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Accelerated Pre-treatment Evaluation for HCV Infected Persons Who Inject Drugs

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ClinicalTrials.gov Identifier: NCT02755402
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : January 25, 2018
Gilead Sciences
Information provided by (Responsible Party):
Valérie Martel-Laferrière, Centre hospitalier de l'Université de Montréal (CHUM)

Brief Summary:

Persons who inject drugs (PWID) are overrepresented among hepatitis C infected patients, but underrepresented among those who are treated, despite many studies showing that treatment is feasible and effective in this population.

The hepatitis C diagnosis and pre-treatment evaluation are multistep processes. Every step is a potential occasion for disengagement and loss to follow-up. This is especially true with hard-to-reach populations such as PWID in whom competing needs are numerous and psychosocial situation can change rapidly.

By using new technologies that can quickly provide clinical results, like Xpert HCV Viral Load (Cepheid) and transient elastography (fibroscan), a provider could determine if a patient needs treatment rapidly or not on the day of the initial visit.

The aim of this study is to explore whether an accelerated pre-treatment evaluation can result in an improved linkage-to-care (defined as linkage to health care, addiction or social services) and, eventually, linkage-to-treatment among PWID.

Condition or disease Intervention/treatment
Hepatitis C Intravenous Drug Users Device: Xpert HCV Viral load Device: Transient elastography

Detailed Description:

This is a non-randomized, open-label study that aims to include HCV-infected patients who inject drugs and who do not know their treatment eligibility status. A total of 200 patients will be evaluated using our rapid evaluation protocol, which will include basic blood tests, viral load measurement using Cepheid's Xpert® HCV Viral Load technique (which will be controlled at the same time by COBAS® AmpliPrep/ COBAS® TaqMan® HCV Quantitative Test, version 2.0 (Roche), available at the CHUM and approved by Health Canada), a liver fibrosis assessment and HCV genotyping. The results of the basic tests, viral load tests and FibroScan® test will be available on the same day as the patient's visit and will allow the investigator to determine straightaway whether or not the patient is treatable based on the RAMQ's reimbursement criteria at the time of the study.

If the patient is treatable, once the genotype result has been obtained, the most appropriate treatment for their medical condition, degree of liver fibrosis and genotype will be prescribed. There will be no other visits between the initial visit and the treatment initiation visit. The patient will be given an appointment for the treatment initiation visit once the medication has been approved by the RAMQ or the patient's private insurer. The patient will be seen again at weeks 2 and 4 of treatment, at the end of treatment (usually week 12), then 12, 24 and 36 weeks post-treatment.

If the patient is not treatable, he/she will be referred to the CHUM Addiction Medicine Clinic or the UHRESS (if HIV-coinfected status) for management, which will include longitudinal follow-up of his HCV and substance abuse. The patient will be seen again at 6 months and 1 year to determine whether or not there has been linkage-to-care, initiation of opioid substitution therapy if indicated and if the patient has reduced his injection drug use.

At the same time, we will review the records of patients seen at the CHUM Addiction Medicine Clinic between October 2014 and June 2016 who meet the inclusion criteria for the study cohort and the RAMQ's treatment eligibility criteria. This cohort will be used as an historical cohort to determine the rate of linkage to treatment with the standard pre-treatment evaluation protocol.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Impact of an Accelerated Pre-treatment Evaluation on Linkage-to-care and Linkage-to-treatment for HCV Infected Persons Who Inject Drugs
Actual Study Start Date : January 2017
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hepatitis C
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Rapid evaluation
Transient elastography, Xpert HCV Viral load, medical and nurse visits
Device: Xpert HCV Viral load
HCV viral load testing
Device: Transient elastography
Evaluation of liver fibrosis

Primary Outcome Measures :
  1. Proportion of patients who initiate treatment after first visit [ Time Frame: 1 year ]
    Proportion of patients who initiate treatment among those who are treatment-eligible based on Quebec's treatment reimbursement guidelines following the accelerated intervention and comparison with historical controls

Secondary Outcome Measures :
  1. Proportion of patients who attend at least two visits in one year [ Time Frame: 1 year ]
    To compare linkage-to-care proportion at one year of treated PWID with untreated PWID at one year.

  2. Proportion of patients who initiate opioid substitution therapy during follow-up [ Time Frame: 1 year ]
    To compare opioid substitution therapy initiation rates at one year of treated and untreated PWID.

  3. Difference in number of injection between the month prior to study entry and the last month of follow-up [ Time Frame: 1 year ]
    To compare drug use reduction during the study period of treated PWID with untreated PWID at one year.

  4. Sustained virological response (undetectable HCV viral load 12 weeks post-end-of-treatment [ Time Frame: 12 weeks post-treatment ]
    To compare proportion of treated patients who achieved SVR12 with historical controls treated in phase III trials.

  5. Proportion of patients with a re-infection within six months of end-of-treatment [ Time Frame: 6 months post-treatment ]
    To evaluate rapid re-infection rates (<6 months) of patients who achieve end-of-treatment undetectability.

  6. Difference in HCV viral load results between techniques [ Time Frame: At enrollment ]
    To compare Xpert HCV Viral Load® (Cepheid) viral loads results to HCV RealTime® (Abbott) results.

Information from the National Library of Medicine

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

Inclusion Criteria:

  • Person who inject drugs, defined as having injected in the past year
  • Able to give an informed consent
  • Unknown treatment eligibility status
  • Naïve to HCV treatment.

Exclusion Criteria:

  • Patients actively engaged in HCV follow up
  • Patients visibly intoxicated at initial study visit
  • Pregnant or breastfeeding women
  • Pacemaker.

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): NCT02755402

Contact: Valérie Martel-Laferrière, MD, MSc 514-890-8000 ext 26588 valerie.martel-laferriere.chum@ssss.gouv.qc.ca

Canada, Quebec
Centre hospitalier de l'Université de Montréal Recruiting
Montréal, Quebec, Canada, H2X 3J4
Contact: Claire Casavant, RN    514-890-8000 ext 26588      
Principal Investigator: Valérie Martel-Laferrière, MD, MSc         
Sponsors and Collaborators
Centre hospitalier de l'Université de Montréal (CHUM)
Gilead Sciences
Principal Investigator: Valérie Martel-Laferrière, MD, MSc CRCHUM

Responsible Party: Valérie Martel-Laferrière, Medical microbiologist, Centre hospitalier de l'Université de Montréal (CHUM)
ClinicalTrials.gov Identifier: NCT02755402     History of Changes
Other Study ID Numbers: IN-CA-337-2100
First Posted: April 28, 2016    Key Record Dates
Last Update Posted: January 25, 2018
Last Verified: January 2018

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