Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV).

Autor: Fadnes LT; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Norway., Aas CF; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Norway., Vold JH; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Norway., Leiva RA; Department of Medicine, Haukeland University Hospital, Norway., Ohldieck C; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway., Chalabianloo F; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Norway., Skurtveit S; Norwegian Centre for Addiction Research, University of Oslo, Norway.; Department of Mental Disorders, Norwegian Institute of Public Health, Oslo, Norway., Lygren OJ; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; ProLAR Nett, Norway., Dalgård O; Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway.; Institute for Clinical Medicine, University of Oslo, Norway., Vickerman P; Population Health Sciences, Bristol Medical School, University of Bristol, United Kingdom., Midgard H; Department of Infectious Diseases, Akershus University Hospital, Lørenskog, Norway.; Department of Gastroenterology, Oslo University Hospital, Norway., Løberg EM; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Clinical Psychology, University of Bergen, Norway.; Division of Psychiatry, Haukeland University Hospital, Norway., Johansson KA; Bergen Addiction Research, Department of Addiction Medicine, Haukeland University Hospital, Norway.; Department of Global Public Health and Primary Care, University of Bergen, Norway.
Jazyk: angličtina
Zdroj: PLoS medicine [PLoS Med] 2021 Jun 01; Vol. 18 (6), pp. e1003653. Date of Electronic Publication: 2021 Jun 01 (Print Publication: 2021).
DOI: 10.1371/journal.pmed.1003653
Abstrakt: Background: The standard pathways of testing and treatment for hepatitis C virus (HCV) infection in tertiary healthcare 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.
Methods and Findings: INTRO-HCV is a multicenter, randomized controlled clinical trial. Participants recruited from opioid agonist therapy (OAT) and community care clinics in Norway over 2017 to 2019 were randomly 1:1 assigned to the 2 treatment approaches. Integrated treatment was delivered by multidisciplinary teams at opioid agonist treatment clinics or community care centers (CCCs) for people with substance use disorders. This included on-site testing for HCV, liver fibrosis assessment, counseling, treatment, and posttreatment follow-up. Standard treatment was delivered in hospital outpatient clinics. Oral direct-acting antiviral (DAA) medications were administered in both arms. The study was not completely blinded. The primary outcomes were time-to-treatment initiation and sustained virologic response (SVR), defined as undetectable HCV RNA 12 weeks after treatment completion, analyzed with intention to treat, and presented as hazard ratio (HR) and odds ratio (OR) with 95% confidence intervals. Among 298 included participants, 150 were randomized to standard treatment, of which 116/150 (77%) initiated treatment, with 108/150 (72%) initiating within 1 year of referral. Among those 148 randomized to integrated care, 145/148 (98%) initiated treatment, with 141/148 (95%) initiating within 1 year of referral. The HR for the time to initiating treatment in the integrated arm was 2.2 (1.7 to 2.9) compared to standard treatment. SVR was confirmed in 123 (85% of initiated/83% of all) for integrated treatment compared to 96 (83% of initiated/64% of all) for the standard treatment (OR among treated: 1.5 [0.8 to 2.9], among all: 2.8 [1.6 to 4.8]). No severe adverse events were linked to the treatment.
Conclusions: Integrated treatment for HCV in PWID was superior to standard treatment in terms of time-to-treatment 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.
Trial Registration: ClinicalTrials.gov.no NCT03155906.
Competing Interests: The authors LTF, CFA, JHV, SS, CO, FC, EML, KAJ, have declared that no competing interests exist. We have read the journal’s policy and these authors of this manuscript have the following competing interests: AL has received lecture and advisory fees from Gilead, GSK and MSD. OJL has received project grants from AbbVie, Gilead 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.
Databáze: MEDLINE
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