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

Lars T Fadnes, Christer Frode Aas, Jørn Henrik Vold, Christian Ohldieck, Rafael Alexander Leiva, Fatemeh Chalabianloo, Svetlana Skurtveit, Ole Jørgen Lygren, Olav Dalgård, Peter Vickerman, Håvard Midgard, Else-Marie Løberg, Kjell Arne Johansson, INTRO-HCV Study Group, Christer Frode Aas, Vibeke Bråthen Buljovcic, Fatemeh Chalabianloo, Jan Tore Daltveit, Silvia Eiken Alpers, Lars T Fadnes, Trude Fondenes Eriksen, Per Gundersen, Velinda Hille, Kristin Holmelid Håberg, Kjell Arne Johansson, Rafael Alexander Leiva, Siv-Elin Leirvåg Carlsen, Martine Lepsøy Bonnier, Lennart Lorås, Else-Marie Løberg, Mette Hegland Nordbotn, Cathrine Nygård, Maria Olsvold, Christian Ohldieck, Lillian Sivertsen, Hugo Torjussen, Jørn-Henrik Vold, Jan-Magnus Økland, Tone Lise Eielsen, Nancy Laura Ortega Maldonado, Ewa Joanna Wilk, Ronny Bjørnestad, Ole Jørgen Lygren, Marianne Cook Pierron, Olav Dalgard, Håvard Midgard, Svetlana Skurtveit, Peter Vickerman, Lars T Fadnes, Christer Frode Aas, Jørn Henrik Vold, Christian Ohldieck, Rafael Alexander Leiva, Fatemeh Chalabianloo, Svetlana Skurtveit, Ole Jørgen Lygren, Olav Dalgård, Peter Vickerman, Håvard Midgard, Else-Marie Løberg, Kjell Arne Johansson, INTRO-HCV Study Group, Christer Frode Aas, Vibeke Bråthen Buljovcic, Fatemeh Chalabianloo, Jan Tore Daltveit, Silvia Eiken Alpers, Lars T Fadnes, Trude Fondenes Eriksen, Per Gundersen, Velinda Hille, Kristin Holmelid Håberg, Kjell Arne Johansson, Rafael Alexander Leiva, Siv-Elin Leirvåg Carlsen, Martine Lepsøy Bonnier, Lennart Lorås, Else-Marie Løberg, Mette Hegland Nordbotn, Cathrine Nygård, Maria Olsvold, Christian Ohldieck, Lillian Sivertsen, Hugo Torjussen, Jørn-Henrik Vold, Jan-Magnus Økland, Tone Lise Eielsen, Nancy Laura Ortega Maldonado, Ewa Joanna Wilk, Ronny Bjørnestad, Ole Jørgen Lygren, Marianne Cook Pierron, Olav Dalgard, Håvard Midgard, Svetlana Skurtveit, Peter Vickerman

Abstract

Background: A 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.

Methods: INTRO-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.

Discussion: This 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 registration: ClinicalTrials.gov.no. NCT03155906.

Keywords: Chronic hepatitis C; Integrated health care; Opiate substitution treatment; Substance abuse treatment centres.

Conflict of interest statement

The authors LTF, CFA, JHV, SS, CO, FC, EML, KAJ, have no competing interests. AL has received lecture and advisory fees from Gilead, GSK and MSD. OD has received research grants from and been in advisory board for MSD, Abbvie and Gilead. PV has received an unrestricted research grant off Gilead. HM has received lecture and advisory fees from Gilead, Abbvie and MSD.

Figures

Fig. 1
Fig. 1
Overview of follow-up for the study * The arrows are indications of when the various measured are timed

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Source: PubMed

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