Direct-acting Antiviral Therapy and Reinfection Among People With Chronic Hepatitis C Virus Infection and Recent Injecting Drug Use in the Prison Setting

NCT03740906 | Completed

• 1 other identifier: VHCRP1606
• Study Type: observational
• Target: 202
• Locations: 1 country
• Sites: 1

Brief Summary

SHARP-P 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 from correctional centres in New South Wales, Australia. 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

Outcome Measures

Primary Outcomes (1)

• To evaluate the incidence of HCV reinfection following successful DAA therapy among people with chronic HCV infection and recent injecting drug use in the prison setting.

  3 years

Secondary Outcomes (3)

• To evaluate the proportion of participants with undetectable HCV RNA at 12 weeks post end of treatment (SVR12) following DAA HCV therapy among PWID with chronic HCV infection and recent injecting drug use

  2.5 years

• To evaluate the proportion of participants who complete treatment

  3 years

• To evaluate the proportion of participants with 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.
• Report of recent injecting drug use (within the previous 6 months).
• Eligible for DAA therapy as per the PBS
• HIV-1 infected participants enrolled in the study must meet the following additional 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 will be excluded from participating in the study 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 (1)

NSW Correctional Centres

Sydney, New South Wales, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

EDTA Plasma, PBMCs, Whole blood

MeSH Terms

Conditions

Hepatitis C, Chronic

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

Study Officials

• Andrew Lloyd

  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 12, 2018
• First Posted: November 14, 2018
• Study Start: September 6, 2019
• Primary Completion: January 31, 2022
• Study Completion: March 31, 2022
• Last Updated: April 14, 2022

Record last verified: 2022-04

Locations

AU (1)