CONTROL ID: 1424861 | |||||||||||||||||||||||||||||||||||||||||||||||||
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PRESENTATION TYPE: Oral or Poster | |||||||||||||||||||||||||||||||||||||||||||||||||
CURRENT CATEGORY: Hepatitis B | |||||||||||||||||||||||||||||||||||||||||||||||||
CURRENT DESCRIPTORS: I03. Virology and Diagnostics | |||||||||||||||||||||||||||||||||||||||||||||||||
TITLE: Quantitative HBsAg Titers in a Multi-Drug Resistance Chronic Hepatitis B cohort on Tenofovir Disoproxil Fumarate Rescue Therapy | |||||||||||||||||||||||||||||||||||||||||||||||||
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AUTHORS (FIRST NAME, LAST NAME): Lucy Y. Lim1, 2, Scott Patterson1, Rachel Hammond2, James M. Trauer1, Nadia Warner2, Jacob George3, Simone I. Strasser4, Alice U. Lee5, William Sievert6, Amanda J. Nicoll7, Stuart K. Roberts8, Paul V. Desmond9, Scott Bowden2, Alexander J. Thompson2, 9, Stephen Locarnini2, Peter W. Angus1 | |||||||||||||||||||||||||||||||||||||||||||||||||
Institutional Author(s): | |||||||||||||||||||||||||||||||||||||||||||||||||
INSTITUTIONS (ALL): 1. Gastroenterology and Liver Transplant Unit, Austin Hospital, Melbourne, VIC, Australia. | |||||||||||||||||||||||||||||||||||||||||||||||||
ABSTRACT BODY: Background: In CHB patients, quantitative hepatitis B surface antigen (QHBsAg) have recently been associated with predicting response to peg-interferon-alfa, including HBsAg seroconversion (SC) & loss or decline. Long-term nucleos(t)ide analogues (NA) suppresses HBV replication in the majority of patients, however very few actually undergo HBsAg SC. The utility of QHBsAg analysis in these patients is poorly understood & the impact of multi-drug resistant (MDR) variants has not been explored. | |||||||||||||||||||||||||||||||||||||||||||||||||
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题目:多重抗药耐药慢性乙肝患者运用富马酸替诺福韦补救疗法的表面抗原定量 |
摘要:背景:最近发现,慢性乙肝患者表面抗原定量与聚乙二醇干扰素-α治疗的应答预期(表面抗原血清学转换和消失/下降)具有相关性。对于大部分病人,长效核苷(酸)类似物可抑制HBV复制,但非常少数能达到表面抗原血清学转换。目前,针对在这些乙肝患者表面抗原定量分析的效用知之甚少,而多重抗药性变异的影响目前尚未探究出来。
目的:评估一个多重抗药耐药(rtA181T/V)特征明显的HBV队列,通过接受多个核苷(酸)类似物药7年以上治疗(其中包括最少3年替诺福韦治疗)后,表面抗原的下降。
方法:TDF109是一项由研究者发起,具有前瞻性、多中心的开放试验:为60位接受拉米夫定治疗失败后加用或改用阿德福韦酯的病人采取替诺福韦补救疗法。之前我们已经介绍了2年期的病毒学性结果。(Patterson,Gut 2011)所有患者坚持替诺福韦长期定期随访,现在是第四年。表面抗原滴度每6个月和在基线回顾性量化,以IU/ml 表达(RocheElecsys)。
根据基线病毒载量及基线显示的HBV耐药性替代类型得出亚分析。
结果:基线时显示,表面抗原滴度定量中位数为5226IU/ml,表面抗原基线与HBVDNA水平基线呈正相关(R= 0.33,P= 0.0168),E抗原阳性患者(p=0.13)的表面抗原基线更高。用药第一、二、三年的表面抗原滴度定量中位数分别为:2772IU/ml,2284IU/ml 及1819IU/ml (P<0.0001,基线对比3年)。检查出rtA181T/V变异的病人,表面抗原定量基线较低,且表面抗原呈现逐步下降趋势(p=0.002)。而没法检查出耐药或基线没有表达出乙型肝炎聚合酶蛋白对拉米夫定耐药的病人,表面抗原定量基线较高,但表面抗原下降速度更快。(表)
CONTROL ID: 1423799 | ||||||||||||||||||||||||
PRESENTATION TYPE: Oral or Poster | ||||||||||||||||||||||||
CURRENT CATEGORY: Hepatitis B | ||||||||||||||||||||||||
CURRENT DESCRIPTORS: I02. Treatment and Clinical Trials | ||||||||||||||||||||||||
TITLE: Six Years of Treatment with Tenofovir DF for Chronic Hepatitis B Virus Infection is Safe and Well Tolerated and Associated with Sustained Virological, Biochemical and Serological Responses with no Detectable Resistance | ||||||||||||||||||||||||
AUTHORS (FIRST NAME, LAST NAME): Patrick Marcellin1, Maria Buti2, Edward J. Gane3, Naoky Tsai4, William Sievert5, Ira M. Jacobson6, George Germanidis7, John F. Flaherty8, Phillip Dinh8, Kathryn M. Kitrinos8, John G. McHutchison8, Nezam Afdhal9 | ||||||||||||||||||||||||
Institutional Author(s): | ||||||||||||||||||||||||
INSTITUTIONS (ALL): 1. Hôpital Beaujon, Clichy, France. 2. Hospital General Universitari Vall d’Hebron and Ciberehd, Barcelona, Spain. 3. Auckland City Hospital, Auckland, New Zealand. 4. University of Hawaii at Manoa, Honolulu, CA, United States. 5. Monash University and Monash Medical Centre, Melbourne, VIC, Australia. 6. Weill Cornell Medical College, New York, NY, United States. 7. AHEPA University Hospital, Aristotle University Medical School, Thessaloniki, Greece. 8. Gilead Sciences, Foster City, CA, United States. 9. Beth Israel Deaconess Medical Center, Boston, MA, United States. | ||||||||||||||||||||||||
ABSTRACT BODY: Background: We previously reported that 5 years of tenofovir DF (TDF) therapy in mostly treatment naïve patients results in sustained virological suppression with no development of resistance and was associated with either the halting or regression of fibrosis in 96% of patients. Here we present 6 year results from these two ongoing 8 year studies (Studies 102 and 103). Methods: After 48 weeks of double-blind comparison of TDF to adefovir dipivoxil, all patients undergoing liver biopsy were eligible to continue open-label TDF. Patients were assessed every 3 months for safety and efficacy with annual resistance surveillance; annual assessments of bone mineral density (BMD) of the spine and hip by DXA were added starting at year 4. Results: In a total 641 patients who were initially randomized and treated, 585 (93%) entered the TDF extension phase, and at Year 6, 466 (73%) remain on study. Efficacy results at Year 6 are shown in the table. TDF was well tolerated over the 6 year evaluation period. Less than 2% of patients discontinued TDF due to an adverse event, and ≤1.5% experienced a confirmed renal event (≥0.5 mg/dL increase in serum creatinine from baseline, phosphorus <2 mg/dL, or CrCL <50 mL/min). BMD (T scores) was stable over 2 years of evaluation. No resistance to TDF has been detected through Year 6. Conclusions: In these two trials, TDF remains safe and effective over a 6 year treatment period, with no detectable resistance to TDF; a relatively low rate of renal events and no evidence of clinically relevant bone loss were also observed. | ||||||||||||||||||||||||
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