obtain LA-PrEP vs 1 hour, with a strong aversion to 3 hours. Overall, there was an aversion to opting out of LA-PrEP, with variations: those with only one partner, no/other insurance or who were Black, Indigenous or People of Colour were significantly less likely to prefer LA-PrEP, while those who were Hispanic/Latino, college educated and <40 years significantly preferred LA-PrEP.ConclusionsA large proportion of MSM expressed a preference for LA-PrEP over daily oral pills. Most respondents chose LA-PrEP regardless of cost, clinic time, side effects or protection level; however, preferences varied by sociodemographics. These varied groups likely require tailored intervention strategies to achieve maximum LA-PrEP uptake and persistence.

2024-04-01·The Lancet HIV

Acceptability and tolerability of long-acting injectable cabotegravir or rilpivirine in the first cohort of virologically suppressed adolescents living with HIV (IMPAACT 2017/MOCHA): a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study

Article

作者: Adeyeye, Adeola ; Chapman, Jennifer ; Buisson, Sarah ; Kneebone, Jared ; Huang, Jenny ; Ward, Shawn ; Harrington, Conn ; Heckman, Barbara ; Crauwels, Herta ; McCoig, Cynthia C ; Chounta, Vasiliki ; Smith-Anderson, Christiana ; Calabrese, Katherine ; Agwu, Allison L ; Gaur, Aditya H ; Milligan, Ryan ; Bearden, Allison ; Bolton-Moore, Carolyn ; Van Solingen-Ristea, Rodica M ; Yin, Dwight E ; Baltrusaitis, Kristin ; D'Angelo, Jessica ; Camacho-Gonzalez, Andres ; Ohrenschall, Rachel ; Lowenthal, Elizabeth D

BACKGROUNDLong-acting injectable cabotegravir and rilpivirine have demonstrated safety, acceptability, and efficacy in adults living with HIV-1. The IMPAACT 2017 study (MOCHA study) was the first to use these injectable formulations in adolescents (aged 12-17 years) living with HIV-1. Herein, we report acceptability and tolerability outcomes in cohort 1 of the study.METHODSIn this a secondary analysis of a phase 1/2, multicentre, open-label, non-comparative dose-finding study, with continuation of pre-study oral combination antiretroviral treatment (ART), 55 adolescents living with HIV-1 were enrolled to receive sequential doses of either long-acting cabotegravir or rilpivirine and 52 received at least two injections. Participants had a body weight greater than 35 kg and BMI less than 31·5 kg/m² and had been on stable ART for at least 90 consecutive days with an HIV-1 viral load of less than 50 copies per mL at a participating IMPAACT study site. Participants had to be willing to continue their pre-study ART during cohort 1. The primary objectives of the study were to confirm doses for oral and injectable cabotegravir and for injectable rilpivirine in adolescents living with HIV. This analysis of participant-reported outcomes included a face scale assessment of pain at each injection and a Pediatric Quality of Life Inventory (PedsQL) at baseline and week 16 for participants in the USA, South Africa, Botswana, and Thailand. A subset of 11 adolescents and 11 parents or caregivers in the USA underwent in-depth interviews after receipt of one or two injections. This trial is registered at ClinicalTrials.gov, NCT03497676.FINDINGSBetween March 19, 2019, and Nov 25, 2021, 55 participants were enrolled into cohort 1. Using the six-point face scale, 43 (83%) of participants at week 4 and 38 (73%) at week 8 reported that the injection caused "no hurt" or "hurts little bit", while only a single (2%) participant for each week rated the pain as one of the two highest pain levels. Quality of life was not diminished by the addition of one injectable antiretroviral. In-depth interviews revealed that parents and caregivers in the USA frequently had more hesitancy than adolescents about use of long-acting formulations, but parental acceptance was higher after their children received injections.INTERPRETATIONHigh acceptability and tolerability of long-acting cabotegravir or rilpivirine injections suggests that these are likely to be favoured treatment options for some adolescents living with HIV.FUNDINGNational Institutes of Health and ViiV Healthcare.

