葛兰素史克（GSK）和辉瑞（Pfizer）合资公司ViiV Healthcare 6月27日宣布，三合一HIV药物Triumeq（dolutegravir/abacavir/lamivudine，dolutegravir/阿巴卡韦/拉米夫定）获得了欧洲药品管理局（EMA）人用医药产品委员会（CHMP）的积极意见。CHMP建议批准Triumeq用于12岁及以上且体重至少40公斤的青少年及成人HIV感染者的治疗。欧盟委员会（EC）预计将于2014年第三季度做出最终审查决定。Triumeq是ViiV的首个HIV复方片。
CHMP的积极意见，是基于2个关键性III期研究的数据，其中一项III期研究（SINGLE）调查了dolutegravir和abacavir/lamivudine作为单独的片剂；另一项研究调查了固定剂量dolutegravir/abacavir/lamivudine作为单一片剂相对于dolutegravir片和abacavir/lamivudine片组合疗法的生物等效性。
本月中旬，ViiV Healthcare宣布，与强生（JNJ）签署了一项合作协议，开发和商业化含dolutegravir（商品名Tivicay）和rilpivirine（商品名Edurant）的复方片剂。此次合作，也代表着ViiV的首个外部合作。（详见《ViiV与杨森合作开发HIV药物Tivicay/Edurant复方片》）
Edurant（rilpivirine）为高活性的抗逆转录病毒治疗（HAART）药物之一，属于非核苷类逆转录酶抑制剂（NNRTI），通过阻断HIV复制来发挥作用，该药已获批与其他抗逆转录病毒药物联合用于初治HIV-1成人感染者的治疗。如果获批，这种dolutegravir/rilpivirine固定剂量组合疗法将有望为HIV感染者提供一种选择，一旦稳定抑制病毒载量后，可从当前标准的3种药物组合疗法转向dolutegravir/rilpivirine固定剂量组合疗法。
关于Triumeq：
Triumeq（dolutegravir/abacavir/lamivudine）为每日一次的实验性三合一HIV复方单片，该药是一种基于dolutegravir的HIV治疗方案，由固定剂量的dolutegravir、abacavir（阿巴卡韦）、lamivudine（拉米夫定）组成。
关于Tivicay：
Tivicay（dolutegravir）是一种HIV整合酶抑制剂，该药为每日一次的口服药物，已获FDA、欧盟、加拿大批准，与其他抗逆转录病毒制剂联合用于既往已治疗过、或初治HIV-1成人和12岁及以上青少年感染者的治疗。
2016年Tivicay成主流
此前，独立分析公司datamonitor Healthcare发布报告指出，Tivicay若获欧盟批准，必将对全球HIV市场产生巨大的影响，到2016年，Tivicay必将成为HIV治疗的主流整合酶抑制剂。
Tivicay疗效优于Prezista或Isentress
在临床试验中，Tivicay疗效优于强生（JNJ）的蛋白酶抑制剂Prezista（darunavir，地瑞那韦），同时与当前的标准护理药物整合酶抑制剂Isentress（raltegravir，拉替拉韦）疗效相当。Isentress由默沙东（Merck & Co）开发。
datamonitor Healthcare分析师Joseph Hedden称，Tivicay与其他一些竞争药物不同，该药不需要与药物促进剂联合用药，同时也具有一个非常有吸引力的耐药属性。在接下来几年里，以整合酶抑制剂销售额计算，这些属性将推动Tivicay至排名第一的位置。
关于ViiV Healthcare：
ViiV医疗保健公司是葛兰素史克（GSK）和辉瑞（Pfizer）于2009年联合成立的HIV/AIDS药物研发公司，目前，GSK持有ViiV 76.5%的股份，辉瑞持有10%的股份，日本盐野义（Shionogi）持有10%的股份。
英文原文：Triumeq® (dolutegravir/abacavir/lamivudine) single-tablet regimen receives positive CHMP opinion in Europe for the treatment of HIV
ViiV Healthcare’s first investigational once-daily single-tablet regimen, combining the integrase inhibitor dolutegravir and nucleoside analogues abacavir/lamivudine.
London, UK, 27June 2014
ViiV Healthcare today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for Triumeq® (dolutegravir/abacavir/lamivudine) for the treatment of HIV infection in adults and adolescents aged 12 years and older and weighing at least 40kg.
"Today's positive opinion takes us a step closer to bringing physicians and people living with HIV a dolutegravir based regimen that can be taken once-daily as a single-tablet," said Dr John Pottage, Chief Scientific and Medical Officer, ViiV Healthcare. "This opinion supports the potential of dolutegravir based regimens, as well as the importance of our ongoing research into additional single-tablet treatment options.”
The CHMP positive opinion is based upon data from two pivotal studies:
——the Phase III study of dolutegravir (SINGLE), conducted with dolutegravir and abacavir/lamivudine as separate pills
——a separate bioequivalence study of the fixed-dose combination of dolutegravir/abacavir/lamivudine when taken as a single tablet compared to the administration of dolutegravir and abacavir/lamivudine as separate pills.
A CHMP positive opinion is one of the final steps before marketing authorisation is granted by the European Commission (EC), but does not always result in marketing authorisation. A final decision by the EC is anticipated during the third quarter of 2014.
about Triumeq
Triumeq (dolutegravir/abacavir/lamivudine) is not currently approved in any country and is an investigational once-daily single tablet dolutegravir based regimen, containing the integrase inhibitor dolutegravir which was approved by the EMA in January 2014 under the brand name Tivicay®.
A New Drug Application (NDA) for abacavir/dolutegravir/lamivudine was submitted to the U.S. Food and Drug Administration (FDA) in October 2013, and is currently under review. The regulatory submission and review processes have also been initiated in Canada, Australia, Brazil and Japan.
important Safety Information for Tivicay (dolutegravir) and Kivexa (abacavir/lamivudine) in the European unio: Please refer to the full European Summary of Product Characteristics for full prescribing information for dolutegravir and abacavir/lamivudine.
Kivexa®, Tivicay and Triumeq are registered trademarks of the ViiV Healthcare group of companies. The use of the brand name TRIUMEQ is not approved by any regulatory authorities.
|手机版|药群论坛
( 蜀ICP备15007902号 )
收藏
支持
反对
