索非布韦（Sovaldi）的英文说明书

India Sophie Bouvet, English Sofosbuvir, trade name: Sovaldi) is the development of Gilead's new drug for the treatment of chronic hepatitis C, in November 25, 2017 listed in china.

The drug is the first drug that can safely and effectively treat partial hepatitis C with no combination of interferon. Clinical trials for 1 and 4 of hepatitis C, the drug combination of pegylated interferon and Leigh Bhave Lin's overall rate of sustained virological response (SVR) up to 90%; for the 2 type of hepatitis C, combined with Leigh Bhave Lin the drug SVR 89%-95%; in 3 hepatitis C, the drug SVR 61%-63% combined with ribavirin forest. It is worth mentioning that the cable clinical trial also contains some non boue hepatitis C patients with cirrhosis, the curative effect is significant.

The medication guide / Sophie Bouvet

usage and dosage

Every piece of 400mg, one day, an empty stomach, or a meal

Combined with Leigh Bhave Lin or combined with Leigh Bhave Lin + peginterferon in the treatment of chronic hepatitis C (CHC). The following table is recommended for the combined treatment program:

HCV infection alone

Duration of treatment for HCV/HIV-1 combined infection treatment

1 or 4 gene type Sophie Bouvet + pegylated interferon alpha + 12 weeks Leigh Bhave Lin

Genotype 2 Sophie Bouvet plus ribavirin for 12 weeks

Genotype 3 Sophie Bouvet plus ribavirin for 24 weeks

Cannot use the type 1 interferon in patients with chronic hepatitis C may consider the use of Sophie Bouvet combined with Leigh Bhave Lin for 24 weeks.

Waiting for liver transplantation for patients with hepatocellular carcinoma using Sophie Bouvet combined with Leigh Bhave Lin in the treatment of chronic hepatitis C, 48 weeks or until liver transplantation, with the first subject.

A dose of advice can not be given to patients with severe renal impairment or end-stage renal disease.

Dosage form

Each piece: 400mg.

Contraindication

Sophie Bouvet pegylated interferon alpha alone or combined with Leigh Bhave Lin + Leigh Bhave Lin, when in use, all contraindications to peginterferon alfa and / or Leigh Bhave Lin also applies to Sophie Bouvet combined treatment.

Because Leigh Bhave Lin may cause fetal malformation or stillbirth, therefore Sophie Bouvet pegylated interferon alpha + Leigh Bhave Lin, or Leigh Bhave Lin Sophie Bouvet alone should be disabled in pregnant women and pregnant couples in men.

Indications and uses

Sophivir is a NS5B polymerase inhibitor of hepatitis C virus (HCV) nucleotides. It is suitable for treating chronic hepatitis C (CHC) infection as a combination component of combined antiviral therapy.

- Sophie Bouvet confirmed to be effective in the treatment of 1, 2, 3 genes or type 4 HCV subjects, including hepatocellular carcinoma with the Milan standard are waiting for liver transplantation subjects and subjects with HCV/HIV-1 infection.

Warning and precautions

Pregnancy: ribavirin may lead to fetal congenital malformation or stillbirth, and animal experiments show interferon can lead to abortion. Therefore, the spouse of women who take this drug and the spouse of the male should avoid pregnancy. Before the treatment begins, the patient's pregnancy test must be negative, at least two non hormone methods have been used, and a monthly pregnancy test is required.

Adverse reaction

The most common adverse reactions caused by combined Leigh Bhave Lin Sophie Bouvet known (incidence rate is equal to or greater than 20%, all levels) were headache and fatigue; Sophie Bouvet pegylated interferon alpha and Leigh Bhave Lin caused by the known as the most common adverse reactions include fatigue, headache, nausea, insomnia and anemia.

Drug interaction

Potent intestinal glycoprotein (P-gp) inducer (RFP) may change Sophie Bouvet plasma concentrations of drugs. Before use, please refer to the complete drug instructions for the interaction between drugs.

Special drug use

HCV/HIV-1 patients with infection: the safety and effectiveness of the drug have been confirmed.

Patients with hepatocellular carcinoma waiting for liver transplantation: the safety and effectiveness of the drug have been confirmed.

Note / Sophie Bouvet

1. take Sophie Bouvet must be on time every day, must not leak, take every day at the same time.

2. in the morning to eat, the evening to eat influence is not very, usually before or after one hour after eating the best effect.

3. with Sophie Bouvet during avoid drinking, drinking more than 5ml will affect the efficacy of drugs every day.

4. severe renal injury / dialysis patients should undergo a medical consultation scheme, the known data show that cable metabolites in Zimbabwe renal insufficiency or renal failure patients in vivo accumulation.