144

项与卡替拉韦钠相关的新闻（医药）

2024-05-14

·医药观澜

艾滋病感染风险降低91%！长效HIV疗法又一适应症在华获批

5月13日，葛兰素史克（GSK）宣布，其HIV药物专研合资公司ViiV Healthcare卡替拉韦钠片和卡替拉韦注射液近日同时获得中国NMPA批准，用于有感染风险的成人和青少年（体重≥35kg）进行HIV-1暴露前预防（PrEP），以降低性传播感染HIV-1的风险，结合安全的性行为措施以达到更好的HIV-1 PrEP效果。这是一款无需每日服药就能预防HIV感染的疗法。在一项2b/3期临床研究中，与对照组相比，卡替拉韦长效注射液组的HIV感染风险降低91%。暴露前预防（PrEP）是通过使用抗病毒药物来预防HIV感染的一种有效的生物学预防方法。卡替拉韦长效注射液是一种整合酶链转移抑制剂（INSTI），通过阻止病毒DNA整合到人类免疫细胞（T细胞）的遗传物质来抑制HIV复制。这一步在HIV复制周期中至关重要，也是造成其为慢性病的原因。卡替拉韦注射液及卡替拉韦钠片此前已于2023年7月正式获得中国NMPA批准，联合利匹韦林注射液和利匹韦林片剂使用，用于治疗已达到病毒学抑制的HIV-1感染者。根据GSK新闻稿介绍，卡替拉韦长效方案仅需每年注射最少6次即可实现HIV暴露前预防。使用者将在前两个月内接受每月600mg（3ml）的起始注射，随后每两个月接受一次600mg（3ml）的继续注射。在首次注射前，使用者可选择先口服卡替拉韦钠片剂大约一个月（至少28天），以评估药物的耐受性。此次中国获批基于两项国际2b/3期多中心、随机、双盲、阳性对照研究（HPTN 083和HPTN 084），旨在评估卡替拉韦长效注射液对于HIV-1阴性男男同性性行为者、跨性别女性及顺性别女性HIV暴露前预防的安全性和有效性。其中，HPTN 083研究在4566例存在高风险的HIV-1阴性男男性行为者、与男性发生性行为的跨性别女性中进行；HPTN 084研究则针对3224例HIV感染高风险的顺性别女性展开。研究评估了每日口服富马酸替诺福韦二吡呋酯/恩曲他滨（TDF/FTC）片剂与每8周给药一次卡替拉韦长效注射方案对于预防HIV的安全性和疗效。研究在肌肉注射给药前，通过设置口服导入期评估使用者对卡替拉韦的耐受性。 HPTN 083研究结果显示，与对照组方案相比，接受卡替拉韦长效注射液的参与者感染HIV的风险降低了68%（12 vs 39; 年发病率: 0.37% vs 1.22%）。HPTN 084研究结果显示，相较于对照组，长效注射液组的HIV感染风险降低91%（3 vs 36; 年发病率: 0.15% vs 1.85%）。参考资料： [1] HIV暴露前预防长效药物卡替拉韦钠片和卡替拉韦注射液在中国正式获批. Retrieved May 13, 2024, from https://mp.weixin.qq.com/s/uBRI8fPX8CvZ2FdZkSGm8Q [2]万凯锐®和瑞卡必®在中国获批作为HIV-1长效注射治疗方案联合使用. Retrieved Oct 27, 2023, from https://mp.weixin.qq.com/s/gNvcw51ubLXDyYVuiESfcQ 内容来源于网络，如有侵权，请联系删除。

