GESA MEDIA RELEASE

Monday 29 February 2016

AUSTRALIAN RECOMMENDATIONS FOR THE MANAGEMENT OF HCV INFECTION: A CONSENSUS STATEMENT

Chronic hepatitis C virus (HCV) infection affects 230,000 people in Australia, who are at risk of progressive liver fibrosis leading to cirrhosis, liver failure and hepatocellular carcinoma. The burden of liver disease due to HCV is projected to triple by 2030.

Several new treatments for HCV that are highly effective and well tolerated will be listed on the Pharmaceutical Benefits Scheme (PBS) from the 1st of March 2016, and all Australians living with HCV should now be considered for antiviral therapy. The Consensus Statement has been developed to provide healthcare professionals with guidance in the use of these new HCV medicines. The Statement presents evidence-based, expert-developed recommendations for hepatitis C management.

The PBS listing allows the new HCV medicines to be prescribed by gastroenterologists, hepatologists or infectious diseases physicians who are experienced in treating chronic HCV infection, as well as by general practitioners who are eligible to prescribe under the PBS in consultation with one of these specialists, removing the need for formal accreditation for GPs.

PBS authority approval will be required for each prescription; the medicines will not be available under streamlined authority. They will be available through the PBS General Schedule (S85 authority), allowing dispensing by approved pharmacists in the community, as well as through the Section 100 Highly Specialised Drugs Program, which makes provision for treatment of prisoners.

Treatment in primary care is suitable for most people with HCV, in particular people with no cirrhosis. It is estimated that 80% of Australians with HCV do not have significant liver damage. People with cirrhosis, complex medical problems or other types of liver disease should still be referred for specialist care.

PBS eligibility requires evidence of chronic infection documented by repeated HCV RNA positivity. Treatment regimen and duration is determined by HCV genotype and the presence or absence of cirrhosis, so all patients should have HCV genotype tested, as well as a liver fibrosis assessment. There is the potential for drug–drug interactions, requiring a careful assessment of concomitant drugs, including herbal, over-the-counter and recreational drugs.

New HCV medicines that will be available on the 1st of March include sofosbuvir, ledipasvir and daclatasvir. Several interferon-free regimens involving combinations of sofosbuvir, ledipasvir, daclatasvir and/or ribavirin for 8, 12 or 24 weeks will be available for treating people with genotypes 1–3 HCV, including those with decompensated liver disease. For now, the treatment for genotypes 4–6 HCV continues to involve peginterferon-alfa, in combination with ribavirin and sofosbuvir. More new medicines for HCV are expected to be available on the PBS later this year.

Populations who require special consideration when determining appropriate treatment regimen and timing are patients requiring a liver transplant, people with HIV or HBV coinfection, those with renal impairment and people with acute HCV infection.

The Consensus Statement was prepared by an expert panel representing the Gastroenterological Society of Australia (Australian Liver Association), the Australasian Society for Infectious Diseases, the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine, the Australasian Hepatology Association, the Royal Australian College of General Practitioners and Hepatitis Australia.

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More Information: gesa@gesa.org.au