News - Pharmaceuticals
Hepatitis B overhaul as prescribing rules face major rewrite

Australian clinicians will no longer need specialist accreditation to prescribe hepatitis B antiviral treatments under a reform aimed at removing longstanding barriers to care. The change follows years of advocacy by peak bodies and patient advocacy groups seeking to make hepatitis B treatment more accessible.
Hepatitis B is the most common blood-borne virus in Australia, with nearly 230,000 people living with chronic hepatitis B. Without appropriate management, the infection can progress to serious liver disease or liver cancer. Under the new arrangements, all medical practitioners and authorised nurse practitioners will be able to prescribe PBS-subsidised antiviral medicines for eligible patients, reducing reliance on specialist services.
Alexis Apostolellis, CEO of ASHM, said the reform would strengthen the role of primary care in managing hepatitis B shifting the reliance on specialists who currently write more than 75% of hepatitis B treatment prescriptions.
“While we have seen growing involvement from primary care in the management of chronic hepatitis B, care is still largely concentrated in specialist settings where some hospitals have waitlists that exceed two years,” said Apostolellis. “By allowing more GPs and nurse practitioners to prescribe hepatitis B treatments, we can bring care closer to home, reduce pressure on specialist clinics, and help more Australians access the treatment and monitoring they need.”
The reform also maintains access to established first-line antiviral therapies. Gilead’s Vemlidy (tenofovir alafenamide), Viread (tenofovir disoproxil fumarate), generic forms of tenofovir and generic forms of BMS’s Baraclude (entecavir) remain effective first-line treatments in line with Gastroenterological Society of Australia (GESA) guidelines.
Despite the availability of effective therapies, significant gaps remain in the delivery of guideline-recommended care. Currently, only one in four people living with chronic hepatitis B are receiving guideline-recommended clinical care, while less than half of those eligible for treatment are receiving it.
Lucy Clynes, CEO of Hepatitis Australia, said expanding prescribing rights would allow people living with hepatitis B to access treatment through healthcare providers they already know and trust.
“Making access simple is essential. Many people with hepatitis B rely on GPs who speak their language or are close to home. This change means they can access care through the providers they already know and trust, just as they would for any other chronic condition,” said Clynes. “The first functional cures are on the horizon, but they will be most effective for people whose hepatitis B is well managed.”
The reform is expected to strengthen Australia’s efforts to meet its 2030 hepatitis B elimination target.
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