In an individual who is HCV antibody-positive, current HCV infection should be confirmed by a PCR assay for HCV RNA. Quantitative PCR may be considered as part of the pre-treatment assessment because HCV RNA level can identify people who are eligible for a short treatment duration with sofosbuvir plus ledipasvir (see Treatment for chronic hepatitis C).
As noted, the first point-of-care test for HCV RNA was approved by the TGA in May 2020. The Xpert® HCV viral load assay (Cepheid) measures HCV RNA from a finger-prick blood sample (100 µL) and provides a real-time result in less than 60 minutes. This assay will promote the development of hepatitis C “test-and-treat” models of care to increase screening and treatment rates.
The introduction of pan-genotypic treatment regimens for HCV infection means that it is no longer mandatory to determine HCV genotype before prescribing treatment.
HCV genotype is not required by the PBS criteria before prescribing: sofosbuvir plus velpatasvir (first-line, treatment-naive); glecaprevir plus pibrentasvir (first-line, treatment-naive); and sofosbuvir plus velpatasvir plus voxilaprevir (NS5A inhibitor-experienced).
However, where possible, it is recommended that HCV genotype be documented in the patient’s medical record. Documenting HCV genotype is useful for people at high risk of reinfection, where genotype switch can differentiate reinfection from relapse. HCV genotype is also still relevant to decision making regarding sofosbuvir plus velpatasvir for people with cirrhosis, and for glecaprevir plus pibrentasvir in people who are treatment-experienced (see Treatment for chronic hepatitis C)
HCV genotyping is a routine laboratory test and is reimbursed on the Medicare Benefits Schedule (MBS).
It is particularly important to document HCV genotype before prescribing DAA treatment regimens that are genotype-specific. Elbasvir plus grazoprevir and sofosbuvir plus ledipasvir are both genotype-specific treatment regimens, and HCV genotype should be determined before prescribing either regimen.
It is important to document any prior treatment for HCV infection. Key information includes treatment regimen, duration, adherence and response. These may influence the choice of treatment regimen and/or treatment duration (see Treatment for chronic hepatitis C). Patients in whom a previous IFN-free regimen has failed frequently have resistant HCV variants.