Treatment for Hepatitis C in Hospitalized Patients Who Inject Drugs
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
This study is testing if a new hepatitis C treatment works better for hospitalized patients who inject drugs and have related infections, to see how many of them stay virus-free after 12 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kirby Institute Government |
| Drugs / interventions | prednisone |
| Locations | 7 sites (Randwick, New South Wales and 6 other locations) |
| Trial ID | NCT03981211 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of direct-acting antiviral (DAA) treatments for hepatitis C in hospitalized patients who inject drugs and are suffering from injecting related infectious diseases. It involves a multicenter, sequential cohort design where participants will be treated with either a standard or short duration therapy while hospitalized. The study aims to determine the proportion of patients achieving sustained virological response at 12 weeks post-treatment. By leveraging the hospital stay, the study seeks to improve care linkage and treatment outcomes for this vulnerable population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who have injected drugs within the last 6 months and are hospitalized with an injecting related infectious disease.
Not a fit: Patients who do not have hepatitis C or are not hospitalized for injecting related infectious diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could significantly improve hepatitis C treatment outcomes and linkage to care for people who inject drugs.
How similar studies have performed: Other studies have shown promising results in treating hepatitis C in similar populations, indicating that this approach has potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Randwick, New South Wales and 6 other locations
- Prince of Wales Hospital — Randwick, New South Wales, Australia (Not_yet_recruiting)
- St Vincent's Hospital Sydney — Sydney, New South Wales, Australia (Recruiting)
- Blacktown Mt Druitt Hospital — Sydney, New South Wales, Australia (Not_yet_recruiting)
- Westmead Hospital — Westmead, New South Wales, Australia (Not_yet_recruiting)
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Not_yet_recruiting)
- The Alfred Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
- St Vincent's Hospital — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Amanda Erratt
- Email: aerratt@kirby.unsw.edu.au
- Phone: 61 2 9385 0882
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.