This version of the consensus statement includes the following important updates.
Prescribing by nurse practitioners
Prescribing rights have been extended to authorised nurse practitioners under the Highly Specialised Drugs Program (Section 100), as well as the PBS General Schedule (prescribing rights for nurse practitioners were previously restricted to the General Schedule) (see Models of care for the treatment of HCV infection in Australia).
Removal of the PBS requirement to document HCV genotype before prescribing pan-genotypic treatment regimens for hepatitis C
The PBS General Statement for Drugs for the Treatment of Hepatitis C has been amended to remove the requirement for documenting HCV genotype to determine patient eligibility for subsidisation of hepatitis C treatment under the PBS (Section 4.1.2). Rather, it is now recommended that, where possible, evidence of the HCV genotype be documented in the patient’s medical record. HCV genotype must still be documented for regimens that are not pan-genotypic (see Treatment for chronic hepatitis C).
PBS listing of sofosbuvir plus velpatasvir plus voxilaprevir
Sofosbuvir plus velpatasvir plus voxilaprevir is a pan-genotypic regimen that was listed on the PBS in April 2019 for the treatment of people who had failed therapy with a regimen including an NS5A inhibitor (see Sofosbuvir plus velpatasvir plus voxilaprevir). Details of the previous NS5A inhibitor-containing treatment regimen are now required at the time of application to the PBS for sofosbuvir plus velpatasvir plus voxilaprevir.
Removal of the PBS requirement that patients be aged 18 years or older before prescribing treatment for hepatitis C
Children under the age of 18 years can now be prescribed HCV treatment that is listed on the PBS (see Children). Treatment regimens that have been evaluated in children under the age of 18 years include sofosbuvir plus velpatasvir, glecaprevir plus pibrentasvir and sofosbuvir plus ledipasvir (for Gt 1 HCV). Children under the age of 18 years should be referred to a paediatrician who is experienced in the treatment of HCV for discussion about therapy. A document providing specific guidance on the treatment of HCV infection in children aged under 18 years is in development.
TGA approves the first point-of-care assay for hepatitis C
The first point-of-care test for HCV RNA was approved by the Australian TGA in May 2020. The Xpert® HCV viral load assay (Cepheid) measures HCV RNA from a finger-prick blood sample (100 L) and provides a real-time result in less than 60 minutes. The availability of this assay may promote screening for hepatitis C, as well as the development of “test-and-treat” models of care in high-risk populations (see Models of care for the treatment of HCV infection in Australia).