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

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ClinicalTrials.gov Identifier: NCT02555475
Recruitment Status : Completed
First Posted : September 21, 2015
Last Update Posted : May 24, 2018
Sponsor:
Collaborator:
St Vincent's Hospital Melbourne
Information provided by (Responsible Party):
Macfarlane Burnet Institute for Medical Research and Public Health Ltd

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hepatitis C Other: community based hepatitis C care and treatment Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Prime Study - Comparing Hepatitis C Care and Treatment in a Primary Health Care Service With a Tertiary Hospital: a Randomised Trial
Actual Study Start Date : March 2016
Actual Primary Completion Date : December 22, 2017
Actual Study Completion Date : May 22, 2018

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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. ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. 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 ]
  4. 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 ]
  5. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02555475


Locations
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Australia, Victoria
St Vincents Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Burnet Institute
Melbourne, Victoria, Australia, 3181
New Zealand
Hospital Liver Clinic
Greenlane, Auckland, New Zealand, 1051
Auckland Opioid Treatment Service (AOTS)
Pt Chevalier, Auckland, New Zealand, 1025
Hepatitis C Community Clinic
Sydenham, Christchurch, New Zealand, 8011
Calder Centre Auckland
Auckland, New Zealand, 1010
Auckland Central liver Clinic
Auckland, New Zealand, 1023
Community Alcohol and Drug Services
Auckland, New Zealand, 1023
Sponsors and Collaborators
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
St Vincent's Hospital Melbourne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Macfarlane Burnet Institute for Medical Research and Public Health Ltd
ClinicalTrials.gov Identifier: NCT02555475     History of Changes
Other Study ID Numbers: HREC/15/SVHM/41
First Posted: September 21, 2015    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: July 2017

Keywords provided by Macfarlane Burnet Institute for Medical Research and Public Health Ltd:
Hepatitis C
primary care

Additional relevant MeSH terms:
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Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections