Clinical trial NCT02786758: Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals
Official title: Eliminating Hepatitis C Transmission by Enhancing Care and Treatment Among HIV Co-infected Individuals: The Co-EC Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
HIV
Lead sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Sponsor class: OTHER
Collaborators: name: The Alfred
First posted: 2016-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Any HCV/HIV co-infected individuals attending any of the six clinical sites involved in this study will be eligible to participate. While the study's objective are to focus on HCV among HIV infected gay and bisexual men, females and men not identifying as gay or bisexual will also be able to participate and receive HCV treatment.

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.

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

Primary outcomes:
measure: Treatment uptake
timeFrame: 18 months
measure: Sustained virological response after treatment (SVR12)
timeFrame: Change in sustained viral response rates post-treatment (SVR12).
measure: HCV prevalence
timeFrame: 12 months
measure: HCV incidence
timeFrame: 12 months
Secondary outcomes:
measure: Change in HCV testing among HIV-infected gay and bisexual men
timeFrame: 18 months
measure: 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.
timeFrame: 18 months
measure: Medical adherence
timeFrame: Up to 24 weeks, documented at each study visit
Other outcomes:
Locations:
city: Carlton
country: Australia
facility: Melbourne Sexual Health Centre
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Health, The Alfred Hospital
state: Victoria
city: North Fitzroy
country: Australia
facility: Northside Clinic
state: Victoria
city: Parkville
country: Australia
facility: Melbourne Health, Royal Melbourne Hospital
state: Victoria
city: Prahran
country: Australia
facility: Prahran Market Clinic
state: Victoria
city: St Kilda
country: Australia
facility: Centre Clinic
state: Victoria
Study officials:
affiliation: Burnet Institute
name: Margaret Hellard
role: PRINCIPAL_INVESTIGATOR
affiliation: The Alfred
name: Joseph Doyle
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.