Today, UNSW Australia announced that it will lead a world-first study to evaluate highly curative new hepatitis C treatments as a means of preventing hepatitis C spread within prisons.
The SToP-C study (Surveillance and Treatment of Prisoners with hepatitis C) is being undertaken in collaboration with the Justice Health and Forensic Mental Health Network, Corrective Services NSW, NSW Health, Hepatitis NSW, NSW Users and AIDS Association, and the Community Restorative Centre.
The study will begin recruiting prisoners in selected correctional facilities in New South Wales starting in September 2014. UNSW researchers and project partners will investigate whether a significant reduction in hepatitis C infections in NSW prisons is possible with a “treatment as prevention” strategy, which will seek to treat consenting prisoners for their hepatitis C infection, both to improve their own health and to make onward transmission to others less likely.
“There is significant evidence from the world of HIV research to suggest that treating an HIV positive person with antiviral drug therapy dramatically reduces their risk of passing the virus on,” said study co-lead, Professor Greg Dore from the Kirby Institute at UNSW. “Our aim is to evaluate a similar strategy for hepatitis C in the prison setting in New South Wales, where there are extremely high numbers of existing and new hepatitis C infections.”
New South Wales prisons are a suitable setting for the study, given an existing innovative hepatitis C treatment nurse-led model developed by study co-lead, Professor Andrew Lloyd from the Inflammation and Infection Research Centre at UNSW. About 30% of all prisoners have chronic hepatitis C infection, but the current interferon-based treatment causes high rates of side-effects and demands significant health care resources to manage patients through the 6-12 months of treatment.
“The StoP-C study builds on our previous research documenting high rates of hepatitis C transmission in New South Wales prisons, but also the successes of the nurse-led model of hepatitis C treatment provided by Justice Health and Forensic Mental Health Network, which offers the potential to rapidly scale-up treatment through simpler and more effective therapy,” explained Professor Andrew Lloyd.
The regimen to be used in the SToP-C study, funded by pharmaceutical company Gilead Sciences Inc., is one tablet (two drugs co-formulated) once a day for 12 weeks.
“With clinical trial data indicating few side-effects, a cure rate above 90%, and activity against all strains of hepatitis C, these new interferon-free therapies will transform how we treat people with hepatitis C, and provide the feasibility to greatly enhance existing harm reduction prevention.” said Professor Dore.
The study is expected to take five years to complete. Phase 1 will involve 450 consenting prisoners in each of two maximum security facilities. For the first year, study participants will undergo blood tests to monitor their hepatitis C status and be scanned for liver disease (an outcome of chronic hepatitis C infection). Participants will be interviewed about their risk behaviours and attend harm reduction education sessions.
After one year, consenting prisoners in one facility will be treated with the new interferon-free hepatitis C treatment. Consenting prisoners in a second prison will be offered the current standard hepatitis C treatment (interferon-containing), but will have access to the same new interferon-free treatment 12 months later.
Phase 2 of the trial is planned to be conducted in several medium security facilities, to assess how effective a treatment as prevention strategy is in transient populations that move more frequently between prison and the community.
Plans for the study are being presented today (Wednesday 17 September)at the 9th Australasian Viral Hepatitis Conference in Alice Springs.
“The StoP-C trial is revolutionary and could eventually have a significant impact on the hepatitis C epidemic globally.” - Stuart Loveday, Chief Executive Officer of Hepatitis NSW
“The SToP-C trial presents excellent opportunities to provide people with hepatitis C in NSW prisons access to new treatment as well as exploring the role of treatment as a prevention tool.”
- Dr Kerry Chant, NSW Chief Health Officer
“Approximately 28% of men and 45% of women in custody in NSW have been exposed to hepatitis C1. With the high prevalence of hepatitis C in the custodial setting, the SToP-C trial presents an excellent opportunity to provide our patients with access to new treatment that has the potential to greatly improve their health and wellbeing.” – Julie Babineau, Chief Executive of Justice Health and Forensic Mental Health Network
1 Inmate Health Survey 2009
“Corrective Services NSW strongly supports the value of this research and its potential for improving the health and wellbeing of prisoners in NSW and reducing the risks to staff who work in custodial settings.” - Luke Grant, Assistant Commissioner, Corrective Services NSW
“The concept of treatment as prevention is complex, particularly within marginalised communities. SToP-C is providing an opportunity to explore how treatment as prevention may contribute to reducing the incidence of hepatitis C and contribute to the already validated harm reduction tools that we have, such as the needle and syringe program and peer education.”- Nicky Bath, Chief Executive Officer of NSW Users and AIDS Association
“The Community Restorative Centrerecognises the complex and often undiagnosed and untreated health needs of people in prison. For many, prison will be the first time (in many years) they will access health services. For some, prison will be the place they are diagnosed with the hep C virus. In contrast to the usual feelings of alienation from health services in the community, the SToP-C trial will provide a unique opportunity to those affected by the criminal justice system to access innovative treatment in the area of hep C.” – Alison Churchill, Chief Executive Officer of the Community Restorative Centre