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吉利德HIV治疗新药TAF将有望取代Viread成为新一代利器

来源:生物谷 2015-03-03 09:13

2015年3月3日讯/生物谷BIOON/--在近日的“逆转录与感染”会议上,吉利德宣布该公司的HIV新药TAF已被证明能够安全用于那些患有轻至中度肾损伤的患者,有望取代当前市面上的治疗方法。

3期临床试验共有242名从未接受过治疗的HIV阳性患者参与,用于评估TAF对HIV-1型病毒感染的有效性。研究发现肾功能也并未遭到损伤。事实上,当患者放弃传统的HIV疗法而接受以TAF为基础的鸡尾酒疗法后,相关的肾病标志物水平反而下降了。

去年11月,吉利德向FDA提交了TAF的应用申请。目前该药物正在FDA审批中,有望代替吉利德的组合疗法Viread。

吉利德的Viread将于2017年专利保护到期,目前吉利德正努力推进TAF的审批,希望在Viread专利到期前获得批准,保证自身在HIV市场上的竞争力。因此,吉利德目前正努力证明TAF的安全性和有效性,试图让TAF成为比Viread更有竞争力的加强版。

据悉,2015年11月之前,吉利德的TAF获批与否将会得到决定。去年9月,吉利德宣布了两次临床试验的结果,试验共在1733名未接受过治疗的HIV患者中进行。结果表明TAF能有效抑制HIV,而且比传统药物更加安全。

吉利德的COO John Milligan在一月份的摩根大通医疗会议上表示,HIV药物已经有几十年的历史了,那些从20多岁开始接受HIV治疗的患者有望活到70多岁,这就意味着他们要接受终身治疗。因此我们需要最简单、最安全的治疗方式,TAF可以作为这些长期治疗手段的重要组成部分。

野村证券的分析师M. Ian Somaiya认为,此番对TAF的陈述将HIV推到关注的焦点位置,扩大了吉利德的投资组合,而不再仅仅局限于丙肝药物。正如M. Ian Somaiya所言,这些数据为Viread到TAF的市场转型提供了一条清晰的道路,并且帮助吉利德获得持续到21世纪20年代中期专营权。(生物谷Bioon.com)

原文 Gilead Sciences, Inc. HIV Drug TAF Could Replace Current Standard Treatment Viread

Gilead Sciences, Inc.’s (NASDAQ:GILD) next-generation HIV drug, called TAF, proved to be safe for use in patients suffering from a mild-to-moderate form of kidney impairment, the company announced Thursday at the Conference on Retroviruses and Opportunistic Infections.

The Phase III study, carried out on 242 HIV-positive patients, evaluated the effectiveness of the drug when used to treat HIV-1 infection in treatment-na?ve adults. The study found that kidney function did not deteriorate. In fact, a marker of kidney disease actually decreased when patients in the trial switched from using conventional HIV treatment drugs to a TAF-based cocktail.

The biopharmaceutical company filed a new drug application for TAF in November last year. The drug, which is currently awaiting a US Food and Drug Administration ruling, is likely to replace Gilead’s Viread in HIV combinational therapy treatments.

Gilead will lose US patent protection for Viread in 2017. The company is working on ensuring that TAF is approved well before the patent protection on Viread expires. Gilead, hence, is working hard to present TAF's safety and efficacy profile as one that can indicate that the TAF-based regimen is a newer, more improved version of Viread, giving doctors a reason to recommend patients to switch to the new regimen.

Gilead is likely to receive a ruling pertaining to the fate of its new drug by November 2015. The company said in September that the treatment was effective in subduing the virus and safer than an older medicine, based on two trials among 1,733 patients who had not been treated before.

HIV medication “is given for decades, people who come onto therapy in their 20s are estimated to be able to live to their 70s and they need lifelong therapy,” said John Milligan, Gilead’s chief operating officer, in a January presentation at the JPMorgan Healthcare Conference.

“That means we need the simplest, safest medication for these patients going forward, and we think that TAF can be the most important component of that long-term therapy,” he further added.

Finance firm Nomura’s analyst M. Ian Somaiya believes that the TAF presentation brings “HIV succession planning into focus,” broadening the company's portfolio once again from not just being centered on hepatitis C drugs. The data, as per the analyst, provides Gilead with “a clear path to transition the market away from Viread to TAF,” while boosting “the sustainability of the franchise to mid-2020.”

 

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