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Title: Efficacy of response-guided directly observed pegylated interferon and self-administered ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: The ACTIVATE study
Authors: Grebely, Jason
Dalgard, Olav
Cunningham, Evan B.
Hajarizadeh, Behzad
Foster, Graham R.
Bruggmann, Philip
Conway, Brian
Backmund, Markus
Swan, Tracy
Amin, Janaki
Marks, Philippa S.
Quiene, Sophie
Applegate, Tanya L.
Weltman, Martin
Shaw, David
Dunlop, Adrian
Hellard, Margaret
Bruneau, Julie
Midgard, Havard
Bourgeois, Stefan
Staehelin, Cornelia
Dore, Gregory J.
Issue Date: 2017
Abstract: Background: There are few data on treatment for hepatitis C virus (HCV) infection among people with ongoing injecting drug use. This study evaluated the efficacy of response-guided therapy for chronic HCV genotypes 2/3 infection among people with ongoing injecting drug use or receiving opioid substitution therapy (OST). A secondary aim was to identify predictors of HCV treatment response. Methods: ACTIVATE was a multicentre clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b and self-administered ribavirin for 12 (undetectable HO/ RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Participants were recruited from drug treatment clinics, private practices, hospital clinics and community clinics in Australia, Canada, and five countries in Europe. The primary study outcome was sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment). Results: Among 93 people with ongoing injecting drug use or receiving OST treated for HCV genotype 2/3, 59% had recently (past month) injected drugs, 77% were receiving OST and 56% injected drugs during therapy. Overall SVR was 66% (61/93). SVR was 84% in those with undetectable HCV RNA at week 4 (12 weeks) compared to 38% in those without (24 weeks). In adjusted analysis, cirrhosis vs. no/mild fibrosis [adjusted OR (aOR) 0.33, 95% CI 0.13, 0.86] predicted reduced SVR, while response at week 4 was associated with increased SVR [aOR 8.11, 95% CI 2.73, 24.10]. Recent injecting drug use at baseline or during therapy was not associated with SVR. Conclusion: This study demonstrates that people with recent injecting drug use or OST with chronic HCV can achieve responses to interferon-based therapy similar to other populations, despite injecting drugs prior to or during therapy. Cirrhosis was predictive of reduced response to HCV therapy, while response at week 4 (despite shortened therapy) was predictive of improved response. (C) 2017 Elsevier B.V. All rights reserved.
Notes: [Grebely, Jason; Cunningham, Evan B.; Hajarizadeh, Behzad; Amin, Janaki; Marks, Philippa S.; Quiene, Sophie; Applegate, Tanya L.; Dore, Gregory J.] UNSW Sydney, Kirby Inst, Wallace Wurth Bldg, Sydney, NSW 2052, Australia. [Dalgard, Olav] Akershus Univ Hosp, Oslo, Norway. [Foster, Graham R.] Queen Mary Univ London, Liver Unit, London, England. [Bruggmann, Philip] Arud Ctr Addict Med, Zurich, Switzerland. [Conway, Brian] Vancouver Infect Dis Ctr, Vancouver, BC, Canada. [Backmund, Markus] Ludwig Maximilian Univ Munich, Munich, Germany. [Robaeys, Geert] Ziekenhuis Oost Limburg, Dept Gastroenterol & Hepatol, Genk, Belgium. [Robaeys, Geert] UZ Leuven, Dept Hepatol, Leuven, Belgium. [Robaeys, Geert] Hasselt Univ, Fac Med & Life Sci, Hasselt, Belgium. [Swan, Tracy] Int Network Hepatitis Subst Users, New York, NY USA. [Weltman, Martin] Nepean Hosp, Sydney, NSW, Australia. [Shaw, David] Royal Adelaide Hosp, Adelaide, SA, Australia. [Dunlop, Adrian] Univ Newcastle, Sch Med & Publ Hlth, Newcastle, NSW, Australia. [Hellard, Margaret] Burnet Inst, Melbourne, Vic, Australia. [Bruneau, Julie] CHU Montreal CRCHUM, Res Ctr, Montreal, PQ, Canada. [Bourgeois, Stefan] Stuivenberg ZNA, Antwerp, Belgium. [Staehelin, Cornelia] Univ Bern, Univ Hosp Bern, Dept Infect Dis, Bern, Switzerland. [Dalgard, Olav] Univ Oslo, Oslo, Norway. [Amin, Janaki] Macquarie Univ, Fac Med & Hlth Sci, Sydney, NSW, Australia. [Midgard, Havard] Akershus Univ Hosp, Dept Infect Dis, Lorenskog, Norway. [Midgard, Havard] Univ Oslo, Inst Clin Med, Oslo, Norway. [Midgard, Havard] Oslo Univ Hosp, Dept Gastroenterol, Oslo, Norway.
Keywords: Hepatitis C; HCV treatment; PWID; Drug use;Hepatitis C; HCV treatment; PWID; Drug use
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ISSN: 0955-3959
e-ISSN: 1873-4758
DOI: 10.1016/j.drugpo.2017.05.020
ISI #: 000412613000022
Category: A1
Type: Journal Contribution
Validations: ecoom 2018
Appears in Collections:Research publications

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