title: Virologic monitoring of hepatitis B virus therapy in clinical trials and practice: recommendations for a standardized approach.
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.
authors.affiliation: French National Reference Center for Viral Hepatitis B, C and delta, Department of Virology, Henri Mondor Hospital, University of Paris XII, Créteil, France. jean-michel.pawlotsky@hmn.aphp.fr
authors.forename: Jean-Michel
authors.initials: JM
authors.lastname: Pawlotsky
authors.forename: Geoffrey
authors.initials: G
authors.lastname: Dusheiko
authors.forename: Angelos
authors.initials: A
authors.lastname: Hatzakis
authors.forename: Daryl
authors.initials: D
authors.lastname: Lau
authors.forename: George
authors.initials: G
authors.lastname: Lau
authors.forename: T Jake
authors.initials: TJ
authors.lastname: Liang
authors.forename: Stephen
authors.initials: S
authors.lastname: Locarnini
authors.forename: Paul
authors.initials: P
authors.lastname: Martin
authors.forename: Douglas D
authors.initials: DD
authors.lastname: Richman
authors.forename: Fabien
authors.initials: F
authors.lastname: Zoulim
mesh_terms: D000998:Antiviral Agents / Q000627:therapeutic use*; D015415:Biomarkers / Q000378:metabolism; D002986:Clinical Trials as Topic / Q000592:standards; D023381:Endpoint Determination; D006509:Hepatitis B / Q000097:blood / Q000188:drug therapy*; D006801:Humans; D007372:Interferons / Q000627:therapeutic use*; D017410:Practice Guidelines as Topic / Q000592:standards; D016896:Treatment Outcome; D014779:Virus Replication / Q000187:drug effects*
chemical_list: D000998:Antiviral Agents; D015415:Biomarkers; D007372:Interferons