World first prison-based hepatitis C treatment – just one tablet a day
UNSW will lead a world-first study to evaluate the effectiveness of a one tablet per day hepatitis C treatment as a means of preventing the spread of the virus in 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.