Evaluating the Chain of Addiction Care (CAC) (HepC:CAC)

Evaluating the Hepatitis C Chain of Addiction Care Pathway for People Who Inject(ed) Drugs in Addiction Care

The investigators want to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. Secondary objective: to measure the impact of hepatitis C clearance on MET (+metabolite) and BUP (+metabolite) trough levels in patients on Opioid substitution Therapy (OST). This is an exploratory, observational study.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C, Chronic; Substance Use Disorders

Detailed Description

People who (have) inject(ed) drugs (PWID) are at high risk for hepatitis C infection. Establishing adequate linkage to care in this population can be a challenge. Many of these patients receive opioid substitution, hepatitis C treatment possibly influences pharmacokinetics of those substitutes. This protocol describes a study on hepatitis C in people who (have) inject(ed) drugs (PWID), consisting of two substudies. 1) An exploratory, observational study in which we evaluate the decentralised hepatitis C care pathway in addiction care centres. 2) An observational pharmacokinetic study in hepatitis C patients on opioid substitution therapy (OST) embedded within the first study.

Rationale: 1) Many PWIDs are lost during the process of testing and linkage to care and do therefore not receive adequate hepatitis C treatment. Decentralising care in addiction care centres deems hospital visits unnecessary, an approach that has become increasingly popular in this population over the last few years. This practice however has not yet been evaluated in the Netherlands. 2) In the Netherlands the PWID population is often treated for opioid addiction by opioid substitution therapy (OST) with methadone (MET) or buprenorphine (BUP). There is evidence that liver inflammation has a negative effect on pharmacokinetics of drugs. Consequently, we hypothesize that HCV treatment results in reduced liver inflammation and a decrease in MET and/or BUP levels, which is clinically relevant in the PWID/OST population.

Objective: 1) to evaluate the feasibility of a decentralised hepatitis C care pathway (the Chain of Addiction Care (CAC) pathway) in several addiction care centres in the east of the Netherlands. 2. to measure the impact of hepatitis C clearance on MET (+metabolites) and BUP (+metabolites) levels and craving in patients on OST.

Study design: This is an exploratory, observational study with a pharmacokinetic observational study embedded within the same population.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Daan Von den Hoff, M.D.; Phone Number: +31625678779; Email: daan.vondenhoff@radboudumc.nl

Study Locations

• Netherlands
  • Gelderland
    • Nijmegen, Gelderland, Netherlands, 6525GA
      • Recruiting
      • Radboudumc
      • Contact: Daan Von Den Hoff, MD; Phone Number: +31625678779; Email: daan.vondenhoff@radboudumc.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

PWID of 18 years or older who visit the participating addiction care centre

Description

Inclusion Criteria:

• Aged 18 years or older
• Able and willing to give informed consent
• Currently inject or previously injected drugs at least once, including nasal snorting of drugs using aids such as basepipes or straws.
• Visit the participating addiction care centre at least once during the study period

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Participants; Consecutive people who use drugs and visit the addiction care centre

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HCV prevalence (both anti-HCV and HCV RNA).	Participants are invited to undergo viral hepatitis screening (standard care)	At screening (week 0)
Treatment acceptance rate.	Participants with chronic HCV infection are invited to be treated (standard care)	After evaluation (~week 3)
Sustained virologic response	Participants who were treated and were 'cured' (standard care)	12 weeks after treatment (~week 30)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptance rate of on-site testing.	Number of participants that engage in testing	through study completion, an average of 1 year
Re-infection rate.	Patients re-infected after successful treatment	through study completion, an average of 1 year
Mean decrease in MET and BUP trough levels	Difference in concentration of methadone or buprenorphine before and after treatment.	through study completion, an average of 1 year
Change in dosage of MET and BUP during follow-up	Physician initiated dosage change before compared to after treatment of hepatitis C	through study completion, an average of 1 year
Patient reported drug use	Drug use during study timeframe	through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Radboud University Medical Center
• Collaborators: AbbVie; Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 31, 2022
• First Posted (Actual): June 2, 2022

Study Record Updates

• Last Update Posted (Actual): June 2, 2022
• Last Update Submitted That Met QC Criteria: May 31, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis, Chronic; Substance-Related Disorders; Hepatitis; Hepatitis C; Hepatitis C, Chronic
• Other Study ID Numbers: 2019-5939

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No