The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital

May 22, 2018 updated by: Macfarlane Burnet Institute for Medical Research and Public Health Ltd

The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

140

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3065
        • St Vincents Hospital Melbourne
      • Melbourne, Victoria, Australia, 3181
        • Burnet Institute
  • New Zealand
      • Auckland, New Zealand, 1010
        • Calder Centre Auckland
      • Auckland, New Zealand, 1023
        • Auckland Central liver Clinic
      • Auckland, New Zealand, 1023
        • Community Alcohol and Drug Services
    • Auckland
      • Greenlane, Auckland, New Zealand, 1051
        • Hospital Liver Clinic
      • Pt Chevalier, Auckland, New Zealand, 1025
        • Auckland Opioid Treatment Service (AOTS)
    • Christchurch
      • Sydenham, Christchurch, New Zealand, 8011
        • Hepatitis C Community Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Aged ≥18 years;
  • Attendance at a study PHCS defined as; Attended appointment at PHCS at least once in 2014 or; Attended at least one consultation with a study community hepatitis nurse between 2012-2014
  • Evidence of chronic G1 HCV infection (HCV antibody positive for > 6 months and HCV RNA positive);
  • Absence of cirrhosis defined as one of the following:

Liver biopsy within 24 months prior to screening demonstrating absence of cirrhosis (e.g. a Metavir score of 3 or less or an Ishak score of 4 or less); or A screening FibroScan result of <9.6 kPa; or if a FibroScan is unsuccessful A screening Aspartate Aminotransferase to Platelet Ratio Index (APRI) ≤ 2 and no clinical or laboratory evidence of cirrhosis;

  • HCV treatment naive or pegylated or standard interferon and ribavirin experienced;
  • Willing and able to provide written informed consent

Subjects must have the following laboratory parameters at screening:

  • ALT ≤ 10 times the upper limit of normal (ULN);
  • AST ≤ 10 times ULN
  • Haemoglobin ≥ 12g/dL for males; ≥ 11g/dL for female subjects;
  • Platelet count ≥ laboratory lower limit of normal;
  • INR ≤ laboratory upper limit of normal, unless stable on an anticoagulant regimen affecting INR;
  • Albumin ≥ laboratory lower limit of normal;
  • Direct bilirubin ≤ laboratory upper limit of normal;
  • Creatinine clearance (Clcr) ≥ 60mL/min as calculated by Cockcroft-Gault equation.

Exclusion Criteria:

  • Known cirrhosis defined as:

Liver biopsy within 24 months prior to screening demonstrating cirrhosis (e.g. a Metavir score > 3 or an Ishak score > 4); or A FibroScan result of >12.5 kPa; or Prior clinical evidence of cirrhosis or portal hypertension (i.e. ascites, varices).

  • Prior exposure to HCV DAA protease inhibitors
  • Currently receiving HCV treatment;
  • Testing positive for HIV;
  • Testing positive for HBsAg;
  • HCC;
  • Pregnancy or breastfeeding at screening or baseline;
  • Evidence of any condition, therapy, laboratory abnormality or other circumstance (current or prior) that may confound the study's results, or interfere with participation for the full duration of the study, such that it is not in the best interest of the participant;
  • Use of concomitant medications that are contraindicated with Viekira Pak within 28 days of the baseline/day 1 visit, that are unable to be ceased for the duration of treatment.

Additional exclusion criteria for participants receiving ribavirin:

  • increased baseline risk for anaemia (i.e. history of thalassaemia, spherocytosis, history of GI bleeding) or;
  • patients for whom anaemia would be medically problematic or;
  • documented of presumed coronary artery disease or cerebrovascular disease, if in the judgement of the investigator, an acute decrease in haemoglobin by up to 4 g/dL (as may be seen with ribavirin) would not be well tolerated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Group 1, tertiary hospital based care
Group 1: (n=190) Following their initial screen, these participants will be referred to a tertiary hospital for hepatitis C care, transient elastography and DAA treatment (traditional / standard model of care).
Experimental: Group 2, community based care
Group 2: (n=190) Following their initial screen, these participants will be offered community based hepatitis C care and treatment. Hepatitis C care, transient elastography and DAA treatment will be delivered at the primary healthcare centre only.
Other: community based hepatitis C care and treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Sustained virology response (SVR) rates at week 12 post treatment.

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
up to 12 weeks post treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Collaborators

St Vincent's Hospital Melbourne

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2016

Primary Completion (Actual)

December 22, 2017

Study Completion (Actual)

May 22, 2018

Study Registration Dates

First Submitted

September 17, 2015

First Submitted That Met QC Criteria

September 18, 2015

First Posted (Estimate)

September 21, 2015

Study Record Updates

Last Update Posted (Actual)

May 24, 2018

Last Update Submitted That Met QC Criteria

May 22, 2018

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/15/SVHM/41

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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