本帖最后由 StephenW 于 2010-12-23 15:53 编辑
Three-Year Efficacy and Safety of Tenofovir
http://www.gastrojournal.org/article/S0016-5085%2810%2901499-X/abstract
Disoproxil Fumarate Treatment for Chronic Hepatitis B- E. Jenny Heathcote
Affiliations- University of Toronto, Toronto, Ontario, Canada
Patrick Marcellin
Affiliations- Hôpital Beaujon, APHP, University of Paris 7 and INSERM U773, CRB3, Clichy, France
Maria Buti
Affiliations- Servicio de Medicina Interna Hepatologia, Hospital General Universitari Vall d'Hebron and Ciberehd, Barcelona, Spain
Edward Gane
Affiliations- Middlemore Hospital, Auckland, New Zealand
Robert A. De Man
Affiliations- Erasmus MC, University Medical Center Rotterdam, The Netherlands
Zahary Krastev
Affiliations- University Hospital “St Ivan Rilsky,” Sofia, Bulgaria
George Germanidis
Affiliations- American Hellenic Educational Progressive Association University Hospital of Thessaloniki, Thessaloniki, Greece
Samuel S. Lee
Affiliations- University of Calgary, Calgary, Alberta, Canada
Robert Flisiak
Affiliations- Medical University of Bialystok, Bialystok, Poland
Kelly Kaita
Affiliations- John Buhler Research Centre, University of Manitoba, Winnipeg, Manitoba, Canada
Michael Manns
Affiliations- Medizinische Hochschule, Hannover, Germany
Iskren Kotzev
Affiliations- University Hospital “Sveta Marina,” Varna, Bulgaria
Konstantin Tchernev
Affiliations- Medical University, Sofia, Bulgaria
Peter Buggisch
Affiliations- Universitaetsklinik Hamburg, Hamburg, Germany
Frank Weilert
Affiliations- Waikato Hospital, Hamilton, New Zealand
Oya Ovunc Kurdas
Affiliations- Haydarpasa Numune Hospital, Istanbul, Turkey
Mitchell L. Shiffman
Affiliations- Virginia Commonwealth University Medical Center, Richmond, VA
- Affiliations are as reported for the conduct of the studies through year 3. Current affiliations: Mitchell L. Schiffman, Liver Institute of Virginia, Bon Secours Health System, Newport News, Virginia and Jeff Sorbel, Triangle Biostatistics, Wake Forest, North Carolina.
Huy Trinh
Affiliations- San Jose Gastroenterology, San Jose, California
Selim Gurel
Affiliations- University of Uludag, Bursa Turkey
Andrea Snow–Lampart
Affiliations- Gilead Sciences, Durham, North Carolina
Katyna Borroto–Esoda
Affiliations- Gilead Sciences, Durham, North Carolina
Elsa Mondou
Affiliations- Gilead Sciences, Durham, North Carolina
 Reprint requests Address requests for reprints to: Elsa Mondou, MD, Gilead Sciences, 4611 University Drive, Durham, North Carolina 27707. fax: (650) 522-1795
Jane Anderson
Affiliations- Gilead Sciences, Durham, North Carolina
Jeff Sorbel
Affiliations- Gilead Sciences, Durham, North Carolina
- Affiliations are as reported for the conduct of the studies through year 3. Current affiliations: Mitchell L. Schiffman, Liver Institute of Virginia, Bon Secours Health System, Newport News, Virginia and Jeff Sorbel, Triangle Biostatistics, Wake Forest, North Carolina.
Franck Rousseau
Affiliations- Gilead Sciences, Durham, North Carolina
Received 16 June 2010; accepted 4 October 2010. published online 18 October 2010. Background & AimsTenofovir disoproxil fumarate (TDF), a nucleotide analogue and potent inhibitor of hepatitis B virus (HBV) polymerase, showed superior efficacy to adefovir dipivoxil in treatment of chronic hepatitis B through 48 weeks. We evaluated long-term efficacy and safety of TDF monotherapy in patients with chronic hepatitis B who were positive or negative for hepatitis B e antigen (HBeAg+ or HBeAg−). MethodsAfter 48 weeks of double-blind comparison of TDF to adefovir dipivoxil, patients who underwent liver biopsy were eligible to continue the study on open-label TDF for 7 additional years; data presented were collected up to 3 years (week 144) from 85% of participants. Primary efficacy end points at week 144 included levels of HBV DNA and alanine aminotransferase, development of resistance mutations, and presence of HBeAg or hepatitis B surface antigen (HBsAg).
ResultsAt week 144, 87% of HBeAg− and 72% of HBeAg+ patients treated with TDF had levels of HBV DNA <400 copies/mL. Among patients who had previously received adefovir dipivoxil and then received TDF, 88% of the HBeAg− and 71% of the HBeAg+ patients had levels of HBV DNA <400 copies/mL; overall, 81% and 74%, respectively, maintained normalized levels of alanine aminotransferase and 34% had lost HBeAg. Amino acid substitutions in HBV DNA polymerase that are associated with resistance to tenofovir were not detected in any patient. Cumulatively, 8% of HBeAg+ patients lost HBsAg. TDF maintained a favorable safety profile for up to 3 years. ConclusionsTDF was safe and effective in the long-term management of HBeAg+ and HBeAg− patients with chronic hepatitis B.
