A TEst and Treat Intervention aMong Current People Who Inject Drugs With HCV Attending Needle and Syringe PrOgrams (TEMPO)

Kirby Institute

Status: Completed

Conditions: Hepatitis C

Treatments: Drug: Sofosbuvir/velpatasvir; Device: HCV RNA Point of Care; Drug: Glecaprevir/pibrentasvir

Study type: Interventional

Funder types: Other

Identifiers

NCT03492112

VHCRP1705

Details and patient eligibility

About

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.

Enrollment: 101 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Screening

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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101 participants in 1 patient group

People attending needle syringe programs in Australia

Experimental group

Description:

Participants will be screened for Hepatitis C using the Finger-stick whole blood HCV RNA Point of Care GeneXpert. Participants with hepatitis C will be offered treatment with a pan-genotypic DAA HCV therapy- either 12 weeks of sofosbuvir/velpatasvir or 8 weeks of glecaprevir/pibrentasvir.

Treatment:

Drug: Glecaprevir/pibrentasvir

Drug: Sofosbuvir/velpatasvir

Device: HCV RNA Point of Care