The Prime Study is a randomised trial investigating models of care for hepatitis C in the era of direct acting antiviral (DAA) therapy. The study aims to compare outcomes of hepatitis C care and DAA treatment provided in a primary health care service with a tertiary hospital.
This open label randomised trial will investigate the efficacy of treating people with G1 HCV with DAA in primary healthcare services compared with tertiary hospital clinics. Three hundred and eighty G1 HCV infected patients attending study primary healthcare centres will be invited to participate in the study. At the primary healthcare centre participants will be randomly allocated to two groups: Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for transient elastography and DAA treatment (traditional model of care) Group 2: (n=190) Following their initial screen, these participants will be offered transient elastography and DAA treatment delivered at the primary healthcare service only. Treatment will consist of fixed dose combination paritaprevir, ombitasvir and ritonavir packaged together with dasabuvir, known as Viekira Pak, +/- weight based ribavirin. As cirrhotic patients will be excluded from the study, the duration of treatment is 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
140
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia
Burnet Institute
Melbourne, Victoria, Australia
Hospital Liver Clinic
Greenlane, Auckland, New Zealand
Auckland Opioid Treatment Service (AOTS)
Point Chevalier, Auckland, New Zealand
To measure the proportion of people attending at a Primary Health Care Service for their genotype 1 HCV infection who commence antiviral treatment (Viekira Pak and ribavirin) and have a SVR 12.
Time frame: Sustained virology response (SVR) rates at week 12 post treatment.
To measure the proportion of people attending a PHCS with G1 HCV infection who commence antiviral treatment (Viekira Pak and ribavirin) if they are managed at a PHCS compared to those who are referred to and managed at a tertiary hospital.
Time frame: Treatment uptake within 8 weeks of randomisation
To measure the proportion of people with G1 HCV who have an SVR12 at a PHCS compared a tertiary hospital.
Time frame: SVR rate at week 12 post treatment
To measure the reduction in HCV viraemia (community viral load) among participants considering retention through the cascade of care and SVR12.
Time frame: up to 24 weeks post treatment
To measure the cost effectiveness of managing and treating people in a primary health service compared to a tertiary hospital.
Time frame: up to 24 weeks post treatment
To define the cascade of care for patients referred to a community hepatitis nurse for assessment of HCV.
Time frame: up to 12 weeks post treatment
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Hepatitis C Community Clinic
Sydenham, Christchurch, New Zealand
Calder Centre Auckland
Auckland, New Zealand
Auckland Central liver Clinic
Auckland, New Zealand
Community Alcohol and Drug Services
Auckland, New Zealand