What’s new?
This version of the consensus statement includes the following important updates.
Update to the recommended definition of chronic hepatitis C
The recommended definition for chronic hepatitis C has been expanded to include people who have detectable HCV RNA in plasma and the absence of clinical features of acute hepatitis (see Screening and Diagnosis).
Update to the recommendations for screening and diagnosis of hepatitis C
When screening for hepatitis C, we recommend that clinicians request reflex testing for HCV RNA if HCV serology is positive (see Screening and Diagnosis).
We recommend ongoing evaluation of the role of point-of-care tests for plasma HCV RNA in high-prevalence clinical settings, to increase rates of screening and reduce the rate of loss to follow-up between testing and diagnosis.
There are practical issues that remain to be resolved for the long-term implementation of these tests, including establishment of relationships between high-prevalence clinical settings and National Association of Testing Authorities (NATA)-accredited medical testing laboratories, development and participation in quality assurance programs, and reimbursement for HCV RNA testing in the absence of documented HCV serology (see Screening and Diagnosis).
Update to the recommended indications for treatment for hepatitis C infection
We continue to recommend that, except for those with limited (< 12 months) life expectancy due to non-liver or non-HCV-related comorbidities, all people living with hepatitis C should be considered for treatment.
The recommendation for treatment has been extended to include all people with a risk factor for hepatitis C transmission who are found to have detectable HCV RNA in plasma, regardless of the duration of infection.
This includes treatment for acute hepatitis C, which is recommended for people with risk factors for hepatitis C transmission, to prevent transmission events (see Treatment for chronic hepatitis C and Special populations: treatment of people with acute HCV infection).
Label updates: glecaprevir plus pibrentasvir
The recommended treatment duration using glecaprevir plus pibrentasvir is now 8 weeks for treatment-naive people with or without cirrhosis (see Glecaprevir plus pibrentasvir).
The Australian product information for glecaprevir plus pibrentasvir now includes treatment for children 3 years or older (no dose adjustment is required for children aged 12 years or older or those weighing > 45 kg) (see Children).
Label updates: sofosbuvir plus velpatasvir
The Australian product information for sofosbuvir plus velpatasvir has been updated to include efficacy and safety data for adult patients with severe renal impairment or end-stage renal disease (ESRD).
No dose adjustment is required for patients with renal impairment, including those with ESRD requiring dialysis (see Sofosbuvir plus velpatasvir and Special populations: treatment of HCV in people with renal impairment).
The Australian product information for sofosbuvir plus velpatasvir now includes treatment for children aged 12 years or older and weighing > 30 kg (no dose adjustment is required) (see Children).
Simplified testing pathway to confirm cure
Recent data suggest there is a very high correlation between SVR4 (undetectable plasma HCV RNA using a highly sensitive polymerase chain reaction (PCR) assay 4 weeks after completion of DAA therapy) and SVR12 (undetectable plasma HCV RNA using a highly sensitive PCR assay 12 weeks after completion of DAA therapy; the current definition for cure).
Therefore, opportunistic testing of HCV RNA at any time beyond 4 weeks after treatment completion is adequate, especially when there is concern about subsequent loss to follow-up (e.g. in prisoners for whom release to the community may be imminent) (see Confirm SVR (cure).
Use of non-invasive tools to screen for complications of portal hypertension in people living with cirrhosis
All individuals with cirrhosis should be assessed for their risk of clinically significant portal hypertension (CSPH).
Guidelines now recommend that non-invasive tools (liver stiffness measurement and platelet count) be used to triage risk of CSPH (see Screen for complications of cirrhosis).
Updates on treatment of hepatitis C in people with HCC
Treatment of hepatitis C in people with cirrhosis reduces their risk of HCC.
There is a small reduction in the rate of sustained virological response (SVR) in people with HCC.
There are no conclusive data that DAA therapy is associated with risk of recurrent HCC or rapid progression of HCC.
All people with HCC should be considered for DAA therapy, but treatment decisions should be individualised, taking into account life expectancy, and made in consultation with a multidisciplinary team.
All people with HCV cirrhosis remain at risk of HCC, even after achieving SVR, and surveillance should continue long term (see Direct-acting antiviral therapy and risk of hepatocellular carcinoma in people with cirrhosis).
Recommendations for managing dose interruptions in people receiving DAA therapy
Adherence to DAA therapy is important and should be actively supported.
Dose interruption is not recommended. However, as dose interruption does occur, specific recommendations regarding management of dose interruptions are now included (see On-treatment monitoring).