Hepatitis C guidance: AASLD‐IDSA recommendations for testing, managing, and treating adults infected with hepatitis C virus

Abstract

Potential conflict of interest: Listed at the end of the article for all authors. These recommendations have been approved by the American Association for the Study of Liver Diseases and the Infectious Diseases Society of America. Potential conflict of interest: Listed at the end of the article for all authors. All 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. Preamble The pace of hepatitis C virus (HCV) drug development in recent years has accelerated dramatically. For patients to benefit from these impressive advances, practitioners need access to the most up‐to‐date data and to advice from experienced experts. Such information and advice can be difficult to access readily given the diverse sources from which information is available and the sometimes lengthy time needed for publication of original articles and scholarly perspectives. Traditional practice guidelines for more established areas of medicine and care often take years to develop and bring to publication. In the new era in hepatitis C treatment, such a process would not be nimble or timely enough to address the needs of patients with HCV infection, practitioners caring for these patients, or payers approving therapies for use. A living document made available in a web‐based system, such as that used by the US Department of Health and Human Services for human immunodeficiency virus (HIV) treatment recommendations (http://aidsinfo.nih.gov/guidelines), was selected as the best model to provide timely recommendations for hepatitis C management. In 2013, the two major membership societies supporting liver and infectious disease specialists (American Association for the Study of Liver Diseases [AASLD] and Infectious Diseases Society of America [IDSA]) joined forces to develop guidance for the management of hepatitis C in this rapidly moving field. The International Antiviral Society‐USA, which has experience in developing treatment guidelines in HIV disease, was invited to join the effort as a collaborating partner responsible for managing the panel and the guidance development process. The goal of the hepatitis C guidance is to provide up‐to‐date recommendations for HCV care practitioners on the optimal screening, management, and treatment for adults with HCV infection in the United States, using a rigorous review process to evaluate the best available evidence. This review provides a condensed summary of recommendations from the guidance. The complete guidance, which is updated regularly, is available at www.hcvguidelines.org. Process This was conceived to be a living document that would reside online and undergo real‐time revisions as the field evolved. To lead the process, two cochairs selected by the governing boards of each founding society were joined by a fifth cochair representing the International Antiviral Society‐USA. These cochairs selected 10 panel members from each society. The panel members were chosen to represent expertise in the diagnosis, management, treatment, research, and patient care from the fields of hepatology and infectious diseases. At least 51% of the panelists could have no substantive industry support other than research advisory boards, data safety monitoring boards, or research funding that went to the member's employer. The panel first convened in person in October 2013. Panel members were divided into teams to review available data and to propose preliminary guidance in three areas: (1) testing and linkage to care, (2) initial treatment of HCV infection, and (3) retreatment of patients in whom prior HCV treatment had failed. The treatment section teams also reviewed data for special considerations in patients with hepatitis C, including those with HCV/HIV coinfection, with decompensated cirrhosis, and who had undergone liver transplantation. The teams and cochairs met regularly by conference call. All panel members reviewed and approved the final recommendations. Each society's governing board peer‐reviewed the final recommendations. The first version of the guidance was uploaded (www.hcvguidelines.org) on January 29, 2014. By September 2014, three additional sections were developed: (1) treatment of acute HCV infection, (2) monitoring during and after therapy, and (3) when and whom to treat. In October 2014, the panel reconvened in person to update recommendations to consider data on pending new treatments. The updated recommendations (and appropriate revisions of all current guidance) were uploaded on December 20, 2014. This report was prepared on May 20, 2015. Funding for the guidance itself was provided by the AASLD and the IDSA. No industry funding was solicited or accepted. The Centers for Disease Control and Prevention (CDC) provided separate funding for identifying and reviewing data pertaining to testing and linkage to care. Collecting, Evaluating, and Rating the Evidence The