FDA批准用于丙型肝炎病毒的新疗法

StephenW

www.natap.org

FDA NEWS RELEASE

For Immediate Release: Nov. 22, 2013
Media Inquiries: Stephanie Yao, 301-796-0394, [email protected]
Consumer Inquiries: 888-INFO-FDA

FDA approves new treatment for hepatitis C virus

The U.S. Food and Drug Administration today approved Olysio (simeprevir), a new therapy to treat chronic hepatitis C virus infection.

Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure. Most people infected with the hepatitis C virus have no symptoms of the disease until liver damage becomes apparent, which may take several years. Most of these people then go on to develop chronic hepatitis C. Some will also develop scarring and poor liver function (cirrhosis) over many years, which can lead to complications such as bleeding, jaundice (yellowish eyes or skin), fluid accumulation in the abdomen, infections or liver cancer. According to the Centers for Disease Control and Prevention, about 3.2 million Americans are infected with the hepatitis C virus.

Olysio is a protease inhibitor that blocks a specific protein needed by the hepatitis C virus to replicate. It is to be used as a component of a combination antiviral treatment regimen. In clinical studies, Olysio was evaluated in combination with peginterferon-alfa and ribavirin, two drugs also used to treat hepatitis C virus infection. Olysio is intended for adults with compensated liver disease (a diseased liver that is still functioning), including cirrhosis, who have not received treatment for their infection (treatment naïve) or for whom previous treatment has not been effective (treatment experienced).

“Olysio is the third FDA-approved protease inhibitor to treat chronic hepatitis C virus infection, and provides health professionals and patients with a new, effective treatment for this serious disease,” said Edward Cox, M.D., director of the Office of Antimicrobial Products in the FDA’s Center for Drug Evaluation and Research.

In 2011, the FDA approved Victrelis (boceprevir) and Incivek (telaprevir) for the treatment of hepatitis C. Olysio was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that, if approved, would provide safe and effective therapy when no satisfactory alternative therapy exists, or offer significant improvement compared to available therapies.

The safety and effectiveness of Olysio were evaluated in five clinical studies of 2,026 treatment-naive and treatment-experienced participants randomly assigned to receive Olysio plus peginterferon-alfa and ribavirin or placebo plus peginterferon-alfa and ribavirin. The studies were designed to measure whether a participant’s hepatitis C virus was no longer detected in the blood at least 12 weeks after finishing treatment (sustained virologic response), suggesting a participant’s infection had been cured.

Results showed 80 percent of treatment-naive participants given Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response, compared to 50 percent of participants receiving peginterferon-alfa and ribavirin alone. In one of the studies with treatment-experienced participants whose infection returned (prior relapsers), 79 percent receiving Olysio plus peginterferon-alfa and ribavirin achieved sustained virologic response compared to 37 percent of participants receiving peginterferon-alfa and ribavirin alone.

Another study examined Olysio’s safety and effectiveness in treatment-experienced participants, including prior relapsers, those who partially responded to prior therapy (partial responders) and those who did not respond to prior therapy (null responders). Adding Olysio improved response rates in each of these subgroups compared to peginterferon-alfa and ribavirin alone.

A reduction in Olysio’s effectiveness was observed in participants infected with the genotype 1a hepatitis C virus with an NS3 Q80K polymorphism, a strain of the hepatitis C virus commonly found in the United States. Olysio’s drug label includes a recommendation to screen for the presence of the strain prior to beginning therapy and to consider alternative therapy if the strain is detected.

The most common side effects reported in clinical study participants treated with Olysio in combination with peginterferon-alfa and ribavirin were rash (including photosensitivity), itching (pruritis) and nausea. Serious photosensitivity reactions resulting in hospitalization were reported. Patients will be advised to limit sun exposure and to use sun protective measures during treatment with Olysio in combination with peginterferon alfa and ribavirin. Olysio should not be used alone to treat chronic hepatitis C infection.

Olysio is marketed by Janssen Pharmaceuticals, based in Raritan, N.J. Victrelis is marketed by Whitehouse Station, N.J.-based Merck, and Incivek is marketed by Cambridge, Mass.-based Vertex Pharmaceuticals.

