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Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study

BACKGROUND: The aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection. METHODS: ACTIVATE was a multicenter...

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Autores principales: Cunningham, Evan B., Hajarizadeh, Behzad, Dalgard, Olav, Amin, Janaki, Hellard, Margaret, Foster, Graham R, Bruggmann, Philip, Conway, Brian, Backmund, Markus, Robaeys, Geert, Swan, Tracy, Marks, Philippa S., Quiene, Sophie, Applegate, Tanya L, Weltman, Martin, Shaw, David, Dunlop, Adrian, Bruneau, Julie, Midgard, Håvard, Bourgeois, Stefan, Thurnheer, Maria Christine, Dore, Gregory J, Grebely, Jason
Formato: Online Artículo Texto
Lenguaje:English
Publicado: BioMed Central 2017
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5470219/
https://www.ncbi.nlm.nih.gov/pubmed/28610605
http://dx.doi.org/10.1186/s12879-017-2517-3
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author Cunningham, Evan B.
Hajarizadeh, Behzad
Dalgard, Olav
Amin, Janaki
Hellard, Margaret
Foster, Graham R
Bruggmann, Philip
Conway, Brian
Backmund, Markus
Robaeys, Geert
Swan, Tracy
Marks, Philippa S.
Quiene, Sophie
Applegate, Tanya L
Weltman, Martin
Shaw, David
Dunlop, Adrian
Bruneau, Julie
Midgard, Håvard
Bourgeois, Stefan
Thurnheer, Maria Christine
Dore, Gregory J
Grebely, Jason
author_facet Cunningham, Evan B.
Hajarizadeh, Behzad
Dalgard, Olav
Amin, Janaki
Hellard, Margaret
Foster, Graham R
Bruggmann, Philip
Conway, Brian
Backmund, Markus
Robaeys, Geert
Swan, Tracy
Marks, Philippa S.
Quiene, Sophie
Applegate, Tanya L
Weltman, Martin
Shaw, David
Dunlop, Adrian
Bruneau, Julie
Midgard, Håvard
Bourgeois, Stefan
Thurnheer, Maria Christine
Dore, Gregory J
Grebely, Jason
author_sort Cunningham, Evan B.
collection PubMed
description BACKGROUND: The aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection. METHODS: ACTIVATE was a multicenter clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b (PEG-IFN) and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Outcomes included treatment completion, PEG-IFN adherence, ribavirin adherence, and sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment). RESULTS: Among 93 people treated, 59% had recently injected drugs (past month), 77% were receiving OST and 56% injected drugs during therapy. Overall, 76% completed treatment. Mean on-treatment adherence to PEG-IFN and ribavirin were 98.2% and 94.6%. Overall, 6% of participants missed >1 dose of PEG-IFN and 31% took <95% of their prescribed ribavirin., Higher treatment completion was observed among those receiving 12 vs. 24 weeks of treatment (97% vs. 46%, P < 0.001) while the proportion of participants with 95% on-treatment ribavirin adherence was similar between groups (67% vs. 72%, P = 0.664). Receiving 12 weeks of therapy was independently associated with treatment completion. No factors were associated with 95% RBV adherence. Neither recent injecting drug use at baseline nor during therapy was associated with treatment completion or adherence to ribavirin. In adjusted analysis, treatment completion was associated with SVR (aOR 23.9, 95% CI 2.9–193.8). CONCLUSIONS: This study demonstrated a high adherence to directly observed PEG-IFN and self-administered ribavirin among people with ongoing injecting drug use or receiving OST. These data also suggest that shortening therapy from 24 to 12 weeks can lead to improved treatment completion. Treatment completion was associated with improved response to therapy. ACTIVATE trial registration number: NCT01364090 - May 31, 2011 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12879-017-2517-3) contains supplementary material, which is available to authorized users.
