An interventional study of Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet in Hepatitis C, Liver Inflammation and Liver Cirrhoses, sponsored by Kirby Institute. Terminated at 7 sites in Australia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-26.
Sponsored by Kirby Institute · Not applicable, Interventional, and Treatment
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.
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.
2,321 studies on the registry are indexed under Hepatitis C; 102 are open to participants now.
This study's enrollment of 21 is below the median of 79 across 1,633 interventional studies indexed under Hepatitis C.
Browse Hepatitis C studies →Kirby Institute is the lead sponsor of 94 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Participants must meet all of the following inclusion criteria to be eligible to participate in this study.
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.
If co-infection with HIV is documented, the subject must meet the following criteria:
Exclusion Criteria:
Participants who meet any of the exclusion criteria are not to be enrolled in this 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
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.
8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy).
Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
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).
Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet · Drug: Sofosbuvir 400 MG + Glecaprevir/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
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
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.
Time frame: 12 weeks post completion of commenced treatment
This study is terminated, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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