Effect of Integrated Treatment of Hepatitis C Virus Infection On Treatment Initiation and Sustained Virologic Response Among People Who Inject Drugs: A Multi-Center Randomized Controlled Trial (Intro-HCV)

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

Theme: Clinical Research Year: 2022

The standard pathways of testing and treatment for hepatitis C virus (HCV) infection in tertiary health
care are not easily accessed by people who inject drugs (PWID). The aim of this study was to evaluate
the efficacy of integrated treatment of chronic HCV infection among PWID.

INTRO-HCV is a multi-center, randomized controlled clinical trial. Participants recruited from opioid
agonist therapy and community care clinics in Norway over 2017-2019 were randomly assigned to
the two treatment approaches (non-blinded). Integrated treatment was delivered by
multidisciplinary teams at opioid agonist treatment clinics or community care centers for people with
substance use disorders. This included on-site testing for HCV, liver fibrosis assessment, counselling,
treatment, and post-treatment follow-up. Standard treatment was delivered in hospital outpatient
clinics. Oral direct-acting antiviral medications were administered in both arms. The primary
outcomes were time-to-treatment initiation and sustained virologic response (SVR), defined as
undetectable HCV RNA 12 weeks after treatment completion.

Among 298 included participants, 150 were randomized to standard treatment, of which 116/150
(77%) initiated treatment, with 108/150 (72%) initiating within one year of referral. Among those 148
randomized to integrated care, 145/148 (98%) initiated treatment, with 141/148 (95%) initiating
within one year of referral. The hazard ratio for the time to initiating treatment in the integrated arm
was 2.2 (1.7-2.9) compared to standard treatment. SVR was confirmed in 123 (93% of among those
tested) for integrated treatment compared to 84 (73% of those tested) for the standard treatment
(odds ratio 5.0 (2.3-11). No severe adverse events were linked to the treatment.

Integrated treatment for HCV in PWID was superior to standard treatment in terms of time-totreatment initiation and subsequently more people achieved SVR. Among those who initiated
treatment, the SVR rates were comparable. Scaling-up of integrated treatment models could be an
important tool for elimination of HCV.

Disclosure of Interest Statement:
Nothing to disclose.

Download abstract