临床结果上市批准申请上市

2024-05-13

·信狐药迅

仿制药上市申请有14个品规发通知件；临床申请品种均默示许可| 新获批（5.6-5.12）

每周药品注册获批数据，分门别类呈现，一目了然。(5.6-5.12）小编收到有些用户反应，不想收到咱们每周文章的推送提醒，而有些用户又特别需要这个提醒，在小编强烈要求下，我们给力的程序员终于实现了可以关闭提醒的功能，这个绝对全网独一家喔，不想收到提醒的，只要在信狐药迅对话框内回复关键词“拒收文章提醒”，那么就可以不受推送的打扰啦!新药上市申请药品名称企业注册分类受理号TQB2450注射液正大天晴药业集团南京顺欣制药有限公司1CXSS2300003新药临床申请药品名称企业注册分类受理号TQ05105片正大天晴药业集团股份有限公司1CXHL2400232TQ05105片正大天晴药业集团股份有限公司1CXHL2400231SPH7485片上海医药集团股份有限公司1CXHL2400219SPH7485片上海医药集团股份有限公司1CXHL2400220SPH7485片上海医药集团股份有限公司1CXHL2400221SPH7485片上海医药集团股份有限公司1CXHL2400222ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400216ENN0403胶囊轶诺(浙江)药业有限公司1CXHL2400215HS-10382片江苏豪森药业集团有限公司1CXHL2400207HS-10382片江苏豪森药业集团有限公司1CXHL2400206SIPI6398片上海中泽医药科技有限公司1CXHL2400205SSS39注射剂沈阳三生制药有限责任公司1CXHL2400204INR101注射液云核医药(天津)有限公司1CXHL2400200ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400184ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400183ISM3412胶囊英矽智能科技(上海)有限公司1CXHL2400181GP681干混悬剂江西青峰药业有限公司1CXHL2400185BW-20507注射液杭州舶临医药科技有限公司1CXHL2400176JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400167JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400166JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400165JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400164JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400163JYP0066乳膏广州嘉越医药科技有限公司1CXHL2400162BIOS2207浙江赛默制药有限公司2.2CXHL2400229BIOS2207浙江赛默制药有限公司2.2CXHL2400228GBI268注射液广州智耀生物科技有限公司2.2CXHL2400230注射用瑞卢戈利诺桥制药(成都)有限责任公司2.2CXHL2400194布立西坦注射液江西银涛药业股份有限公司3CYHL2400040糠酸莫米松富马酸福莫特罗吸入气雾剂长风药业股份有限公司3CYHL2400038酒石酸匹莫范色林胶囊华中药业股份有限公司3CYHL2400037JP001片北京慧宝源生物技术股份有限公司2.4;2.3CXHL2400202BAT1308注射液百奥泰生物制药股份有限公司1CXSL2400161注射用BAT8006百奥泰生物制药股份有限公司1CXSL2400162QX013N注射液江苏荃信生物医药股份有限公司1CXSL2400165注射用BL-B16D1成都百利多特生物药业有限责任公司1CXSL2400159LAE102注射液来凯医药科技(上海)有限公司1CXSL2400155CM383注射液康诺亚生物医药科技(成都)有限公司1CXSL2400154混合活化杀伤(MAK)免疫细胞注射液北京拓华伟业生物科技有限公司1CXSL2400119异体人源脂肪间充质干细胞注射液江苏得康生物科技有限公司1CXSL2400111RJK002注射液上海瑞吉康生物医药有限公司1CXSL2400117仿制药申请药品名称企业注册分类受理号酮咯酸氨丁三醇注射液福建天泉药业股份有限公司3CYHS2301619盐酸哌罗匹隆片四川科瑞德制药股份有限公司3CYHS2301594恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301339恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301337恩格列净二甲双胍缓释片上海汇伦江苏药业有限公司3CYHS2301336双氯芬酸钠注射液北京世桥生物制药有限公司3CYHS2301043盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300596盐酸多巴胺注射液山东达冠医药科技有限公司3CYHS2300594阿齐沙坦片浙江诺得药业有限公司3CYHS2300009国;CYHS2300009盐酸奥洛他定颗粒南京明生医药有限公司3CYHS2202150国;CYHS2202150盐酸丙卡特罗颗粒安徽百奥药业有限公司3CYHS2201846国;CYHS2201846盐酸苯达莫司汀注射液齐鲁制药有限公司3CYHS2201798国;CYHS2201798盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201562国;CYHS2201562盐酸多柔比星脂质体注射液常州吾合生物医药有限责任公司3CYHS2201561国;CYHS2201561低钙腹膜透析液(乳酸盐-G2.5)安徽丰原药业股份有限公司3CYHS2201233国;CYHS2201233低钙腹膜透析液(乳酸盐-G1.5)安徽丰原药业股份有限公司3CYHS2201232国;CYHS2201232注射用甲氨蝶呤上海上药睿尔药品有限公司3CYHS2102209国;CYHS2102209卡络磺钠注射液康普药业股份有限公司3CYHS2101509国;CYHS2101509