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 1). 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 (may be considered)
    - document the HCV treatment history
  • Evaluate for the presence of cirrhosis
    - if present, screen for complications of cirrhosis                 
  • Evaluate for the presence of HBV or 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 1. 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 (may be considered)*
  • HBV (HBsAg, anti-HBc, anti-HBs†), HIV‡, HAV serology

Investigations
  • Full blood examination, liver function tests, eGFR, INR
  • Pregnancy test for women of childbearing potential
  • Liver fibrosis assessment§, e.g.:
       - Elastography (FibroScan®, ARFI, SWE)
       - Serum biomarker (APRI, FIB-4, Hepascore, ELF test‡)
  • For people with cirrhosis:
    - Liver ultrasound  to exclude hepatocellular carcinoma (should be performed within 3 months before starting DAAs)
    - Screening for clinically significant portal hypertension and osteoporosis

anti-HBc = hepatitis B core antibody; anti-HBs = hepatitis B surface antibody; APRI = aspartate aminotransferase to platelet ratio index; ARFI = acoustic radiation force impulse; DAA = direct-acting antiviral; eGFR = estimated glomerular filtration rate; ELF = Enhanced Liver Fibrosis; FIB-4 = Fibrosis-4; HAV = hepatitis A virus; HBsAg = hepatitis B surface antigen; HBV = hepatitis B virus; HIV = human immunodeficiency virus; INR = international normalised ratio; PBS = Pharmaceutical Benefits Scheme; PCR = polymerase chain reaction; SWE = shear wave elastography.

* HCV genotype is no longer required by the PBS criteria for pan-genotypic regimens: sofosbuvir + velpatasvir (first-line, treatment-naive); glecaprevir + pibrentasvir (first-line, treatment-naive); and sofosbuvir + velpatasvir + voxilaprevir (NS5A inhibitor-experienced). Testing HCV genotype may be considered (see text).

† All three tests for HBV may be requested if the clinical notes indicate acute or chronic hepatitis.

‡ If testing for HBV and HIV cannot be performed before starting DAA therapy, especially in high-prevalence clinics where people are being screened for HCV using point-of-care tests, HBV and HIV testing should be performed within 4 weeks of starting DAAs.

§ If fibrosis assessment cannot be organised in a timely fashion, people should immediately start hepatitis C treatment, especially when there is concern about loss to follow-up.

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