三年慢性乙型肝炎疗效和富马酸泰诺福韦Disoproxil治疗的安全性乙
*五珍妮希思科特
兼职
Ø多伦多大学，多伦多，安大略省，加拿大
*，帕特里克Marcellin
兼职
Ø总医院Beaujon，APHP，巴黎7和INSERM的U773，CRB3，克利希，法国大学
*，玛丽亚布提
兼职
Ø Servicio德Medicina际有Hepatologia，医院总务Universitari瓦尔德希伯伦和Ciberehd，巴塞罗那，西班牙
*，爱德华加恩
兼职
Ø米德尔莫尔医院，奥克兰，新西兰
*，罗伯特A德曼
兼职
Ø管委会伊拉斯谟大学医学中心的鹿特丹，荷兰
*，Zahary Krastev
兼职
o大学医院“圣伊万Rilsky，”索非亚，保加利亚
*，乔治Germanidis
兼职
Ø美国希腊萨洛尼卡教育协进会，塞萨洛尼基，希腊大学医院
*，塞缪尔李选
兼职
Ø卡尔加里大学，卡尔加里，加拿大
*罗伯特Flisiak
兼职
Ø医科大学比亚韦斯托克，Bialystok，波兰
*，凯利Kaita
兼职
Ø约翰布勒研究中心，曼尼托巴大学，温尼伯，马尼托巴省，加拿大
*，迈克尔曼斯
兼职
Ø>公司> Hochschule的汉诺威，德国
*，Iskren Kotzev
兼职
o大学医院“Sveta匡，”瓦尔纳，保加利亚
*，康斯坦丁Tchernev
兼职
Ø医学大学，索非亚，保加利亚
*，彼得Buggisch
兼职
Ø Universitaetsklinik汉堡，汉堡，德国
*，弗兰克Weilert
兼职
Ø怀卡托医院，哈密尔顿，新西兰
*，大屋Ovunc Kurdas
兼职
Ø Haydarpasa Numune医院，伊斯坦布尔，土耳其
*，米切尔属Shiffman
兼职
Ø弗吉尼亚联邦大学医学中心，里士满，弗吉尼亚州
Ø联系等公布了第3年的研究，通过进行。当前背景：米切尔属希夫曼，肝弗吉尼亚研究所邦塞科尔卫生系统，纽波特纽斯，弗吉尼亚州和杰夫Sorbel，三角生物统计，维克森林，北卡罗莱纳州。
*，于伊郑氏
兼职
Ø圣何塞胃肠病学杂志，美国加州圣何塞
*，塞利姆Gurel
兼职
Ø大学Uludag，土耳其布尔萨
*，安德烈雪Lampart
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
*，Katyna Borroto - Esoda
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
*，艾尔莎Mondou
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
Ø通讯作者InformationReprint请求地址的请求重印到：艾尔莎Mondou医师，Gilead Sciences公司，4611大学路，达勒姆，北卡罗莱纳州27707。传真：（650）522-1795
电子邮件地址
*，简安德森
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
*，杰夫Sorbel
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
Ø联系等公布了第3年的研究，通过进行。当前背景：米切尔属希夫曼，肝弗吉尼亚研究所邦塞科尔卫生系统，纽波特纽斯，弗吉尼亚州和杰夫Sorbel，三角生物统计，维克森林，北卡罗莱纳州。
*，弗兰克卢梭
兼职
Ø Gilead Sciences公司，达勒姆，北卡罗莱纳州
收到2010年6月16号，接受2010年10月4日。网上公布2010年10月18号。
背景和目的
富马酸泰诺福韦disoproxil（华盈），一个核苷酸类似物和有效抑制乙型肝炎病毒（HBV）的聚合酶，显示效果优于对阿德福韦通过48周的阿德福韦酯治疗慢性乙型肝炎。我们评估慢性乙肝患者谁是阳性或阴性B型肝炎e抗原（HBeAg的+或e抗原）的长期疗效和安全性的单一华盈。
方法
经过48双盲比较周华盈阿德福韦酯，病人接受肝活检谁才有资格继续增加7年的开放标签华盈的研究，数据收集提出了从85至三年（144周）％与会者。 144周的主要疗效终点包括HBV DNA和丙氨酸氨基转移酶，抗突变的发展，e抗原或乙肝表面抗原（HBsAg）的存在水平。
结果
144周时，与华盈87％的治疗e抗原和e抗原72％+患者的HBV DNA <400拷贝/ mL水平。患者中谁曾收到阿德福韦酯，再接到华盈，88％的e抗原和71 HBeAg的％+患者的HBV DNA <400拷贝/ mL水平，整体而言，81％和74％，分别维持规范化水平谷丙转氨酶和34％的人失去了HBeAg的。在乙型肝炎病毒DNA聚合酶氨基酸，与相关替代品的抗泰诺福韦没有发现任何病人。累计8％的HBeAg +患者失去了乙肝表面抗原。华盈保持了长达3年良好的安全性。
结论
华盈是安全和有效的HBeAg的长期管理+和e抗原慢性乙型肝炎患者 |
发表于 2010-12-23 15:48
