Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

Study Overview
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Brief Summary
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A community-based test and treat intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.

Detailed Description
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SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.

Official Title
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Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

Conditions
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Hepatitis C, Hepatitis, Liver Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Digestive System Diseases

Intervention / Treatment
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* Device: Fingerstick GeneXpert HCV RNA quantitative assay
* Drug: sofosbuvir/velpatesvir
* Drug: glecaprevir/pibrentasvir


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older; voluntarily signed the informed consent form. Exclusion Criteria: Pregnant women.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Fingerstick Point of Care GeneXpert HCV Test<br>Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay. | Device: Fingerstick GeneXpert HCV RNA quantitative assay<br>* All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly<br>Drug: sofosbuvir/velpatesvir<br>* Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia<br>* Other names: Epclusa;Drug: glecaprevir/pibrentasvir<br>* Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia<br>* Other names: Maviret;|
| Treat - SOF/VEL<br>Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir | Drug: sofosbuvir/velpatesvir<br>* Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia<br>* Other names: Epclusa;|
| Treat - G/P<br>Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir | Drug: glecaprevir/pibrentasvir<br>* Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia<br>* Other names: Maviret;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hepatitis C prevalence | Change in the proportion of people with current HCV infection (HCV RNA positive) | Week 0 to week 144 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Hepatitis C incidence | Change in HCV incidence will be calculated using person-time of observation. | Week 0 to week 144 | 
| DAA uptake | Proportion with HCV infection initiating DAA therapy | To week 144 | 
| Treatment response rate (SVR12 rate) | Overall SVR12 rate in those who commence treatment | From week 0 to Week 144 | 
| HCV reinfection incidence post treatment | Participants will be assessed six monthly post end of treatment for HCV recurrence. | 6 monthly from end of treatment until week 144 |