Direct-acting Antiviral Therapy and Reinfection Among PWID With Chronic HCV in Community-based Settings

NCT03343925 | Completed

• 1 other identifier: VHCRP1605
• Study Type: observational
• Target: 140
• Locations: 1 country
• Sites: 4

Brief Summary

SHARP-C is an observational cohort study investigating the effect of direct-acting antiviral (DAA) therapy and reinfection in people with chronic hepatitis C virus (HCV) and recent injecting drug use. A prospective, observational cohort design will be used to enrol patients attending tertiary drug and alcohol and primary health care services. Participants will be prescribed a direct-acting HCV medication as per the standard of care. The on treatment phase will vary dependent on the type of a direct-acting antiviral prescribed as per the standard of care. Once patients have completed their treatment course they will be followed up every 3 months for up to 3 years following the end of treatment phase. The study will aim to evaluate the incidence of HCV reinfection following successful DAA treatment over the three years of follow up. The study will also evaluate the proportion of patients with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) with direct-acting anti-viral HCV therapy.

Conditions

Hepatitis C, Chronic

Keywords

Reinfection

Outcome Measures

Primary Outcomes (1)

• Reinfection

  Incidence of HCV reinfection following successful DAA therapy.

  3 years

Secondary Outcomes (3)

• Undetectable HCV RNA at SVR12

  2.5 years

• Treatment completion

  3 years

• Undetectable HCV RNA at the end of treatment

  3 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Participants with chronic HCV infection and recent injecting drug use who are 18 years or over and are eligible for DAA therapy as per the PBS criteria.

You may qualify if:

• Participants have voluntarily signed the informed consent form.
• Be ≥18 years of age on day of signing informed consent form.
• Have chronic HCV infection.
• Recent injecting drug use (previous 6 months).
• Eligible for DAA therapy as per the Pharmaceutical Benefits Scheme (PBS) criteria
• HIV-1 infected participants enrolled in the study must meet the following criteria:
• Have HIV infection documented by any licensed rapid HIV test or HIV enzyme or chemiluminescence immunoassay (E/CIA) test kit at any time prior to study entry (Baseline) and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
• Be on HIV Antiretroviral Therapy (ART) for at least 4 weeks prior to study entry using an ART regimen that is allowable with the intended DAA regimen as determined by the current PI and the Liverpool drug interaction website (http://www.hiv-druginteractions.org/) OR be naive to treatment with any antiretroviral therapy (ART) with a baseline CD4 count of \>200 and have no plans to initiate ART treatment while participating in this study and through to at least Follow-up Week 4.

You may not qualify if:

• \) The participant must be excluded from participating in the trial if the subject is unable or unwilling to provide informed consent or abide by the requirements of the study.

Sponsors & Collaborators

• Kirby Institute: lead

Study Sites (4)

St Vincent's Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Nepean Hospital

Kingswood, New South Wales, 2751, Australia

Location

Drug and Alcohol Services (Hunter)

Newcastle, New South Wales, 2300, Australia

Location

Infectious Diseases Clinic, Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Plasma, PBMCs, Whole blood

MeSH Terms

Conditions

Hepatitis C, Chronic; Reinfection

Condition Hierarchy (Ancestors)

Hepatitis C; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Recurrence

Study Officials

• Jason Grebely

  Kirby Institute

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: November 8, 2017
• First Posted: November 17, 2017
• Study Start: August 17, 2018
• Primary Completion: July 1, 2021
• Study Completion: April 11, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

AU (4)