Integrated treatment of hepatitis C virus infection among people who inject drugs: study protocol for a randomised controlled trial (INTRO-HCV)

Lars T Fadnes,Peter Vickerman,Fatemeh Chalabianloo,Jørn Henrik Vold,Rafael Alexander Leiva,Christer Frode Aas,Svetlana Skurtveit,Else-Marie Løberg,Håvard Midgard,Olav Dalgård,Kjell Arne Johansson,Ole Jørgen Lygren,Christian Ohldieck

doi:10.1186/s12879-019-4598-7

Abstract

BackgroundA large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. It is unknown whether inclusion of HCV diagnostics and treatment into integrated substance use disorder treatment and care clinics will improve uptake and outcome of HCV treatment in PWID. The aim is to assess the efficacy of integrating HCV treatment to PWID and this paper will present the protocol for an ongoing trial.MethodsINTRO-HCV is a multicentre, randomised controlled clinical trial that will compare the efficacy of integrated treatment of HCV in PWID with the current standard treatment. Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics. Most of these clinics for PWID provide opioid agonist therapy while some clinics provide low-threshold care without opioid agonist therapy. Standard care involves referral to further diagnostics, treatment and treatment follow-up given in a hospital outpatient clinic with equivalent medications. The differences between the delivery platforms in the two trial arms involve use of a drop-in approach rather than specific appointment times, no need for additional travelling, less blood samples taken during treatment, and treatment given from already known clinicians. The trial will recruit approximately 200 HCV infected individuals in Bergen and Stavanger, Norway. The primary outcomes are time to treatment initiation and sustained virologic response, defined as undetectable HCV RNA 12 weeks after end of treatment. Secondary outcomes are cost-effectiveness, treatment adherence, changes in quality of life, fatigue and psychological well-being, changes in drug use, infection related risk behaviour, and risk of reinfection. The target group is PWID with HCV diagnosed receiving treatment and care within clinics for PWID.DiscussionThis study will inform on the effects of an integrated treatment program for HCV in clinics for PWID compared to standard care aiming to increase access to treatment and improving treatment adherence. If the integrated treatment model is found to be safe and efficacious, it can be considered for further scale-up.Trial registrationClinicalTrials.gov.no. NCT03155906.

Highlights

A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated
This paper presents the protocol of the INTRO-HCV study
Integrated treatment includes testing for HCV, assessing liver fibrosis with transient elastography, counselling, treatment delivery, follow-up and evaluation provided by integrated substance use disorder treatment and care clinics

Summary

Introduction

A large proportion of people who inject drugs (PWID) living with hepatitis C virus (HCV) infection have not been treated. Among HCV-infected people with opioid dependence, one-third develops advanced liver disease within three decades [5] and within this group, liver disease and drug overdose becomes common causes of death among individuals over the age of 50 years [6]. Reports from opioid agonist therapy (OAT) clinics in Norway indicate that more than half of patients receiving OAT have chronic HCV infection [7]. This represents an ageing cohort often at high risk of developing advanced liver disease [8]. Reaching these individuals with HCV treatment is of critical importance both to reduce HCV disease burden and HCV transmission

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