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Phase 3 trial of first generation protease inhibitor therapy for hepatitis C virus/human immunodeficiency virus coinfection

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World Journal of Hepatology 2017年第4期9卷 217-223页

作者： Kenneth E Sherman Minhee Kang Richard Sterling Triin Umbleja Kristen Marks Jennifer J Kiser Beverly Alston-Smith wayne greaves Adeel A Butt 无 Division of Digestive Diseases University of Cincinnati College of Medicine harvard T.h. Chan School of Public health Department of Gastroenterology Virginia Commonwealth University Division of Infectious Disease Weill Cornell Medical School University of Colorado School of Pharmacy NIAID-Division of AIDS Merck and Co Inc. University of Pittsburgh School of Medicine hamad healthcare Quality Institute the ACTG 5294 BIRTH Study Team

AIM To evaluate efficacy/safety of hepatitis C virus(HCV) protease inhibitor boceprevir with pegylated interferon(PEG-IFN) alfa and weight-based ribavirin(RBV) in a phase 3 trial. METHODS A prospective, multicenter, phase 3, open-label, singlearm study of PEG-IFN alfa, weight-based RBV, and boceprevir, with a PEG-IFN/RBV lead-in phase was performed. The HCV/human immunodeficiency virus coinfected study population included treatment na?ve(TN) and treatment experienced(TE) patients. Treatment duration ranged from 28 to 48 wk dependent upon response-guided criteria. All patients had HCV Genotype 1 with a viral load > 10000 IU/ml. Compensated cirrhosis was allowed. Sample size was determined to establish superiority to historical(PEG-IFN plus RBV) rates in sustained viral response(SVR). RESULTS A total of 257 enrolled participants were analyzed(135 TN and 122 TE). In the TN group, 81.5% were male and 54.1% were black. In the TE group, 76.2% were male and 47.5% were white. Overall SVR12 rates(HCV RNA < lower limit of quantification, target not detected, target not detected) were 35.6% in TN and 30.3% in TE. Response rates at SVR24 were 28% in TN and 10% in TE, and exceeded those in historical controls. The highest rate was observed in TN non-cirrhotic participants(36.8% and the lowest in TE cirrhotics(26.3%). Cirrhotic TN participants had a 27.8% SVR12 rate and 32.1% of TE non-cirrhotics achieved SVR12. Significantly lower response rates were observed among black participants; in the TE, SVR12 was 39.7% in white participants but only 13.2% of black subjects(P = 0.002). Among the TN, SVR12 was 42.1% among whites and 27.4% among blacks(P = 0.09). CONCLUSION The trial met its hypothesis of improved SVR compared to historical controls but overall SVR rates were low. All-oral HCV treatments will mitigate these difficulties.

关键词：人的免疫不全病毒丙肝病毒 Boceprevir Pegylated 干扰素 A Ribavirin

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从木材解剖学视角看公元6世纪中期晚古小冰期的开始时间

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Science Bulletin 2022年第22期67卷 2336-2344页

作者： Ulf Büntgen Alan Crivellaro Dominique Arseneault Mike Baillie David Barclay Mauro Bernabei Jarno Bontadi Gretel Boswijk David Brown Duncan AChristie Olga VChurakova Edward RCook Rosanne D’Arrigo Nicole Davi Jan Esper Patrick Fonti Ciara greaves Rashit MHantemirov Malcolm KHughes Alexander VKirdyanov Paul JKrusic Carlos Le Quesne Fredrik CLjungqvist Michael McCormick Vladimir SMyglan Kurt Nicolussi Clive Oppenheimer Jonathan Palmer 秦春 Frederick Reinig Matthew Salzer Markus Stoffel Max Torbenson Mirek Trnka Ricardo Villalba Nick Wiesenberg Greg Wiles 杨保 Alma Piermattei Department of Geography University of CambridgeCambridge CB23ENUK Swiss Federal Research Institute(WSL) Birmensdorf 8903Switzerland Global Change Research Centre(CzechGlobe) Brno 60300Czech Republic Department of Geography Faculty of ScienceMasaryk UniversityBrno 61300Czech Republic Forest Biometrics Laboratory Faculty of Forestry“Stefan cel Mare”University of SuceavaSuceava 720229Romania Department of Biology Chemistry and GeographyUniversity of Quebec in RimouskiRimouski Qc.G5L 3A1Canada Archaeology&Palaeoecology School of Natural and Built EnvironmentQueen’s University BelfastBelfast BT71NNUK Department of Geology State University of New York at CortlandCortland NY 13045USA CNR-IBE Institute of BioEconomyNational Research CouncilTrento 38121Italy School of Environment The University of AucklandAuckland 1010New Zealand Laboratorio de Dendrocronología y Cambio Global Universidad Austral de ChileValdivia 509000Chile Center for Climate and Resilience Research(CR) Santiago 8370449Chile Cape Horn International Center(CHIC) Punta Arenas 6200000Chile Institute of Ecology and Geography Siberian Federal UniversityKrasnoyarsk 660041Russia Tree-Ring Laboratory Lamont-Doherty Earth ObservatoryColumbia UniversityPalisades NY 10964USA Department of Environmental Science William Paterson UniversityWayne NJ 07470USA Department of Geography Johannes Gutenberg UniversityMainz 55099Germany Institute of Plant and Animal Ecology Ural BranchRussian Academy of SciencesYekaterinburg 620144Russia Ural Institute of Humanities Ural Federal UniversityYekaterinburg 620002Russia Laboratory of Tree-Ring Research University of ArizonaTucson AZ 85721USA Sukachev Institute of Forest SB RAS Krasnoyarsk 660036Russia Department of Physical Geography Bolin Centre for Climate ResearchStockholm UniversityStockholm 10691Sweden Department of History Stockholm UniversityStockholm 10691Sweden Bolin Centre for Climate Research Stockholm UniversityStockholm 10691Sweden Swedish Collegium for Advanced Study

公元536~540年间的大规模火山喷发使得晚古小冰期成为过去两千年最为寒冷的时期.然而,受限于现有气候代用资料的时间分辨率和空间覆盖度,晚古小冰期的开始时间和空间范围仍存有争议.本文分析了全球23个森林样点、20个树种的106个树轮样... 详细信息

公元536~540年间的大规模火山喷发使得晚古小冰期成为过去两千年最为寒冷的时期.然而,受限于现有气候代用资料的时间分辨率和空间覆盖度,晚古小冰期的开始时间和空间范围仍存有争议.本文分析了全球23个森林样点、20个树种的106个树轮样本资料,从细胞尺度揭示了公元530~550年间北半球发生的短暂夏季冷却现象.经过交叉定年和染色处理后,在北半球的树轮样品中共识别出89个蓝轮(缺失细胞壁木质化过程)、9个霜轮(细胞分裂受阻)和93个浅轮(细胞壁增厚减弱).研究结果表明,公元536年7月中旬至8月初期间整个北美和欧亚大陆均发生了最剧烈的温度下降,而更多的区域性“冷夏”出现于公元532年、540~543年和548年.然而,本研究在南半球的树轮资料中并未发现异常的解剖结构,其原因可能与南半球的海洋热惯性减缓了火山降温效应有关,也或与南半球其时正值非生长季有关.相较于传统的树轮年代学方法,本研究的木材解剖学的方法能为地球系统模式提供更为精细的参考标准,有望服务于气候与人类历史交叉学科研究,同时对“全球气候平均”概念的使用提出质疑.

关键词：地球系统模式小冰期火山喷发树轮年代学全球气候欧亚大陆冷夏染色处理

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