Point Of Care Hepatitis C testing and subsequent treatment uptake in Addiction Medicine residential withdrawal unit (POCAM): a pilot study

The aim of this study is to evaluate the uptake and acceptability of point of care (POC) testing using the Xpert HCV VL Fingerstick test in individuals with substance dependence presenting to a residential withdrawal unit. Further, we seek to evaluate the initiation (prescription and/or dispensing) of DAA therapy in participants offered POC testing, compared to initiation among participants who have undergone standard-of-care (SOC) HCV testing at the residential withdrawal unit over a similar time period. The study will take place at Depaul House, the residential withdrawal facility attached to St Vincent's Hospital. The intervention being examined is the Cepheid Xpert Hepatitis C (HCV) Viral Load (VL) Fingerstick test, which is run on the Cepheid GeneXpert platform. The Cepheid GeneXpert platform is a bench top machine that performs real-time polymerase chain reaction (PCR) in a self-contained cartridge to provide a HCV RNA result within 60 minutes. It is done via fingerprick and only requires 100uL of capillary blood for a test to be run. The fingerprick takes between 2 and 5 minutes to perform; it will be performed once on admission to Depaul House and again for assessment of adherence to therapy at week 4 and week 8 post commencing direct acting antiviral (DAA) as well as at 4 weeks post therapy for sustained virological response. Duration of participation in the study will depend on need for initiation of DAA therapy; individuals that are negative on HCV VL Fingerstick will participate in the study until their test results are disclosed and have undertaken post testing questionnaire (expected to be between 1 and 2 days). Individuals that test positive on HCV VL Fingerstick will be offered commencement of DAA therapy and will be followed up for a minimum of 12 weeks: either 8 or 12 weeks of treatment depending on DAA regimen and at least a further 4 weeks to assess for sustained virological response (SVR4+). The HCV VL fingerstick will be administered by a St Vincent’s Hospital doctor or nurse from the departments of Addiction medicine or Gastroenterology who has been undertaken the prior training of administering the HCV VL fingerstick. Treatment adherence will be monitored through administration of questionnaires at week 4 and week 8 follow-up appointments post commencing treatment; furthermore administration of HCV VL fingerstick at week 4 and week 8 of DAA therapy will act as a further surrogate marker for treatment adherence. Attendance to these appointments will be recorded. Other investigations offered as part of the study conform with current standard of care practice. - At the time of venepuncture, other pathology results obtained will include a HIV test (with counseling), hepatitis A serology, hepatitis B serology, liver function test panel including ALT, AST, Albumin and bilirubin, FBE, INR and a beta-HCG where appropriate. - FibroScan (transient elastography) allows a rapid, non-invasive evaluation of liver fibrosis via the measurement of liver stiffness. It is a performed with a participant lying supine with an ultrasound-like probe place on the skin over the liver area, typically in the right mid-axillary line. Typically the test takes around 10 minutes to perform and causes no discomfort. FibroScan is an accepted and commonly used clinical tool in the assessment of fibrosis in people with or at risk of chronic liver disease. - Participants with a positive HCV RNA will be prescribed treatment with direct acting antiviral (DAA) therapy which will be at the discretion of the prescribing doctor. Primarily, one of two pangenotypic DAA regimens will be used (reflecting standard clinical practice). This will be done via a pharmaceutical benefits scheme (PBS) funded script, in compliance with PBS criteria and in accordance with Australasian Liver Association/Gastroenterological Society of Australia guidelines.