氟比洛芬凝胶贴膏江苏万高药业股份有限公司4CYHS2301698盐酸罗匹尼罗缓释片江西金水宝制药有限公司4CYHS2301463碘克沙醇注射液通用电气药业(上海)有限公司4CYHS2301166硝酸异山梨酯注射液河北东圣科宇医药科技有限公司4CYHS2300695氢溴酸伏硫西汀片福建省闽东力捷迅药业股份有限公司4CYHS2300559泮托拉唑钠肠溶片寿光富康制药有限公司4CYHS2300571他达拉非片安徽贝克生物制药有限公司4CYHS2300404多索茶碱注射液赤峰万泽药业股份有限公司4CYHS2300257盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300150盐酸帕罗西汀肠溶缓释片山东京卫制药有限公司4CYHS2300149二甲双胍维格列汀片(III)浙江诺得药业有限公司4CYHS2300142地氯雷他定片合肥国药诺和药业有限公司4CYHS2201952国;CYHS2201952沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201907国;CYHS2201907沙库巴曲缬沙坦钠片常州制药厂有限公司4CYHS2201906国;CYHS2201906替米沙坦氢氯噻嗪片南京海纳医药科技股份有限公司4CYHS2201841国;CYHS2201841盐酸二甲双胍缓释片河南羚锐制药股份有限公司4CYHS2201750国;CYHS2201750注射用美罗培南江苏睿实生物科技有限公司4CYHS2201715国;CYHS2201715注射用美罗培南江苏睿实生物科技有限公司4CYHS2201714国;CYHS2201714头孢泊肟酯片齐鲁制药有限公司4CYHS2201687国;CYHS2201687盐酸托莫西汀口服溶液长兴制药股份有限公司4CYHS2201404国;CYHS2201404盐酸帕罗西汀肠溶缓释片北京北陆药业股份有限公司4CYHS2201525国;CYHS2201525复方聚乙二醇电解质散(III)浙江诺得药业有限公司4CYHS2201517国;CYHS2201517吸入用乙酰半胱氨酸溶液扬子江药业集团江苏紫龙药业有限公司4CYHS2201444国;CYHS2201444苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200990国;CYHS2200990苯磺酸左氨氯地平片平光制药股份有限公司4CYHS2200989国;CYHS2200989注射用硫酸艾沙康唑江苏奥赛康药业有限公司4CYHS2200985国;CYHS2200985盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200968国;CYHS2200968盐酸多奈哌齐口腔崩解片迪沙药业集团有限公司4CYHS2200967国;CYHS2200967阿普米司特片江苏知原药业股份有限公司4CYHS2200944国;CYHS2200944阿普米司特片江苏知原药业股份有限公司4CYHS2200942国;CYHS2200942他达拉非片浙江康恩贝制药股份有限公司4CYHS2200884国;CYHS2200884碘佛醇注射液成都倍特药业股份有限公司4CYHS2200395国;CYHS2200395进口申请药品名称企业注册分类受理号注射用盐酸曲拉西利G1 Therapeutics, Inc.5.1JXHS2300075吡仑帕奈片Eisai Europe Limited5.1JXHS2300026吡仑帕奈片Eisai Europe Limited5.1JXHS2300025卡替拉韦注射液ViiV Healthcare Pty Ltd.5.1JXHS2200099国;JXHS2200099卡替拉韦钠片ViiV Healthcare Pty Ltd.5.1JXHS2200098国;JXHS2200098重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100014国;JXSS2100014重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100013国;JXSS2100013重组人促卵泡激素δ注射液辉凌医药咨询(上海)有限公司3.1JXSS2100012国;JXSS2100012盐酸昂丹司琼注射液Gland Pharma Limited5.2JYHS2000049国;JYHS2000049PF-07220060Pfizer Inc.1JXHL2400059PF-07220060Pfizer Inc.1JXHL2400058PF-07220060Pfizer Inc.1JXHL2400057注射用JR8603JiaRay Pharmaceuticals, Inc.1JXHL2400043镥[177Lu]Lu-NeoB注射液Novartis Pharma AG1JXHL2400032米罗那非片AriBio Co., Ltd.2.4JXHL2400048米罗那非片AriBio Co., Ltd.2.4JXHL2400047甲磺酸贝舒地尔片Kadmon Pharmaceuticals, LLC2.4JXHL2400045布地奈德硫酸沙丁胺醇吸入气雾剂AstraZeneca Pharmaceuticals LP2.4JXHL2400036注射用BL-8040冻干粉BioLineRx Ltd.5.1JXHL2400046DE-117B滴眼液Santen Pharmaceutical Co., Ltd.5.1JXHL2400033盐酸羟甲唑啉滴眼液Santen Pharmaceutical Co., Ltd.5.2JYHL2400001MEDI5752AstraZeneca AB1JXSL2400055Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400054Amlitelimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400053AMG 451Amgen Inc.1JXSL2400047Itepekimab注射液Sanofi-Aventis Recherche & Developpement1JXSL2400044中药相关申请药品名称企业注册分类受理号宝心艾维西木口服液新疆维吾尔药业有限责任公司4CYZL2400001注：灰色字体部分结论为不批准或收到通知件；

