Hepatitis C
Conditions
Brief summary
TEMPO is an interventional cohort study recruiting injecting drug users attending needle and syringe programs (NSP) in Australia. Three hundred participants will be invited to on-site HCV testing with NSP integrated care for HCV treatment. Participants will be screened for HCV using point-of-care testing and HCV positive participants will be offered treatment with Sofosbuvir/Velpatasvir. Of those who initiate treatment, participants will receive weekly peer-based support on-treatment and return at End of Treatment (ETR) and 12 weeks following end of treatment (SVR12) for clinical follow-up.
Interventions
DEVICEHCV RNA Point of Care
Participants attending needle syringe programmes in Australia will be screened for hepatitis C using the finger-stick whole blood GeneXpert HCV RNA cartridge.
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Participants with a detectable HCV RNA will be offered treatment with either glecaprevir/pibrentasvir or sofosbuvir/velpatasvir.
Sponsors
Kirby Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Participants must meet all the following inclusion criteria to be eligible to participate in this study: 1. Participants have voluntarily signed the informed consent form; 2. 18 years of age or older; 3. Current injecting drug use (previous month); 4. HCV RNA positive participants commencing treatment must be eligible to initiate therapy with Sofosbuvir/Velpatasvir; and 5. In the opinion of the Investigator, the participant is suitable for NSP-based HCV treatment delivery.
Exclusion criteria
1\) For HCV RNA positive participants commencing treatment: 1. Any clinically significant condition or history known to contraindicate the use of Sofosbuvir/Velpatasvir or would not be suitable for management within a NSP-based treatment setting; 2. Any contraindicated medication in the Sofosbuvir/Velpatasvir product information; 3. Has previous HCV DAA treatment experience 4. Has a fibroscan score \> 12.5 Kpa 5. HIV co-infection 6. HBV co-infection 7. Is female and is pregnant or breastfeeding 8. Is unable or unwilling to provide informed consent or abide by the requirements of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Uptake of HCV DAA therapy among current PWID | 4 Weeks | Treatment uptake (i.e. proportion of participants initiating DAA therapy) |
Countries
Australia
Outcome results
None listed