Gilead's Descovy Approved for HIV Prevention

美国FDA批准吉利德的Descovy用于预防艾滋病毒

2019-10-08 09:00:20 BioSpace

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The U.S. Food and Drug Administration (FDA) approved Gilead Sciences’ Descovy for HIV pre-exposure prophylaxis (PrEP). Descovy is a doublet combination of 200 mg of emtricitabine and 25 mg of tenofovir alafenamide. It was not approved, however, for at-risk individuals from receptive vaginal sex because it hasn’t been tested for that indication. Descovy was approved for this indication under the FDA’s priority review designation. The drug also carries a Boxed Warning in the U.S. because of the risk of post treatment acute exacerbation of hepatitis B. It also includes a Boxed Warning over the risk of drug resistance with PrEP use in undiagnosed early HIV-1 infection. The supplemental New Drug Application (sNDA) was built on the DISCOVER Phase III clinical trial results. This trial evaluated more than 5,300 adult cisgender men who have sex with men or transgender women who have sex with men. The primary efficacy endpoint was the incidence of documented HIV infection per 100 person-years after follow-up for at least 48 weeks and at least half of the group had a follow-up at 96 weeks. “Descovy for PrEP provides a new HIV prevention option that matches Truvada’s high efficacy with statistically significant improvements in renal and bone safety, which can be an important consideration as people at risk increasingly use PrEP for longer periods of time,” said Daniel O’Day, chairman and chief executive officer of Gilead. “This is a reflection of Gilead’s continued commitment to addressing the evolving needs of people living with or at risk for HIV and to driving innovation across the HIV care continuum.” The only other drug currently approved in the U.S. for HIV PrEP is Gilead’s Truvada (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). In the DISCOVER trial, Descovy was found to be noninferior to Truvada in terms of efficacy for this patient population, and there were significant advantages over Truvada for six pre-specified secondary endpoints related to renal and bone laboratory parameters. “PrEP drugs are highly effective when taken as indicated in the drug labeling and can prevent HIV infection,” stated Jeffrey Murray, deputy director of the Division of Antiviral Products in the FDA’s Center for Drug Evaluation and Research. “This approval provides more prevention options for certain patients at-risk for acquiring HIV and helps further efforts by the FDA and the U.S. Department of Health and Human Services to facilitate the development of HIV treatment and prevention options to reduce new HIV infections.” HIV PrEP has come with some controversy. Truvada runs about $20,000 a year. A generic version is expected to hit the market in 2020. The Trump Administration has indicated it wants to increase access to PrEP as part of its efforts to end HIV transmission by 2030. However, in a U.S. House of Representatives hearing in May, O’Day took some heat for the price of the drug that had some government research funding. There was likely some political posturing in this. It’s true that the original basic research was funded by the U.S. Centers for Disease Control and Prevention (CDC), which holds patents on the drug, and by the U.S. National Institutes of Health (NIH). Gilead has argued that the government’s 2015 patent for Truvada is invalid. Much of this revolves around research conducted by a retired CDC researcher, Thomas Folks, who conducted monkey research at the CDC. Truvada was approved for HIV in 2004 and the CDC wanted to conduct into whether it could be used as a preventive measure. Gilead supplied the drugs to the research team. The researchers repeatedly infected monkeys with small amounts of HIV, about the level found in semen, to prove that drug would prevent infection. In 2012, Gilead received FDA approval for that use.
美国食品药品监督管理局(Food and Drug Administration)( FDA )批准吉利德科学(Gilead Sciences)的 Descov 用于 HIV 暴露前预防( PrEP )。Descovy 是一种200毫克的 emtripatine 和25毫克的替诺福韦拉非那酰胺的双重组合。然而,由于尚未对接受阴道性行为的高危个体进行检测,因此该方法未获批准。 Descovy 在 FDA 的优先审评指定下被批准用于该适应症。由于治疗后乙肝急性加重的风险,该药物在美国也带有 Boxed 警告,还包括一种 Boxe 警告,警告在未确诊的早期 HIV-1感染中使用 PrEP 会产生耐药性。 补充新药申请( sNDA )建立在 DISCOVER Ⅲ期临床试验结果之上。这项试验评估了5300多名与男性有性关系的成年男性或变性女性。主要疗效终点为每100人年在随访至少48周后发生 HIV 感染的记录,其中至少有一半的人在96周内进行了随访。 Gilead 董事长兼首席执行官丹尼尔•奥戴( Daniel O ’ Day )表示:“ Descovy for PrEP 提供了一种新的艾滋病毒预防方案,将 Truvada 的高疗效与肾脏和骨骼安全方面的统计显著改善相匹配,这可能是一个重要的考虑因素,因为面临风险的人越来越多地长期使用 PrEP 。”“这反映出吉利德(Gilead)继续致力于满足艾滋病毒感染者或有风险人群不断变化的需求,并推动整个艾滋病毒护理领域的创新。” 目前在美国批准用于 HIV PrEP 的唯一其他药物是吉利德(Gilead)的 Truvada ( emtripatine 200 mg /替诺福韦二吡呋酯300 mg )。在 DISCOVER 试验中,发现 Descovery 在这一患者群体的疗效方面不逊于 Truvada ,并且在六个预先指定的与肾脏和骨实验室参数相关的二级终点方面比 Truvada 有显著优势。 FDA 药品评估和研究中心抗病毒产品部门的副主任 Jeffrey Murray 说:“如果按照药品标签上的指示服用, PrEP 药物是非常有效的,可以防止 HIV 感染。”“这一批准为某些面临感染艾滋病毒风险的患者提供了更多的预防选择,并帮助 FDA 和美国卫生和公众服务部进一步努力,以促进开发艾滋病毒治疗和预防方案,以减少新的艾滋病毒感染。” HIV PrEP 引起了一些争议。Truvada 每年的运营成本约为2万美元。预计仿制药将在2020年上市。特朗普政府表示,希望增加获得 PrEP 的机会,这是到2030年结束艾滋病毒传播工作的一部分。然而,在美国众议院5月份举行的听证会上, O ’ Day 对有政府研究经费的药品的价格有些恼火。 在这方面可能有一些政治姿态。确实,最初的基础研究是由美国疾病控制和预防中心(疾病预防控制中心(CDC))资助的,该中心拥有该药物的专利,并由美国国立卫生研究院( NIH )资助。吉利德(Gilead)认为政府2015年针对 Truvada 的专利无效。 其中大部分是由一位退休的 CDC 研究员托马斯·福克斯进行的研究,他在疾病预防控制中心(CDC)进行猴子研究。杜鲁瓦达于2004年被批准用于艾滋病毒,疾病预防控制中心希望对是否可以将其作为预防措施进行调查。吉利德(Gilead)向研究小组提供药物。研究人员反复感染少量艾滋病病毒的猴子,大约是精液中发现的水平,以证明药物能够预防感染。2012年,吉利德(Gilead)获得了 FDA 的批准。

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