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Diagnosis, Management, and Treatment of Hepatitis C: An Update. The hepatitis C virus (HCV) is a major public health problem and a leading cause of chronic liver disease
AASLD PRACTICE GUIDELINES Diagnosis, Management, and Treatment of Hepatitis C: An Update
Marc G. Ghany,1 Doris B. Strader,2 David L. Thomas,3 and Leonard B. Seeff4
This document has been approved by the AASLD, the Infectious Diseases Society of America, and the American College of Gastroenterology. Intended for use by physicians, these recommendations suggest preferred approaches to the diagnostic, therapeutic and preventive aspects of care. They are intended to be flexible, in contrast to standards of care, which are inflexible policies to be followed in every case. Specific recommendations are based on relevant published information. To more fully characterize the quality of evidence supporting recommendations, the Practice Guidelines Committee of the AASLD requires a Class (reflecting benefit versus risk) and Level (assessing strength or certainty) of Evidence to be assigned and reported with each recommendation (Table 1, adapted from the American College of Cardiology and the American Heart association Practice Guidelines).3,4
These recommendations provide a data-supported approach to establishing guidelines. They are based on the following: (1) a formal review and analysis of the recently published world literature on the topic (Medline search up to September 2008); (2) the American College of Physicians’ Manual for Assessing Health Practices and Designing Practice Guidelines;1 (3) guideline policies, including the American Association for the Study of Liver Diseases’ (AASLD) Policy on the Development and Use of Practice Guidelines and the American Gastroenterological Association’s Policy Statement on the Use of Medical Practice Guidelines;2 and (4) the experience of the authors in regard to hepatitis C.
Abbreviations: AASLD, American Association for the Study of Liver Diseases; ALT, alanine aminotransferase; ANC, absolute neutrophil count; anti-HCV, antibody to HCV; AST, aspartate aminotransferase; CKD, chronic kidney disease; CTP, Child-Turcotte-Pugh; EIA, enzyme immunoassay; ETR, end-of-treatment response; EVR, early virological response; FDA, U.S. Food and Drug Administration; HCV, hepatitis C virus; HIV, human immunodeficiency virus; PCR, polymerase chain reaction; PEG, polyethylene glycol; RVR, rapid virological response; SVR, sustained virological response; ULN, upper limit of normal. From the 1Liver Diseases Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Department of Health and Human Services, Bethesda, MD; 2Division of Gastroenterology/Hepatology, Fletcher Allen Health Care, University of Vermont College of Medicine, Burlington, VT; 3Infectious Disease, The Johns Hopkins University School of Medicine, Baltimore MD; 4Liver Disease Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Bethesda, MD. Received November 21, 2008; accepted November 23, 2008. Disclaimer Statement: The views expressed in these guidelines do not necessarily represent the views of the Department of Health and Human Services, the National Institutes of Health, the National Institute of Diabetes and Digestive and Kidney Diseases, or the United States Government. Address reprint requests to: Leonard B. Seeff, M.D., Liver Disease Research Branch, National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health, Building 31, Room 9A27, Bethesda, MD 20892. Email: firstname.lastname@example.org; fax: 301-480-7926. Copyright © 2009 by the American Association for the Study of Liver Diseases. Published online in Wiley InterScience (www.interscience.wiley.com). DOI 10.1002/hep.22759 Potential conflict of interest: Drs. Marc Ghany, Leonard Seeff, and Doris Strader have no financial relationships to declare. Dr. David Thomas was on the Advisory Board of Merck, Sharpe and Dohme at the time of writing but has since resigned from this position. All American Association for the Study Liver Diseases (AASLD) Practice Guidelines are updated annually. If you are viewing a Practice Guideline that is more than 12 months old, please visit www.aasld.org for an update in the material.
The hepatitis C virus (HCV) is a major public health problem and a leading cause of chronic liver disease.5 An estimated 180 million people are infected worldwide.6 In the United States (U.S.), the prevalence of HCV infection between the years 1999 and 2002 was 1.6%, equating to about 4.1 million persons positive for antibody to hepatitis C (anti-HCV), 80% of whom are estimated to be viremic.7 Hepatitis C is the principal cause of death from liver disease and the leading indication for liver transplantation in the U.S.8 Some calculations suggest that mortality related to HCV infection (death from liver failure or hepatocellular carcinoma) will continue to increase over the next two decades.9 The purpose of this document is to provide clinicians with evidence-based approaches to the prevention, diagnosis, and management of HCV infection.
Testing and Counseling
Testing. The optimal approach to detecting HCV infection is to screen persons for a history of risk of exposure to the virus, and to test selected individuals who have an identifiable risk factor.10 Currently, injection drug use is the primary mode of HCV transmission in the U.S; thus, all persons who use or have used illicit injection drugs in the present or past, even if only once, as well as intranasal drug users who share paraphernalia, should be tested for HCV infection.7,11,12 Individuals who have received a blood or blood component transfusion or an