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Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs (TOPIC)

Primary Purpose

Hepatitis C, Liver Inflammation, Liver Cirrhoses

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Sponsored by
Kirby Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C focused on measuring people who inject drugs, injecting related infectious diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Participants must meet all of the following inclusion criteria to be eligible to participate in this study.

  1. Have voluntarily signed the informed consent form.
  2. 18 years of age or older.
  3. Injected drugs within the last 6 months

  4. Hospitalised with an IRID with an anticipated inpatient stay of > 1 week

    Participants must meet the following additional inclusion criteria to be treated in this study.

  5. HCV RNA positive
  6. Compensated liver disease
  7. Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA

  8. If co-infection with HIV is documented, the subject must meet the following criteria:

    1. ART naïve with CD4 T cell count >500 cells/mm3; OR
    2. On a stable ART regimen (containing only permissible ART) for >4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection.

Exclusion Criteria:

Participants who meet any of the exclusion criteria are not to be enrolled in this study.

  1. Inability or unwillingness to provide informed consent or abide by the requirements of the study

  2. Actively intoxicated.

    Participants that meet any of the additional exclusion criteria are not to be treated in this study.

  3. History of any of the following:

    b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs

  4. Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only)
  5. Pregnant or nursing female
  6. Decompensated liver disease
  7. Use of prohibited concomitant medications
  8. Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks)
  9. Prior treatment failure with an NS5A based DAA regimen

Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay > 1 week may also be included at discretion of study team.

Sites / Locations

  • Prince of Wales Hospital
  • St Vincent's Hospital SydneyRecruiting
  • Blacktown Mt Druitt Hospital
  • Westmead Hospital
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • St Vincent's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohort A: 8 weeks G/P standard therapy

Cohort B: 4 weeks SOF/G/P shortened therapy

Arm Description

8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).

4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).

Outcomes

Primary Outcome Measures

SVR12 outcomes for all total patient population
To evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID and commencing inpatient DAA treatment within public hospital services.

Secondary Outcome Measures

Full Information

First Posted
May 31, 2019
Last Updated
March 28, 2022
Sponsor
Kirby Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03981211
Brief Title
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
Acronym
TOPIC
Official Title
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 12, 2021 (Actual)
Primary Completion Date
February 12, 2023 (Anticipated)
Study Completion Date
February 12, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kirby Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study will evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID (injecting related infectious diseases) and commencing inpatient DAA treatment within public hospital services.
Detailed Description
This study will be conducted as a Phase IV, multicentre, sequential cohort trial. 60 participants will be enrolled from participating hospital inpatient services. They will be evaluated for eligibility by the use of rapid point-of-care (POC) confirmation of viraemia in people who inject drugs (PWID) hospitalised for IRID. The period of hospitalisation for management of IRID, particularly when prolonged, may represent an ideal opportunity to engage HCV-infected PWID and a potential important strategy for broader HCV elimination. Eligible patients will be enrolled into one of two treatment cohorts A and B. A) 30 patients will immediately commence treatment whilst an inpatient of G/P (glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (standard duration therapy). Following the successful completion of Cohort A, eligible patients will be enrolled into Cohort B. B) 30 patients will immediately commence treatment whilst an inpatient of 4 weeks of SOF/G/P (sofosbuvir/glecaprevir/pibrentasvir) with continuation of therapy and follow-up in viral hepatitis services post discharge (short duration therapy). Any patient with recurrent viraemia during follow-up will be genotyped +/- sequenced to exclude re-infection. If relapse is confirmed the patient will be offered re-treatment with standard of care (SOC) salvage therapy based on results of resistance testing.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Liver Inflammation, Liver Cirrhoses
Keywords
people who inject drugs, injecting related infectious diseases

