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Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials

BACKGROUND: We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infecte...

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Autores principales: Grebely, Jason, Puoti, Massimo, Wedemeyer, Heiner, Cooper, Curtis, Sulkowski, Mark S, Foster, Graham R, Berg, Thomas, Villa, Erica, Rodriguez-Perez, Federico, Wyles, David L, Schnell, Gretja, Alami, Negar N, Zhang, Zhenzhen, Dumas, Emily, Dore, Gregory J
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Oxford University Press 2018
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6222025/
https://www.ncbi.nlm.nih.gov/pubmed/30430131
http://dx.doi.org/10.1093/ofid/ofy248
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author Grebely, Jason
Puoti, Massimo
Wedemeyer, Heiner
Cooper, Curtis
Sulkowski, Mark S
Foster, Graham R
Berg, Thomas
Villa, Erica
Rodriguez-Perez, Federico
Wyles, David L
Schnell, Gretja
Alami, Negar N
Zhang, Zhenzhen
Dumas, Emily
Dore, Gregory J
author_facet Grebely, Jason
Puoti, Massimo
Wedemeyer, Heiner
Cooper, Curtis
Sulkowski, Mark S
Foster, Graham R
Berg, Thomas
Villa, Erica
Rodriguez-Perez, Federico
Wyles, David L
Schnell, Gretja
Alami, Negar N
Zhang, Zhenzhen
Dumas, Emily
Dore, Gregory J
author_sort Grebely, Jason
collection PubMed
description BACKGROUND: We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. METHODS: Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. RESULTS: Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. CONCLUSIONS: Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST.
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spelling pubmed-62220252018-11-14 Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials Grebely, Jason Puoti, Massimo Wedemeyer, Heiner Cooper, Curtis Sulkowski, Mark S Foster, Graham R Berg, Thomas Villa, Erica Rodriguez-Perez, Federico Wyles, David L Schnell, Gretja Alami, Negar N Zhang, Zhenzhen Dumas, Emily Dore, Gregory J Open Forum Infect Dis Major Articles BACKGROUND: We evaluated the impact of opioid substitution therapy (OST) on the completion, adherence, efficacy, and safety of the 3-direct-acting antiviral regimen of ombitasvir, paritaprevir (identified by AbbVie and Enanta) co-dosed with ritonavir, and dasabuvir ± ribavirin among patients infected with hepatitis C virus (HCV) genotype (GT) 1, with or without compensated cirrhosis. METHODS: Data were pooled from GT1-infected patients enrolled in 12 phase II/III/IIIb clinical trials and categorized by use of OST. Patients with ongoing drug use were excluded. HCV treatment completion, treatment adherence (≥90%), sustained virologic response at post-treatment week 12 (SVR12), and adverse events were assessed. RESULTS: Of 4747 patients, 3% (n = 149) received OST. Among patients receiving OST vs those not receiving OST, 82% (n = 122) vs 52% (n = 2409) had GT1a infection; 76% (n = 113) vs 61% (n = 2792) were treatment naïve; and 17% (n = 25) vs 18% (n = 830) had cirrhosis, respectively. The proportion of patients completing HCV treatment did not differ between those receiving and not receiving OST (97% [n = 144] vs 98% [n = 4510], respectively), whereas adherence to treatment was reduced in patients receiving vs those not receiving OST (88% [n = 105] vs 97% [n = 4057], respectively). SVR12 was similar between patients receiving and not receiving OST (94% [n = 140] vs 96% [n = 4405], respectively; P = .273). Treatment was well tolerated. CONCLUSIONS: Although treatment adherence was lower in patients receiving OST vs those not receiving OST, treatment completion and SVR12 were similar between groups. These data support the use of direct-acting antiviral therapies in patients receiving OST. Oxford University Press 2018-09-27 /pmc/articles/PMC6222025/ /pubmed/30430131 http://dx.doi.org/10.1093/ofid/ofy248 Text en © The Author(s) 2018. Published by Oxford University Press on behalf of Infectious Diseases Society of America. http://creativecommons.org/licenses/by/4.0/ This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted reuse, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Major Articles
Grebely, Jason
Puoti, Massimo
Wedemeyer, Heiner
Cooper, Curtis
Sulkowski, Mark S
Foster, Graham R
Berg, Thomas
Villa, Erica
Rodriguez-Perez, Federico
Wyles, David L
Schnell, Gretja
Alami, Negar N
Zhang, Zhenzhen
Dumas, Emily
Dore, Gregory J
Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title_full Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title_fullStr Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title_full_unstemmed Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title_short Efficacy and Safety of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in Patients With Chronic Hepatitis C Virus Genotype 1 Infection Receiving Opioid Substitution Therapy: A Post Hoc Analysis of 12 Clinical Trials
title_sort efficacy and safety of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in patients with chronic hepatitis c virus genotype 1 infection receiving opioid substitution therapy: a post hoc analysis of 12 clinical trials
topic Major Articles
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6222025/
https://www.ncbi.nlm.nih.gov/pubmed/30430131
http://dx.doi.org/10.1093/ofid/ofy248
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