For more information:

FDA: Approved Drugs: Questions and Answers

FDA: Drug Innovation disclaimer icon

FDA: What’s New at FDA in Hepatitis

CDC: Hepatitis C Information for the Public disclaimer icon

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

StephenW

www.natap.org

FDA新闻稿

即时发布： 2013年11月22日
媒体查询：斯蒂芬妮瑶， 301-796-0394 ， stephanie.yao @ fda.hhs.gov
消费查询： 888-INFO-FDA

FDA批准用于丙型肝炎病毒的新疗法

美国食品和药物管理局今天批准Olysio （ simeprevir ） ，一种新的疗法来治疗慢性丙型肝炎病毒感染。

丙型肝炎是一种病毒疾病，它引起可导致减少的肝功能或肝功能衰竭的肝的炎症。感染了丙型肝炎病毒的人，没有疾病的症状，直到肝功能损害变得明显，这可能需要几年时间。这些人大多之后再去发展为慢性丙型肝炎有些还将开发疤痕和欠佳肝功能（肝硬化）多年来，这可能会导致并发症，如出血，黄疸（黄色眼睛或皮肤） ，在液体积聚腹部，感染或肝癌。根据疾病控制中心和预防，大约320万美国人感染了丙型肝炎病毒。

Olysio是一种蛋白酶抑制剂，阻止所需的丙型肝炎病毒的特定蛋白进行复制。它是被用来作为一个组合的抗病毒治疗方案的组成部分。在临床研究中， Olysio ，评价与聚乙二醇干扰素- α和利巴韦林的组合，两种药物也可用于治疗丙型肝炎病毒感染。 Olysio用于成人的代偿性肝病（患病的肝脏仍能正常工作） ，包括肝硬化，还没有接受治疗的感染谁（初次接受治疗） ，或对他们来说，以前的治疗一直没有有效的（治疗经验） 。

“ Olysio是第三FDA批准的蛋白酶抑制剂治疗慢性丙型肝炎病毒感染，并提供卫生专业人员和患者提供一种新的，有效的治疗这种严重的疾病， ”爱德华·考克斯，医学博士，抗菌产品办公室的主任说FDA的药品评价中心和研究。

2011年， FDA批准VICTRELIS （ boceprevir治疗）和Incivek （特拉匹韦）对丙型肝炎Olysio的治疗是根据FDA的优先审查程序，这为药物快速审查，如果获得批准，将提供审查安全有效治疗时，没有满意的替代疗法存在，或提供显著的改善相比，可用的治疗。

Olysio的安全性和有效性的随机分配接受Olysio加聚乙二醇干扰素- α和利巴韦林或安慰剂加聚乙二醇干扰素- α和利巴韦林2,026治疗初治和治疗经验的学员5项临床研究进行了评价。该研究旨在衡量是否参与者的丙型肝炎病毒不再精加工处理（持续病毒学应答） ，这表明参与者的感染已经痊愈后至少12周在血液中检测。

结果表明： 80％的未治疗过的参与者给出Olysio加聚乙二醇化干扰素- α和利巴韦林达到持续病毒学应答相比，接受聚乙二醇干扰素- α和利巴韦林单独参与者的50％。与治疗经验的参与者，其感染退换（既往复发者） ， 79 ％的接受Olysio加聚乙二醇干扰素- α和利巴韦林达到持续病毒学应答相比，接受聚乙二醇干扰素- α和利巴韦林单独的参与者37 ％的研究之一。

另一项研究调查Olysio在处理有经验的参与者，包括既往复发者，那些谁部分回应之前的治疗（部分应答）和那些谁没有到之前的治疗（无应答）响应的安全性和有效性。加入Olysio提高应答率在这些亚组相比，聚乙二醇干扰素- α和利巴韦林孤单。

观察到在感染了基因型1a的丙型肝炎病毒用NS3 Q80K多态性，丙型肝炎病毒在美国常见的菌株参与者Olysio的有效性的降低。 Olysio的药品标签包含一个建议，筛选菌株的开始治疗，并考虑替代疗法，如果检测该菌株之前存在。

报道与Olysio与聚乙二醇干扰素- α和利巴韦林联合治疗的临床研究的参与者中最常见的副作用为皮疹（包括光） ，瘙痒（瘙痒）和恶心。导致住院严重光敏反应的报道。患者将被建议限制太阳暴晒和Olysio治疗与聚乙二醇干扰素α和利巴韦林的组合过程中要使用防晒保护措施。 Olysio不应单独用于治疗慢性丙型肝炎感染。

Olysio是由西安杨森制药公司，总部设在力登销售，新泽西州VICTRELIS是由白宫站，新泽西州的默克和Incivek销售是由剑桥，马萨诸塞州的Vertex制药公司销售。

欲了解更多信息，请访问：

美国FDA ：批准的药品：问题和解答

FDA ：药物创新免责声明图标

FDA ：最新的FDA于肝炎

疾病预防控制中心：公开声明图标丙型肝炎信息

美国食品药物管理局，卫生和人类服务部美国的一个机构，以确保人类和兽药，疫苗等生物制品的人用，和医疗器械的安全性，有效性和安全保护公众健康。该机构还负责我们国家的食品供应，化妆品，膳食补充剂，发出的电子辐射产品，以及监管烟草产品的安全性和安全性。