Price / Sophie Bouvet

At present, Sophie Bouvet in the United States sold about $1 thousand in 1, a course of 3 bottles, a total of 12 weeks, such a course of less than 60 thousand yuan

最后，木木彡小编附上索非布韦的中文说明书：

印度索非布韦，英文名Sofosbuvir，商品名Sovaldi)是吉利德公司开发用于治疗慢性丙肝的新药，于2017年11月25日在华上市。

该药物是首个无需联合干扰素就能安全有效治疗部分基因型丙肝的药物。临床试验证实针对1和4型丙肝，该药物联合聚乙二醇干扰素和利巴韦林的总体持续病毒学应答率(SVR)高达90%;针对2型丙肝，该药物联合利巴韦林的SVR为89%-95%;针对3型丙肝，该药物联合利巴韦林的SVR为61%-63%。值得一提的是，索非布韦的临床试验还包含了一些丙肝合并肝硬化的患者，疗效也较显著。

用药指南/索非布韦

用法用量

每片400mg，一日一片，空腹或随餐服用

可联合利巴韦林或者联合利巴韦林+聚乙二醇干扰素治疗慢性丙型肝炎(CHC)。推荐联合治疗方案如下表：

HCV单独感染

或HCV/HIV-1合并感染治疗方案治疗持续时间

基因1或4型索非布韦+聚乙二醇干扰素-α+利巴韦林12周

基因2型索非布韦+利巴韦林12周

基因3型索非布韦+利巴韦林24周

无法使用干扰素的1型慢性丙肝患者可考虑使用索非布韦联合利巴韦林治疗24周。

等待肝移植的肝细胞癌患者应使用索非布韦联合利巴韦林治疗慢性丙肝，持续48周或直至接受肝移植，以首先发生为准。

无法对患有严重肾功能损害或处于终末期肾病的患者给出剂量建议。

剂型

每片：400mg。

禁忌症

索非布韦联合聚乙二醇干扰素-α+利巴韦林，或单独联合利巴韦林使用时，所有聚乙二醇干扰素-α和/或利巴韦林的禁忌症也适用于索非布韦联合治疗。

由于利巴韦林有可能导致胎儿先天畸形或死胎，因此索非布韦联合聚乙二醇干扰素α+利巴韦林，或索非布韦单独联合利巴韦林应在孕妇和伴侣已怀孕的男性中禁用。

适应症及用途

·索非布韦是一种丙型肝炎病毒(HCV)核苷酸类似物NS5B聚合酶抑制剂，适用于作为联合抗病毒治疗方案中的组合成分治疗慢性丙肝(CHC)感染。

·索非布韦经试验证实可有效治疗基因1、2、3或4型丙肝受试者，包括符合米兰标准正在等待肝移植的肝细胞癌受试者以及HCV/HIV-1合并感染受试者。

警告与注意事项

妊娠：利巴韦林有可能导致胎儿先天畸形或死胎，并且动物实验显示干扰素可引发流产。因此，服用此药的女性患者及男性患者的配偶都应避免怀孕。在开始治疗前，患者的妊娠测试必须为阴性，至少使用过两种非激素方法避孕，并且需每月进行妊娠测试。

不良反应

索非布韦联合利巴韦林引起的已知最常见不良反应(发生率等于或大于20%，所有等级)是头痛与乏力;索非布韦联合聚乙二醇干扰素-α及利巴韦林引起的已知最常见不良反应包括乏力、头痛、恶心、失眠和贫血。

药物相互作用

强效的肠道糖蛋白(P-gp)诱导剂(如利福平)可能改变索非布韦的药物血浆浓度。使用前，药物间相互作用请参看完整药品说明书。

特殊人群用药

HCV/HIV-1合并感染患者：该药的安全性和有效性得到研究确认。

等待肝移植的肝细胞癌患者：该药的安全性和有效性得到研究确认。

注意事项/索非布韦

1.服用索非布韦一定要每天按时，一定不要漏，每天都在同一时间服用。

2.早晨吃，晚上吃影响并不大，一般饭前或饭后一小时服用效果最好。

3.用索非布韦期间切忌不要饮酒，每天饮酒超过5ml就会影响药物疗效。

4.严重肾功能损伤/透析患者必须要进行医疗方案咨询，已知的数据显示，索非布韦的代谢产物在肾功能不全或者肾功能衰竭患者的体内有累积。

价格/索非布韦

目前索非布韦在美国的售价约1千美元1片，一个疗程3瓶，共12周，这样一个疗程不足6万人民币。