OLYSIO（Simeprevir）是一种丙型肝炎病毒(HCV)NS3/4A蛋白酶抑制剂，由美国强生/杨森研发，2013年11月获FDA及欧洲批准上市，OLYSIO Simeprevir适用为慢性丙型肝炎(CHC)感染作为抗病毒治疗方案联用的一个组分的治疗。 OLYSIO（司美匹韦 simeprevir）胶囊，口服使用 最初美国批准：2013 目前的主要变化 适应证和用途 10/2015 适应证和用途，使用限制 02/2016 剂量和给药方法 02/2016 作用机理 Simeprevir是针对丙型肝炎病毒直接作用的抗病毒药物（DAA）代理[见微生物学]。 适应症和用法 OLYSIO是丙型肝炎病毒（HCV），与慢性丙型肝炎病毒（HCV）感染的成人治疗NS3/4A蛋白酶抑制剂显示： 在无肝硬化或代偿肝硬化患者HCV基因型1索非布韦组合 与患者的HCV基因型1或4聚乙二醇干扰素α（PEG-IFN-阿尔法）和利巴韦林（RBV）组合无肝硬化或代偿性肝硬化。 使用限制： 与Peg-IFN-α和利巴韦林组合OLYSIO的功效在感染HCV基因型1a用NS3 Q80K多态性的患者显着降低。 在谁曾治疗失败对治疗方案，包括OLYSIO或其它HCV蛋白酶抑制剂的患者不推荐OLYSIO。 用法用量 测试前开始治疗： 之前在感染HCV基因型1a患者OLYSIO治疗与Peg-IFN-α和利巴韦林组合的起始，筛选病毒的存在与NS3 Q80K多态性强烈建议并且如果检测Q80K替代疗法应予以考虑。 显示器前，和OLYSIO联合治疗期间肝脏化学试验。 推荐用量：同食，每日一次采取的一项150毫克的胶囊。治疗方案和患者人群患者群治疗方案持续时间 *随后的12个或36个聚乙二醇干扰素 - 阿尔法+ RBV的额外周根据HIV-1共感染之前响应状态和存在。 基因型1 无肝硬化OLYSIO +索非布韦12周 基因型1 代偿性肝硬化（Child-Pugh分级A）OLYSIO +索非布韦24周 基因型1或4 无肝硬化或代偿期肝硬化（Child-Pugh分级A），有或无HIV-1共感染OLYSIO +聚乙二醇干扰素 - 阿尔法+ RBV12周* 请参阅完整的处方信息对与Peg-IFN-阿尔法+ RBV和计量上的调整和中断的信息组合停止OLYSIO时停止规则的细节。 患者的中度或重度肝功能不全（Child-Pugh分级B级或C）不建议OLYSIO。 剂型和规格 胶囊：150毫克 禁忌症 因为OLYSIO仅用于与其它抗病毒药物（包括聚乙二醇化的IFN-α和利巴韦林），用于慢性HCV感染的治疗组合，禁忌其他药物也适用于组合方案。 警告和注意事项 严重的症状性心动过缓伴索非布韦和胺碘酮当共同管理：可发生于服用胺碘酮与索非布韦结合OLYSIO，尤其是在患者的患者也接受β受体阻滞剂严重心动过缓症状，或有潜在心脏合并症和/或晚期肝病。不推荐与索非布韦结合OLYSIO胺碘酮共同施用。在患者无替代治疗方案，建议心脏监测。 肝功能失代偿和肝功能衰竭：肝功能失代偿和肝功能衰竭，包括致命的病例报告中晚期患者和/或失代偿性肝硬化。显示器前，和OLYSIO联合治疗期间肝脏化学试验。 光敏性：OLYSIO联合治疗期间出现严重光敏反应已经被观察到。使用防晒措施，并限制OLYSIO联合治疗期间阳光下曝晒。考虑停药如果发生光敏反应。 皮疹：皮疹OLYSIO联合治疗过程中被观察到。停止OLYSIO如果出现严重皮疹。 不良反应 疲劳，头痛和恶心：在12或24周的治疗中OLYSIO与索非布韦报道最常见的不良事件。 皮疹（包括光敏性），皮肤瘙痒和恶心：在第一次治疗12周与OLYSIO与聚乙二醇化干扰素α和利巴韦林报道最常见的不良反应。 药物相互作用 在与OLYSIO组合索非布韦胺碘酮联合给药可能导致严重的症状的心动过缓。 OLYSIO共同给予用药物是中等或强的诱导剂或CYP3A的抑制剂可显著影响simeprevir的血浆浓度。对药物 - 药物相互作用的潜在必须之前和治疗过程中加以考虑。 Olysio (simeprevir) Drug SummaryJanssen Products LP OLYSIO™ (simeprevir) receives marketing authorisation in the European Union for the treatment of adults with hepatitis C genotype 1 and 4 infection Simeprevir provides a new triple therapy treatment option, as well as the first ever 12-week interferon-free and ribavirin independent treatment regimen, in combination with sofosbuvir, for appropriate patients in Europe BEERSE, BELGIUM [May 16, 2014] Janssen-Cilag International NV today announced that its next generation protease inhibitor (PI) OLYSIOTM (simeprevir) has been granted marketing authorisation by the European Commission (EC) for the treatment of adults with genotype 1 and 4 chronic hepatitis C (CHC), in combination with other medicinal products, which includes1: This marketing authorisation represents a significant milestone in the development of new triple therapy hepatitis C (HCV) treatment options for genotype 1 and 4 patients. It also includes simeprevir as part of an all oral 12-week IFN-free direct-acting antiviral (DAA) regimen with or without RBV, in genotype 1 or 4 patients, who are intolerant to or ineligible for IFN treatment.1 "The EC marketing authorisation for simeprevir is a great milestone as it adds an important new treatment option for patients, demonstrating the continued role of triple therapy in the treatment of HCV. In addition, the introduction of an all oral, 12-week interferon-free treatment regimen provides a new option for sustained virologic response in HCV patients with genotypes 1 or 4 intolerant to or ineligible for interferon-based treatment," said Thomas Stark, Medical Director, Janssen EMEA. HCV represents a major global public health concern. There are an estimated nine million people2 living with HCV in Europe which, if untreated, can cause severe damage to the liver, including cirrhosis and hepatocellular carcinoma (HCC). HCV represents a leading cause of liver transplantation in Europe.3 Whilst the number of patients being newly diagnosed with HCV is declining, it takes approximately 20 - 30 years for symptoms to appear, with HCV cases expecting to peak between 2030 and 2035.4,5 Dr Andrew Ustianowski, Chair of the British Viral Hepatitis Group and Consultant in Infectious Diseases at North Manchester