Pre-treatment assessment

All people living with HCV infection should be considered for treatment, except those with limited life expectancy (< 12 months) due to non-liver-related or non-HCV-related comorbidities. It is important that all people considered for treatment undergo a comprehensive pre-treatment assessment (Table 2). This assessment provides the foundation for a successful virological outcome by establishing a therapeutic and collaborative relationship.

Access to peer and social support; psychological, alcohol and drug counselling; and information about preventing transmission of HCV and avoidance of HCV reinfection should be provided.

Key elements of the pre-treatment assessment are to:

  • Perform a virological evaluation to:
    - confirm the diagnosis of chronic HCV infection
    - identify the genotype of HCV infection
    - document the HCV treatment history
  • Evaluate for the presence of cirrhosis
  • Evaluate for the presence of hepatitis B virus (HBV) or human immunodeficiency virus (HIV) coinfection
  • Consider whether coexisting liver diseases are present
  • Consider concomitant medications for risk of drug–drug interactions, including ethinyloestradiol-containing oral contraceptives, over-the-counter preparations and recreational substances.
  • Evaluate renal function
  • Discuss the need for contraception
  • Discuss the importance of treatment adherence.

Table 2. Pre-treatment assessment of people with chronic hepatitis C virus (HCV) infection

History

  • Estimated duration of HCV infection
  • Previous HCV treatment experience — date, regimen and response
  • Cofactors for liver disease progression: alcohol intake, marijuana use, virological cofactors (HIV, HBV), diabetes, obesity
  • For those planned to receive ribavirin, note history of ischaemic heart disease or cardiovascular risk factors
  • Vaccinations against HBV and HAV
  • Physical and psychiatric comorbidities
  • Ongoing risk factors for viral transmission and reinfection
  • Social issues — potential barriers to medication adherence

Medication

  • Concomitant medications (prescription, over-the-counter, illicit)

Physical examination

  • Features of cirrhosis: hard liver edge, spider naevi, leukonychia
  • Features of decompensation or portal hypertension: jaundice, ascites, oedema, bruising, muscle wasting, encephalopathy
  • Body weight and body mass index

Virology

  • HCV PCR
  • HCV genotype*
  • Consider HCV RNA level (quantitative)
  • HBV (HBsAg, anti-HBc, anti-HBs), HIV, HAV serology

Investigations

  • Full blood examination, liver function tests, urea and electrolytes, eGFR, INR
  • Pregnancy test for women of childbearing potential
  • Liver fibrosis assessment, e.g.:
       - Elastography (FibroScan®, ARFI, SWE)
       - Serum biomarker (APRI, Hepascore, ELF test, FibroGENE§)
  • Liver ultrasound should be performed in people with cirrhosis to exclude hepatocellular carcinoma (within 3 months before starting DAAs)
  • Electrocardiogram should be performed if ribavirin therapy is planned and patient is > 50 years of age or has cardiac risk factors

HIV = human immunodeficiency virus. HBV = hepatitis B virus. HAV = hepatitis A virus. PCR = polymerase chain reaction. HBsAg = hepatitis B surface antigen. anti-HBc = hepatitis B core antibody. anti-HBs = hepatitis B surface antibody. eGFR = estimated glomerular filtration rate. INR = international normalised ratio. ARFI = acoustic radiation force impulse. SWE = shear wave elastography. APRI = aspartate aminotransferase to platelet ratio index. ELF = Enhanced Liver Fibrosis. DAA = direct-acting antiviral. PBS = Pharmaceutical Benefits Scheme.
* HCV genotype is required by the PBS criteria; it is important before prescribing elbasvir plus grazoprevir or sofosbuvir plus ledipasvir.
† HCV RNA level is important for determining eligibility for 8-week treatment duration with sofosbuvir plus ledipasvir.
‡ All three tests for HBV may be requested if the clinical notes indicate acute or chronic hepatitis.
Online calculator available at: http://www.fibrogene.com/viral_hepatitis.html.

Note: People living with hepatitis C can receive information, support and referral from community services, including:
·         Hepatitis Australia
·         Hepatitis Information Line: 1800 437 222
·         Australian Injecting & Illicit Drug Users League