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Updated Guidance for Use of Hepatitis C Drugs

Experts revise 2014 recommendations

The American Association for the Study of Liver Diseases (AASLD), in partnership with the Infectious Diseases Society of America (IDSA) and in collaboration with the International Antiviral Society–USA (IAS-USA), created online Recommendations for Testing, Managing, and Treating Hepatitis C in 2014 to aid practitioners treating patients infected with hepatitis C virus (HCV). Now updated guidance, with a summary of recommendations regarding treatment with direct-acting antiviral drugs, has been published in the AASLD journal Hepatology.

HCV is a blood-borne virus that infects the liver and may lead to cirrhosis or hepatocellular carcinoma. During the past 25 years, HCV infection has gone from an undiagnosed disease to epidemic levels, with the World Health Organization (WHO) estimating that up to 150 million people worldwide have chronic disease.

In the U.S., nearly 30,000 new acute cases of HCV infection were reported in 2013, and 2.7 million Americans have chronic HCV infection, according to the Centers for Disease Control and Prevention.

“The good news is that HCV [infection] is now on the cusp of being a curable disease for millions of Americans, many of whom are undiagnosed,” said Dr. Gary Davis, co-chair of the AASLD/IDSA HCV Guidance writing panel. “The web-based guidance document is an easy-to-use resource for practitioners treating HCV patients with novel antivirals.”

A panel of 26 hepatologists and infectious-disease specialists, along with a patient advocate, developed the original consensus recommendations, which include:

  • HCV testing details and linkage to care
  • Recommendations for initial treatment of HCV infection in patients starting treatment
  • Retreatment information in persons in whom prior therapy has failed
  • Unique patient population data

Specifically, the updated recommendations offer the following guidance:

  • One-time HCV testing is recommended for persons born between 1945 and 1965, without prior ascertainment of risk.
  • Other persons should be screened for risk factors for HCV infection, and one-time testing should be performed for all persons with behaviors, exposures, and conditions associated with an increased risk of HCV infection.
  • Annual HCV testing is recommended for persons who inject drugs and for human immunodeficiency virus (HIV)-seropositive men who have unprotected sex with men. Periodic testing should be offered to other persons with ongoing risk factors for exposure to HCV.
  • An anti-HCV test is recommended for HCV testing, and if the result is positive, current infection should be confirmed by a sensitive HCV RNA test.
  • Among persons with a negative anti-HCV test who are suspected of having liver disease, testing for HCV RNA or follow-up testing for HCV antibody is recommended if exposure to HCV occurred within the past 6 months; testing for HCV RNA can also be considered in persons who are immunocompromised.
  • Among persons at risk of reinfection after previous spontaneous or treatment-related viral clearance, initial HCV RNA testing is recommended because an anti-HCV test is expected to be positive.
  • Quantitative HCV RNA testing is recommended prior to the initiation of antiviral therapy to document the baseline level of viremia (i.e., the baseline viral load).
  • Testing for the HCV genotype is recommended to guide the selection of the most appropriate antiviral regimen.
  • If individuals are found to have positive results for an anti-HCV test and negative results for HCV RNA by polymerase chain reaction, they should be informed that they do not have evidence of current (active) HCV infection.
  • Individuals with current (active) HCV infection should receive education and interventions aimed at reducing the progression of liver disease and preventing the transmission of HCV.
  • Evaluation by a practitioner who is prepared to provide comprehensive management, including the consideration of antiviral therapy, is recommended for all persons with current (active) HCV infection.

Sources: Wiley; June 25, 2015; and HCV Guidance; June 2015.

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