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spelling pubmed-54702192017-06-19 Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study Cunningham, Evan B. Hajarizadeh, Behzad Dalgard, Olav Amin, Janaki Hellard, Margaret Foster, Graham R Bruggmann, Philip Conway, Brian Backmund, Markus Robaeys, Geert Swan, Tracy Marks, Philippa S. Quiene, Sophie Applegate, Tanya L Weltman, Martin Shaw, David Dunlop, Adrian Bruneau, Julie Midgard, Håvard Bourgeois, Stefan Thurnheer, Maria Christine Dore, Gregory J Grebely, Jason BMC Infect Dis Research Article BACKGROUND: The aims of this analysis were to investigate treatment completion and adherence among people with ongoing injecting drug use or receiving opioid substitution therapy (OST) in a study of response-guided therapy for chronic HCV genotypes 2/3 infection. METHODS: ACTIVATE was a multicenter clinical trial recruited between 2012 and 2014. Participants with genotypes 2/3 were treated with directly observed peg-interferon alfa-2b (PEG-IFN) and self-administered ribavirin for 12 (undetectable HCV RNA at week 4) or 24 weeks (detectable HCV RNA at week 4). Outcomes included treatment completion, PEG-IFN adherence, ribavirin adherence, and sustained virological response (SVR, undetectable HCV RNA >12 weeks post-treatment). RESULTS: Among 93 people treated, 59% had recently injected drugs (past month), 77% were receiving OST and 56% injected drugs during therapy. Overall, 76% completed treatment. Mean on-treatment adherence to PEG-IFN and ribavirin were 98.2% and 94.6%. Overall, 6% of participants missed >1 dose of PEG-IFN and 31% took <95% of their prescribed ribavirin., Higher treatment completion was observed among those receiving 12 vs. 24 weeks of treatment (97% vs. 46%, P < 0.001) while the proportion of participants with 95% on-treatment ribavirin adherence was similar between groups (67% vs. 72%, P = 0.664). Receiving 12 weeks of therapy was independently associated with treatment completion. No factors were associated with 95% RBV adherence. Neither recent injecting drug use at baseline nor during therapy was associated with treatment completion or adherence to ribavirin. In adjusted analysis, treatment completion was associated with SVR (aOR 23.9, 95% CI 2.9–193.8). CONCLUSIONS: This study demonstrated a high adherence to directly observed PEG-IFN and self-administered ribavirin among people with ongoing injecting drug use or receiving OST. These data also suggest that shortening therapy from 24 to 12 weeks can lead to improved treatment completion. Treatment completion was associated with improved response to therapy. ACTIVATE trial registration number: NCT01364090 - May 31, 2011 ELECTRONIC SUPPLEMENTARY MATERIAL: The online version of this article (doi:10.1186/s12879-017-2517-3) contains supplementary material, which is available to authorized users. BioMed Central 2017-06-13 /pmc/articles/PMC5470219/ /pubmed/28610605 http://dx.doi.org/10.1186/s12879-017-2517-3 Text en © The Author(s). 2017 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
spellingShingle Research Article
Cunningham, Evan B.
Hajarizadeh, Behzad
Dalgard, Olav
Amin, Janaki
Hellard, Margaret
Foster, Graham R
Bruggmann, Philip
Conway, Brian
Backmund, Markus
Robaeys, Geert
Swan, Tracy
Marks, Philippa S.
Quiene, Sophie
Applegate, Tanya L
Weltman, Martin
Shaw, David
Dunlop, Adrian
Bruneau, Julie
Midgard, Håvard
Bourgeois, Stefan
Thurnheer, Maria Christine
Dore, Gregory J
Grebely, Jason
Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title_full Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title_fullStr Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title_full_unstemmed Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title_short Adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis C virus genotype 2/3 infection: the ACTIVATE study
title_sort adherence to response-guided pegylated interferon and ribavirin for people who inject drugs with hepatitis c virus genotype 2/3 infection: the activate study
topic Research Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5470219/
https://www.ncbi.nlm.nih.gov/pubmed/28610605
http://dx.doi.org/10.1186/s12879-017-2517-3
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