co-EC Study: Hepatitis C infection and treatment to eliminate HIV-hepatitis C co-infection among gay and bisexual men

The co-EC study aims to eliminate hepatitis C/HIV coinfection in the community through scale up treatment of Hepatitis C in primary care and hospital settings.This study involves an open label, non-randomised clinical trial of hepatitis C treatment for people with HIV coinfection.

Hepatitis C virus (HCV) infection is a significant health issue among individuals with human immunodeficiency virus (HIV) infection and has been associated with more rapid progression to HCV-related liver disease and increased risk for cirrhosis and liver cancer. In Victoria Australia, the highest prevalence of HCV/HIV co-infection is in gay and bisexual men.

The advent of directly acting antiviral (DAA) treatment provides us with a unique opportunity to increase the number of people accessing hepatitis C treatment. In most cases, new DAA treatment offers shorter treatment times and fewer side effects than previous HCV treatment. Importantly it is likely that the treatment could be administered in the primary health care setting improving treatment capacity and accessibility, whilst potentially reducing treatment costs.

Individuals who are aged at least 18 years (regardless of sex), with HIV infection and evidence of chronic HCV infection, and who meet routine clinical care criteria for commencing HCV treatment are eligible to participate in this study.

Treatment will involve any combination of hepatitis C antiviral therapy approved for use in Australia appropriate for the participants’ hepatitis C genotype. All participants will receive open label hepatitis C treatment selected at the decision of their treating clinicians.

Treatment is based at six clinics in Melbourne, including both HIV primary care clinics and specialist clinics:

1. The Alfred Hospital, Melbourne
2. Melbourne Sexual Health Centre, Carlton
3. Prahran Market Clinic, Prahran
4. Royal Melbourne Hospital, Parkville
5. Centre Clinic, St Kilda
6. Northside Clinic, North Fitzroy.

This study will offer proof of concept that scaling up treatment could lead to elimination of HCV/HIV co-infection in gay and bisexual men by treating prevalent infection thereby reducing new primary infections and re-infection.

If you would like more information or are interested in being part of this study, contact Janine Roney from The Alfred Hospital clinical research team on (03) 9076 6908 or email Julia Cutts at Burnet Institute (co-ec@burnet.edu.au).

Timeline

The study will run for 36 months, including 18 months for recruitment and treatment and 12 months follow-up, from April 2016 - 2019