Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach
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 stan...
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| Veröffentlicht in: | Gastroenterology (New York, N.Y. 1943) N.Y. 1943), 2008-02, Vol.134 (2), p.405-415 |
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| container_title | Gastroenterology (New York, N.Y. 1943) |
| container_volume | 134 |
| creator | Pawlotsky, Jean–Michel Dusheiko, Geoffrey Hatzakis, Angelos Lau, Daryl Lau, George Liang, T. Jake Locarnini, Stephen Martin, Paul Richman, Douglas D Zoulim, Fabien |
| description | 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. |
| doi_str_mv | 10.1053/j.gastro.2007.11.036 |
| format | Article |
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The reported results of clinical trials have used varying definitions of efficacy, failure, and resistance based on different measures of virologic responses. 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| fulltext | fulltext |
| identifier | ISSN: 0016-5085 |
| ispartof | Gastroenterology (New York, N.Y. 1943), 2008-02, Vol.134 (2), p.405-415 |
| issn | 0016-5085 1528-0012 |
| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_2676233 |
| source | MEDLINE; Elsevier ScienceDirect Journals; Alma/SFX Local Collection |
| subjects | Antiviral Agents - therapeutic use Biomarkers - metabolism Clinical Trials as Topic - standards Endpoint Determination Gastroenterology and Hepatology Hepatitis B - blood Hepatitis B - drug therapy Humans Interferons - therapeutic use Practice Guidelines as Topic - standards Treatment Outcome Virus Replication - drug effects |
| title | Virologic Monitoring of Hepatitis B Virus Therapy in Clinical Trials and Practice: Recommendations for a Standardized Approach |
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