General Hospital, commented: "The treatment environment in hepatitis C infection is evolving rapidly. Simeprevir is a well-tolerated and efficacious addition to our therapies against hepatitis C, and is a very welcome development for both those with genotype 1 and those with genotype 4." The EC marketing authorisation for simeprevir with PegIFN + RBV is based on a clinical trial programme involving three pivotal Phase 3 studies, with over 1000 patients. The trials, QUEST-1, QUEST-26 and PROMISE7, explored the use of simeprevir in combination with PegIFN + RBV in treatment-naïve patients and patients who have relapsed after prior interferon-based treatment. All three studies met their primary endpoints and demonstrated that simeprevir, in combination with PegIFN + RBV, achieves significant sustained virological response rates when compared with PegIFN + RBV alone. The EC marketing authorisation for the combination of simeprevir and sofosbuvir also contains results from the Phase 2 study, COSMOS, in treatment-naïve patients. This was based upon prior null responder and treatment-naïve patients.8 Simeprevir is taken once-daily for 12 weeks, with treatment-naïve and prior-relapser patients receiving pegylated interferon and ribavirin for 24 weeks, and for 48 weeks total by those shown to be prior non-responder patients (including partial and null responders)1. It is generally well tolerated, with the most common adverse events reported in clinical trials (incidence ? 5%) including nausea, rash, pruritus, dyspnoea, blood bilirubin increase and photosensitivity reaction.1 In March 2013, simeprevir was approved for the treatment of genotype 1 HCV in Japan, in Canada in September 2013, and the U.S. in November 2013, with the most recent approval occurring in Russia in March 2014. Following the EC marketing authorisation, it is anticipated that simeprevir will be available across a number of European Union countries, in conjunction with reimbursement, in the second half of 2014. About Simeprevir Simeprevir is an NS3/4A protease inhibitor jointly developed by Janssen R&D Ireland and Medivir AB. Janssen is responsible for the global clinical development of simeprevir and has exclusive, worldwide marketing rights, except in the Nordic countries. Medivir AB retains marketing rights for simeprevir in these countries under the marketing authorisation held by Janssen-Cilag International NV. Simeprevir was approved for the treatment of genotype 1 hepatitis C in September 2013 in Japan, in November 2013 in Canada and the U.S., and in March 2014 in Russia. About hepatitis C HCV is a major global public health concern. It is a serious and complex blood-borne virus which manifests itself through complications of the liver. If left untreated, it can cause significant and potentially fatal damage to the liver including cirrhosis, leading to eventual transplantation. In Europe HCV is a leading cause of liver transplantation.2 The World Health Organisation (WHO) and the European Association for the Study of the Liver (EASL) estimate that 150 million people worldwide were chronically infected with HCV in 2011.9 The virus is responsible for 350,000 deaths globally9 and 86,000 deaths in the European region each year.10 As the disease is often asymptomatic in its early stages it can be difficult to diagnose and treat. Up to 90 percent of those with HCV do not clear the virus without treatment and become chronically infected.11 The WHO estimates that 20 percent of people with HCV will develop cirrhosis and, of those, up to 20 percent may progress to liver cancer.12 Genotype 1 HCV is the most prevalent form of the virus worldwide13 and one of the most challenging to treat successfully. About Janssen Pharmaceutical Companies The Janssen Pharmaceutical Companies of Johnson & Johnson are dedicated to addressing and solving the most important unmet medical needs of our time, including oncology, immunology, neuroscience, infectious