SOVALDI(sofosbuvir)片为新一代治疗丙型肝炎病毒最有效的口服药
批准日期：2013年12月6日；公司：Gilead Sciences
美国初次批准：2013
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。
为报告怀疑不良反应，联系Gilead Sciences，Inc.电话1-800-GILEAD-5或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.
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。

Indication
SOVALDI is a hepatitis C virus (HCV) nucleotide analog NS5B polymerase inhibitor indicated for the treatment of chronic hepatitis C (CHC) as a component of a combination antiviral treatment regimen.
•SOVALDI efficacy has been established in subjects with HCV genotype 1, 2, 3 or 4 infection, including those with hepatocellular carcinoma meeting Milan criteria (awaiting liver transplantation) and those with HCV/HIV-1 co-infection
Prescribing Considerations:
•Monotherapy of SOVALDI is not recommended.
•Treatment regimen and duration are dependent on both viral genotype and patient population.
•Treatment response varies based on baseline host and viral factors.
Important Safety Information
Contraindications
•SOVALDI combination treatment with ribavirin or with peginterferon alfa plus ribavirin is contraindicated in women who are pregnant or may become pregnant and men whose female partners are pregnant because of the risk for birth defects and fetal death associated with ribavirin. Contraindications to peginterferon alfa and ribavirin also apply to SOVALDI combination treatment. Refer to the prescribing information of peginterferon alfa and ribavirin for a list of their contraindications.
Warnings and Precautions
•Pregnancy: Use with Ribavirin or Peginterferon Alfa/Ribavirin: Ribavirin therapy should not be started unless a report of a negative pregnancy test has been obtained immediately prior to initiation of therapy. Female patients of childbearing potential and their male partners must use 2 forms of non-hormonal contraception during treatment and for at least 6 months after treatment has concluded. Routine monthly pregnancy tests must be performed during this time. Refer to the prescribing information for ribavirin.
•Use with Potent P-gp Inducers: Rifampin and St. John's wort should not be used with SOVALDI as they may significantly decrease sofosbuvir plasma concentration, reducing its therapeutic effect.
Adverse Reactions
Most common (≥20%, all grades) adverse reactions for:
•SOVALDI + peginterferon alfa + ribavirin combination therapy were fatigue, headache, nausea, insomnia, and anemia
•SOVALDI + ribavirin combination therapy were fatigue and headache
Drug interactions
•In addition to rifampin and St. John's wort, coadministration of SOVALDI is not recommended with carbamazepine, oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifapentine, and tipranavir/ritonavir. Such coadministration is expected to decrease the concentration of sofosbuvir, reducing its therapeutic effect.
关于Sovaldi（sofosbuvir）
Sofosbuvir为每日一次的口服核苷类似物聚合酶抑制剂，已获FDA、欧盟、加拿大批准，以商品名Sovaldi上市，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，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，Sovaldi已获批联合利巴韦林（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，Sovaldi已获批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。