申请上市临床申请

2024-05-13

·BioSpace

ViiV Healthcare Announces Health Canada Approval for APRETUDE (Cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV

Approved for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV infection in at-risk adults and adolescents aged 12 years and older, weighing at least 35 kg, including men who have sex with men, transgender women, and cisgender women. APRETUDE (cabotegravir extended release injectable suspension) is the first and only long-acting injectable PrEP treatment approved in Canada. Given as few as six times per year after initiation and demonstrated superior efficacy to a daily oral PrEP option (FTC/TDF tablets) in reducing the risk of HIV acquisition in 2 clinical trials.1 The latest Canadian surveillance data shows that there were 1,833 new HIV diagnoses in 2022, a 24.9 per cent increase from 2021.2 MONTRÉAL, May 13, 2024 /CNW/ - ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc (GSK), with Pfizer Inc. and Shionogi as shareholders, announced that Health Canada has granted approval for APRETUDE (cabotegravir tablets and extended release injectable suspension) for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in at risk individuals who are HIV-1 negative.1 APRETUDE is indicated for at-risk adults and adolescents aged 12 years and older and weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection.1 APRETUDE is the only long-acting injectable HIV PrEP option approved in Canada that reduces the number of doses needed for effective HIV prevention from daily pills to as few as six injections per year. Cabotegravir tablets and extended release injectable suspension for PrEP has demonstrated superior efficacy to daily oral emtricitabine/tenofovir disoproxil fumarate (FTC/TDF tablets) in reducing the risk of HIV acquisition in 2 clinical trials, giving Canadians more options for PrEP.1 Jean-Francois Fortin, Country Medical Director, Canada at ViiV Healthcare, said: "With the approval of APRETUDE in Canada, we are proud to be able to offer a new prevention option for Canadians at risk of acquiring HIV. We are confident that by providing another highly effective preventative option for Canadians, we are one step closer to our collective goal of ending the HIV epidemic. We look forward to working with provincial, territorial, and national health authorities to bring APRETUDE to Canadians across the country." HIV remains a critical public health issue in Canada, with cases of HIV increasing by 24.9 per cent in 2022 from 2021.2 PrEP has been identified as an effective tool in reducing new cases of HIV, key to ending the HIV epidemic. Despite the wide availability of daily oral PrEP, inconsistent adherence as well as structural and cultural barriers lead to underutilization in key populations. Health Canada approval was based on the results of two key phase IIb/III studies, HPTN 083 and HPTN 084, which evaluated the safety and efficacy of cabotegravir long-acting for PrEP in men who have sex with men, transgender women, and cisgender women who were at increased risk of HIV.3,4 The studies demonstrated that cabotegravir long-acting injectables for PrEP was superior to daily oral emtricitabine/tenofovir disproxil fumarate (FTC/TDF), with clinical trial participants experiencing 69 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 083, and a 90 per cent lower rate of HIV acquisition compared to FTC/TDF tablets in HPTN 084.5,6 About Cabotegravir extended release injectable suspension Cabotegravir extended release injectable suspension is the first and only long-acting injectable pre-exposure prophylaxis (PrEP) option proven superior to daily oral FTC/TDF in reducing HIV acquisition. It is indicated for at-risk adults and adolescents aged 12 years and older, weighing at least 35 kg for PrEP to reduce the risk of sexually acquired HIV-1 infection. Cabotegravir extended release injectable suspension is administered as a single 600 mg (3-ml) intramuscular (IM) injection of cabotegravir in the buttocks by a health care professional every two months after two initiation injections administered one month apart. Cabotegravir tablets can be used as an optional oral lead-in to assess tolerability or as short-term oral PrEP in individuals who will miss planned dosing with cabotegravir extended release injectable suspension. Cabotegravir is an integrase strand transfer inhibitor (INSTI). INSTIs, like cabotegravir extended release injectable suspension, 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.1 About HPTN 083 (NCT02720094)7 The HPTN 083 trial is a phase IIb/III double blind non-inferiority trial designed to evaluate the safety and efficacy of long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg). The trial included the prespecified ability to test for superiority of long-acting cabotegravir over FTC/TDF. