What guidelines have been published for the diagnosis of hepatitis C (hep C) infection?

Updated: Oct 07, 2019
  • Author: Vinod K Dhawan, MD, FACP, FRCPC, FIDSA; Chief Editor: BS Anand, MD  more...
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Please note that guidelines for the current diagnostic workup and management of hepatitis C (HCV) infection continue to rapidly evolve. Clinicians are advised to refer frequently to HCV Guidance: Recommendations for Testing, Managing, and Treating Hepatitis C, the most recent recommendations of the American Association for the Study of Liver Diseases (AASLD) and Infectious Diseases Society of America (ISDA). Other resources can also be found at the IDSA website.

AASLD/ISDA guidelines

The AASLD/ISDA recommend the following for initial HCV testing and followup [9] :

  • Initial HCV testing: HCV-antibody test; if the result is positive, confirm current infection with a sensitive HCV-RNA test.
  • Negative HCV-antibody test but clinical suspicion of liver disease: Test for HCV RNA or followup testing for HCV antibody if HCV exposure occurred within the past 6 months; consider testing for HCV RNA in immunocompromised individuals.
  • Reinfection after previous spontaneous or treatment-related viral clearance: Obtain initial HCV-RNA testing (because an HCV-antibody test is expected to be positive).
  • Before initiation of antiviral therapy: Obtain quantitative HCV-RNA testing to document baseline viral load.
  • Selection of the most appropriate antiviral regimen: Use HCV genotype testing for guidance.
  • Positive HCV-antibody test with negative HCV RNA by polymerase chain reaction (PCR): Inform patients they do not have evidence of current (active) HCV infection.

All patients with HCV infection are recommended to have an evaluation for advanced fibrosis with the use of liver biopsy, imaging, and/or noninvasive markers to aid in decision making regarding treatment strategies and to determine whether additional measures for the management of cirrhosis should be initiated (eg, screening for hepatocellular carcinoma). [9] Patients in whom therapy is deferred should undergo repeat liver assessment on an ongoing basis.

WHO guidelines

The World Health Organization (WHO) recommends nucleic acid testing for qualitative or quantitative HCV RNA detection as well as for test of cure at 12 or 24 weeks following antiviral treatment completion. [50] In areas with limited resources, the WHO suggests using the aminotransferase/platelet ratio index (APRI) or the fibrosis-4 (FIB-4) score for evaluating hepatic fibrosis rather than other noninvasive tests that require more resources (eg, elastography, FibroTest), as follows [50] :

  • APRI = [(AST (IU/L)/AST_ULN (IU/L))×100]/platelet count (10 9 /L)
  • FIB-4= age (years) × AST (IU/L)/platelet count (10 9)/L × [ALT (IU/L)1/2]

where ALT is alanine aminotransferase, AST is aspartate aminotransferase, IU is international unit, and ULN is the upper limit of normal.

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