CEASE: Control and Elimination within AuStralia of HEpatitis C from people living with HIV

Date Commenced:
July 2014
Project Status
Ongoing
Expected Date of Completion:
Ongoing
Currently recruiting
Yes
CEASE: Control and Elimination within AuStralia of HEpatitis C from people living with HIV

About the Project

CEASE is 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.

Rationale

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.

Rapid development of directly acting antiviral (DAA) drugs against HCV has led to the reality of interferon-free regimens being available for the treatment of HCV. These regimens are short course and easily tolerated, and 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 extension into community prescribing.

Aims

This project has five 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 five components 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 (2014-2016), follow-up 1 (2017-2018) and follow-up 2 (2019-2020). 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 (ISTEP)

HCV treatment scale-up with PBS listed regimens will involve primary and tertiary clinics. All patients who are commencing HCV treatment will be invited to participate in CEASE-T which will involve data collection regarding treatment with PBS listed regimens.  The regimen and duration will be determined by the treating clinician according to PBS prescribing guidelines. At selected sites subjects will be offered enrollment into a more intensive follow-up substudy (ISTEP) involving collection of research EDTA plasma samples, patient completedbehaviouralquestionnaires and FibroScan® (where available).  Patients with recurrent viraemia during or following treatment (relapse/reinfection) may also be entered into a separate substudy cohort (CEASE-V)

CEASE-V: Recurrent Viraemia  

At selected sites patients with on-treatment virological failure (non-response or viral breakthrough) or post-treatment recurrent viraemia (relapse or reinfection) will be entered into an intensive follow-up cohort (CEASE-V). Participation will involve providing informed consent, collection of research EDTA plasma samples and patient completed behavioural questionnaires.Patients may be offered retreatment with PBS listed regimens.  The decision to retreat as well as the regimen and duration will be determined by the treating clinician according to PBS prescribing guidelines

Progress/Update

Enrolment is currently open for CEASE-D (the surveillance phase). Enrolment for ISTEP and CEASE-V will open in mid-2016.

Benefits

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.

Output

Nil to date

Project Members
image - Greg Dore
Professor and Program Head
Ph 02 9385 0900
image - Arlen. I Think
Clinical Project Coordinator
Ph +61 2 9385 9970
image - Marrianne Martinello
Research Associate
Ph +61 (0)2 9385 0900
image - Pip Marks
Clinical Trials Manager
Ph +61 (0)2 9385 0886
image - Jasmine
Clinical Project Coordinator
Ph (02) 9385 0932
image - Sharmila Siriragavan
Data Manager
Ph +61 (02) 9385 0983
Project Collaborators: External

The CEASE project is a collaboration between Kirby Institute and Burnet Institute, with many stakeholders and participating sites around Australia.

CEASE is based in the following hospitals and clinics:

St. Vincent’s Hospital, NSW

Blacktown Hospital. NSW

Blue Mountains Sexual Health, NSW

Dr. Doong’s  Surgery, NSW

East Sydney Doctors, NSW

Holdsworth House Medical Practice, NSW

Kirketon Road Centre, NSW

Nepean Sexual Health and HIV Clinic, NSW

Sydney Sexual Health Centre, NSW

Taylor Square Private Clinic, NSW

The Albion Centre, NSW

Western Sydney Sexual Health Centre, NSW

Westmead Hospital, NSW

Brisbane Sexual Health Clinic, QLD

Cairns Sexual Health, QLD

Royal Brisbane Hospital, QLD

Melbourne Sexual Health Centre, VIC

Northside Clinic, VIC

Prahran Market Clinic, VIC

Royal Melbourne Hospital, VIC

The Alfred Hospital, VIC

The Centre Clinic, VIC

Royal Adelaide Hospital, SA

Project Research Area

Project Contacts

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