产地国家：英国 处方药：是 所属类别： 400毫克/片 28片/瓶 包装规格： 400毫克/片 28片/瓶 计价单位：瓶 生产厂家英文名：Gilead 原产地英文商品名：Sovaldi filmcoated tablets 400mg/Tablets 28Tablets/bottle 原产地英文药品名：Sofosbuvir 中文参考商品译名：Sovaldi薄膜片 400毫克/片 28片/瓶 中文参考药品译名：索非布韦

简介

20141月17日,丙肝新药Sovaldi(sofosbuvir，400mg片剂)获欧盟批准，作为抗病毒治疗方案的一部分，用于慢性丙型肝炎(HCV)成人感染者的治疗。Sovaldi为每日一次的口服核苷类似物聚合酶抑制剂，此次批准，为该药在整个欧盟的上市铺平了道路。此前，Sovaldi已于2013年11月获得了欧洲药品管理局(EMA)人用医药产品委员会(CHMP)建议批准的积极意见。CHMP通过加速审批程序对Sovaldi上市许可申请(MAA)进行了评估，该药MAA由6个III期研究(NEUTRINO, FISSION, POSITRON, FUSION, VALENCE, PHOTON-1)的数据支持。在美国，Sovaldi已于2013年12月获FDA批准，该药是首个获批可用于C型肝炎全口服治疗方案的药物，在用于特定基因型慢性丙型肝炎治疗时，可消除对传统注射药物干扰素(IFN)的需求。具体而言，FDA已批准sofosbuvir联合利巴韦林(ribavirin)用于基因型2和基因型3慢性丙型肝炎(hepatitis C)成人患者的治疗。同时，FDA还批准sofosbuvir联合聚乙二醇干扰素(PEG-IFN)和利巴韦林，用于基因型1和基因型4慢性丙型肝炎初治(treat-naive)成人患者的治疗。在欧洲和世界各地，慢性丙型肝炎(HCV)是导致肝癌和肝移植的主要原因。当前的HCV护理标准涉及长达48周的含聚乙二醇干扰素(peg- IFN)/利巴韦林(RBV)方案。这些方案并不总是有效，而且具有显著的副作用，并与其他药物具有用药禁忌。在欧洲，许多患者被认为不适合当前的治疗方案。 适应证和用途 SOVALDI是一种丙型肝炎病毒(HCV)核苷酸类似物NS5B聚合酶抑制剂适用为慢性丙型肝炎(CHC)感染的治疗作为组合抗病毒治疗方案的一个组分。(1)SOVALDI疗效已在有HCV基因型1，2，3或4感染受试者中被确定，包括有肝细胞癌符合米兰[Milan]标准(等待肝移植)和有HCV/HIV-1共-感染受试者。 剂量和给药方法 (1)一片400 mg片每天1次有或无食物服用。 (2)应与利巴韦林[ribavirin]联用或与聚乙二醇化干扰素[pegylated干扰素]和利巴韦林联用为CHC的治疗。 建议联合治疗：(3)SOVALDI与利巴韦林联用共24周干扰素不合格可被考虑为被基因型1感染CHC患者。(4)在有肝细胞癌等待肝移植直至48周或直至肝移植患者应被与联用利巴韦林为CHC的治疗，以先发生为准。(5)对有严重肾受损或肾病终末期患者不能建议剂量。 剂型和规格片：400mg。 禁忌证 (1)当与聚乙二醇干扰素α/利巴韦林或单独利巴韦林联用时，对聚乙二醇干扰素α和/或利巴韦林的所有禁忌证也都应用于SOVALDI联合治疗。 (2)因为利巴韦林可能引起出生缺陷和胎儿死亡，在妊娠妇女和男性其女性伴侣妊娠时禁忌SOVALDI与聚乙二醇干扰素α/利巴韦林或利巴韦林联用。 警告和注意事项 妊娠：利巴韦林可能致出生缺陷和胎儿死亡和动物研究已证明干扰素有流产效应;女性患者和男性患者的女性伴侣避免妊娠。治疗开始前患者必须有一个阴性妊娠测试，使用至少2种有效非激素避孕方法和每月妊娠测试。 不良反应 SOVALDI与利巴韦林联用观察到最常见不良事件(发生率大于或等于20%，所有级别)是疲乏和头痛。SOVALDI与聚乙二醇干扰素α和利巴韦林联用观察到最常见不良事件是疲乏，头痛，恶心，失眠和贫血。药物相互作用药物是强肠道P-gp诱导剂(如，利福平[rifampin]，圣约翰草[St. John’s wort])可能改变sofosbuvir的浓度。对潜在药物-药物相互作用使用前咨询完整咨询资料。 特殊人群中使用 (1)有HCV/HIV-1共-感染患者: 曾研究安全性和疗效。 (2)有肝细胞癌等待肝移植患者: 曾研究安全性和疗效。

英文版说明书

Important Safety InformationWhat is the most important information I should know about SOVALDI?SOVALDI combination therapy with ribavirin or peginterferon alfa and ribavirin can cause birth defects or death of your unborn baby. If you or your sexual partner is pregnant or plans to become pregnant, do not take these medicines.•You and your sexual partner must use 2 effective forms of birth control and should not become pregnant while being treated with SOVALDI combination therapy and for 6 months after your treatment is over. Talk to your doctor about forms of birth control.•If you or your partner can become pregnant you must have a pregnancy test before starting treatment with SOVALDI combination therapy, every month while being treated, and for 6 months after your treatment ends.•Tell your healthcare provider right away if a pregnancy occurs while taking or within 6 months after you stop taking SOVALDI combination therapy. You or your healthcare provider should contact the Ribavirin Pregnancy Registry. If you are also infected with HIV and taking medicines to treat your HIV infection, an Antiretroviral Pregnancy Registry is also available. For contact information, please see full Prescribing Information.You should not take SOVALDI alone. SOVALDI should be used together with ribavirin or in combination with peginterferon alfa and ribavirin to treat chronic hepatitis C infection.More Important Safety InformationWhat should I tell my healthcare provider before taking SOVALDI?•If you have: liver problems other than hepatitis C infection; had a liver transplant; severe kidney problems or are on dialysis; HIV; any other medical condition; or if you are breastfeeding or plan to breastfeed. You and your healthcare provider should decide if you will take SOVALDI or breastfeed. You should not do both.•If you take amiodarone (Cordarone®, Nexterone®, Pacerone®), rifampin (Rifadin®, Rifamate®, Rifater®), St. John’s wort or a product that contains St. John’s wort. Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Other medicines may affect how SOVALDI works.What are the most common side effects of SOVALDI?For SOVALDI used in combination with ribavirin they include tiredness and headache and for SOVALDI used in combination with peginterferon alfa and ribavirin they include the additional side effects of nausea, difficulty sleeping, and low red blood cell count.