What was the societal challenge?
An estimated 47 million people are living with hepatitis C infection globally, most in low- and middle-income countries.
People who inject drugs are at high risk for acquiring hepatitis C. These populations face complex health challenges, but due to stigma and discrimination are often neglected in health policy and research.
Because of concerns around people who inject drugs not taking consistently takingthe treatments consistently, and the risk that they may be reinfected with the virus, a strong evidence base was needed to ensure those most at risk of hepatitis C could access highly curative treatments that could dramatically improve their health. True access for all is required to prevent ongoing spread of hepatitis C among those at risk.
High rates of incarceration for drug-related crimes translate into an enormous over-representation of people who inject drugs within prisons, with around half of the incarcerated population having a history of injecting drug use. Prison-specific strategies for hepatis C treatment and prevention were urgently needed.
How is the challenge being addressed?
The Kirby Institute at UNSW Sydney was the first in Australia and among the first globally to show that treatment was safe and feasible in people who were currently injecting drugs when the treatment was based on long, and only partially effective courses of injected interferon from the early 2000s.
This world-leading clinical research, together with detailed epidemiological studies of transmission among people who inject drugs in Australia, established the Kirby Institute as leaders and provided the foundation for US government funding to lead towards the evaluation of treatment outcomes among people who inject drugs and people living with HIV with acute and recently acquired hepatitis C infection. This was particularly important with the availability in the 2010s of direct-acting antivirals (DAAs), which were much easier to take and far more effective than the older treatments.
The Kirby Institute established multiple major clinical trials networks in Australia and globally, designed to recruit people who inject drugs into studies. This required significant community engagement to build trust and partnership with impacted communities.
Through these networks, the Kirby Institute conducted pivotal clinical trials funded through public and private industry grants, including a world-first randomised controlled trial to evaluate new therapies for hepatitis C in recently acquired infection. Collectively, these trials demonstrated that people who inject drugs were likely to complete their treatment courses and had cure rates above 90 percent, like non-injecting populations.
After demonstrating definitively that people who inject drugs can adhere to curative treatment, the Kirby Institute has led research that showed where the gaps in access to effective hepatitis C treatment were in 166 countries – providing crucial data to inform global advocacy for equitable care.
In prisons, the Kirby Institute-led, world-first SToP-C initiative evaluated how effectively the new treatments prevented transmission, as people who are on treatment or cured of HCV cannot transmit it to others.
What are the outcomes and societal impact?
This research has provided the evidence base to remove discriminatory barriers to health care, transforming the approach to hepatitis C treatment access internationally to including people with ongoing injecting drug use. Our work has contributed to more than 100,000 people being able to access the treatments in Australia, and millions of people globally.
The favourable treatment outcomes demonstrated through Kirby Institute-led clinical trials, particularly with DAA regimens, have had a major impact on public health policy and outcomes:
- Our trials are referenced in all major international hepatitis C treatment guidelines (World Health Organization, Europe, US) and incorporated within clinician education activities.
- The outcomes have been used by research-based biopharmaceutical company Gilead Sciences and US regulators to include people who inject drugs in medication indications, providing impetus and justification for the removal of ongoing drug use reimbursement restrictions for new therapies.
- Our research has allowed more people who inject drugs and people who are incarcerated to access these life-saving treatments.
- Our research has improved drug user healthcare delivery and reduced stigma related to hepatitis C.
As importantly, positive engagement with community throughout two decades of clinical research has garnered enormous trust and respect for the Kirby Institute nationally and internationally within the hepatitis C and drug user health sectors. It is these relationships that will enable future Kirby Institute-led research towards eliminating hepatitis C as a public health threat.
Key collaborators
National Health and Medical Research Council (NHMRC)