About the Project
A five year plan of enhanced HCV monitoring, primary care–based workforce development, rapid scale-up of HCV treatment and public health policy action in HIV positive individuals within Australia.
Hepatitis C is recognised as a major contributor to co-morbidity in people with HIV. Unfortunately HCV therapies have been largely unsuccessful within this population, and complicated by toxicity and tolerability issues, limiting the ability to deliver large scale treatment delivery and success.
There is little doubt that new directly acting antiviral (DAA) drug regimens, available for treating HCV within the next few years, will be short course and easily tolerated, and likely to be equally successful in HIV positive and negative individuals. Prescription of these regimens needs to move from the specialist liver clinic out to community-based prescribers if large scale access to treatment is to be achieved. For the HIV positive community, this is likely to be easier than in the monoinfected population, given that S100 prescribing of antivirals for HIV is already established amongst HIV care providers.
CEASE is a major national collaborative venture with the ultimate aim of controlling and eliminating HCV infection from the Australian HIV positive population. This is not only imperative given the high rates of co-morbidity in this group coupled with an unprecedented rise in new infections, but also now potentially achievable given the reality of Interferon-free combination therapies and the likely extension into community prescribing.
This project has four major components which will occur independently but are linked to the central theme of controlling and eliminating HCV infection from the majority of the Australian HIV positive population.
Primary objective: To evaluate the feasibility of rapid scale-up of interferon-free DAA treatments and impact on the proportion with HCV viraemia within the HIV-HCV population of Australia.
Design & Method
The study will consist of four phases as detailed below:
CEASE-D : Surveillance of HCV
The surveillance phase is a prospective longitudinal cohort. The proportion with HCV viraemia within the HIV-HCV population will be monitored through three cross-sectional surveys of participants; at enrolment (2014-2015), follow-up 1 (2016) and follow-up 2 (2018). Participation will involve providing informed consent, a dried blood spot, patient-completed questionnaires and FibroScan® (where available). It is estimated that approximately 1000 participants will participate in the surveillance component of the study.
CEASE-M : Modelling
The data from the first cross-sectional survey of CEASE-D will be used to inform modelling to examine various treatment strategies.
CEASE-E: HCV Education for HIV Prescribers
A comprehensive education program in HCV treatment with interferon-free direct activity antiviral therapy will be conducted with HIV prescribers with high HCV caseloads in preparation for rapid scale-up of HCV treatment.
CEASE-T : HCV Treatment Scale-Up
An initial pilot phase will involve primary and tertiary clinics with existing HCV treatment programs, with early access to interferon-free DAA regimens pre-PBS listing through pharma-sponsored early access schemes or clinical trials protocols. This will be followed by an expanded phase following PBS listing.
Enrolment is currently open for CEASE-D (the surveillance phase).
Availability of highly efficacious well tolerated short course treatments for HCV not only provides hope of cure for the individual, but also offers significant potential benefits at a population level. Providing treatment coverage can reach a certain level, transmission dynamics will be affected and even interrupted, thus ending ongoing epidemics of transmission. This concept of treatment as prevention to bring about disease elimination is central to the control of HCV on a global level. Pilot elimination projects such as CEASE have the potential to crucially inform public health policy into the future.
Ph +61 2 9385 0877
Professor and Program Head
Ph 02 9385 0900
Ph +61 (0)2 9385 0900
Clinical Trials Manager
Ph +61 (0)2 9385 0886
Clinical Project Coordinator
Ph (02) 9385 0932
Ph +61 (02) 9385 0983
Project Collaborators: External
St. Vincent’s Hospital, NSW
Taylor Square Private Clinic, NSW
Holdsworth House Medical Practice, NSW
Kirketon Road Centre, NSW
Nepean Sexual Health, NSW
Blue Mountains Sexual Health, NSW
Sydney Sexual Health, NSW
Royal Adelaide Hospital, SA
Cairns Sexual Health, QLD