美国FDA批准Gilead的Epclusa®（索非布韦/ Velpatasvir）丙肝炎所有

StephenW

U.S. Food and Drug Administration Approves Gilead’s Epclusa® (Sofosbuvir/Velpatasvir) for the Treatment of All Genotypes of Chronic Hepatitis C
FDA Product Insert / Label


– Epclusa is the First and Only All-Oral, Pan-genotypic Single Tablet Regimen for Chronic Hepatitis C Virus Infection and Gilead’s Third Sofosbuvir-Based Regimen –

FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 28, 2016-- Gilead Sciences, Inc. (NASDAQ: GILD) today announced that the U.S. Food and Drug Administration (FDA) has approved Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), the first all-oral, pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for ribavirin. Epclusa for 12 weeks was approved in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C).

“The approval of Epclusa represents an important step forward in the global effort to control and potentially eliminate HCV as it provides a safe, simple and effective cure for the majority of HCV-infected patients, regardless of genotype,” said Ira Jacobson, MD, Chairman of the Department of Medicine at Mount Sinai Beth Israel, New York City and a principal investigator in the Epclusa clinical trials. “Building on the established backbone of sofosbuvir, Epclusa demonstrated consistently high cure rates across all genotypes, including among patients with genotype 2 and 3, who traditionally have required ribavirin or other multi-pill regimens.”

Photos and multimedia gallery available at www.GileadHCVMedia.com.

The FDA granted Epclusa a Priority Review and Breakthrough Therapy designation, which is given to investigational medicines that may offer major advances in treatment over existing options.

Epclusa’s approval is supported by data from four international Phase 3 studies, ASTRAL-1, ASTRAL-2, ASTRAL-3 and ASTRAL-4. In the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,035 patients with genotype 1-6 chronic HCV infection, without cirrhosis or with compensated cirrhosis received 12 weeks of Epclusa. The ASTRAL-4 study randomized 267 patients with genotype 1-6 HCV infection, with decompensated cirrhosis (Child-Pugh B), to receive 12 weeks of Epclusa with or without RBV or 24 weeks of Epclusa. The primary endpoint for all studies was SVR12.

Of the 1,035 patients treated with Epclusa for 12 weeks in the ASTRAL-1, ASTRAL-2 and ASTRAL-3 studies, 1,015 (98 percent) achieved SVR12. In ASTRAL-4, patients with decompensated cirrhosis receiving Epclusa with RBV for 12 weeks achieved a high SVR12 rate (94 percent) compared to those who received Epclusa for 12 weeks or 24 weeks (83 percent and 86 percent, respectively).

Headache and fatigue were the most common adverse reactions (≥10 percent) experienced by HCV-infected patients treated with Epclusa in ASTRAL-1, ASTRAL-2 and ASTRAL-3 and occurred at a similar or higher frequency in placebo-treated patients. In the 87 HCV-infected patients with decompensated cirrhosis treated with Epclusa and ribavirin in the ASTRAL-4 study, fatigue, anemia, nausea, headache, insomnia and diarrhea were the most common adverse reactions (≥10 percent). Two and four patients treated with Epclusa and Epclusa with RBV respectively discontinued treatment due to adverse events.

“Today’s approval represents a significant advance for patients with HCV genotypes 2 and 3, who previously required more complex and costly regimens,” said John Milligan, Ph.D., President and Chief Executive Officer of Gilead. “As the first and only pan-genotypic cure for hepatitis C, Epclusa has the potential to eliminate the need for genotype testing, which can be a barrier to treatment in certain resource-constrained settings. We look forward to making Epclusa available to patients around the world as quickly as possible.”

Epclusa should not be administered with ribavirin in patients for whom ribavirin is contraindicated. See below for Important Safety Information for Epclusa.

StephenW

美国食品和药物管理局批准Gilead公司Epclusa®（索非布韦/ Velpatasvir）慢性丙型肝炎的所有基因型的治疗
FDA产品插入/标签
美国FDA批准Gilead公司的Epclusa®（索非布韦/ Velpatasvir）丙肝炎的所有基因型的治疗

- Epclusa是第一个也是唯一全口服，泛基因型单锭养生慢性丙型肝炎病毒感染和基于索非布韦三Gilead公司的养生之道 -

福斯特城 - （美国商业资讯） - 六月。 28，2016--吉利德科学公司（纳斯达克股票代码：GILD）今天宣布，美国食品和药物管理局（FDA）已批准E​​pclusa®（索非布韦400毫克/ 100 velpatasvir毫克），则首先口服，泛基因型用于治疗成人基因型1-6慢性丙型肝炎病毒（HCV）感染的单片剂方案。 Epclusa也是批准用于患者的HCV基因型2和3的治疗的第一单片剂方案，而不需要利巴韦林。 Epclusa 12周被批准在患者无肝硬化或代偿性肝硬化（Child-Pugh分级A），并与利巴韦林（RBV）结合患者的失代偿期肝硬化（Child-Pugh分级B或C）。

“Epclusa的批准代表全球努力控制并可能消除HCV因为它为广大HCV感染患者的安全，简便，有效的治疗，无论基因型迈出的重要一步，”艾拉·雅各布森博士表示，医学西奈山贝斯以色列，纽约市系主任，并在Epclusa临床试验主要研究者。 “关于索非布韦的既定骨干号楼Epclusa表明一致的高的治愈率在所有基因型，包括患者的基因型2和3之间，谁传统上需要利巴韦林或其它多丸方案”。

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美国食品药物管理局批准Epclusa优先审查和突破治疗称号，这是考虑到研究药物可能治疗比现有方案提供重大进展。

Epclusa的批准由四个国际三期研究ASTRAL-1，ASTRAL-2，ASTRAL-3数据，ASTRAL-4支持。在ASTRAL-1，ASTRAL-2和ASTRAL-3项研究，1035例基因型1-6慢性HCV感染，无肝硬化或代偿性肝硬化收到Epclusa的12周。星光-4的随机研究267例基因型1-6 HCV感染，肝硬化失代偿期（Child-Pugh分级B），接收12周Epclusa的有或无利巴韦林或Epclusa 24周。对于所有研究的主要终点是SVR12。

与Epclusa在ASTRAL-1，ASTRAL-2和ASTRAL-3研究治疗12周1035名患者中，1015（98％）达到SVR12。在ASTRAL-4，患者的失代偿期肝硬化接收Epclusa与RBV 12周实现相比，谁收到Epclusa 12周或24周（分别为83％和86％，）高SVR12率（94％）。

头痛和疲劳是通过与Epclusa在ASTRAL-1，ASTRAL-2和ASTRAL-3处理的HCV感染的病人所经历的最常见的不良反应（≥10％）和在安慰剂治疗的患者的类似或更高的频率发生。在87 HCV感染患者与Epclusa和星体-4的研究中，乏力，贫血，恶心，头痛，失眠，腹泻利巴韦林治疗失代偿性肝硬化是最常见的不良反应（≥10％）的。与Epclusa和Epclusa处理与RBV二和四分别病人停止治疗，由于不良事件。

“今天的批准代表了患者显著事先与HCV基因型2和3，谁以前需要更复杂和昂贵的治疗方案，”约翰·米利甘，博士，总裁和Gilead公司的首席执行官说。 “作为第一和唯一的泛基因型治愈丙型肝炎，Epclusa具有消除需要基因型测试，这可能是一个障碍，以一定的资源有限的治疗潜力。我们期待着让Epclusa提供给世界各地的患者尽快“。

Epclusa不应在为谁利巴韦林是禁忌患者利巴韦林给药。请参阅以下重要的是Epclusa安全信息。