Gilead公司启动第3期临床计划为替诺福韦Alafenamide，一种新型

StephenW

[Tenofovir Alafenamide is GS 7340]
Gilead Initiates Phase 3 Clinical Program for Tenofovir Alafenamide, a Novel Low-Dose Prodrug for the Treatment of HIV

-- Two Studies Will Compare a Tenofovir Alafenamide-Based Single Tablet Regimen to Gilead’s Stribild® --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 24, 2013-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced the initiation of the first of two Phase 3 clinical trials (Study 104) evaluating a single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. TAF is a novel prodrug of tenofovir, the active agent in Viread® (tenofovir disoproxil fumarate). The Phase 3 studies will examine a once-daily single tablet regimen of TAF 10 mg/elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg compared to Gilead’s Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) among patients new to HIV therapy. The second Phase 3 study (Study 111) will be initiated later this quarter.

“We are pleased to move TAF into Phase 3 clinical research,” said Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences. “We believe that TAF’s smaller milligram size has the potential to offer safety and tolerability advantages over existing therapies, and may enable the creation of new single tablet regimens for HIV.”

In October 2012, Gilead announced topline results from a Phase 2 study comparing the TAF/elvitegravir/cobicistat/emtricitabine single tablet regimen to Stribild. The study found that the TAF-based regimen met its primary objective based on the proportion of patients with HIV RNA (viral load) levels < 50 copies/mL at 24 weeks of therapy. In addition, statistically significant differences in bone and renal safety were observed between the two arms in favor of the TAF-containing regimen. Both the type and frequency of laboratory abnormalities and adverse events were otherwise comparable between study arms. Full results from the Phase 2 study will be presented at an upcoming medical conference.

Stribild was approved by the U.S. Food and Drug Administration (FDA) in August 2012 and is Gilead’s third single tablet regimen for HIV. A marketing application for Stribild is currently pending in Europe.

StephenW

[替诺福韦Alafenamide是GS 7340]

Gilead公司启动第3期临床计划为替诺福韦Alafenamide，一种新型的低剂量治疗艾滋病毒的前体药物

- 两个研究将比较一个的替诺福韦Alafenamide为基础的单一平板方案，以Gilead公司的Stribild® -

福斯特城，加利福尼亚州 - （BUSINESS WIRE） -  1月。 24，2013  - 吉利德科学公司（纳斯达克股票代码：GILD）今天宣布启动的两个三期临床试验（研究104）评估一个单一的平板电脑方案包含替诺福韦alafenamide用于治疗HIV-1（TAF）在治疗初治成人的感染。 TAF是一种新的前药的替诺福韦，VIREAD的®（富马酸替诺福韦酯）中的活性剂。该阶段3研究会检查一个每日一次的单一平板电脑方案的TAF 10毫克/ elvitegravir 150毫克/ cobicistat 150毫克/恩曲他滨200毫克Gilead公司的Stribild®（elvitegravir 150毫克/ cobicistat 150毫克/恩曲他滨200毫克/替诺福韦诺福韦富马酸相比， 300毫克），新的抗逆转录病毒药物治疗的患者。在本季度晚些时候将开始第二阶段的3期研究（研究111）。

“我们很高兴，说：”移动TAF进入3期临床研究诺伯特Bischofberger，博士，执行副总裁，研究与发展兼首席科学​​官，吉利德科学公司（Gilead Sciences）。 “我们相信，TAF的小毫克的大小有可能超过现有的治疗方法，以提供安全性和耐受性优势，可以使创造新的单锭方案的艾滋病毒。”

在2012年10月，Gilead公司宣布从第二阶段的研究比较TAF / elvitegravir / cobicistat /恩曲他滨单锭方案，以Stribild的营收结果。研究发现，TAF为基础的疗法的患者与HIV RNA（病毒载量）的比例达到了主要目标水平<50拷贝/毫升在24周的治疗。此外，统计上的显着差异，骨和肾脏安全性，观察两者之间的武器在TAF的方案有利于。实验室检查异常和不良事件的类型和频率的其他研究组之间的比较。第二阶段的研究结果将发表在即将举行的医学会议。

Stribild是2012年8月，是由美国食品和药物管理局（FDA）批准Gilead公司的第三单锭方案的艾滋病毒。一位营销为Stribild中的应用，目前正在等待欧洲。

咬牙硬挺

没有艾滋病，就没有我们吃的药物，祸兮福所倚…