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标题: 日本批准 taf上市 [打印本页]

作者: 齐欢畅2 时间: 2016-12-19 19:38 标题: 日本批准 taf上市

本帖最后由齐欢畅2 于 2016-12-20 19:08 编辑

-- A Once-Daily Treatment that Demonstrated Comparable Efficacy with Improved Renal and Bone Laboratory Safety Parameters Compared to Tenofovir Disoproxil Fumarate (TDF) --

FOSTER CITY, Calif.--(BUSINESS WIRE)--Dec. 19, 2016-- Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has approved Vemlidy® (tenofovir alafenamide) 25mg, a once-daily treatment for suppression of viral replication in chronic hepatitis B patients with evidence of hepatitis B virus replication and abnormal liver function.

Vemlidy is a novel targeted prodrug of tenofovir that has demonstrated antiviral efficacy similar to and at a dose less than one-tenth that of tenofovir disoproxil fumarate (TDF) 300mg. Data show that Vemlidy has greater plasma stability and delivers tenofovir to hepatocytes more efficiently compared to TDF. As a result, Vemlidy can be given at a lower dose, reducing the concentration of tenofovir in the bloodstream. Vemlidy has also shown improvements in renal and bone laboratory safety parameters compared to TDF.

"It is very exciting that a new treatment with improvements in renal and bone safety parameters is now approved for patients with chronic hepatitis B. This is an important advancement, as these patients often require lifelong therapy," said Namiki Izumi, MD, the President of Musashino RedCross Hospital.

Vemlidy’s approval is supported by 48-week data from two international Phase 3 studies (Studies 108 and 110) among 1,298 treatment-naïve and treatment-experienced adult patients with HBeAg-negative and HBeAg-positive chronic HBV infection. Study 108 randomized and treated 425 HBeAg-negative patients with either Vemlidy or TDF, and Study 110 randomized and treated 873 HBeAg-positive patients with either Vemlidy or TDF. Study 108 enrolled 27 patients from 11 sites in Japan and Study 110 enrolled 46 patients from 16 sites in Japan. Both studies met their primary endpoint of non-inferiority to TDF based on the percentage of patients with chronic hepatitis B with plasma HBV DNA levels below 29 IU/mL at 48 weeks of therapy.

In an integrated analysis of both studies, patients receiving Vemlidy demonstrated improvements in bone and renal laboratory parameters compared to those treated with TDF. Patients in the Vemlidy arm also experienced numerically higher rates of normalization of serum alanine aminotransferase (ALT) levels.

Vemlidy and TDF were generally well-tolerated by patients in both studies and discontinuations due to adverse events were 1% and 1.2%, respectively. In both studies, the most commonly reported adverse events included headache, abdominal pain, fatigue, cough, nausea and back pain and occurred at similar rates in patients receiving either Vemlidy or TDF.

“There are currently more than one million people in Japan chronically infected with hepatitis B, and we believe Vemlidy is an important option for patients living with this disease,” said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development, and Chief Scientific Officer. “We have been pleased to partner with the medical community here in Japan to demonstrate the efficacy and safety profile of Vemlidy, and we look forward to making the medication available in Japan soon.”

Gilead is now preparing to launch Vemlidy as quickly as possible.

In Japan, TDF is sold by GlaxoSmithKline K.K.

Important Safety Information and Indication for Vemlidy in the U.S.

BOXED WARNING: LACTIC ACIDOSIS/SEVERE HEPATOMEGALY WITH STEATOSIS and POST TREATMENT SEVERE ACUTE EXACERBATION OF HEPATITIS B

Lactic acidosis and severe hepatomegaly with steatosis, including fatal cases, have been reported with the use of nucleoside analogs.
Discontinuation of anti-hepatitis B therapy, including VEMLIDY, may result in severe acute exacerbations of hepatitis B. Hepatic function should be monitored closely with both clinical and laboratory follow-up for at least several months in patients who discontinue anti-hepatitis B therapy, including VEMLIDY. If appropriate, resumption of anti-hepatitis B therapy may be warranted.
Warnings and Precautions

