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

NCT02786758 | Completed DMC

• 1 other identifier: burnet_coec_2016
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 6

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.

Conditions

Hepatitis C; HIV

Outcome Measures

Primary Outcomes (4)

• 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

• 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).

• 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

• 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 Outcomes (3)

• Change in HCV testing among HIV-infected gay and bisexual men

  18 months

• 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

• Medical adherence

  Up to 24 weeks, documented at each study visit

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Aged ≥18 years;
• Attendance for medical care of HIV at any study site;
• Evidence of chronic HCV infection (HCV antibody or RNA positive for ≥6 months and HCV RNA positive);
• HIV infected;
• 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.

You may not qualify if:

• Pregnancy or breastfeeding at time of HCV antiviral treatment;
• 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

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• The Alfred: collaborator

Study Sites (6)

Melbourne Sexual Health Centre

Carlton, Victoria, 3053, Australia

Location

Northside Clinic

Fitzroy North, Victoria, 3068, Australia

Location

Alfred Health, The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Melbourne Health, Royal Melbourne Hospital

Parkville, Victoria, 3052, Australia

Location

Prahran Market Clinic

Prahran, Victoria, 3181, Australia

Location

Centre Clinic

St Kilda, Victoria, 3182, Australia

Location

Related Publications (1)

• 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.

  PMID: 33010149 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Standard of care blood tests (whole blood) will be obtained at screening and subsequent visits, depending on HCV medication regimen and health status, in order to assess: HCV genotype, HCV RNA viral load, host IL28B genotype, liver function, full blood examinations, iron studies, vitamin D, lipid profile, clotting profile, alpha-feto protein, HIV RNA viral load and hepatitis B virus serology. In addition, a study specimen for HCV NS3/NS5 sequencing will be collected at screening and stored. Specimens for pregnancy tests will be collected where applicable. Biospecimens from this study will be frozen and stored in secure laboratories at the Burnet and Victorian Infectious Diseases Reference Laboratory, for a minimum of 15 years in a biobank, under custody of the principal investigator.

MeSH Terms

Conditions

Hepatitis C

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Margaret Hellard

  Burnet Institute

  PRINCIPAL INVESTIGATOR

• Joseph Doyle

  The Alfred

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2016
• First Posted: June 1, 2016
• Study Start: April 1, 2016
• Primary Completion: July 1, 2019
• Study Completion: August 1, 2019
• Last Updated: February 28, 2020

Record last verified: 2020-02

Locations

AU (6)