Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals

NCT ID: NCT02786758

Last Updated: 2020-02-28

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2019-08-31

Brief Summary

This study will offer proof of concept that scaling up treatment for Hepatitis C virus (HCV) in individuals co-infected with HIV 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.

Detailed Description

The co-EC study aims to to enhance HCV care and treatment among HIV-infected individuals through a predominantly nurse-led model of care in primary care as well as hospital settings. It involves:

1. A nurse-led model of care in primary health care to increase access to PBS HCV treatment with interferon-free HCV antiviral treatment; and

2. An integrated HCV/HIV surveillance system and database to deliver and monitor the impact of the program at the local and statewide level.

The study is based in Victoria, Australia where the highest prevalence of HIV/HCV co-infection is in gay and bisexual men (GBM). HCV infection is a significant health issue among individuals with HIV infection and has been associated with more rapid progression to HCV-related liver disease and increased risk for cirrhosis and liver cancer. Hepatitis C is a major cause of hospital admissions and is a leading cause of death among HIV-infected persons.

The advent of directly acting antiviral (DAA) treatment provides us with a unique opportunity to increase the number of people accessing hepatitis C 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.

The primary objectives of co-EC Study are:

1. Achieve HCV sustained virological response (SVR12) to treatment among HIV co-infected participants in a real-world primary care or hospital clinic setting; and

2. Measure the impact of treating HCV in HIV infected individuals on primary HCV and reinfection incidence and HCV prevalence in gay and bisexual men in Victoria.

The study design involves an open label, non-randomised clinical trial of hepatitis C treatment for people with HIV coinfection. Treatment will involve any combination of hepatitis C antiviral therapy approved for use in Australia appropriate for the participants' hepatitis C genotype and selected at the decision of their treating clinicians.

Conditions

Hepatitis C; HIV

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. Aged ≥18 years;

2. Attendance for medical care of HIV at any study site;

3. Evidence of chronic HCV infection (HCV antibody or RNA positive for ≥6 months and HCV RNA positive);

4. HIV infected;

5. Willing and able to provide written informed consent;

Subjects must meet routine clinical care criteria for commencing HCV treatment, in accordance with Australian licensing, prescribing restrictions, manufacturers' recommendations and best- practice clinical care.

Exclusion Criteria

1. Pregnancy or breastfeeding at time of HCV antiviral treatment;

2. Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Alfred

OTHER

Sponsor Role: collaborator

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret Hellard

Role: PRINCIPAL_INVESTIGATOR

Burnet Institute

Joseph Doyle

Role: PRINCIPAL_INVESTIGATOR

The Alfred

Locations

Melbourne Sexual Health Centre

Carlton, Victoria, Australia

Northside Clinic

Fitzroy North, Victoria, Australia

Alfred Health, The Alfred Hospital

Melbourne, Victoria, Australia

Melbourne Health, Royal Melbourne Hospital

Parkville, Victoria, Australia

Prahran Market Clinic

Prahran, Victoria, Australia

Centre Clinic

St Kilda, Victoria, Australia

Countries

Australia

References

Doyle JS, van Santen DK, Iser D, Sasadeusz J, O'Reilly M, Harney B, Traeger MW, Roney J, Cutts JC, Bowring AL, Winter R, Medland N, Fairley CK, Moore R, Tee BK, Asselin J, El-Hayek C, Hoy JF, Matthews GV, Prins M, Stoove MA, Hellard ME. Microelimination of Hepatitis C Among People With Human Immunodeficiency Virus Coinfection: Declining Incidence and Prevalence Accompanying a Multicenter Treatment Scale-up Trial. Clin Infect Dis. 2021 Oct 5;73(7):e2164-e2172. doi: 10.1093/cid/ciaa1500.

Reference Type: DERIVED

PMID: 33010149 (View on PubMed)

Other Identifiers

burnet_coec_2016

Identifier Type: -

Identifier Source: org_study_id