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

HIV Clinical Trial

— co-EC  

Official title:

Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786758
• Other study ID #: burnet_coec_2016
• Status: Completed
• Start date: April 2016
• Est. completion date: August 2019

Study information

• Verified date: February 2020
• Source: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: August 2019
• Est. primary completion date: July 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis C
• HIV

Locations

Country	Name	City	State
Australia	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

Sponsors (2)

Lead Sponsor	Collaborator
Macfarlane Burnet Institute for Medical Research and Public Health Ltd	The Alfred

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment uptake	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.	18 months
Primary	Sustained virological response after treatment (SVR12)	Determined using any licensed qualitative HCV RNA test among all those receiving at least one dose of HCV treatment.	Change in sustained viral response rates post-treatment (SVR12).
Primary	HCV prevalence	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).	12 months
Primary	HCV incidence	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).	12 months
Secondary	Change in HCV testing among HIV-infected gay and bisexual men	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.	18 months
Secondary	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.	Number of HCV/HIV reinfections in gay and bisexual men management plan will be increased.	18 months
Secondary	Medical adherence	Primar care and clinic based nurses will increase medical adherence.	Up to 24 weeks, documented at each study visit