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 083 was conducted in 4,566 men who have sex with men and transgender women who have sex with men. The study opened to enrollment in November 2016 at research centres in Argentina, Brazil, Peru, United States, South Africa, and Vietnam.5 At a pre-planned interim review of trial data, a multinational Data and Safety Monitoring Board (MDSMB) recommended that the blinded phase of HPTN 083 be stopped due to the demonstration of superior efficacy of cabotegravir when compared to daily, oral FTC/TDF and that subjects randomized to the active FTC/TDF group be offered cabotegravir. The most common adverse reactions (all grades) observed in at least 1 per cent of subjects receiving long acting cabotegravir were injection sites reactions, diarrhea, headache, pyrexia, fatigue, sleep disorders, nausea, dizziness, flatulence, and abdominal pain.5 For further information on HPTN 083 please see . About HPTN 084 (NCT03164564)6 The HPTN 084 trial is a phase III double blind superiority trial designed to evaluate the safety and efficacy of the long-acting injectable cabotegravir for HIV prevention administered every eight weeks compared to daily oral FTC/TDF tablets (200 mg/300 mg) in 3,224 cisgender women who are at increased risk of HIV acquisition. The trial design included an oral lead-in phase to assess tolerability to cabotegravir before administering the intramuscular injection. HPTN 084 opened to enrolment in November 2017 and is being conducted at research centres in Botswana, Kenya, Malawi, South Africa, Eswatini, Uganda, and Zimbabwe.6 The MDSMB recommended early termination of the blinded, randomized portion of HPTN 084 after an interim analysis indicated that pre-specified stopping criteria had been met (superiority of cabotegravir compared with FTC/TDF). The most common adverse reactions (all grades) observed in at least 1% of subjects receiving long acting cabotegravir were injection site reactions, diarrhea, headache, fatigue, sleep disorders, nausea, dizziness, abdominal pain, vomiting, myalgia, and rash.6 For further information please see . About HIV HIV (human immunodeficiency virus) is a virus that attacks the body's immune system.8 HIV is spread by contact with certain bodily fluids of a person with HIV, most commonly during unprotected sex (sex without a condom or HIV medicine to prevent or treat HIV), or through sharing injected drug equipment.9 If HIV is not treated, it can lead to AIDS (acquired immunodeficiency virus). AIDS is the most severe stage of HIV (Stage 3).10 There is currently no cure for HIV, but with proper treatment and care, people with HIV can maintain a high quality of life and avoid passing HIV to others. At the end of 2022, 39 million people lived with HIV around the world, with 1.3 million new diagnoses that year and 630,000 deaths from AIDS-related illnesses.11 Important Safety Information for APRETUDE for PrEP1 The APRETUDE Product Monograph includes a Serious Warning and Precautions Box: RISK OF DRUG RESISTANCE WITH USE OF APRETUDE IN UNDIAGNOSED HIV-1 INFECTION.1 Individuals must be tested for HIV-1 infection prior to initiating APRETUDE and should be tested for HIV-1 infection with each subsequent injection of APRETUDE. APRETUDE must not be prescribed until confirmation of negative HIV-1 infection status. Drug-resistant HIV-1 variants have been identified with use of APRETUDE by individuals with undiagnosed HIV-1 infection. Do not initiate APRETUDE if signs or symptoms of acute HIV-1 infection are present unless negative infection status is confirmed.1 Individuals who become infected with HIV-1 while receiving APRETUDE must transition to a complete HIV-1 treatment regimen. The Product Monograph also includes warnings and precautions regarding hypersensitivity reactions, hepatotoxicity (liver damage) and depressive disorders.1 The Product Monograph, posted at , should be consulted for complete administration and safety information, including contraindications, additional warnings and precautions, adverse reactions and drug interactions.1 Prior to being posted online, the Product Monograph is also available by calling 1-877-393-8448. 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 are at risk of acquiring HIV. 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. SOURCE ViiV Healthcare

