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Management of Chronic Hepatitis B

Management of Chronic Hepatitis B

Evidence Reports/Technology Assessments - Agency for Healthcare Research and Quality (US)

Version: October 2008


Hepatitis B is a highly prevalent disease with 350 million chronic cases worldwide. Despite immunization efforts, 6,212 incident cases of hepatitis B were diagnosed in the United States in 2004 and 4,713 cases in 2006. An estimated 2,000 to 4,000 deaths per year are related to CHB liver diseases, including liver cirrhosis and hepatocellular carcinoma. The natural history of hepatitis B is variable but generally indolent for many years to decades. Up to two-thirds of adults infected with hepatitis B virus do not experience symptoms, and approximately 5 percent of acutely infected immunocompetent adults develop CHB. Demographic, clinical, and hepatitis B disease factors are believed to be associated with the development of CHB (CHB), poor prognosis among those who develop CHB, and response to therapy. These include the mode and timing of infection, gender, race/ethnicity, geographic location, comorbid conditions, including alcohol use and coinfections with hepatitis C and human immunodeficiency virus (HIV), as well as biochemical, virological, and histological intermediate measures of hepatitis B activity.


We searched MEDLINE® via PubMed®, the Cochrane library, Medwatch, and United Kingdom Current Problems in Pharmacovigilance. We used the European Public Assessment Report to find original epidemiologic studies of adults with CHB published in English that reported mortality, incidence of hepatocellular carcinoma (HCC), or liver failure, prevalence and incidence of cirrhosis, HBeAg or HBsAg presence or seroconversion, viral load of hepatic virus B deoxyribonucleotide acid (HBV DNA), ALT levels, histological necroinflammatory and fibrosis scores, and adverse events after antiviral drugs approved by the Food and Drug Administration (FDA) for CHB, including interferon alfa-2b, pegylated interferon alfa-2a, lamivudine, adefovir, entecavir, tenofovir, and telbivudine. The search strategies for the four research questions are described in Appendix A * Appendixes and evidence tables cited in this report are provided electronically at http://www.ahrq.gov/downloads/pub/evidence/ pdf/hepb/hepb.pdf . Excluded references are shown in Appendix B. All work was conducted under the guidance of a Technical Expert Panel (TEP), whose members are identified in Appendix C.


This report synthesizes the evidence of the natural history of CHB and the effectiveness and harms of antiviral drugs on clinical, virological, histological, and biochemical outcomes. The primary goal in the management of adults with CHB is to initiate effective and safe therapies to improve health outcomes. CHB is a common and potentially serious health condition with a very long and complex clinical course. Predicting its natural history and accurately evaluating the effectiveness of treatments is very difficult, in part due to the long-term and heterogeneous nature of the disease. The data available are insufficient to provide patients, clinicians, researchers, and policymakers with high-quality information with which to make accurate prognostic and treatment decisions. Evidence from 38 observational studies suggested that increased age and duration of infection, male gender, coinfection with HIV, HCV or HDV, increased HBV DNA viral load, and cirrhosis were associated with increased risk of death and cancer, though the absolute risk is generally small. The magnitude and the confidence in the risk estimates of these variables varied. Cirrhosis was the factor associated with the highest degree of risk and greatest certainty in effect estimate.

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