替诺福韦(Viread/TDF/TFV)已被欧盟批准上市用于慢乙肝治疗

mlu

好消息，对于需要核苷（酸）类药物抗病毒治疗的慢乙肝病人，无论是初治患者，还是各类耐药患者（特别是在不久的将来必然要出现的MDR多重耐药患者），都多了一个很好的选择。 希望尽快能在国内上市，造福患者。


European Commission Approves Viread(R) for Chronic Hepatitis B
Important New Treatment Option for Millions of Europeans Affected

                      by Life-Threatening DiseaseFOSTER CITY, Calif.--(BUSINESS WIRE)--April 25, 2008--Gilead Sciences, Inc. (NASDAQ:GILD) today announced that the European Commission has granted marketing authorisation for Viread(R) (tenofovir disoproxil fumarate) for the treatment of chronic hepatitis B in all 27 member states of the European Union.

A once-daily tablet, Viread works by blocking hepatitis B virus (HBV) DNA polymerase, the enzyme that is necessary for the virus to replicate in liver cells. Viread has been approved in the European Union for use in adult chronic HBV patients with compensated liver disease, with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active inflammation and/or fibrosis. The product was recently approved for the treatment of chronic hepatitis B in Turkey and New Zealand, and marketing applications are currently pending regulatory review in the United States, Canada and Australia.

"Hepatitis B is a significant problem in Europe, where approximately 20,000 people die of complications from the disease each year," said Patrick Marcellin, MD, PhD, Professor of Hepatology at the University of Paris and Head of the Viral Hepatitis Research Unit (INSERM) at the Hopital Beaujon in Clichy, France. "As a physician and researcher who has studied this drug extensively in large-scale clinical trials, I believe Viread is an important treatment option for patients who are just starting therapy, as well as for those who may have had previous experience with other medications, including lamivudine."

Today's approval is based primarily on data from two ongoing Phase III clinical trials, Studies 102 and 103, in patients (n = 375) chronically infected with HBV who were new to HBV therapy (treatment-naive). Some patients (n=51) in the Phase III trials have had previous experience with lamivudine (treatment-experienced). These studies evaluate the efficacy, safety and tolerability of Viread compared to Hepsera(R) (adefovir dipivoxil). Positive data from these studies were presented in late-breaker presentations at the annual meeting of the American Association for the Study of Liver Diseases in Boston, Massachusetts, November 2007. Additional 72-week data from these studies were presented at the annual meeting of the European Association for the Study of the Liver in Milan, Italy, April 23-27.

"Data from studies 102 and 103 demonstrate that Viread has many of the preferred qualities of an antiviral treatment: rapid and profound viral suppression, a well-established safety profile with more than one million years of patient experience, and convenient once-daily administration," said Kevin Young, Executive Vice President, Commercial Operations at Gilead Sciences. "Now that Viread is approved for chronic hepatitis B in Europe, our top priority is working to ensure that all individuals who need the medication have access to it as quickly as possible."

Viread represents Gilead's second once-daily antiviral for the treatment of chronic hepatitis B; the first, Hepsera, is currently widely used as a treatment for chronic hepatitis B in Europe. In addition, the company is also developing small molecule compounds for the treatment of hepatitis C and a hepatoprotectant for hepatitis-related liver fibrosis.

Viread has been available in Europe as a part of combination therapy for HIV infection in adults since 2002. Its active ingredient, tenofovir disoproxil, is the most widely prescribed molecule for the treatment of HIV infection in several European Union nations.

走遍四方

看上去三期的n值太小了点。
有人能提供更多的信息吗？

笑着@面对

顶上去~~~~~~~~

mlu

怎样操作才能置顶啊？

mlu

更多的替诺福韦的信息可参阅今年EASL年会的相关报道

走遍四方

要买置顶卡。。。

mlu

替诺福韦可有效治疗HBeAg阴性慢性乙肝

    　　法国学者Marcellin报告的一项多国多中心研究证实,替诺福韦(TDF)连续治疗48周后,继续应用仍可进一步抑制病毒。在阿德福韦(ADV)治疗48周后,转为应用TDF,也可产生明显的病毒抑制,而且患者对72周TDF治疗的耐受性良好。

    　　受试者为HBeAg阴性的慢性乙型肝炎(CHB)单纯感染者,将其以2:1的比例双盲随机分配至TDF组(250例)或 ADV组 (125例)接受48周治疗。48周后,通过肝活检选出合适的患者转为或继续接受TDF治疗,为期4年。

    　　结果显示,有112例最初被分配至ADV组的患者在48周后转为接受TDF治疗,其中35例在换药之前HBV DNA>400 copies/ml。在转为TDF治疗24周后,112例受试者中有108例HBV DNA<400 copies/ml,2例HBV DNA>400 copies/ml,2例患者失访。



在接受过核苷酸类似物治疗的HBV感染者中替诺福韦治疗效果令人满意

    　　最近的一些对照研究证实,在未经治疗的HBeAg阳性或阴性患者中,替诺福韦(TDF)具有很强的活性。但是,对于那些接受过核苷酸类似物治疗的患者,TDF的有效性还是未知。在本届大会上,德国学者van B?觟mmel报告了一项对接受过核苷酸类似物治疗的单纯性HBV感染者开展的研究,结果显示,替诺福韦疗效令人满意,且患者对其耐受性良好。

    　　该项研究在德国和荷兰的15个医学中心实施,127例患者接受了中位治疗期为20个月的治疗。有6例患者是首次接受治疗,121例患者曾经接受过治疗。治疗12个月后,在接受持续观察的103例患者中,HBV DNA水平平均下降了(4.1±1.3)log,85%( 88例)的患者HBV DNA水平降至不能检测到,未观察到病毒学突破,有12例(16%)患者发生了HBeAg血清学转换,1例(1%)患者出现了HBsAg丢失。



替诺福韦治疗伴肝硬化的慢性乙肝疗效佳

    　　在本届大会上,西班牙学者Buti报告了2项关于替诺福韦(TDF)安全性和有效性的3期注册试验结果发现,TDF表现出高度的有效性、患者的良好耐受性以及优于阿德福韦(ADV)的HBV DNA抑制能力。

    　　研究共招募了123例肝硬化患者,将其按照2:1的比例随机双盲分配至TDF 300 mg或者ADV 10 mg治疗组中,每日给药一次,治疗48周。结果提示,在肝硬化亚组,TDF有效性应答的比例高,其中组织学应答为79%,抑制HBV DNA<400 copies/ml比例达85%,血清丙氨酸氨基转移酶(ALT)正常者为69%。与ADV相比,TDF抑制HBV DNA<400 copies/ml的比例更高(P<0.001),且两组的组织学和ALT反应是可比的

走遍四方

ETV可以更换到TDF吗？

坚强胜利

大概有是多少金，消费的起才是硬道理阿！

mlu

目前没有ETV和TDF交叉耐药的·报道，可以更换。

在国外的售价不详。