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SOVALDI(sofosbuvir tabs)

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软件语言:  简体中文  更新时间:  2014-03-27 
版本号:  1.0  软件平台:  Win2000/WinXP/Win2003 
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软件介绍

Sovaldi(sofosbuvir,400mg片剂)索非布韦片
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。
FDA批准Sovaldi用于治疗慢性丙型肝炎病毒感染
12月6日宣布,丙肝新药Sovaldi(sofosbuvir,400mg片剂)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。
Pharmacological Class:
Hepatitis C virus (HCV) NS5B polymerase inhibitor.

Active Ingredient(s):
Sofosbuvir 400mg; tabs.

Company
Gilead Sciences, Inc.
Indication(s):
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.

Pharmacology:
Sofosbuvir is an inhibitor of the HCV NS5B RNA-dependent RNA polymerase, which is essential for viral replication. This nucleotide prodrug undergoes intracellular metabolism to form the pharmacologically active uridine analog triphosphate (GS-461203), which can be incorporated into HCV RNA by the NS5B polymerase and acts as a chain terminator.

Clinical Trials:
The safety and efficacy of Sovaldi was evaluated in five Phase 3 trials in a total of 1,724 HCV mono-infected subjects with genotypes 1–6 CHC and one Phase 3 trial in 223 HCV/HIV-1 co-infected subjects with genotype 1, 2 or 3 CHC. The primary endpoint was sustained virologic response (SVR) which was defined as HCV RNA less than lower limit of quantification at 12 wks after the end of treatment.

NEUTRINO was an open-label, single-arm trial that evaluated 12 wks of treatment with Sovaldi in combination with peginterferon (PegIFN) alfa 2a and ribavirin (RBV) in treatment-naïve subjects (N=327) with genotype 1, 4, 5 or 6 HCV infection compared to pre-specified historical control SVR rate of 60% (P<0.001). The overall SVR rate was 90% (295/327). The SVR rates by specific genotype were: Genotype 1 (89%) and Genotype 4 (96%).

FISSION was an active-controlled trial that evaluated 12 wks of treatment with Sovaldi + RBV vs. 24 wks with PegIFN + RBV in treatment-naïve subjects with genotype 2 and 3 HCV. The overall SVR rate for both arms were 67%. The SVR rates for Genotype 2 was (95% vs. 78%) and Genotype 3 was (56% vs. 63%) in the Sovaldi  + RBV arm compared to the PegIFN + RBV arm, respectively.

For more clinical trial data, see full labeling.

Legal Classification:
Rx

Adults:
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:
<18yrs: not established.

Contraindication(s):
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.

Interaction(s)
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 Reaction(s)
Fatigue, headache, nausea, insomnia, anemia, pruritus, rash.

Notes:
For peginterferon alfa and ribavirin specific dosing and safety information, refer to their respective prescribing information.

How Supplied:
Tabs—28

LAST UPDATED:
2/7/2014

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