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

RECRUITING

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.

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Study details:

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.

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Eligibility criteria

Researchers look for people who fit a certain description, called eligibility criteria. See if you qualify.

Inclusion criteria

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

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: 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

Inability or unwillingness to provide informed consent or abide by the requirements of the study

Actively intoxicated.

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

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

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Eligibility

Age eligible for study : 18 and older

Healthy volunteers accepted : No

Gender eligible for study: All

Things to know

Study dates

Study start: 2021-02-12

Primary completion: 2025-02-12

Study completion finish: 2025-02-12

Study type

TREATMENT

Phase

Trial ID

NCT03981211

Intervention or treatment

DRUG: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet

DRUG: Sofosbuvir 400 MG + Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet

Conditions

• Hepatitis C
• Liver Inflammation
• Liver Cirrhoses

Condition: Hepatitis C, Liver Inflammation and more
DRUG: Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet and other drugs
Randwick, New South Wales, Australia and more
Sponsor: Kirby Institute

You may be eligible to participate in this trial based on your search. Check eligibility by answering some questions.

Are you running this trial? If you're a clinic or sponsor, you can claim this study. Claim or learn more.

Find a site

Closest Location:

Prince of Wales Hospital

Research sites nearby

Select from list below to view details:

Prince of Wales Hospital
Randwick, New South Wales, Australia
St Vincent's Hospital Sydney
Sydney, New South Wales, Australia
Blacktown Mt Druitt Hospital
Sydney, New South Wales, Australia
Westmead Hospital
Westmead, New South Wales, Australia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Participant Group/Arm	Intervention/Treatment
EXPERIMENTAL: Cohort A: 8 weeks G/P standard therapy 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 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
EXPERIMENTAL: Cohort B: 4 weeks SOF/G/P shortened therapy 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 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

What is the study measuring?

Primary outcome

Primary Outcome Measure	Primary Outcome Description	Primary Outcome Time Frame
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.	12 weeks post completion of commenced treatment

Secondary outcome

Frequently Asked Questions

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You may be eligible to participate in this trial based on your search.Apply for study

Are you running this trial? If you're a clinic or sponsor, you can claim this study.Claim this trial

References

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