Risk of Development of HIV-1 Resistance in HBV/HIV-1 Coinfected Patients: Due to this risk, VEMLIDY alone is not recommended for the treatment of HIV-1 infection. Safety and efficacy of VEMLIDY have not been established in HBV/HIV-1 coinfected patients. HIV antibody testing should be offered to all HBV-infected patients before initiating therapy with VEMLIDY, and, if positive, an appropriate antiretroviral combination regimen that is recommended for HBV/HIV-1 coinfected patients should be used.
New Onset or Worsening Renal Impairment: Cases of acute renal failure and Fanconi syndrome have been reported with the use of tenofovir prodrugs. In clinical trials of VEMLIDY, there have been no cases of Fanconi syndrome or proximal renal tubulopathy (PRT). Patients with impaired renal function and/or taking nephrotoxic agents (including NSAIDs) are at increased risk of renal-related adverse reactions. Discontinue VEMLIDY in patients who develop clinically significant decreases in renal function or evidence of Fanconi syndrome.
Renal monitoring: Assess serum creatinine, serum phosphorus, CrCl, urine glucose, and urine protein prior to initiating and during therapy in all patients as clinically appropriate.
Adverse Reactions

Most common adverse reactions (incidence ≥5%; all grades) were headache, abdominal pain, fatigue, cough, nausea and back pain.

Drug Interactions

Coadministration of VEMLIDY with drugs that reduce renal function or compete for active tubular secretion may increase concentrations of tenofovir and the risk of adverse reactions.
Coadministration of VEMLIDY is not recommended with the following: oxcarbazepine, phenobarbital, phenytoin, rifabutin, rifampin, rifapentine, or St. John’s wort. Such coadministration is expected to decrease the concentration of tenofovir alafenamide, reducing the therapeutic effect of VEMLIDY. Drugs that strongly affect P-gp and BCRP activity may lead to changes in VEMLIDY absorption.
Consult the full prescribing information for VEMLIDY for more information on potentially significant drug interactions, including clinical comments.

Dosage and Administration

Dosage: Adults; 1 tablet taken once daily with food.
Renal Impairment: Not recommended in patients with CrCl <15 mL/min.
Hepatic Impairment: Not recommended in patients with decompensated (Child-Pugh B or C) hepatic impairment.
Testing prior to initiation: HIV infection.
Indication

VEMLIDY is indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults with compensated liver disease.

作者: 齐欢畅2 时间: 2016-12-19 19:43

日本版TAF上市啦！！

作者: 天涯在此时 时间: 2016-12-20 21:20

是否意味着可以到日本去代购？

作者: smilingcloud 时间: 2016-12-22 22:10

天涯在此时发表于 2016-12-20 21:20
是否意味着可以到日本去代购？

TAF治疗HBV，在日本属于处方药。
原则上没有医生开具的药方，是不能随意拿药的。

去日本代购处方药，有一定难度。

作者: MP4 时间: 2016-12-23 01:48

天涯在此时发表于 2016-12-20 21:20
是否意味着可以到日本去代购？

日本的药不是一般的贵

作者: smilingcloud 时间: 2016-12-27 10:51

根据现有抗病毒药物价格，来估计TAF的定价。

https://medley.life/medicine/item/6250029F1024
恩替バラクルード錠0.5mg　　1061.8円 (0.5mg1錠) 63元RMB／片
替诺テノゼット錠３００ｍｇの基本情報　996.5円 (300mg1錠) 59元／片
拉米ゼフィックス錠１００　532.8円 (100mg1錠) 32元／片
阿德ヘプセラ錠１０　1287.9円 (10mg1錠) 76元／片

替诺每个月需要， 59元 x 30片＝ 1770 元
按照传闻美国TAF价格低于TDF来看，
乐观估计的话日本TAF 应该每月少于 1770元人民币。

作者: newchinabok 时间: 2016-12-27 11:01

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吉利德的，良心大大的坏了。哈哈

作者: 重韧 时间: 2016-12-27 12:10

国内不知道啥时候能拿到TAF。用了TDF　快三年感觉　磷掉的明显。

作者: newchinabok 时间: 2016-12-27 12:38

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我相信政府会慢慢拖延taf上市进度，因为乙肝病人这块肥肉给中国药厂吃，哪会白送给吉利德。

