CLINICAL-LIVER, PANCREAS, AND BILIARY TRACT
Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach
JEAN-MICHEL PAWLOTSKY, GEOFFREY DUSHEIKO, ANGELOS HATZAKIS,DARYL LAU, GEORGE LAU,T. JAKE LIANG,STEPHEN LOCARNINI, PAUL MARTIN, DOUGLAS D. RICHMAN,and FABIEN ZOULIM
French National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, University of Paris XII, Créteil, France; INSERM U841, Créteil, France; §Centre for Hepatology, Royal Free and University College School of Medicine, London, United Kingdom; _Department of Hygiene, Epidemiology and Medical Statistics, Athens University Medical School, Athens, Greece; Liver Center, Department of Medicine, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts; Department of Medicine, Queen Mary Hospital, University of Hong Kong, Hong Kong SAR, China; Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, Maryland; Victorian Infectious Diseases Reference Laboratory, North Melbourne, Victoria, Australia; Division of Liver Diseases and Recanati-Miller Transplant Institute, Mount Sinai School of Medicine, New York, New York; _ _VA San Diego Healthcare System and University of California San Diego, La Jolla, California; and INSERM U871, Hospices Civils de Lyon, Department of Liver Diseases, Université Lyon 1, Lyon, France
Abstract 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.
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