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

• Status: Recruiting
• Trial end date: 2022-02-12
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kirby Institute
• Treatments: Sofosbuvir

Criteria

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.