Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: Recommendations for a standardized approach

被引:168
作者
Pawlotsky, Jean-Michel [1 ,2 ]
Dusheiko, Geoffrey [3 ]
Hatzakis, Angelos [4 ]
Lau, Daryl [5 ]
Lau, George [6 ]
Liang, T. Jake [7 ]
Locarnini, Stephen [8 ]
Martin, Paul [9 ]
Richman, Douglas D. [10 ]
Zoulim, Fabien [11 ]
机构
[1] Univ Paris 07, Hop Henri Mondor, French Natl Ref Ctr Viral Hepatitis B C & Delta, Dept Virol, Creteil, France
[2] INSERM, U841, Creteil, France
[3] UCL Royal Free & Univ Coll, Sch Med, Ctr Hepatol, London, England
[4] Univ Athens, Sch Med, Dept Hyg Epidemiol & Med Stat, Athens, Greece
[5] Harvard Univ, Sch Med, Beth Israel Deaconess Med Ctr, Liver Ctr,Dept Med, Boston, MA USA
[6] Univ Hong Kong, Queen Mary Hosp, Dept Med, Hong Kong, Peoples R China
[7] Natl Inst Hlth, NIDDK, Liver Dis Branch, Bethesda, MD USA
[8] Victorian Infect Dis Ref Lab, Melbourne, Vic, Australia
[9] Mt Sinai Sch Med, Recanati Miller Transplant Inst, Div Liver Dis, New York, NY USA
[10] Univ Calif San Diego, VA San Diego Hlthcare Syst, La Jolla, CA USA
[11] Univ Lyon 1, Hosp Civils Lyon, INSERM, Dept Liver Dis,U871, Lyon, France
关键词
D O I
10.1053/j.gastro.2007.11.036
中图分类号
R57 [消化系及腹部疾病];
学科分类号
摘要
Treatment of chronic hepatitis B virus (HBV) infection is aimed at suppressing viral replication to the lowest possible level, and thereby to halt the progression of liver disease and prevent the onset of complications. Two categories of drugs are used in HBV therapy: the interferons, including standard interferon alfa or pegylated interferon alfa, and specific nucleoside or nucleotide HBV inhibitors that target the reverse-transcriptase function of HBV-DNA polymerase. The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. This article discusses HBV virologic markers and tests, and their optimal use both for planning and reporting clinical trials and in clinical practice.
引用
收藏
页码:405 / 415
页数:11
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