Hepatitis C, Liver Cirrhoses, Liver Inflammation
Conditions
Keywords
people who inject drugs, injecting related infectious diseases
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.
Interventions
DRUGGlecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
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
DRUGSofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
Sponsors
Kirby Institute
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| SVR12 outcomes for all total patient population | 12 weeks post completion of commenced treatment | 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. |
Countries
Australia
Outcome results
None listed