Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination (SCALE-C)

Kirby Institute

Status: Unknown

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

Treatments: Drug: glecaprevir/pibrentasvir; Device: Fingerstick GeneXpert HCV RNA quantitative assay; Drug: sofosbuvir/velpatesvir

Study type: Observational

Funder types: Other

Identifiers

NCT03776760

VHCRP1802

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 years of age or older;
• voluntarily signed the informed consent form.

Exclusion criteria

• Pregnant women.

Trial design

600 participants in 3 patient groups

Fingerstick Point of Care GeneXpert HCV Test

Description:

Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.

Treatment:

Drug: sofosbuvir/velpatesvir

Device: Fingerstick GeneXpert HCV RNA quantitative assay

Drug: glecaprevir/pibrentasvir

Treat - SOF/VEL

Description:

Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir

Treatment:

Drug: sofosbuvir/velpatesvir

Treat - G/P

Description:

Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir

Treatment:

Drug: glecaprevir/pibrentasvir