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cohort A: 8 weeks G/P standard therapy
Arm Type
Experimental
Arm Description
8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
Arm Title
Cohort B: 4 weeks SOF/G/P shortened therapy
Arm Type
Experimental
Arm Description
4 weeks treatment of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (shortened duration therapy).
Intervention Type
Drug
Intervention Name(s)
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Intervention Description
8 weeks of 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily or 4 weeks of 1 tablet sofosbuvir 400 mg and a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
Intervention Description
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Primary Outcome Measure Information:
Title
SVR12 outcomes for all total patient population
Description
To evaluate the proportion of patients achieving confirmed SVR12 (undetectable HCV RNA at time point 12 weeks plus post treatment commencement) in patients hospitalised for IRID and commencing inpatient DAA treatment within public hospital services.
Time Frame
12 weeks post completion of commenced treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must meet all of the following inclusion criteria to be eligible to participate in this study. Have voluntarily signed the informed consent form. 18 years of age or older. Injected drugs within the last 6 months Hospitalised with an IRID with an anticipated inpatient stay of > 1 week Participants must meet the following additional inclusion criteria to be treated in this study. HCV RNA positive Compensated liver disease Documented non-cirrhotic at enrolment with a qualifying liver FibroScan ≤ 9.5 kpA If co-infection with HIV is documented, the subject must meet the following criteria: ART naïve with CD4 T cell count >500 cells/mm3; OR On a stable ART regimen (containing only permissible ART) for >4 weeks prior to screening visit, with CD4 T cell count ≥200 cells/mm3 and a plasma HIV RNA level below the limit of detection. Exclusion Criteria: Participants who meet any of the exclusion criteria are not to be enrolled in this study. Inability or unwillingness to provide informed consent or abide by the requirements of the study Actively intoxicated. Participants that meet any of the additional exclusion criteria are not to be treated in this study. History of any of the following: b. Clinical hepatic compensation (i.e. ascites, encephalopathy or variceal haemorrhage) c. Solid organ transplant d. History of severe, life-threatening or other significant sensitivity to study drugs (glecaprevir/pibrentasvir/sofosbuvir) or any excipients of the study drugs Creatinine clearance (CLcr) < 30 mL/min at screening (Cohort B only) Pregnant or nursing female Decompensated liver disease Use of prohibited concomitant medications Chronic use of systemically administered immunosuppressive agents (e.g. prednisone equivalent > 10 mg/day for >2 weeks) Prior treatment failure with an NS5A based DAA regimen Patients without an IRID but who fulfill all other criteria and are admitted with an expected duration of stay > 1 week may also be included at discretion of study team.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amanda Erratt
Phone
61 2 9385 0882
Email
aerratt@kirby.unsw.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Pip Marks
Phone
61 2 9385 0886
Email
pmarks@kirby.unsw.edu.au
Facility Information:
Facility Name
Prince of Wales Hospital
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeffrey Post
Email
Jeffrey.Post@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Jeffrey Post
Facility Name
St Vincent's Hospital Sydney
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gail Matthews
Email
gmatthews@kirby.unsw.edu.au
First Name & Middle Initial & Last Name & Degree
Gail Matthews, MBChB PhD
Facility Name
Blacktown Mt Druitt Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Golo Ahlenstiel, MD
Email
golo.ahlenstiel@health.nsw.gov.au
First Name & Middle Initial & Last Name & Degree
Golo Ahlenstiel
Facility Name
Westmead Hospital
City
Westmead
State/Province
New South Wales
ZIP/Postal Code
2145
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Douglas
Email
mark.douglas@sydney.edu.au
First Name & Middle Initial & Last Name & Degree
Mark Douglas
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Rowe
Email
emily.rowe@sa.gov.au
First Name & Middle Initial & Last Name & Degree
Emily Rowe
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Doyle
Email
joseph.doyle@burnet.edu.au
First Name & Middle Initial & Last Name & Degree
Joseph Doyle
Facility Name
St Vincent's Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Thompson
Email
Alexander.THOMPSON@svha.org.au
First Name & Middle Initial & Last Name & Degree
Alexander Thompson

12. IPD Sharing Statement

Learn more about this trial

Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs

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