作者: smilingcloud 时间: 2016-12-27 15:17

本帖最后由 smilingcloud 于 2016-12-27 15:18 编辑

newchinabok 发表于 2016-12-27 11:01
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吉利德的，良心大大的坏了。哈哈

吉利德德良心没有关系。

日本有共产主义的全民医疗保险制度罩着。

纳入医保用药目录的话，无论门诊还是住院这么区分，都可以按照30%价格拿药。

也就是说 TDF 或者 TAF 在日本的每月自费价格是 1770 x 0.3 =531人民币。

而且日本共产主义对乙肝治疗有特别补助，普通收入家庭治疗乙肝的月费用限定自费额度为 1万日元（592元人民币）。
即便恩替和替诺连用，自费负担也不会超过每月600元人民币。

作者: newchinabok 时间: 2016-12-27 15:30

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你很懂日本情况，佩服，佩服，。请问‘’去球‘’，日本话怎么说？哈哈

作者: smilingcloud 时间: 2016-12-27 16:33

newchinabok 发表于 2016-12-27 15:30
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你很懂日本情况，佩服，佩服，。请问‘’去球‘’，日本话怎么说？哈哈 ...

我以前也不了解，都是有来论坛后慢慢查找学习的。

去球－－－つまらない（此马拉奶宜）

我胡乱翻译的，汉语博大精深阿。

呵呵

作者: newchinabok 时间: 2016-12-27 17:27

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这个论坛的河南老乡要骂我了，总和老乡开玩笑，其实我对河南老乡还是很有深厚感情的。因为我在河南工作了几年。呵呵

作者: smilingcloud 时间: 2016-12-27 19:12

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呵呵

上学时，同班同学中有几个河南朋友。
对他们印象不错，也是感情深厚。

作者: smilingcloud 时间: 2017-2-9 10:21

本帖最后由 smilingcloud 于 2017-2-9 11:01 编辑

日本TAF定价 1片 996.5日元（大约61元人民币）。使用TAF1个月的日本成本是 1800元人民币。
TAF同时被纳入国民医保用药。
有日本医疗保险的话，个人承担30%费用大约540元人民币。

－－－－－－
2017年2月8日，日本中央社会保険医療協議会総会（第345回）召开会议，确定了TAF的定价（1片996.5日元）。
http://www.mhlw.go.jp/stf/shingi2/0000150605.html
TAF药价预计2月15日正式公布。
估计日本市场最晚3月份就能拿到TAF。
新药TAF是有2周用药量的限制(一次开药量14天)，限制期为1年（到2018年2月15日）。

作者: yelanglms 时间: 2017-2-9 16:00

鬼子还是比我们更以人为本啊！

作者: yelanglms 时间: 2017-2-9 16:01

我现在不奢望社保了，能尽快在国内买到自费药，1800元一个月，不要像MP4说的美国要7000元一个月就行。

作者: yelanglms 时间: 2017-2-9 16:03

其实，目前有不少人吃TDF，副作用大！
另外，由于TAF临床时间短，随着大量的使用，是不是可以积累更多的经验。
比如AD和拉米合并耐药，而且肾功有损伤的，使用TDF也会引起肾功损伤，那么能直接换成TAF吗？

作者: yelanglms 时间: 2017-2-9 16:07

香港的正规药店不知道什么时候能拿到？

作者: MP4 时间: 2017-2-9 17:33

yelanglms 发表于 2017-2-9 16:01
我现在不奢望社保了，能尽快在国内买到自费药，1800元一个月，不要像MP4说的美国要7000元一个月就行。 ...

按照上面的算定表美国是39.1美元一粒，也就是一个月8128RMB
TDF发生严重副作用几率是非常低的。
肾病自然发生率也挺高的，所以先要确认是不是ADV，TDF导致的，一般按肌酐清除率计算，不一定要换药。

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