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

Completed

• Conditions: Hepatitis C; HIV

• Registration Number: NCT02786758
• Lead Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-25
• Study First Posted: 2016-06-01
• Primary Completion: 2019-07
• Study Completion: 2019-08
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment uptake	18 months	The number of individuals receiving at least one dose of HCV treatment among all HCV/HIV coinfection individuals in care (seen within the previous 12 months) at that health service.
Sustained virological response after treatment (SVR12)	Change in sustained viral response rates post-treatment (SVR12).	Determined using any licensed qualitative HCV RNA test among all those receiving at least one dose of HCV treatment.
HCV incidence	12 months	The number of newly detected HCV RNA cases occurring among all HIV infected individuals during the time in care (determined by clinical visit or HIV RNA test within the previous 12 months).
HCV prevalence	12 months	The proportion HCV RNA positive of all HIV infected individuals in care (seen within the previous 12 months) at that health service. Statewide HCV prevalence will be determined as a proportion of all HIV infected individuals in care (determined by at least one HIV RNA within the previous 12 months).

Secondary Outcome Measures

Name	Time	Method
Change in HCV testing among HIV-infected gay and bisexual men	18 months	Hypothesized that primary care and clinic-based nurses will increase the proportion of people in care receiving HCV testing annually and repeat testing at intervals recommended by national guidelines.
Change in number of HIV/HCV infected gay and bisexual men who have a complete management plan including HCV RNA status, FibroScan and liver function tests.	18 months	Number of HCV/HIV reinfections in gay and bisexual men management plan will be increased.
Medical adherence	Up to 24 weeks, documented at each study visit	Primar care and clinic based nurses will increase medical adherence.

Trial Locations

Locations (6)

Melbourne Sexual Health Centre; 🇦🇺 Carlton, Victoria, Australia

Alfred Health, The Alfred Hospital; 🇦🇺 Melbourne, Victoria, Australia

Northside Clinic; 🇦🇺 North Fitzroy, Victoria, Australia

Melbourne Health, Royal Melbourne Hospital; 🇦🇺 Parkville, Victoria, Australia

Prahran Market Clinic; 🇦🇺 Prahran, Victoria, Australia

Centre Clinic; 🇦🇺 St Kilda, Victoria, Australia