Clinical Guidelines for the Medical Management of Hepatitis C

A. Introduction

Hepatitis C virus (HCV) infection is a major public health problem, a leading cause of chronic liver disease throughout the world, and the leading cause of death from liver disease in the United States (U.S.)1. In New York State (including New York City), there are an estimated 237,000 people with chronic hepatitis C (CHC) based on surveys from the Centers for Disease Control and Prevention (CDC). These estimates of prevalence are likely conservative, because they do not include incarcerated and homeless persons, groups that have a high prevalence of HCV infection.

HCV infection is a reportable disease in New York State (10NYCRR2.1). In the past, reporting guidelines have emphasized the reporting of new acute cases of HCV; however, as of 2002, reporting guidelines require the reporting of both new acute and chronic HCV cases. Furthermore, in January 2003, CDC made CHC a nationally reportable disease and since then, the New York State Department of Health (NYSDOH) is submitting all reported cases of CHC to CDC on a weekly basis.

CHC accounts for at least 40% of liver transplants in the U.S. today and the number of HCV-infected patients with cirrhosis is estimated to double over the next 20 years.1 Identifying and treating patients with bridging fibrosis or cirrhosis on liver biopsy best accomplish reduction in complications of cirrhosis. Although antiviral treatment with interferon-based regimens is successful in many patients, this treatment may be complex to administer and requires careful patient monitoring for the occurrence of adverse events and dose adjustments, as needed, as well as experienced providers to manage patient care2.

In 2004, the NYSDOH convened a panel of experts in the field of HCV medical care, and consumers to develop these guidelines. The purpose of the guidelines is to provide clinicians with practical, state-of-the-art information on the diagnosis, medical management, and prevention of HCV infection. These guidelines are intended for the medical management of adults and children infected with HCV. While the field of HCV medicine is still evolving, these guidelines review the currently available evidence to support the recommendations, and, where published data are lacking, present standards of care as recommended by the panel.

The final guidelines will be presented in two formats: (1) a condensed version with recommendations and tables and figures, and (2) the full version that includes rationale for the recommendations, appendices, and references.

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