FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV


2021-01-22 07:01:39 BioSpace


 The U.S. Food and Drug Administration  today approved Cabenuva as a complete regimen for the treatment of human immunodeficiency virus type 1 infection in adults to replace a current antiretroviral regimen in those who are virologically suppressed on a stable antiretroviral regimen with no history of treatment failure and with no known or suspected resistance to either cabotegravir or rilpivirine. This is the first FDA-approved injectable, complete regimen for HIV-infected adults that is administered once a month. The FDA also approved Vocabria (cabotegravir, tablet formulation), which should be taken in combination with oral rilpivirine (Edurant) for one month prior to starting treatment with Cabenuva to ensure the medications are well-tolerated before switching to the extended-release injectable formulation. "Currently, the standard of care for patients with HIV includes patients taking daily pills to adequately manage their condition. This approval will allow some patients the option of receiving once-monthly injections in lieu of a daily oral treatment regimen," said John Farley, M.D., M.P.H., director of the Office of Infectious Diseases in the FDA's Center for Drug Evaluation and Research. "Having this treatment available for some patients provides an alternative for managing this chronic condition." The safety and efficacy of Cabenuva were established through two randomized, open-label, controlled clinical trials in 1,182 HIV-infected adults who were virologically suppressed (HIV-1 RNA less than 50 copies/milliliter) before initiation of treatment with Cabenuva. Patients in both trials continued to show virologic suppression at the conclusion of each study, and no clinically relevant change from baseline in CD4+ cell counts was observed. The most common adverse reactions with Cabenuva were injection site reactions, fever (pyrexia), fatigue, headache, musculoskeletal pain, nausea, sleep disorders, dizziness and rash. Cabenuva should not be used if there is a known previous hypersensitivity reaction to cabotegravir or rilpivirine, or in patients who are not virally suppressed (HIV-1 RNA greater than 50 copies/milliliter). Cabenuva and Vocabria were granted Fast Track and Priority Review designation by the FDA. The FDA granted the approval of Cabenuva and Vocabria to ViiV Healthcare. Media Contact: Chanapa Tantibanchachai, 202-384-2219 Consumer Inquiries: Email or 888-INFO-FDA The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. multimedia:http://www.prnewswire.com/news-releases/fda-approves-first-extended-release-injectable-drug-regimen-for-adults-living-with-hiv-301212892.html
美国食品和药物管理局今天批准Cabenuva作为治疗成人人类免疫缺陷病毒1型感染的完整方案,以取代目前的抗逆转录病毒方案,用于那些通过稳定的抗逆转录病毒方案进行病毒学抑制,没有治疗失败的历史,也没有已知或怀疑对卡博替格韦或利匹韦林产生耐药性的人。这是第一个FDA批准的注射,完整的治疗HIV感染成人的方案,每个月给药一次。 FDA还批准了Vocabria(卡博特格拉韦,片剂配方),在开始使用卡贝努瓦治疗之前,应与口服利匹韦林(Edurant)联合服用一个月,以确保药物耐受性良好,然后再改用缓释注射制剂。 FDA's药物评估与研究中心传染病办公室主任John Farley医学博士说:“目前,艾滋病患者的护理标准包括患者每天服用药片以充分控制病情。这项批准将允许一些患者选择每月注射一次,而不是每天口服治疗方案。”“对某些患者进行这种治疗,为治疗这种慢性疾病提供了一种替代方法。” Cabenuva的安全性和有效性是通过两项随机,开放标记,对照临床试验在1182名HIV-感染成人中确定的,这些成人在开始使用Cabenuva治疗之前被病毒学抑制(HIV-1 RNA少于50拷贝/毫升)。两个试验中的患者在每项研究结束时都继续显示病毒学抑制,并且在CD4+细胞计数方面没有观察到与基线相关的临床变化。 卡贝努瓦最常见的不良反应是注射部位反应,发热(发热),疲劳,头痛,肌肉骨骼疼痛,恶心,睡眠障碍,头晕和皮疹。如果以前对卡博替格韦或利匹韦林有已知的超敏反应,或者在没有病毒抑制(HIV-1 RNA大于50拷贝/毫升)的患者中,不应使用Cabenuva。 Cabenuva和Vocabria被FDA授予快速通道和优先审评指定。 FDA批准ViiV Healthcare公司使用Cabenuva和Vocabria。 媒体联系人:Chanapa Tantibanchachai,电话:202-384-2219 消费者咨询:电子邮件或888-info-fda FDA是美国卫生与公众服务部下属的一个机构,通过确保人类和兽药,疫苗和其他人类使用的生物制品以及医疗器械的安全性,有效性和安全性来保护公众健康。该机构还负责我国食品供应,化妆品,膳食补充剂,发出电子辐射的产品的安全和保障,并负责管制烟草产品。 多媒体:http://www.prnewswire.com/news-releases/fda-approves-first-extended-release-injectable-drug-regreen-for-adults-living-with-HIV-301212892.html