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

NCT02555475 | Completed

• 1 other identifier: HREC/15/SVHM/41
• Study Type: interventional
• Target: 140
• Locations: 2 countries
• Sites: 8

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.

Conditions

Hepatitis C

Keywords

Hepatitis C; primary care

Outcome Measures

Primary Outcomes (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.

  Sustained virology response (SVR) rates at week 12 post treatment.

Secondary Outcomes (5)

• 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.

  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.

  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.

  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.

  up to 24 weeks post treatment

• To define the cascade of care for patients referred to a community hepatitis nurse for assessment of HCV.

  up to 12 weeks post treatment

Study Arms (2)

Group 1, tertiary hospital based care

NO INTERVENTION

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).

Group 2, community based care

EXPERIMENTAL

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

Interventions

community based hepatitis C care and treatment OTHER

Group 2, community based care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Macfarlane Burnet Institute for Medical Research and Public Health Ltd: lead
• St Vincent's Hospital Melbourne: collaborator

Study Sites (8)

St Vincents Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Burnet Institute

Melbourne, Victoria, 3181, Australia

Location

Hospital Liver Clinic

Greenlane, Auckland, 1051, New Zealand

Location

Auckland Opioid Treatment Service (AOTS)

Point Chevalier, Auckland, 1025, New Zealand

Location

Hepatitis C Community Clinic

Sydenham, Christchurch, 8011, New Zealand

Location

Calder Centre Auckland

Auckland, 1010, New Zealand

Location

Auckland Central liver Clinic

Auckland, 1023, New Zealand

Location

Community Alcohol and Drug Services

Auckland, 1023, New Zealand

Location

Related Publications (2)

• Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Outcomes of Treatment for Hepatitis C in Primary Care, Compared to Hospital-based Care: A Randomized, Controlled Trial in People Who Inject Drugs. Clin Infect Dis. 2020 Apr 15;70(9):1900-1906. doi: 10.1093/cid/ciz546.

  PMID: 31233117 DERIVED

• Wade AJ, Doyle JS, Gane E, Stedman C, Draper B, Iser D, Roberts SK, Kemp W, Petrie D, Scott N, Higgs P, Agius PA, Roney J, Stothers L, Thompson AJ, Hellard ME. Community-based provision of direct-acting antiviral therapy for hepatitis C: study protocol and challenges of a randomized controlled trial. Trials. 2018 Jul 16;19(1):383. doi: 10.1186/s13063-018-2768-3.

  PMID: 30012192 DERIVED

MeSH Terms

Conditions

Hepatitis C

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2015
• First Posted: September 21, 2015
• Study Start: March 1, 2016
• Primary Completion: December 22, 2017
• Study Completion: May 22, 2018
• Last Updated: May 24, 2018

Record last verified: 2017-07

Locations

NZ (6); AU (2)