12月6日宣布，丙肝新药Sovaldi（sofosbuvir）获FDA批准，作为抗病毒治疗方案的一部分，用于慢性丙型肝炎（HCV）的治疗。 Sovaldi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。 Sofosbuvir为每日一次的口服核苷类似物聚合酶抑制剂。吉利德于2013年4月提交了sofosbuvir的新药申请（NDA），此前FDA已授予sofosbuvir优先审查资格及突破性疗法认定。 目前，在美国，约有400万慢性丙型肝炎患者，其中大部分出生于1945年-1965年婴儿潮时期。慢性丙型肝炎是导致肝癌和肝移植的首要原因，在最近几年来，作为致死病因，HCV已超过了HIV/AIDS。当前，HCV的标准护理包括48周的含聚乙二醇化干扰素（PEG-IFN）/利巴韦林（RBV）方案，但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。 Sovaldi的获批,主要基于4个III期研究（NEUTRINO, FISSION, POSITRON, FUSION）的数据。在FDA审查期间，2个新的III期研究（VALENCE和PHOTON-1）添加至sofosbuvir的新药申请（NDA），FDA根据这些数据，授予sofosbuvir突破性疗法认定。 批准时间：2013年12月6日(美国), 2013年12月13日(加拿大), 2014年1月17日(欧盟) 2015年5月25日（日本） Indicated for treatment of chronic hepatitis C (CHC) infection as a component of a combination antiviral regimen for patients with HCV mono-infection and HCV/HIV-1 coinfection Treatment regimen and duration are dependent on both viral genotype and patient population Genotype 1 or 4: 400 mg PO qDay plus ribavirin and peginterferon alfa for 12 weeks; may consider sofosbuvir plus ribavirin for 24 weeks in genotype 1 patients ineligible to receive peg-interferon-based regimen Genotype 2: 400 mg PO qDay plus ribavirin for 12 weeks Genotype 3: 400 mg PO qDay plus ribavirin for 24 weeks Patients with hepatocellular carcinoma awaiting liver transplantation For prevention of post-transplant HCV reinfection 400 mg PO qDay plus ribavirin for up to 48 weeks or until the time of liver transplantation, whichever occurs first. SOVALDI Rx Generic Name and Formulations: Sofosbuvir 400mg; tabs. Company: Gilead Sciences, Inc. RECENT UPDATES 02/10/14 Monograph added. Indications for SOVALDI: As a component of a combination antiviral treatment regimen for chronic hepatitis C (CHC) genotype 1, 2, 3, or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplant), and those with HCV/HIV-1 co-infection. Not for use as monotherapy. Adult Dose for SOVALDI: 400mg once daily. Genotype 1: treat for 12 wks (with PegIFN alfa + RBV) or 24 wks (with RBV) if interferon-based regimen ineligible. Genotype 2: treat for 12 wks (with RBV). Genotype 3: treat for 24 wks (with RBV). Genotype 4: treat for 12 wks (with PegIFN alfa + RBV). Hepatocellular carcinoma: treat up to 48 wks (with RBV) or until time of liver transplant, whichever occurs first. Dose reduction of sofosbuvir is not recommended. Other dose modifications: see full labeling. If peginterferon alfa or ribavirin are discontinued, sofosbuvir should also be discontinued. Children's Dose for SOVALDI: <18yrs: not established. Pharmacological Class: HCV NS5B polymerase inhibitor. Contraindications: Pregnant women and in men whose partners are pregnant (note: ribavirin is Cat. X). Peginterferon and ribavirin contraindications also apply to combination therapy with sofosbuvir. Warnings/Precautions: Female patients/partners of male patients must have (–) pregnancy test before initiating therapy; use 2 effective non-hormonal methods of contraception during and for 6 months after treatment completion; perform routine monthly pregnancy test. Severe renal impairment or ESRD. Decompensated cirrhosis. Post-liver transplant recipients. Pregnancy (Cat. B). Nursing mothers: not recommended. Interactions: Avoid concomitant strong P-gp inducers (eg, rifampin, St. John’s wort). Antagonized by carbamazepine, phenytoin, phenobarbital, oxcarbazepine, rifabutin, rifapentine, tipranavir/ritonavir; avoid concomitant use. May be co-administered with P-gp and/or BCRP inhibitors (see full labeling). Adverse Reactions: Fatigue, headache, nausea, insomnia, anemia, pruritus, rash. Note: For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective PI. How Supplied: Tabs—28 ---------------------------------------- 注：以下产品不同上市国家详细以咨询为准！ ---------------------------------------- 产地国家: 加拿大 原产地英文商品名: Sovaldi 400mg   28Tablets 原产地英文药品名: Sofosbuvir 中文参考商品译名: Sovaldi 400毫克／片 28片／盒 中文参考药品译名: 索非布韦片 生产厂家英文名: Gilead ------------------------------------------------------ 产地国家: 美国 原产地英文商品名: Sovaldi 400mg  28Tablets 原产地英文药品名: Sofosbuvir 中文参考商品译名: Sovaldi 400毫克／片  28片／盒 中文参考药品译名: 索非布韦片 生产厂家英文名: Gilead