临床3期临床结果上市批准

100 项与卡替拉韦钠相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D10548	卡替拉韦钠	J05AR	DB11751

研发状态

批准上市

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适应症	国家/地区	公司	日期
HIV感染	加拿大	ViiV Healthcare Ltd.	2020-09-21

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
HIV感染	临床3期	意大利	ViiV Healthcare Ltd.	2016-10-27
HIV感染	临床3期	法国	ViiV Healthcare Ltd.	2016-10-27
HIV感染	临床3期	西班牙	ViiV Healthcare Ltd.	2016-10-27
HIV感染	临床3期	俄罗斯	ViiV Healthcare Ltd.	2016-10-27
HIV感染	临床3期	德国	ViiV Healthcare Ltd.	2016-10-27
HIV感染	临床3期	荷兰	ViiV Healthcare Ltd.	2016-10-27
肝炎	临床3期	美国	ViiV Healthcare Ltd.	2011-11-01
疱疹病毒感染	临床1期	-	ViiV Healthcare Ltd.	2010-09-01
HIV相关性脂肪营养不良综合征	药物发现	美国	ViiV Healthcare Ltd.	2013-05-01

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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


NCT03299049 (ATLAS-2M, Pubmed \| Lancet) 人工标引	临床3期	HIV感染	1,045	cabotegravir+rilpivirine (every 8 weeks (cabotegravir 600 mg plus rilpivirine 900 mg))	糧鹹艱製製網鹽觸願獵(構範壓觸構鬱觸鏇餘範) = 選膚醖醖艱遞範淵願願衊窪艱製選衊積齋膚範 (鑰選齋積網壓齋鏇鑰繭 )	积极	2021-12-19
				cabotegravir+rilpivirine (every 4 weeks(cabotegravir 400 mg plus rilpivirine 600 mg))	糧鹹艱製製網鹽觸願獵(構範壓觸構鬱觸鏇餘範) = 夢齋淵齋範壓鑰構膚選衊窪艱製選衊積齋膚範 (鑰選齋積網壓齋鏇鑰繭 )
NCT03639311 (Pubmed) 人工标引	临床2期	HIV感染	97	CAB+RPV long-acting	壓憲壓艱獵鹹網願壓觸(糧膚網鹽憲鏇膚遞齋獵) = 鹹製鬱壓憲遞壓夢廠網衊鬱簾構壓製壓鹹蓋鹽 (壓蓋鬱顧憲餘顧窪鏇襯 ) 更多	积极	2022-02-01
				dolutegravir/RPV	壓憲壓艱獵鹹網願壓觸(糧膚網鹽憲鏇膚遞齋獵) = 廠遞齋廠齋願衊醖膚齋衊鬱簾構壓製壓鹹蓋鹽 (壓蓋鬱顧憲餘顧窪鏇襯 ) 更多
NCT02720094 (Pubmed \| Br Dent J) 人工标引	临床2/3期	HIV感染	1,698	cabotegravir	(鹹蓋餘鹹壓鹹壓憲繭觸) = 夢衊膚鏇簾製積鑰範構膚繭衊齋襯願選遞衊夢 (顧齋壓窪糧簾鏇製鏇窪 ) 更多	积极	2021-08-12