disease, and cardiovascular and metabolic diseases. Driven by our commitment to patients, Janssen develops innovative products, services and healthcare solutions to help people throughout the world. More information can be found at www.janssen-emea.com Janssen Forward Looking Statement This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: economic factors, such as interest rate and currency exchange rate fluctuations; competition, including technological advances, new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approvals; challenges to patents; changes in behavior and spending patterns or financial distress of purchasers of health care products and services; changes to governmental laws and regulations and domestic and foreign health care reforms; general industry conditions including trends toward health care cost containment; and increased scrutiny of the health care industry by government agencies. A further list and description of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 29, 2013, including in Exhibit 99 thereto, and our subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither Janssen nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments. 丙肝新药OLYSIO(simeprevir)获FDA批准 2013年11月25日，强生（JNJ）11月22日宣布，丙肝新药OLYSIO（simeprevir）已获FDA批准，联合聚乙二醇干扰素和利巴韦林（ribavirin），用于基因型1慢性丙型肝炎成人患者代偿性肝脏疾病（包括肝硬化）的治疗。 此前，FDA已于今年5月授予simeprevir新药申请（NDA）优先审查资格，同时该药于今年10月获得了FDA顾问委员会建议批准的积极意见。 Simeprevir监管文件的提交，部分由3个关键性III期临床试验数据支持：QUEST-1和QUEST-2在初治患者中开展，PROMISE则在基于干扰素疗法治疗后复发的患者中开展。 丙型肝炎（HCV）是一种血源性传染性肝脏疾病，若不及时治疗，可能对肝脏造成重大损害。在美国，约有320万丙型肝炎患者，每年约有1.5万人死于该病，大多死于丙型肝炎相关疾病，如肝硬化和肝癌。 关于OLYSIO（simeprevir）： Simeprevir是新一代NS3/4A蛋白酶抑制剂，为每日一次的口服药物，由Medivir公司和杨森（Janssen）联合开发，用于治疗慢性丙型肝炎成年患者的代偿性肝病，包括各个阶段的肝纤维化，其工作原理是通过阻断蛋白酶，来抑制HCV在肝脏细胞中的复制。 今年9月，simeprevir（在日本的商品名为Sovriad）获日本劳动卫生福利部（MHLW）批准，与聚乙二醇化干扰素和利巴韦林（ribavirin）联合用药，用于基因型-1慢性丙型肝炎病毒（HCV）感染者的治疗，这是simeprevir获得的全球首个监管批准。 simeprevir是一种新的直接作用抗病毒药物，也是第二代蛋白酶抑制剂，给药方式为：simeprevir+聚乙二醇干扰素+利巴韦林联合治疗12周，随后进行聚乙二醇干扰素+利巴韦林治疗12周或36周。 https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1816fd68-0ed7-4a37-84bb-e298c5ab6e28 ----------------------------------------------- 产地国家： 美国  原产地英文商品名: Olysio 150mg/caps 28caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio 150毫克/胶囊 28胶囊/瓶 中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen Products LP 生产厂家英文名: Janssen Products LP 曾用名: Receives TMC435 ----------------------------------------------- 产地国家： 美国 原产地英文商品名: Olysio 150mg/caps 7caps/box  原产地英文药品名: simeprevir 中文参考商品译名: Olysio 150毫克/胶囊 7胶囊/瓶 中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen Products LP 生产厂家英文名: Janssen Products LP ----------------------------------------------- 产地国家： 德国 原产地英文商品名: Olysio hard capsules 150mg/caps 28caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 28胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen 曾用名: Receives TMC435 ----------------------------------------------- 产地国家： 德国 原产地英文商品名: Olysio hard capsules 150mg/caps 7caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 7胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen ----------------------------------------------- 产地国家：比利时 原产地英文商品名: Olysio hard capsules 150mg/caps 28caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 28胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen 曾用名: Receives TMC435 ----------------------------------------------- 产地国家：比利时 原产地英文商品名: Olysio hard capsules 150mg/caps 7caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 7胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen ----------------------------------------------- 产地国家：瑞士 原产地英文商品名: Olysio hard capsules 150mg/caps 28caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 28胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen 曾用名: Receives TMC435 ----------------------------------------------- 产地国家：瑞士 原产地英文商品名: Olysio hard capsules 150mg/caps 7caps/box 原产地英文药品名: simeprevir 中文参考商品译名: Olysio硬胶囊 150毫克/胶囊 7胶囊/瓶  中文参考药品译名: 司美匹韦 生产厂家中文参考译名: Janssen 生产厂家英文名: Janssen