AUSTRALIA is at a hepatitis C crossroads.
The burden of hepatitis C virus (HCV)-related liver disease is escalating, including more than a doubling in liver failure and liver cancer cases over the past decade, driven by an ageing HCV-infected population, and low uptake (1%‒2% treated per year) and suboptimal efficacy of interferon-based therapies.
The recent HCV therapeutic development revolution is clearly one of the major advances in clinical medicine in recent decades. All the oral, short duration (8–12 weeks), combination direct acting antiviral (DAA) regimens that have been developed provide cure rates above 90% with minimal toxicity.
Several interferon-free DAA regimens have been licensed in the US and Europe over the past 18 months, although the relatively high drug pricing has led to prioritisation to those patients with advanced liver fibrosis in most settings, to limit the impact on the health budget.
The Pharmaceutical Benefits Advisory Committee (PBAC) at its March and July 2015 meetings recommended Pharmaceutical Benefits Schedule (PBS) listing of four highly effective interferon-free DAA regimens.
Importantly, the PBAC recommended that these regimens be made available without liver disease stage restrictions, thus enabling the vast majority of people with chronic HCV to be eligible. Assuming PBS listing occurs (potentially early 2016), Australia would have a unique opportunity to broadly implement these therapies and limit the rising liver disease burden.
There are several reasons why Australia is in a position to address the rising burden of HCV-related liver disease in the community.
First, public health services including harm reduction for people who inject drugs (PWID) — the key affected population in Australia and most high-income countries — are more broadly accessible than in most other countries.
Second, there are no proposed PBS restrictions based on drug and alcohol use. Recent data suggest that in the majority of US jurisdictions, access to interferon-free DAA regimens is restricted to those patients without ongoing illicit drug use, thus denying the potential for HCV cure to the most marginalised.
Third, the PBAC has recommended that new HCV treatments be accessible through primary care and other community-based settings, with community pharmacy dispensing. Most other countries restrict access to specialist prescribers.
These measures to develop HCV therapeutic strategies for PWID demonstrate Australia’s international public health leadership in responding to hepatitis C.
The 4th International Symposium on Hepatitis Care in Substance Users (INHSU 2015) was recently held in Sydney, the first time outside Europe, and was highly successful. Key to the success of the symposium was the involvement of the affected community, with all sessions co-chaired by a community representative.
Australia is seen as a leader in developing partnerships across clinical, research, community and government sectors to work towards an effective response to HCV.
Australia also played a lead role in developing the INHSU recommendations on hepatitis C management for PWID, recently published in the International Journal of Drug Policy as part of a special issue: “Expanding access to prevention, care and treatment for hepatitis C virus infection among people who inject drugs”.
The INHSU recommendations demonstrate that there is compelling evidence that HCV treatment is safe and effective for people who inject drugs and responses are comparable to those in non-drug using populations. HCV treatment for current and former PWID is also cost-effective, particularly when potential prevention benefits are considered.
When the PBS lists the highly curative interferon-free DAA regimens, Australia will be in a unique position to be one of the world leaders in providing broad access to therapy for people with HCV, thereby working towards its elimination as a major public health issue.
Associate Professor Jason Grebely is a clinical epidemiologist at the Kirby Institute, based at UNSW Australia. Professor Gregory Dore is the Head of the Viral Hepatitis Clinical Research Program at the Kirby Institute.