				tenofovir disoproxil fumarate-emtricitabine	(鹹蓋餘鹹壓鹹壓憲繭觸) = 鑰鏇憲廠獵繭憲簾築憲膚繭衊齋襯願選遞衊夢 (顧齋壓窪糧簾鏇製鏇窪 ) 更多
NCT02938520 (Pubmed \| Br Dent J) 人工标引	临床3期	HIV感染	566	dolutegravir+abacavir+lamivudine+Cabotegravir+Rilpivirine	觸顧簾廠鹹壓衊蓋鬱膚(膚夢遞網繭壓觸鹽觸願) = 淵遞醖膚繭醖艱艱願憲繭廠糧製積繭範襯衊艱 (廠淵壓衊製選淵鏇遞憲 ) 更多	非劣	2020-03-19
				dolutegravir+abacavir+lamivudine	觸顧簾廠鹹壓衊蓋鬱膚(膚夢遞網繭壓觸鹽觸願) = 遞築壓餘鹽積蓋壓遞選繭廠糧製積繭範襯衊艱 (廠淵壓衊製選淵鏇遞憲 ) 更多
NCT02951052 (Pubmed \| Br Dent J) 人工标引	临床3期	HIV感染维持	616	Cabotegravir+Rilpivirine (intramuscular injections)	範壓蓋襯遞鹽網膚壓鹽(襯獵顧製選廠餘艱糧繭) = 鹹構夢夢壓壓簾艱淵淵鏇範窪醖鹽餘壓築鬱願 (鑰齋選顧醖齋憲糧襯獵 ) 更多	非劣	2020-03-19
				standard oral antiretroviral therapy	範壓蓋襯遞鹽網膚壓鹽(襯獵顧製選廠餘艱糧繭) = 艱淵繭範餘網遞鑰壓壓鏇範窪醖鹽餘壓築鬱願 (鑰齋選顧醖齋憲糧襯獵 ) 更多
NCT04399551 (CARISEL, Corporate Publications) 人工标引	临床3期	HIV感染	437	Cabotegravir+Rilpivirine Hydrochloride	遞遞淵簾夢網壓遞夢窪(蓋淵網廠鹽遞衊遞積鹹) = 願鹹範獵鏇積蓋網淵觸襯憲築製構願齋積齋糧 (襯襯遞淵襯鬱夢窪淵夢 ) 更多	积极	2022-10-24
IAS2022	N/A	维持	920	Long-acting cabotegravir+rilpivirine	膚顧鏇窪範壓糧構鏇構(積鏇構鏇廠膚淵鑰膚製) = 憲鑰簾網膚網艱願製製願餘襯鹹襯鑰窪夢淵獵 (壓醖鑰鬱蓋蓋簾願餘網 ) 更多	-	2022-01-01
NCT03164564 (HPTN 084, Corporate Publications) 人工标引	临床3期	HIV感染	3,224	Cabotegravir	(遞憲襯糧憲選繭顧製遞) = 構簾製構選製鹹獵蓋遞蓋簾蓋鬱窪衊選夢廠餘 (壓夢鏇壓簾鏇齋積膚餘 ) 更多	优效	2022-07-28
				Emtricitabine+Tenofovir	(遞憲襯糧憲選繭顧製遞) = 獵憲餘範廠膚觸餘壓夢蓋簾蓋鬱窪衊選夢廠餘 (壓夢鏇壓簾鏇齋積膚餘 ) 更多
NCT03164564 (HPTN 084, Pubmed) 人工标引	临床3期	HIV感染	3,224	Placebo+cabotegravir	(鬱齋壓積構選觸願艱觸) = 範簾網鹹範鹹獵醖廠壓淵築鹽鹽願壓餘選淵簾 (鬱網衊蓋鬱鏇鬱築壓選 ) 更多	优效	2022-04-01
				Placebo+tenofovir diphosphate plus emtricitabine	(鬱齋壓積構選觸願艱觸) = 鹹廠遞夢選願獵製觸衊淵築鹽鹽願壓餘選淵簾 (鬱網衊蓋鬱鏇鬱築壓選 ) 更多
CARLOS cohort (IAS2022)	N/A	HIV感染	236	Cabotegravir + Rilpivirine long acting	(鹽範願鏇醖顧憲鑰選襯) = 築憲鬱鏇齋觸鏇齋壓壓築鹽憲淵繭窪窪憲齋構 (繭獵製糧選餘遞齋範壓 ) 更多	-	2022-01-01