Hepatitis CTOPICNCT03981211
Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Therapeutic Intervention Enhancing Care Linkage in People Who Inject Drugs
A study testing Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet in people with Hepatitis C and Liver Inflammation, run by Kirby Institute at 7 sites in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Liver Inflammation, Liver Cirrhoses
- What is being tested?
- Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 7 sitesAustralia
- Study dates
- 12 Feb 2021to 15 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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:
- 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
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- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Australia7 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
The Alfred Hospital
Melbourne, Victoria, 3004
St Vincent's Hospital
Melbourne, Victoria, 3065
Prince of Wales Hospital
Randwick, New South Wales, 2031
St Vincent's Hospital Sydney
Sydney, New South Wales, 2010
Blacktown Mt Druitt Hospital
Sydney, New South Wales, 2148
Westmead Hospital
Westmead, New South Wales, 2145
About this study
Official title: Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
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.
Read the 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.
- 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.
- 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.
- Conditions
- Hepatitis C, Liver Inflammation, Liver Cirrhoses
- Being tested
- Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet, Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet
- Keywords
- people who inject drugs, injecting related infectious diseases
- Medical subject headings
- Hepatitis C, Hepatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral TabletDrug
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
Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral TabletDrug
4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: 8 weeks G/P standard therapy | Experimental | 8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy). Receives: Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet |
| Cohort B: 4 weeks SOF/G/P shortened therapy | Experimental | 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). Receives: Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet; Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks post completion of commenced treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start12 Feb 2021
- Primary completion11 Dec 2024
- Study completion15 Sep 2025
Why it stopped: The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirby Institute
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03981211
- Sponsor's protocol ID
- VHCRP1902
- Acronym
- TOPIC
- Status last verified
- May 2026
- First submitted
- 31 May 2019
- Last updated
- 26 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of HOsPitalised Inpatients for Hepatitis C (TOPIC): Strategic Therapeutic Intervention to Enhance Linkage to Care in People Who Inject Drugs
- ClinicalTrials.gov ID
- NCT03981211
- Acronym / sponsor ID
- TOPIC / VHCRP1902
- Conditions
- Hepatitis C, Liver Inflammation, Liver Cirrhoses
- Keywords
- people who inject drugs, injecting related infectious diseases
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kirby InstituteOther government
- Study start
- 12 Feb 2021 (actual)
- Primary completion
- 11 Dec 2024 (actual)
- Study completion
- 15 Sep 2025 (actual)
- First posted
- 10 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: 8 weeks G/P standard therapy | Experimental | Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet8 weeks treatment of a three fixed-dose combination of glecaprevir/pibrentasvir 100/40 mg tablets administered once daily with food (standard duration therapy). |
| Cohort B: 4 weeks SOF/G/P shortened therapy | Experimental | Drug: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet, Drug: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet4 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (13 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet8 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 | Drug | Cohort A: 8 weeks G/P standard therapy, Cohort B: 4 weeks SOF/G/P shortened therapy |
| Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet4 weeks of 1 x sofosbuvir (400mg) tablet and 3 x co-formulated tablets of glecaprevir (100mg) and pibrentasvir (40mg) once daily | Drug | Cohort B: 4 weeks SOF/G/P shortened therapy |
Primary outcome
SVR12 outcomes for all total patient population
Time frame: 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.
Results and safety
The study was stopped early (reason given: The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet in people with Hepatitis C and Liver Inflammation, run by Kirby Institute at 7 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study was impacted by the COVID-19 pandemic. Once recruitment recommenced it remained slow. Removal of Sofosbuvir from the PBS November 2020 impacted recruitment into Cohort B. Study closed early on 15-Sep-26.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SVR12 outcomes for all total patient population (time frame: 12 weeks post completion of commenced treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2026.