Theme: Clinical Research Year: 2016
ELIMINATING HEPATITIS C TRANSMISSION BY ENHANCING CARE AND TREATMENT AMONG HIV CO-INFECTED INDIVIDUALS: THE CO-EC STUDY
Doyle JS1,2,3, Sasadeusz J2,4, Iser DM2,5, Hellard ME1,2 on behalf of the co-EC Study Group
1Centre for Population Health, Burnet Institute, Melbourne, VIC;
2Department of Infectious Diseases, The Alfred, Melbourne, VIC;
3Department of Medicine St Vincent’s Hospital, University of Melbourne, Melbourne VIC;
4Victorian Infectious Diseases Service at the Doherty Institute, Melbourne VIC, Australia
5Department of Gastroenterology, St Vincent’s Hospital, Melbourne VIC;
6Monash University, Melbourne VIC Australia
Background: Unrestricted, government-subsided access to HCV direct-acting antivirals (DAAs) in Australia provides an opportunity to dramatically increase HCV treatment uptake. We present the rationale and design of the co-EC Study, which aims to offer proof-of-concept that scaling-up treatment could lead to elimination of HCV/HIV co-infection in Victoria, Australia.
Methods: Study aims: Primary objectives are (1) achieving HCV sustained virological response (SVR12) among HIV co-infected participants in real-world primary care or hospital clinic settings; and (2) measuring the impact of treating HCV among HIV-infected individuals on HCV prevalence, incidence, and reinfection incidence in Victoria.
Study design: The co-EC Study is a physician-directed, non-randomised trial of DAA treatment among people with HCV/HIV co-infection. HCV testing, liver assessment (including transient elastography) and treatment will be delivered by clinicians with nursing support in primary care and tertiary clinic settings. Any DAA licensed and subsidized can be initiated regardless of fibrosis stage. Participants will be followed for up 80 weeks. An enhanced statewide surveillance system of linked laboratory data will be used to monitor changes in HCV epidemiology.
Study outcomes and assumptions: After scaling-up treatment to cure 90% of 375 HCV/HIV co-infected participants over two years, the statewide prevalence of HCV may fall from 10% to 3.4%, before any additional prevention impact of treatment on transmission. Achieving a lower rate of treatment scale-up to 50% in our cohort will have the effect of halving HCV prevalence (from 10% to 5.5%) over two years.
Conclusion: The co-EC study opened in March 2016. It will provide proof-of-concept that scaling-up treatment could lead to elimination of HCV/HIV co-infection by treating prevalent infection thereby reducing new primary infections and re-infection. It will inform the implementation of treatment as prevention strategies among HCV/HIV co-infected individuals in jurisdictions with similar concentrated epidemics.
Disclosure of Interest Statement: The authors declare research funding from Gilead Sciences, Bristol Meyers Squibb and Abbvie. An investigator-initiated research grant for this study has been provided by BMS.
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