Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV).
<h4>Background</h4>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 am...
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doaj-9bb6e6612a1840878acf19b5da6099cb2021-07-02T04:32:28ZengPublic Library of Science (PLoS)PLoS Medicine1549-12771549-16762021-06-01186e100365310.1371/journal.pmed.1003653Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV).Lars T FadnesChrister Frode AasJørn Henrik VoldRafael Alexander LeivaChristian OhldieckFatemeh ChalabianlooSvetlana SkurtveitOle Jørgen LygrenOlav DalgårdPeter VickermanHåvard MidgardElse-Marie LøbergKjell Arne JohanssonINTRO-HCV Study Group<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov.no NCT03155906.https://doi.org/10.1371/journal.pmed.1003653 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
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 Kjell Arne Johansson INTRO-HCV Study Group |
spellingShingle |
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 Kjell Arne Johansson INTRO-HCV Study Group Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). PLoS Medicine |
author_facet |
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 Kjell Arne Johansson INTRO-HCV Study Group |
author_sort |
Lars T Fadnes |
title |
Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). |
title_short |
Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). |
title_full |
Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). |
title_fullStr |
Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). |
title_full_unstemmed |
Integrated treatment of hepatitis C virus infection among people who inject drugs: A multicenter randomized controlled trial (INTRO-HCV). |
title_sort |
integrated treatment of hepatitis c virus infection among people who inject drugs: a multicenter randomized controlled trial (intro-hcv). |
publisher |
Public Library of Science (PLoS) |
series |
PLoS Medicine |
issn |
1549-1277 1549-1676 |
publishDate |
2021-06-01 |
description |
<h4>Background</h4>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.<h4>Methods and findings</h4>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.<h4>Conclusions</h4>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.<h4>Trial registration</h4>ClinicalTrials.gov.no NCT03155906. |
url |
https://doi.org/10.1371/journal.pmed.1003653 |
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