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FDA Approves First Long-Acting HIV Drug Combo
美国食品药物管理局批准首个长效HIV组合治疗药物
The U.S. government has approved the first long-acting drug combination treatment for HIV, the virus responsible for the disease AIDS.
美国政府批准了首个针对艾滋病病毒(HIV)的长效药物组合治方案,艾滋病病毒是引发艾滋病的病毒。
The treatment was approved by the Food and Drug Administration (FDA) last week. It involves monthly injections to replace daily pills now used to control HIV.
这项治疗方案于上周获得了美国食品和药物管理局(简称FDA)的批准。方案包括每月注射,以取代目前用来控制艾滋病病毒的每日药物。
HIV is a virus that is spread through body fluids. Sexual contact can spread the disease but so can infected blood and blood products.
艾滋病病毒是通过体液传播的病毒。性接触会传播艾滋病,感染的血液和血液制品也会传播该疾病。
The two-injection combination treatment is called Cabenuva. The drug is expected to make it easier for people to receive their HIV medicines and to do so with more privacy. The injections mark a big change from methods used in the past. Those treatments required patients to take multiple pills several times a day, carefully timed around meals.
这一两种针剂药物组合治疗被称为Cabenuva。预计这种药物组合使人们不仅能更容易获得艾滋病药物,而且能在确保更多隐私的情况下获得药物。这种注射疗法与过去使用的疗法相比有很大不同。以前的治疗方法要求患者每日多次服用药片,并在进餐前后仔细安排进药时间。
Dr. Steven Deeks is an HIV specialist at the University of California, San Francisco. He told The Associated Press that the new treatment can make patients' lives better because it is only needed once a month. "People don't want those daily reminders1 that they're HIV infected," Deeks said.
史蒂文·迪克斯博士是加州大学旧金山分校的艾滋病专家。他对美联社表示,新疗法可以改善患者的生活质量,因为每个月只需注射一次。迪克斯说,“人们不想要那些每天提醒他们感染了艾滋病毒的东西。”
Cabenuva contains rilpivirine which is sold as Edurant by Janssen, a company owned by Johnson & Johnson. It also contains a new drug called cabotegravir. It is made by ViiV Healthcare. The two are sold together and given as separate injections once a month. The drug is also being tested for use every two months.
Cabenuva包含利匹韦林,强生公司旗下的杨森公司以“恩临”之名销售。Cabenuva药物组合还包含一种名为卡波特格雷韦的新药。该药由ViiV Healthcare公司研发。这两种药物组合出售,每个月分别注射一次。这一药物组合每两个月进行一次注射的剂量也正在试验当中。
The FDA approved Cabenuva for use in adults who have had their disease controlled by other HIV medicines and have not shown signs of viral resistance to the two drugs in Cabenuva.
美国食品和药物管理局批准Cabenuva用于病情已经得到其他艾滋病药物良好控制的成年人,并且病毒对Cabenuva的这两种药物都没有显示出耐药性迹象。
The agency also approved a pill version of cabotegravir to be taken with rilpivarine for one month to ensure the drugs do not cause bad effects.
该机构还批准了一种片剂卡波特格雷韦,与利匹韦林一起服用一个月,以确保药物不会造成不良影响。
ViiV said the injection combination would cost $5,940 for a higher, first dose. The cost would then drop to $3,960 each month. The company said this price was similar to what one-a-day pill combinations cost now. How much each patient pays depends on their insurance, income and other things.
ViiV公司表示,注射剂组合的初始高剂量价格为5940美元。之后每月的价格为3960美元。该公司表示,这和之前服用药片的花费差不多。病人付多少钱取决于保险、收入和其他东西。
Dr. Judith Currier is an HIV specialist at the University of California, Los Angeles. She said studies on the new treatment found that patients greatly favored the injections. "Even people who are taking one pill once a day just reported improvement in their quality of life to switch to an injection," she said. Currier is an advisor2 to ViiV and wrote a commentary about one study on the drug in the New England Journal of Medicine.
朱迪斯·柯瑞尔是加州大学洛杉矶分校的艾滋病专家。她表示,对这种新疗法进行的研究发现,患者明显偏爱注射。她说,“即使是那些每天只吃一片药的人,转为注射药物之后,也报告说他们的生活质量得到了改善。”柯瑞尔是ViiV公司的顾问,她在《新英格兰医学杂志》上为该药物的一项研究撰写了评论。
Deeks said long-acting injections also give hope of reaching groups that have a hard time carrying out daily treatment. He said that includes people with mental illness or substance abuse problems. "There's a great unmet need" that the injections may fill, he added.
迪克斯表示,长效针剂也给难以坚持治疗的群体带来了希望。他表示,这包括有精神疾病或药物滥用问题的人。他补充表示,“有一个巨大的未被满足的需求”,可能会被这些针剂填补。
Separately, ViiV plans to seek approval for the use of cabotegravir to prevent HIV. Two recent studies found that cabotegravir injections given every two months were better than daily Truvada pills for keeping uninfected people from catching3 the virus.
另外,ViiV公司计划申请批准卡波特格雷韦用于艾滋病病毒预防。最近的两项研究发现,在防止未受感染的人从受感染的性伴侣那里感染病毒方面,每两个月注射卡波特格雷韦比每天服用特鲁瓦达药片效果更好。
I'm Bryan Lynn.
布莱恩·林恩报道。
1 reminders | |
n.令人回忆起…的东西( reminder的名词复数 );提醒…的东西;(告知该做某事的)通知单;提示信 | |
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2 advisor | |
n.顾问,指导老师,劝告者 | |
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3 catching | |
adj.易传染的,有魅力的,迷人的,接住 | |
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